Chemical Toxins & Effects of Pharmaceuticals

CHEMICAL TOXINS & EFFECTS OF PHARMACEUTICALS
Omeprazole Side Effects

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OverviewSide EffectsDosageInteractionsFor ProfessionalsMore...

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Some side effects of omeprazole may not be reported. Always consult your doctor or healthcare specialist for medical advice.
You may also report side effects to the FDA.
For the Consumer
Applies to omeprazole: oral capsule delayed release, oral packet, oral powder for suspension, oral tablet delayed release
Along with its needed effects, omeprazole may cause some unwanted effects. Although not all of these side effects may occur, if
they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking omeprazole:
Rare
Back, leg, or stomach pain
bleeding or crusting sores on the lips
blisters
bloody or cloudy urine
chills
continuing ulcers or sores in the mouth
difficult, burning, or painful urination
fever
frequent urge to urinate
general feeling of discomfort or illness
joint pain
loss of appetite
muscle aches or cramps
pain
red or irritated eyes
redness, tenderness, itching, burning, or peeling of the skin
skin rash or itching
sore throat
sores, ulcers, or white spots on the lips, in the mouth, or on the genitals
unusual bleeding or bruising
unusual tiredness or weakness
Incidence not known
Drowsiness
fast, racing, or uneven heartbeat
mood or mental changes
muscle spasms (tetany) or twitching seizures
nausea or vomiting
trembling
Get emergency help immediately if any of the following symptoms of overdose occur while taking omeprazole:
Symptoms of overdose
Blurred vision
confusion
dryness of the mouth
flushing
headache
increased sweating
Some side effects of omeprazole may occur that usually do not need medical attention. These side effects may go away during
treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent
or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are
bothersome or if you have any questions about them:
Less common
Body aches or pain
chest pain
constipation
cough
diarrhea or loose stools
difficulty with breathing
dizziness
ear congestion
gas
heartburn
loss of voice
muscle pain
nasal congestion
runny nose
sneezing
unusual drowsiness
For Healthcare Professionals

Applies to omeprazole: compounding powder, oral delayed release capsule, oral delayed release tablet, oral powder for
reconstitution, oral powder for reconstitution delayed release, oral suspension
General
Omeprazole is generally well tolerated. Any drug which increases gastric pH would be anticipated to stimulate release of gastrin.
Animal studies have demonstrated an increase in plasma gastrin concentrations following the administration of omeprazole. In
addition, long term animal studies have revealed a dose-related increase in the incidence of gastric enterochromaffin-like (ECL)
cell carcinoids. This has given rise to concern regarding the safety of long-term administration of omeprazole in humans.
However, to date, long-term human studies of up to six years duration have not found any suggestion of gastric carcinoid
formation due to omeprazole use.
In humans, plasma gastrin levels rise within days of initial treatment, generally peaking by 2 to 4 months. The usual increase is 2
to 4 fold over baseline, although some patients experience gastrin levels greater than 10 times normal. Hyperplasia of gastric
enterochromaffin-like cells has been observed with long-term use, but no evidence of dysplasia, carcinoid tumors, or other
neoplastic changes have been noted in humans.
Gastrointestinal
Gastric polyposis have been reported in three of eleven patients treated with long-term omeprazole therapy (20 to 40 mg daily).
Hyperplastic and fundic gland polyps developed in the stomach of these patients. Neither dysplasia nor malignancy was present.
The significance of these findings from a small case series is unknown. Controlled studies are needed to fully evaluate this effect.
Ninety-one patients receiving long-term maintenance therapy for gastroesophageal reflux disease were followed for 5 years.
Hyperplasia of gastric enterochromaffin-like cells was noted in 20% of patients and atrophic gastritis in 25%. Effects were more
pronounced in patients with very high serum gastrin levels. The significance of these observed changes is unknown. No evidence
of dysplasia, carcinoid, or other forms of neoplasia were noted.
Gastrointestinal side effects have included diarrhea (3.0% to 3.7%), abdominal pain (2.4%), nausea (2.2% to 4%), vomiting
(1.5% to 3.2%), constipation (1.1%), anorexia, irritable colon, flatulence, dry mouth, esophageal candidiasis, and persistent
achlorhydria in a Zollinger-Ellison patient. Gastric polyps, hyperplasia of gastric enterochromaffin-like cells, and atrophic
gastritis have been reported after long-term therapy. Campylobacter gastroenteritis has been identified in one case-control study.
Rare cases of pancreatitis, some fatal, have been reported during the post marketing period.
Endocrine
Endocrine side effects have included gynecomastia, breast enlargement in females, and breast tenderness.
Hepatic
A 62-year-old man with erosive esophagitis developed signs and symptoms of hepatic disease 17 days after the start of therapy
with omeprazole 20 mg per day. Five days after presentation, the patient died from complications associated with fulminant
hepatic failure. Autopsy findings included massive central zone necrosis and hemorrhage with proliferation of bile ducts.
Hepatic side effects have included elevations in serum transaminases, alkaline phosphatase, bilirubin, and rare cases of hepatitis
and hepatic encephalopathy. Fatal fulminant hepatic failure attributed to omeprazole has also been reported.
Renal
Renal side effects have included elevations in serum creatinine, rare reports of interstitial nephritis, and renal failure.
Hematologic
Hematologic side effects have included rare reports of hemolytic anemia, pancytopenia, thrombocytopenia, neutropenia, anemia,
agranulocytosis and leukocytosis.
The absorption of cyanocobalamin (vitamin B12) has been studied before and after administration of omeprazole 20 mg or 40 mg
per day for 14 days in ten healthy subjects. Omeprazole produced a dose-dependent reduction in protein-bound cyanocobalamin
absorption. Because the effects of long-term omeprazole therapy on cyanocobalamin disposition are unknown, it may be prudent
to monitor cyanocobalamin levels in patients receiving long-term omeprazole therapy.
Respiratory
Respiratory side effects have included cough, and rare reports of epistaxis and pharyngeal pain.
A 42-year-old female with postoperative heartburn experienced chronic, persistent cough coincident with omeprazole therapy.
The cough was permanent, dry, exhausting, and worsened at night. Omeprazole treatment was continued for 4 months because
the persistent cough was thought to be related to gastroesophageal reflux disease. However, no cause of the chronic cough was
identified. After omeprazole was discontinued, the cough resolved.
Nervous system
Nervous system side effects have included headache, dizziness, somnolence, vertigo, hemifacial dysesthesia and numbness,
paresthesias of the extremities, seizures, and a report of reversible gait ataxia.
Cardiovascular
Cardiovascular side effects have been reported rarely. These have included angina, tachycardia, bradycardia, palpitations,
hypertension, and peripheral edema.
Dermatologic
Cutaneous leukocytoclastic vasculitis has been reported to occur in a 71-year-old woman. Three weeks after the start of
omeprazole 20 mg daily for epigastric pain, patient presented with palpable skin rash on both hands and legs and the abdomen,
accompanied with pruritus. Histopathological studies of affected tissue confirmed small vessel vasculitis. Skin lesions completely
resolved within a few days after discontinuation of omeprazole treatment.
An 81-year-old female with severe reflux esophagitis experienced dermatomyositis coincident with omeprazole therapy. She
presented with a progressive pruritic erythematous eruption which began as a vesicular rash on her dorsal hands and then spread
to her face and most of her lower limbs. Three days prior to the onset of skin eruption, she had started omeprazole 40 mg daily.
She was diagnosed with dermatomyositis. Omeprazole was replaced with ranitidine and mometasone furoate ointment twice
daily was administered for the rash. After 1 week, her rash had also settled significantly with less erythema and edema,
particularly over her dorsal hands.
Dermatologic side effects have included rash and rare reports of pruritus, alopecia, dry skin, hyperhidrosis, and cases of
disseminated epidermal necrosis, furunculosis, and exfoliative dermatitis. At least one case of vasculitis has been reported, in
addition to a case of dermatomyositis.
Hypersensitivity
Hypersensitivity side effects have included urticaria and angioedema. One case report of anaphylaxis upon a second use of
omeprazole is documented.
Metabolic
Metabolic side effects have included hypoglycemia, hyponatremia, weight gain, and increased uric acid levels. It has also been
reported that omeprazole may cause hypomagnesemia if taken for prolonged periods of time (in most cases, longer than one
year). Patients who develop hypomagnesemia may experience seizures, dizziness, abnormal or fast heart beat, or skipped
heartbeat, jitteriness, jerking movements or tremors, muscle weakness, spasms of the hands and feet, cramps or muscle aches,
and spasm of the voice box.
A case report of omeprazole associated with symptomatic hyponatremia, probably secondary to inappropriate ADH secretion, has
been reported.
Two case reports have suggested that omeprazole may rarely cause increased uric acid levels and acute gout attacks.
Two cases of hospitalized patients with refractory chronic hypokalemia and hypocalcemia secondary to hypomagnesemia were
resolved after withdrawal of omeprazole.
Psychiatric
Psychiatric side effects have been reported rarely. These have included depression, nervousness, hallucinations, insomnia,
anxiety, dream disturbances, and apathy.
Genitourinary
Genitourinary side effects have included impotence and rare reports of urinary tract infection, pyuria, urinary frequency,
proteinuria, hematuria, glycosuria, and testicular pain.
Musculoskeletal
Musculoskeletal side effects have included the development of a nonspecific polyarthritis, which appears to resolve after
withdrawal of omeprazole. Hip and other bone fractures have been reported. At least one case of acute severe myopathy has also
been reported.
The risk of hip fracture was significantly increased among patients prescribed long-term high dose PPIs.
A 71-year-old male was admitted to the emergency department complaining of severe epigastric pain. He was administered a
single dose of omeprazole 40 mg. After 12 hours, the epigastric pain continued and the patient was hospitalized. Blood analysis
at this time showed an increase in creatinine kinase, creatinine kinase isoenzymes, and myoglobin levels, without concomitant
symptoms of muscle injury. Omeprazole-induced myopathy was suspected, the drug discontinued, and no other gastrointestinal
drugs were given. After one week, he recovered from epigastralgia with a concomitant improvement in laboratory parameters.
Immunologic
Immunologic side effects have been reported rarely. These have included a single case report of an autoimmune disorder with the
development of fever, arthralgias, Raynaud's phenomenon, and a positive ANA titer.
http://www.drugs.com/sfx/isosorbide-mononitrate-side-effects.html
Isosorbide mononitrate Side Effects

Some side effects of isosorbide mononitrate may not be reported. Always consult your doctor or healthcare specialist for medical
advice. You may also report side effects to the FDA.
For the Consumer
Applies to isosorbide mononitrate: oral tablet, oral tablet extended release
Along with its needed effects, isosorbide mononitrate may cause some unwanted effects. Although not all of these side effects
may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking isosorbide mononitrate:
Less common
Abnormal heart sound
absence of or decrease in body movement
arm, back, or jaw pain
black, tarry stools
bladder pain
bleeding after defecation
bleeding gums
blood in the urine or stools
blurred vision
body aches or pain
burning while urinating
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
chest pain or discomfort
chest tightness or heaviness
chills
cold sweats
colds
confusion
convulsions
cough or hoarseness
decreased urine
diarrhea
difficult or labored breathing
dilated neck veins
dizziness
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
dry mouth
ear congestion
extra heartbeats
fainting
fast, slow, irregular, pounding, or racing heartbeat or pulse
fever or chills
flu-like symptoms
frequent urination
headache
headache, severe and throbbing
heart murmur
increased need to urinate
increased sweating
increased thirst
increased volume of pale, dilute urine
irregular breathing
itching, pain, redness, or swelling on the leg
joint pain, stiffness, or swelling
lightheadedness
loss of appetite
loss of voice
lower back, side, or stomach pain
mood changes
muscle aches and pains
muscle cramps
nasal congestion
nausea or vomiting
nervousness
numbness or tingling in the hands, feet, or lips
pain or discomfort in the arms, jaw, back, or neck
pain, tension, and weakness upon walking that subsides during periods of rest
partial or slight paralysis
passing urine more often
pinpoint red or purple spots on the skin
pounding in the ears
runny nose
shakiness in the legs, arms, hands, or feet
shivering
shortness of breath
sneezing
sore on the leg
sore throat
sudden decrease in the amount of urine
sweating
swelling
swelling of the face, fingers, feet, or lower legs
tightness in the chest
trembling or shaking of the hands or feet
trouble with sleeping
troubled breathing
uncomfortable swelling around the anus
vomiting of blood or material that looks like coffee grounds
weakness
weight gain
wheezing
Rare
Bluish-colored lips, fingernails, or palms
dark urine
pale skin
rapid heart rate
Get emergency help immediately if any of the following symptoms of overdose occur while taking isosorbide mononitrate:
Symptoms of overdose
Blurred or loss of vision
bulging soft spot on the head of an infant
change in consciousness
change in the ability to see colors, especially blue or yellow
cold, clammy skin
disturbed color perception
double vision
feeling of constant movement of self or surroundings
halos around lights
headache, severe and throbbing
loss of consciousness
night blindness
overbright appearance of lights
paralysis
sensation of spinning
tunnel vision
Some side effects of isosorbide mononitrate may occur that usually do not need medical attention. These side effects may go
away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about
ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects
continue or are bothersome or if you have any questions about them:
Less common
Acid or sour stomach
anxiety
back pain
belching
blemishes on the skin
bloated
breast pain
burning feeling in the chest or stomach
burning, dry, or itching eyes
change in color vision
changes in vision
cold sweats
congestion
constipation
continuing ringing or buzzing or other unexplained noise in the ears
cough producing mucus
decreased interest in sexual intercourse
difficulty seeing at night
difficulty with moving
discharge, excessive tearing
double vision
drooping upper eyelids
dull ache or feeling of pressure or heaviness in the legs
earache
excess air or gas in the stomach or intestines
feeling of constant movement of self or surroundings
feeling of warmth
feeling unusually cold
frequent urge to defecate
frozen shoulder
full feeling
hearing loss
heartburn
hyperventilation
inability to have or keep an erection
increased appetite
increased sensitivity of the eyes to sunlight
increased sputum
indigestion
irritability
itching skin near damaged veins
lack or loss of strength
loss in sexual ability, desire, drive, or performance
muscle or bone pain
muscle stiffness or weakness
nightmares
noisy breathing
pain or tenderness around the eyes and cheekbones
passing gas
pimples
poor concentration
rash
redness of the face, neck, arms, and occasionally, upper chest
redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
redness, swelling, or soreness of the tongue
restlessness
seeing double
sensation of spinning
sleepiness or unusual drowsiness
sleeplessness
small clicking, bubbling, or rattling sounds in the lung when listening with a stethoscope
small lumps under the skin
sore mouth or tongue
stiff neck
stomach bloating, burning, cramping, or pain
stomach discomfort or upset
straining while passing stool
stuffy nose
sudden sweating
swollen feet and ankles
tender, swollen glands in the neck
tenderness in the stomach area
terrifying dreams causing sleep disturbances
tooth disorder
trouble with swallowing
unable to sleep
uncontrolled twisting movements of the neck
voice changes
weight loss
white patches in the mouth, tongue, or throat
Applies to isosorbide mononitrate: oral tablet, oral tablet extended release
General
Isosorbide mononitrate is generally well-tolerated.
Nervous system
Nitrate-induced headaches are probably due to vasodilation, and may resolve spontaneously over days to weeks or respond to
acetaminophen analgesia.
Nervous system side effects such as headache have occurred in up to 36% of patients. In a large multicenter trial, 1.2% of
patients discontinued therapy due to headache. Up to 8% of patients experienced dizziness/vertigo symptoms.
Cardiovascular
Organic nitrates may induce a sudden drop in systemic blood pressure and enhanced vagal tone, resulting in possible inhibition of
reflex tachycardia and syncope.
Cardiovascular side effects include flushing, increased heart rate, hypotension, and orthostasis. These are more likely in patients
with hypovolemia or who are on antihypertensive medications. Syncope has been reported in rare cases. Due to tolerance to the
antianginal effects of the drug, eccentric dosing is usually recommended. This typically means giving the drug upon wakening
and again approximately seven hours later, leaving a "nitrate-free" period during the night to decrease the incidence of tolerance.
Gastrointestinal
Gastrointestinal side effects are relatively uncommon, and include nausea and constipation in 1% to 3% of patients.
Hypersensitivity
Hypersensitivity reactions, presenting as pruritus and drug rash, are reported with the organic nitrates.
Hematologic
Nitrates converted to nitrites may accelerate the oxidation of hemoglobin, resulting in abnormally high plasma concentrations of
methemoglobin. While most cases of methemoglobinemia are asymptomatic, methemoglobin levels greater than 60% usually
induce symptoms, particularly in the presence of underlying coronary artery disease. Treatment in symptomatic persons is
methylene blue 1% solution 2 mg/kg intravenously over 10 minutes. It is recommended that affected patients be screened for
NADP-methemoglobin reductase deficiency.
A rare hematologic side effect of nitrates is methemoglobinemia.
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Hydralazine
http://www.drugs.com/search.php?searchterm=hydralazine
Hydralazine is a vasodilator that works by relaxing the muscles in your blood vessels to help them dilate (widen). This lowers
blood pressure and allows blood to flow more easily through your veins and arteries. Hydralazine is used to treat high blood
pressure (hypertension). Hydralazine may also be...
Side Effects
Pregnancy / Breastfeeding
Drug Interactions
Dosage
Support Group Q & A
User Reviews
Hydralazine Tablets Prescribing Information
Professional Monograph (FDA)
Generic Name: hydralazine hydrochloride Dosage Form: tablet Hydralazine Hydrochloride Tablets USP Rx only DESCRIPTION
Hydralazine hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine
monohydrochloride, and its structural formula is: Hydralazine...
Hydralazine Side Effects
For the Consumer

Applies to hydralazine: powder for solution, solution, tablet
Along with its needed effects, hydralazine may cause some unwanted effects. Although not all of these side effects may occur, if
Check with your doctor as soon as possible if any of the following side effects occur while taking hydralazine:
Less common
Blisters on skin
chest pain
general feeling of discomfort or illness or weakness
joint pain
muscle pain
numbness, tingling, pain, or weakness in hands or feet
skin rash or itching
sore throat and fever
swelling of feet or lower legs
swelling of lymph glands
Rare
Fever
sore throat
weakness
Some side effects of hydralazine may occur that usually do not need medical attention. These side effects may go away during
More common
Diarrhea
fast heartbeat
headache
loss of appetite
nausea or vomiting
pounding heartbeat
Less common
Constipation
dizziness or lightheadedness
redness or flushing of face
shortness of breath
stuffy nose
watery eyes
Applies to hydralazine: compounding powder, injectable solution, oral tablet
Immunologic
Immunologic side effects including the development of a lupus-like syndrome has been reported. It is more likely in patients who
receive 400 mg or more of hydralazine per day, in female patients, or in patients who are slow acetylators. Of patients who
receive less than 200 mg or 400 mg or more per day of hydralazine, 40% and 50%, respectively, develop a positive ANA titer,
and up to 6% and 14%, respectively, develop a lupus-like syndrome.
The lupus syndrome may present as arthralgias (most common), myalgias, lethargy, malaise, a typical erythematous rash, weight
loss, or dyspnea, but may be found incidentally in asymptomatic patients by urinalysis (proteinuria, hematuria), blood chemistry
(elevated ESR, antinuclear antibody), or chest X-ray (interstitial lung disease, rare). Hypocomplementemia is an extremely rare
finding in hydralazine-induced lupus.
Alternative therapy is recommended for patients who develop the clinical appearance of a lupus syndrome, sustained rises in the
antinuclear antibody titer, or the presence of LE cells. The syndrome is reversible, but may take months to years to resolve.
Because up to 20% of patients who receive 400 mg per day or more develop a systemic lupus erythematosus syndrome, some
experts recommend checking a patient's acetylator status before giving higher doses. Up to 70% of "resistant" patients are fast
acetylators, in whom the dose can be relatively safely increased.
Data suggest that hydralazine lupus may represent a unique hypersensitivity reaction in which antibodies to native DNA occur.
These antibodies are believed to account for the clinical similarities between hydralazine-induced lupus and systemic lupus
erythematosus.
Cardiovascular
Provocation of ischemia in patients with compromised left ventricular systolic dysfunction may be due to the inability of
hydralazine to decrease preload, or left ventricular filling pressures.
The mechanism of increased pulmonary hypertension in patients with PH or COPD is a decrease of systemic vascular resistance
accompanied by an increase in cardiac output without a fall in the pulmonary vascular resistance. In case reports and small series
of patients, the use of hydralazine in such patients resulted in palpitations, chest tightness, unchanged pulmonary vascular
resistance, increased pulmonary artery pressure, decreased systemic vascular resistance, and increased heart rate and cardiac
output. For this reason, if hydralazine must be used, many experts recommend hemodynamic monitoring during hydralazine
therapy in such patients.
Cardiovascular side effects are related to the vasodilatory properties of hydralazine. Reflex tachycardia is commonly observed.
Palpitations, flushing, edema, or chest pain have been reported in less than 5% of patients. The use of hydralazine in patients with
severe chronic heart failure has been associated with ischemia, including episodes of myocardial infarction.
In patients with pulmonary hypertension (PH) and chronic obstructive pulmonary disease (COPD), hydralazine may increase
pulmonary artery hypertension, especially during periods of hypoxia. The use of hydralazine in these patients may, on rare
occasions, result in profound hypotension, tachycardia, and even death.
Rare cases of bradycardia or cardiac tamponade (associated with hydralazine-induced lupus) have been reported. Hydralazine
does not have a deleterious effect on the lipid profile, and, in fact, has been shown to decrease total and LDL cholesterol.
Nervous system
Nervous system side effects including peripheral neuropathy is dose-related and is more common in slow acetylators. The
neuropathy usually first presents as paresthesias, numbness, and tingling in the extremities. It is probably the result of pyridoxine
deficiency, perhaps because formation of a pyridoxal-hydralazine complex inactivates the coenzyme, and can, therefore, be
treated by administration of pyridoxine. Headache or dizziness have been reported in approximately 5% of patients.
A 61-year-old man with hypertension developed ataxia, numbness, and lower extremity weakness approximately six months after
beginning hydralazine (up to 300 mg per day) and reserpine therapy. The neuropathy partially resolved after reduction of the
hydralazine dosage to 60 mg daily. A complete evaluation revealed that this man was a slow acetylator of hydralazine.
Respiratory
A 48-year-old woman with hypertension developed dyspnea, hemoptysis, pleurisy, proteinuria, and hematuria one year after
beginning hydralazine (150 mg per day), polythiazide, and atenolol therapy. Other associated findings included an elevated ESR,
antinuclear factor, anti-DNA titer, a positive LE test, and radiographic findings of diffuse interstitial lung disease. Two weeks
after stopping hydralazine, the signs and symptoms of lupus with pulmonary involvement disappeared.
At least one fatal case of hydralazine-induced lupus pneumonitis has been reported. The patient had been taking hydralazine for
more than a year prior to developing symptoms.
A rare case of hydralazine-induced lupus presenting as laryngeal edema and right vocal fold paralysis has been reported. The
patient had been taking hydralazine 50 mg three times daily and exhibited hoarseness of voice and inspiratory stridor.
Discontinuation of hydralazine resulted in reversal of paralysis.
Respiratory side effects include nasal stuffiness, seen in approximately 3% of patients. A case of "hydralazine lung", associated
with hydralazine-induced lupus has been reported.
Hematologic
Hematologic abnormalities have been associated with the hydralazine-induced lupus-like syndrome. Anemia may be caused by
one of at least four hydralazine-associated problems; hemolysis, the formation of a circulating anticoagulant, thrombocytopenia,
and vasculitis. Rare cases of leukopenia and agranulocytosis have been reported.
A 71-year-old man with hypertension developed anorexia, weight loss, petechiae, and a microcytic anemia during therapy with
hydralazine and oxprenolol. Evaluation for iron deficiency, hemolysis, or marrow depression was negative. The patient was
found to have fecal blood loss, anti-DNA antibodies, decreased complement levels, a normal upper GI series, and biopsy-proven
vasculitis. The syndrome resolved within two weeks after discontinuation of hydralazine.
Renal
Renal side effects are common in idiopathic systemic lupus erythematosus; however, immune complex glomerulonephritis is rare
in drug-induced lupus. Rare cases of rapidly progressive and focal glomerulonephritis associated with the hydralazine-induced
lupus syndrome are often accompanied by anemia, a positive anti-DNA antibody titer, and a positive ANA titer.
In one study, rapidly progressive glomerulonephritis (RPGN) is described in 4 of 444 patients, all of whom were men who were
treated for 5 to 11 years with daily doses of 100 to 250 mg. In three of the four cases, biopsy revealed a focal and segmental
glomerular necrosis with crescents and positive immunofluorescence. The antinuclear antibody titer became positive in three.
Renal function improved in all but one after the withdrawal of hydralazine and institution of corticosteroid therapy. A number of
other cases of RPGN are reported. It appears to be far more common in patients who are slow acetylators.
Dermatologic
A 65-year-old man with ischemic cardiomyopathy developed a pruritic, erythematous, generalized rash within two months after
beginning hydralazine (200 mg per day) therapy. There were no clinical or laboratory signs of lupus. The rash persisted upon
gradual withdrawal of the patient's other medications, but cleared only after discontinuation of hydralazine. Rechallenge resulted
in a recurrent pruritic rash.
Dermatologic manifestations of the hydralazine-induced lupus-like syndrome include cutaneous vasculitis. A generalized,
pruritic rash without evidence of lupus has been associated with hydralazine. Rare cases of Sweet's syndrome (neutrophilic
dermatosis) have been associated with hydralazine.
Hepatic
A 59-year-old woman with hypertension and cholecystic gallbladder disease developed abdominal pain, nausea, vomiting,
painful hepatomegaly, elevated serum transaminases, direct hyperbilirubinemia, and liver biopsy findings of subacute hepatitis
(with bridging necrosis) within two days after hydralazine was added to her medical regimen. The signs and symptoms of
hepatitis resolved after all medications were withheld, but returned upon rechallenge with hydralazine.
Hepatic reactions are rare. Less than ten cases of hepatitis have been reported, many of which were believed to be due to
hypersensitivity. Histological findings include hepatocellular, cholestatic, mixed hepatocellular-cholestatic, and granulomatous
patterns.
Hypersensitivity
A 44-year-old woman with hypertension and acute sinusitis developed acute renal failure, edema, and a generalized
maculopapular erythematous rash during therapy with ampicillin (for sinusitis), hydrochlorothiazide, and hydralazine. A
complete evaluation revealed bilateral hydronephrosis and hydroureters secondary to ureteral obstruction due to retroperitoneal
fibrosis. Renal function returned to baseline after oral prednisone therapy. It is unclear whether this problem was due to one or
more of her medications.
Hypersensitivity reactions are rare. Many of the rare cases of hepatitis are believed to be due to hypersensitivity. A case of
retroperitoneal fibrosis and of occupational asthma are believed to be due to hypersensitivity.
Genitourinary
Genitourinary side effects including impotence in male patients have been reported rarely.
At least two cases of male impotence associated with hydralazine are reported. The mechanism is unclear. There was no evidence
of a neuropathy in either case.
Musculoskeletal
Musculoskeletal manifestations of hydralazine-induced lupus include joint pain, arthralgias, and myalgias. Arthritis in the hands
and wrists is a particularly common clinical manifestation.
General
The incidence of hydralazine-induced systemic lupus erythematosus (SLE) is estimated at 5.4% for patients receiving 100 mg
daily, 10.4% for those receiving 200 mg daily, and 10% to 20% for those receiving 400 mg or more daily. It should be noted that
hydralazine-induced SLE has occurred at doses as low as 50 mg daily. Risk factors associated with development of hydralazine-
induced SLE include slow acetylator status, HLA-DRw4 phenotype, female gender, high daily dose, therapy longer than 3
months, and a family history of autoimmune disease. Black patients appear to develop hydralazine-induced SLE less frequently
than other populations. Musculoskeletal symptoms appear to be the most common clinical manifestation of hydralazine-induced
SLE; however, it appears that any organ system can be involved. Laboratory findings that may aid in the diagnosis of
hydralazine-induced SLE include antinuclear antibody (ANA), lupus erythematosus cells, rheumatoid factor, and antihistone
antibodies.
Ezetimibe
http://www.drugs.com/search.php?searchterm=ezetimibe
Ezetimibe reduces the amount of cholesterol absorbed by the body. Ezetimibe is used to treat high cholesterol. It is sometimes
given with other cholesterol-lowering medications. Ezetimibe may also be used for other purposes not listed in this medication
guide. Important information about ezetimibe Ezetimibe...
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Ezetimibe Professional Information (A-Z Drug Facts)
A-Z Drug Facts (Facts & Comparisons)
Pronunciation: e-ZET-i-mibeClass: Antihyperlipidemic agentTrade Names Zetia - Tablets, oral 10 mg Ezetrol (Canada)
Pharmacology Inhibits absorption of cholesterol by the small intestine. Pharmacokinetics Absorption C max is 3.4 to 5.5 ng / mL
(ezetimibe) and 45 to 71 ng / mL (metabolite). T max is 4 to 12...
http://www.drugs.com/sfx/ezetimibe-side-effects.html
Ezetimibe Side Effects
For the Consumer

Applies to ezetimibe: oral tablet
Along with its needed effects, ezetimibe may cause some unwanted effects. Although not all of these side effects may occur, if
Frequency not determined
Abdominal fullness
black tarry stools
bleeding gums
bloating
blood in urine or stools
chills
constipation
darkened urine
fast heartbeat
fever
gaseous abdominal pain
general tiredness or weakness
indigestion
large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
loss of appetite
light-colored stools
muscle cramps or spasms
muscular tenderness, wasting or weakness
nausea
pains in stomach, side or abdomen, possibly radiating to the back
pinpoint red spots on skin
recurrent fever
severe nausea
skin rash
upper right abdominal pain
vomiting
yellow eyes or skin
Some side effects of ezetimibe may occur that usually do not need medical attention. These side effects may go away during
More common
Fever
headache
muscle pain
runny nose
sore throat
Less common
Back pain
body aches or pain
chest pain
chills
cold or flu-like symptoms
congestion
coughing
diarrhea
difficulty in moving
dizziness
dryness or soreness of throat
hoarseness
muscle pain or stiffness
pain in joints
pain or tenderness around eyes and cheekbones
shortness of breath or troubled breathing
stomach pain
stuffy nose
tender, swollen glands in neck
tightness of chest or wheezing
trouble in swallowing
voice changes
Applies to ezetimibe: oral tablet
General
General side effects including fatigue (2.2%) have been reported.
Gastrointestinal
Gastrointestinal side effects including diarrhea (3.7%) and abdominal pain (3.0%) have been reported. Pancreatitis and nausea
have also been reported in postmarketing experience.
A case of ezetimibe-induced acute pancreatitis occurred two weeks after initiating therapy. Following discontinuation of
ezetimibe the patient's symptoms resolved and pancreatic enzyme levels normalized.
Immunologic
Immunologic side effects including sinusitis (3.6%), pharyngitis (2.3%), and viral infection (2.2%) have been reported.
Musculoskeletal
Musculoskeletal side effects including back pain (4.1%) and arthralgia (3.8%) have been reported. Other effects including
myalgia, arthralgia, elevated creatine phosphokinase, and rare reports of myopathy/rhabdomyolysis have been reported in
postmarketing experience.
Respiratory
Respiratory side effects including coughing (2.3%) have been reported.
Hypersensitivity
Hypersensitivity reactions including angioedema, anaphylaxis, rash, urticaria, and erythema multiforme have been reported in
Hepatic
Hepatic side effects including elevations in liver transaminases, hepatitis, cholelithiasis, and cholecystitis have been reported in
Hematologic
Hematologic side effects including thrombocytopenia have been reported in postmarketing experience.
Nervous system
Nervous system side effects including dizziness, paresthesia, and headache have been associated with ezetimibe in postmarketing
experience.
Psychiatric
Psychiatric side effects including depression have been reported during the postmarketing experience.
Doxazosin
http://www.drugs.com/search.php?searchterm=doxazosin
Doxazosin is in a group of drugs called alpha-adrenergic blockers. Doxazosin relaxes your veins and arteries so that blood can
more easily pass through them. It also relaxes the muscles in the prostate and bladder neck, making it easier to urinate.
Doxazosin is used to treat hypertension (high blood...
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Doxazosin Prescribing Information
Generic Name: Doxazosin mesylate Dosage Form: tablet Doxazosin TABLETS, USP 1 mg, 2 mg, 4 mg and 8 mg Doxazosin
Description Doxazosin mesylate is a quinazoline compound that is a selective inhibitor of the alpha1 subtype of alpha adrenergic
receptors. The chemical name of Doxazosin mesylate is 1-(4-amino-6,7-...
http://www.drugs.com/sfx/doxazosin-side-effects.html
Doxazosin [Side] Effects
For the Consumer

Applies to doxazosin: oral tablet, oral tablet extended release
Along with its needed effects, doxazosin may cause some unwanted effects. Although not all of these side effects may occur, if
Check with your doctor as soon as possible if any of the following side effects occur while taking doxazosin:
More common
Dizziness or lightheadedness
Less common
Blurred vision
confusion
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
fainting (sudden)
fast and pounding heartbeat
irregular heartbeat
shortness of breath
sweating
swelling of feet or lower legs
Rare
Painful or prolonged erection of the penis (called priapism), although extremely rare, must have immediate medical attention. If
painful or prolonged erection occurs, call your doctor or go to an emergency room as soon as possible
Incidence not known
Abdominal or stomach pain
area rash
black, tarry stools
bleeding gums
chills
clay-colored stools
cough
dark urine
diarrhea
difficulty breathing
fever
general tiredness and weakness
headache, sudden and severe
inability to speak
itching
lab results that show problems with liver
loss of appetite
noisy breathing
pain or discomfort in arms, jaw, back or neck
pinpoint red or purple spots on skin
rash
seizures
slow or irregular heartbeat
slurred speech
sore throat
sores, ulcers, or white spots on lips or in mouth
swollen glands
temporary blindness
tightness in chest
unpleasant breath odor
vomiting
vomiting of blood
weakness in arm and/or leg on one side of the body, sudden and severe
wheezing
yellow eyes and skin
Some side effects of doxazosin may occur that usually do not need medical attention. These side effects may go away during
More common
Headache
Less common
back pain
belching
bladder pain
cloudy urine
heartburn
indigestion
joint pain
lower back or side pain
muscle aching, cramping, or weakness
muscle pains or stiffness
nausea
nervousness, restlessness, unusual irritability
runny nose
sleepiness or drowsiness
sneezing
sore throat
stomach discomfort, upset or pain
swollen joints
Incidence not known
Anxiety
burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feeling
change in frequency or urination
dry mouth
feeling of warmth
frequent urination
hair loss
hives or welts
hyperventilation
increased urge to urinate during the night
increased volume of pale dilute urine
loss of appetite
painful urination
redness of skin
redness of the face, neck, arms and occasionally upper chest
shaking
swelling of the breasts or breast soreness in both females and males
thinning of hair
trouble in holding or releasing urine
trouble sleeping
waking to urinate at night
weight loss
Applies to doxazosin: oral tablet, oral tablet extended release
General
Doxazosin is generally well-tolerated. Side effects are usually mild to moderate in intensity and may resolve with continued
therapy.
Cardiovascular
Like other alpha-blockers, doxazosin has been associated with significant decreases in total and LDL serum cholesterol and
serum triglycerides. This beneficial effect on the lipid profile may be important in some patients with ischemic heart disease.
Data from ALLHAT (which led to the discontinuation of the doxazosin-treatment arm of the study) indicated that users
of doxazosin had 25% more cardiovascular events and were twice as likely to be hospitalized for congestive heart failure
compared to users of chlorthalidone. However, these two drugs were found to be similarly effective in preventing heart attacks
and in reducing the risk of death from all causes.
Cardiovascular side effects are the most common. Dizziness has been reported in 3% to 14% of patients and is most likely to
occur 2 to 6 hours after dosing. It may be minimized by administration of the drug at bedtime, particularly at the beginning of
therapy. Rarely, syncope has been associated with doxazosin, and appears to be more likely in patients greater than 65 years old.
Peripheral edema, palpitations, chest pain, and tachycardia have been reported in 7%, 4%, 3%, and 2% of patients, respectively.
Cerebrovascular accidents, postural dizziness, bradycardia, cardiac arrhythmias, and myocardial infarction have been
reported in postmarketing studies.
Patients treated with doxazosin during the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack
Trial (ALLHAT) had a greater likelihood of developing congestive heart failure.
Ocular
Most reports were in patients treated with an alpha-1 blocker at the time IFIS occurred, but in some instances the alpha-1 blocker
had been stopped prior to surgery. The manufacturer recommends that patients be questioned to determine whether or not they
have taken alpha-1 blockers prior to being considered for cataract surgery. If it is determined that the patient has taken an alpha-1
blocker, the patient's ophthalmologist should be prepared for possible modifications to their surgical technique that may be
necessary should IFIS be observed during the procedure.
Ocular side effects including Intraoperative Floppy Iris Syndrome (IFIS) have been observed in some patients undergoing
phacoemulsification cataract surgery while being treated with alpha-1 blockers.
Blurred vision has been reported in postmarketing studies.

Nervous system
Anxiety, insomnia, and paresthesias have each been reported in 2% of patients. Dry mouth and flushing have been reported in
less than 2% of patients.
Nervous system side effects have included dizziness in up to 17%, headache or fatigue/lethargy in 10% to 15%, and somnolence
in 5% of patients. Hypoesthesia and paresthesia have been reported in postmarketing studies.
Respiratory
Respiratory system complaints of dyspnea and rhinitis have been reported in 3% to 4% of patients. Aggravated bronchospasm
has been reported in postmarketing studies.
Gastrointestinal
Gastrointestinal side effects are unusual, and are mainly limited to nausea or diarrhea in 1% to 3% of patients.
Dyspepsia, general abdominal pain, flatulence, and constipation have each been reported in about 1% of patients.
Musculoskeletal
Musculoskeletal pain has been reported in 1% to 5% of patients. Muscle cramps and muscle weakness have been reported in
postmarketing studies.
Genitourinary
Genitourinary complaints are rare. Approximately 3% of men have reported impotence and about 1% have reported urinary
frequency. Hematuria, micturition disorder, micturition frequency, nocturia, polyuria, and gynecomastia have been reported in
postmarketing studies. In addition, at lease one case of priapism associated with doxazosin use has been reported.
The Treatment of Mild Hypertension Study (TOMHS), a randomized, placebo-controlled, double-blind study has shown that
there is a slightly and significantly higher incidence of sexual dysfunction (obtaining and maintaining erections) among male
patients who were taking doxazosin for 48 months compared with placebo
Psychiatric
Psychiatric abnormalities including depression and anxiety have been reported in less than 2% of patients. Anorexia and
nervousness have been reported in postmarketing studies. In addition, at least one case of psychosis associated with doxazosin
use has been reported.
In a study of 23 hypertensive patients with renal insufficiency, a single case of a personality change has been associated with the
use of doxazosin.
Hematologic
Hematologic abnormalities are extremely rare. Decreases in baseline white blood cell and neutrophil counts of 2.4% and 1.0%,
respectively, have been reported from controlled clinical trials. Leukopenia, purpura, and thrombocytopenia have been reported
in postmarketing studies.
The manufacturer has reported 4 possible doxazosin-related cases of neutropenia from a database of 2,400 patients. In cases
where follow-up was available the white blood cell count and differential cell count returned to normal after drug
discontinuation. No patients became symptomatic as a result of the low white blood cell or neutrophil counts.
Hypersensitivity
From a study of 1,548 patients, less than 2% reported a rash.
Hypersensitivity to doxazosin has been rarely reported.
Hepatic
Hepatic side effects including abnormal liver function tests, hepatitis, cholestatic hepatitis, and jaundice have been reported in
postmarketing studies.
Dermatologic
Dermatologic side effects have included urticaria. Alopecia has been reported in postmarketing studies.
Other
Other side effects including fatigue, hot flashes, and malaise have been reported in postmarketing studies.
Diltiazem
http://www.drugs.com/search.php?searchterm=diltiazem
Diltiazem is in a group of drugs called calcium channel blockers. It works by relaxing the muscles of your heart and blood
vessels. Diltiazem is used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders.
Diltiazem may also be used for purposes not listed...
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Diltiazem Extended Release Tablets Prescribing Information
Generic Name: diltiazem hydrochloride Dosage Form: tablet, extended release DILTIAZEM HYDROCHLORIDE
EXTENDED- RELEASE TABLETS Rx only Once-a-day dosage Diltiazem Extended Release Tablets Description Diltiazem
hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist)....
Diltiazem Side Effects
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For the Consumer

Applies to diltiazem: oral capsule extended release, oral capsule extended release 12 hr, oral capsule extended release 24 hr,
oral tablet, oral tablet extended release
Other dosage forms:
intravenous powder for solution, intravenous solution
Along with its needed effects, diltiazem may cause some unwanted effects. Although not all of these side effects may occur, if
Check with your doctor immediately if any of the following side effects occur while taking diltiazem:
More common
Body aches or pain
congestion
cough
dryness or soreness of throat
fever
hoarseness
runny nose
tender or swollen glands in neck
trouble in swallowing
voice changes
Less common
Chest pain or discomfort
chills
diarrhea
difficult or labored breathing
feeling faint, dizzy, or lightheaded
feeling of warmth or heat
flushing or redness of skin, especially on face and neck
headache
joint pain
loss of appetite
muscle aches and pains
nausea
shivering
shortness of breath
slow or irregular heartbeat
sore throat
sweating
swelling of hands, ankles, feet, or lower legs
tightness in chest
trouble sleeping
vomiting
wheezing
Incidence not known
Blistering, peeling, or loosening of skin
itching
large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
no heart beat
red irritated eyes
red skin lesions, often with a purple center
sores, ulcers, or white spots in mouth or on lips
Some side effects of diltiazem may occur that usually do not need medical attention. These side effects may go away during
More common
Sneezing
stuffy nose
Less common
belching
constipation
continuing ringing or buzzing or other unexplained noise in ears
degenerative disease of the joint
hearing loss
heartburn
indigestion
muscle aching or cramping
muscle pains or stiffness
pain or tenderness around eyes and cheekbones
rash
sleeplessness
stomach discomfort, upset, or pain
swollen joints
unable to sleep
Incidence not known
Hair loss or thinning of hair
Applies to diltiazem: compounding powder, intravenous powder for injection, intravenous solution, oral capsule extended
release, oral tablet, oral tablet extended release
General
Diltiazem was generally well-tolerated. Serious side effects have been rare during studies; however, patients with impaired
ventricular function and cardiac conduction abnormalities have generally been excluded from these studies. Side effects were
usually dose-related and of mild to moderate severity.
Cardiovascular
Cardiovascular side effects have included asymptomatic hypotension (4.3%), atrioventricular (AV) block (up to 4%), bradycardia
(up to 3.6%), first-degree AV block (up to 3.3%), symptomatic hypotension (3.2%), vasodilation (up to 3%), palpitations (up to
2%), and extrasystoles (up to 2%). Angina, angina pectoris, arrhythmia (including junctional rhythm or isorhythmic dissociation),
atrial fibrillation, atrial flutter, AV block (second- or third-degree), bundle branch block, sinus bradycardia, bigeminal
extrasystole, congestive heart failure, electrocardiogram abnormalities, hypotension, postural hypotension, hypertension,
myocardial infarct, myocardial ischemia, sinus pause, sinus node dysfunction, tachycardia, phlebitis, ST elevation, vasodilatation,
ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia, and ventricular extrasystoles have been reported in less
than 2% of patients. Sinoatrial depression, atrioventricular depression, sinoatrial heart block, and several cases of sinus arrest,
atrioventricular dissociation, and junctional bradycardia have been reported. A case of nodal bigeminy progressing to complete
heart block has also been reported. Events such as myocardial infarction, which are not readily distinguishable from the natural
history of the disease, and asystole have been reported during postmarketing experience.
Nodal bigeminy progressing to complete heart block has been reported in one cardiac patient who ingested a large amount of
diltiazem in a suicide attempt.
Other
Other side effects have included peripheral edema (up to 15%), lower limb edema (up to 8%), pain (up to 6%), infection (up to
6%), asthenia/fatigue (up to 4.8%), edema (up to 4.6%), influenza syndrome (up to 2.3%), and abdominal enlargement (up to
2%). Increased weight, fever, chest pain, malaise, flushing, pallor, abdominal pain, neck pain, ear pain, otitis media, accidental
injury, and unevaluable reaction have been reported in less than 2% of patients.
Nervous system
Nervous system side effects have included dizziness (up to 10%) and headache (up to 8.9%). Amnesia, abnormal thinking, gait
abnormality, hallucinations, insomnia, neuropathy, paresthesia, somnolence, syncope, tinnitus, vertigo, hypertonia, and tremor
have been reported in less than 2% of patients. Dysosmia, dysgeusia, sensory loss, at least one case of acute Parkinsonism, and at
least 2 cases of hyperactive symptoms or akathisia have been reported. Myoclonus has also been reported. Extrapyramidal
symptoms have been reported during postmarketing experience.
A 62-year-old man with diabetes mellitus, congestive heart failure, and aortic stenosis developed uncontrollable hyperactivity
within 24 hours after starting diltiazem. The akathisia was unresponsive to antihistamines and sedatives, and only resolved after
discontinuation of diltiazem. A rechallenge was positive.
Respiratory
Respiratory side effects have included rhinitis (up to 9.6%), dyspnea (up to 6%), pharyngitis (up to 6%), bronchitis (up to 4%),
increased cough (up to 3%), sinusitis (2%), and sinus congestion (up to 2%). Epistaxis, nasal congestion, respiratory distress, and
respiratory disorder have been reported in less than 2% of patients. At least one case of eosinophilic pleural effusion that resolved
following discontinuation of diltiazem has been reported.
Gastrointestinal
Gastrointestinal side effects have included dyspepsia (up to 6%), constipation (up to 3.6%), nausea (up to 2.2%), vomiting (up to
2%), and diarrhea (up to 2%). Anorexia, colitis, dry mouth, dysgeusia, flatulence, gastrointestinal hemorrhage, stomach ulcers,
tooth disorder, eructation, taste perversion, and thirst have been reported in less than 2% of patients. At least one case of
reversible, functional intestinal obstruction and paralytic ileus has been reported. At least one case of Intestinal obstruction and
epigastric pain has been reported. Gingival hyperplasia has been reported during postmarketing experience.
A 72-year-old man developed gingival hyperplasia while receiving diltiazem. The hyperplasia recurred after surgical removal,
and disappeared without recurrence after diltiazem was discontinued.
A 76-year-old man with CHF and an uncomplicated inguinal hernia developed epigastric pain, nausea, and vomiting associated
with an unchanged ECG within 2 hours after starting diltiazem. Plain abdominal X-rays were suggestive of intestinal obstruction.
The patient recovered within 24 hours after nasogastric suction, discontinuation of oral intake, and discontinuation of diltiazem.
Rechallenge was not done.
Dermatologic
In reported cases of acute generalized exanthematous pustular dermatitis, the rash developed 10 to 20 days after initiating
diltiazem therapy and resolved after discontinuation of the drug.
Dermatologic side effects have included rash (up to 2%). Petechiae, photosensitivity, contact dermatitis, pruritus, sweating, skin
hypertrophy (nevus), and urticaria have been reported in less than 2% of patients. Rarely, acute generalized exanthematous
pustular dermatitis (at least 3 cases), subacute cutaneous, and lupoid lesions have been reported. At least 6 cases of
photodistributed hyperpigmentation have been reported. Acute generalized exanthematous pustulosis, alopecia, erythema
multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity (including lichenoid
keratosis and hyperpigmentation at sun-exposed skin areas), and cases of generalized rash (characterized as leukocytoclastic
vasculitis) have been reported during postmarketing experience.
Hepatic
One patient developed both renal and hepatic failure while taking diltiazem. Although the drug was discontinued and renal and
hepatic function were improving, the patient developed cardiogenic shock and died.
A 61-year-old man with hypertension and angina pectoris presented with fever and a generalized rash associated with
hepatomegaly, a mild leukocytosis, thrombocytopenia, and elevated liver function tests. An infectious etiology was not found.
After all of the patient's medications were continued except for diltiazem, his signs and symptoms resolved within six days. A
macrophage inhibitory factor test and mast cell degranulation test done in the presence of diltiazem were positive.
Hepatic side effects have included mild elevations of SGOT and SGPT in less than 2% of patients. Mild and transient increases
in liver function tests have been reported. Rarely, granulomatous hepatitis and hepatorenal failure have been reported. Extremely
rarely, acute hepatitis has been reported. A case of jaundice associated with elevated serum transaminases has been reported.
Musculoskeletal
A 58-year-old man with hypertension, coronary artery disease, and hypercholesterolemia developed acute and generalized
extremity weakness and chest pain while receiving diltiazem, lovastatin, nitrates, and enalapril. The patient's muscles were tender
to palpation. An ECG was unchanged. With normal liver and thyroid function tests, lovastatin was discontinued, but the patient's
creatine phosphokinase (CPK) levels remained elevated (all CPK-MM) and the patient's symptoms persisted. There was no
evidence of a connective tissue disease, rhabdomyolysis, or renal failure. The patient refused muscle biopsy. Upon
discontinuation of diltiazem, the signs and symptoms of myopathy rapidly resolved, even after lovastatin was readministered. All
signs and symptoms recurred upon rechallenge with diltiazem.
Musculoskeletal side effects have included back pain (up to 2.9%), myalgia (up to 2.3%), and gout (up to 2%). Muscle cramps,
neck rigidity, arthralgia, arthrosis, bursitis, bone pain, and osteoarticular pain have been reported in less than 2% of patients. At
least one case of acute myopathy has been reported.
Metabolic
Metabolic side effects have included hyperglycemia, hyperuricemia, mild elevations of lactate dehydrogenase, mild elevations of
alkaline phosphatase, and increased creatine phosphokinase in less than 2% of patients. Insulin resistance, diabetes-like
symptoms, a case of attenuated hypoglycemia and symptoms of hypoglycemia, a case of polyuria, polydipsia, and elevated blood
glucose, a case of frank hyperosmolar nonketotic hyperglycemic coma, a case of insulinoma, and at least one case of metabolic
acidosis and hyperkalemia have been reported.
A 72-year-old man with coronary artery disease and esophagitis developed a urticarial rash and jaundice associated with elevated
serum transaminases, metabolic acidosis, and hyperkalemia. The patient died of cardiogenic shock complicated by pulmonary
edema.
A 46-year-old woman with insulinoma demonstrated suppressed serum insulin levels after diltiazem 44 mg intravenously was
administered. The patient was subsequently treated with orally administered diltiazem, with a significant decrease in the
frequency of hypoglycemic attacks.
Hypersensitivity
A 42-year-old man with a history of hypertension developed a generalized erythematous, purpuric rash associated with mucosal
ulceration, fever, and elevated liver function tests within two days after starting diltiazem. A skin biopsy revealed histology
consistent with Stevens-Johnson syndrome or severe erythema multiforme. The rash and liver function tests gradually resolved
after discontinuation of diltiazem and institution of corticosteroid therapy. An extensive evaluation failed to reveal an infectious
source.
Hypersensitivity side effects have included allergic reaction (less than 2%). Erythematous rash, urticarial rash, and, rarely,
cutaneous vasculitis and purpuric rash have been reported. Angioedema (including facial or periorbital edema) has been reported
during postmarketing experience.
Psychiatric
Psychiatric side effects have included nervousness (up to 2%). Abnormal dreams, depression, and personality change have been
reported in less than 2% of patients. Reversible mania, acute psychosis, and at least one case of auditory and visual
hallucinations, paranoia, and misinterpretations have been reported.
A 72-year-old woman with hypertension and angina pectoris developed auditory and visual hallucinations, paranoia, and
misinterpretations within two days after beginning diltiazem. In the absence of any other obvious cause, the diltiazem was
stopped, and her psychosis resolved over the next three days. Nifedipine was successfully substituted.
Hematologic
Hematologic side effects have included platelet dysfunction and at least one case of mild leukocytosis. Hemolytic anemia,
increased bleeding time, leukopenia, lymphadenopathy, purpura, and thrombocytopenia have been reported during postmarketing
experience.
A 23-year-old man with a carotid aneurysm and delirium developed an increased bleeding time (15 minutes) after starting
aminocaproic acid, phenobarbital, and diltiazem. His bleeding time resolved to his pretreatment time of 6 minutes after diltiazem
alone was discontinued.
A 61-year-old man with hypertension and angina pectoris presented with fever and a generalized rash associated with
hepatomegaly, a mild leukocytosis, thrombocytopenia, and elevated liver function tests. An infectious etiology was not found.
After all of the patient's medications were continued except for diltiazem, his signs and symptoms resolved within six days. A
macrophage inhibitory factor test and mast cell degranulation test done in the presence of diltiazem were positive.
Ocular
Ocular side effects have included conjunctivitis (up to 2%). Amblyopia, eye irritation, eye hemorrhage, and ophthalmitis have
been reported in less than 2% of patients. Retinopathy has been reported during postmarketing experience.
Genitourinary
Genitourinary side effects have included impotence (up to 2%). Albuminuria, crystalluria, cystitis, kidney calculus,
dysmenorrheal, nocturia, polyuria, sexual difficulties, vaginitis, prostate disease, gynecomastia, and urinary tract infection have
been reported in less than 2% of patients.
Renal
A 53-year-old man, with hypertension and ischemic heart disease, developed a rash and acute renal failure associated with
elevated liver function tests following a single dose of diltiazem.
Several case reports have been published describing renal failure, which appear to be related to diltiazem. A 72-year-old
man with coronary artery disease and esophagitis developed a urticarial rash and jaundice associated with elevated
serum transaminases, metabolic acidosis, and hyperkalemia. The patient died of cardiogenic shock complicated by
pulmonary edema.
Renal side effects have included kidney failure and pyelonephritis in less than 1% of patients. Acute renal failure has
been reported.
Local
Local side effects have included injection site reactions (e.g., itching, burning) in 3.9% of patients
Amitriptyline
http://www.drugs.com/search.php?searchterm=amitriptyline
Amitriptyline is a tricyclic antidepressant. It affects chemicals in the brain that may become unbalanced. Amitriptyline is used
to treat symptoms of depression. Amitriptyline may also be used for purposes not listed in this medication guide. Important
information about amitriptyline You should not use...
Side Effects
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Amitriptyline Prescribing Information
Generic Name: Amitriptyline hydrochloride Dosage Form: tablet, film coated Amitriptyline HYDROCHLORIDE TABLETS,
USP Rx only Amitriptyline Description Amitriptyline HCl is 3-(10,11-dihydro-5H-dibenzo [a,d] cycloheptene-5-ylidene)-N,N-
dimethyl-1-propanamine hydrochloride. Its empirical formula is C20H23N•HCl,...
Amitriptyline Side Effects
http://www.drugs.com/sfx/amitriptyline-side-effects.html
For the Consumer

Applies to amitriptyline: oral tablet
Along with its needed effects, amitriptyline may cause some unwanted effects. Although not all of these side effects may occur,
if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking amitriptyline:
Incidence not known
Abdominal or stomach pain
agitation
black, tarry stools
bleeding gums
blurred vision
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
change in consciousness
changes in patterns and rhythms of speech
chills
cold sweats
coma
confusion
confusion about identity, place, and time
continuing ringing, buzzing, or other unexplained noise in ears
convulsions
cool, pale skin
cough or hoarseness
dark urine
decrease in frequency of urination
decrease in urine volume
decreased urine output
difficulty in breathing
difficulty in passing urine (dribbling)
difficulty in speaking
disturbance of accommodation
disturbed concentration
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
double vision
drooling
dry mouth
excitement
fainting
false beliefs that cannot be changed by facts
fast, slow, or irregular heartbeat
fear or nervousness
fever with or without chills
flushed, dry skin
fruit-like breath odor
general feeling of tiredness or weakness
headache
hearing loss
high fever
high or low blood pressure
hostility
inability to move arms, legs, or facial muscles
inability to speak
increased hunger
increased need to urinate
increased ocular pressure
increased sweating
increased thirst
increased urination
irritability
lack of coordination
lethargy
lip smacking or puckering
loss of appetite
loss of balance control
loss of bladder control
loss of consciousness
lower back or side pain
mental depression or anxiety
muscle spasm or jerking of all extremities
muscle tightness
muscle trembling, jerking, or stiffness
muscle twitching
nausea and vomiting
nightmares or unusually vivid dreams
overactive reflexes
painful or difficult urination
passing urine more often
pinpoint red spots on skin
poor coordination
pounding in the ears
puffing of cheeks
rapid or worm-like movements of tongue
rapid weight gain
restlessness
seeing, hearing, or feeling things that are not there
seizures
severe muscle stiffness
shakiness and unsteady walk
shivering
shortness of breath
shuffling walk
sleeplessness
slow speech
slurred speech
sore throat
sores, ulcers, or white spots on lips or in mouth
stiffness of limbs
stupor
sudden loss of consciousness
sweating
swelling of face, ankles, or hands
swelling or puffiness of face
swollen glands
talking or acting with excitement you cannot control
trouble in speaking
trouble sleeping
troubled breathing
twisting movements of body pain or discomfort in arms, jaw, back, or neck
unable to sleep
uncontrolled chewing movements
uncontrolled movements, especially of arms, face, neck, back, and legs
unexplained weight loss
unpleasant breath odor
unsteadiness, trembling, or other problems with muscle control or coordination
unusually pale skin
vomiting of blood
weakness in arms, hands, legs, or feet
weight gain or loss
yellow eyes and skin
Get emergency help immediately if any of the following symptoms of overdose occur while taking amitriptyline:
Symptoms of Overdose
Clumsiness
drowsiness
low body temperature
muscle aches
muscle weakness
sleepiness
tiredness
weak or feeble pulse
Some side effects of amitriptyline may occur that usually do not need medical attention. These side effects may go away during
Incidence not known
Bigger, dilated, or enlarged pupils (black part of eye)
black tongue
bloating
breast enlargement in females
constipation
decreased interest in sexual intercourse
diarrhea
hair loss, thinning of hair
hives or welts
inability to have or keep an erection
increased in sexual ability, desire, drive, or performance
increased interest in sexual intercourse
increased sensitivity of eyes to light
loss in sexual ability, desire, drive, or performance
loss of sense of taste
redness or other discoloration of skin
severe sunburn
skin rash
swelling of testicles
swelling of the breasts or breast soreness in males
swelling of the parotid glands
swelling or inflammation of the mouth
unexpected or excess milk flow from breasts
Applies to amitriptyline: compounding powder, intramuscular solution, oral tablet
Other
Anticholinergic effects have been reported in more than 50% of patients taking amitriptyline and include dry mouth, blurry
vision, constipation and urinary retention. In one study, anticholinergic and antimuscarinic side effects occurred in 84% of
patients.
Nervous system
Some investigators have estimated an incidence of 4 to 5 tricyclic- induced seizures per 1,000 treated patients.
Nearly all selective serotonin reuptake inhibitors, mixed serotonin/norepinephrine reuptake inhibitors, and tricyclic
antidepressants cause sleep abnormalities to some extent. These antidepressants have marked dose-dependent effects on rapid eye
movement (REM) sleep, causing reductions in the overall amount of REM sleep over the night and delays the first entry into
REM sleep (increased REM sleep onset latency (ROL)), both in healthy subjects and depressed patients. The antidepressants that
increase serotonin function appear to have the greatest effect on REM sleep. The reduction in REM sleep is greatest early in
treatment, but gradually returns towards baseline during long-term therapy; however, ROL remains long. Following
discontinuation of therapy the amount of REM sleep tends to rebound. Some of these drugs (i.e., bupropion, mirtazapine,
nefazodone, trazodone, trimipramine) appear to have a modest or minimal effect on REM sleep.
Nervous system side effects are among the most common. Drowsiness, dizziness, sedation and fatigue occur commonly.
Delirium, tinnitus, sleep abnormalities, cognitive impairment (especially in the elderly), a tardive dyskinesia- like syndrome,
dystonic reactions and seizures have also been reported.
Cardiovascular
Both antiarrhythmic and proarrhythmic effects have been associated with the use of tricyclic antidepressant therapy. Caution is
recommended if amitriptyline must be used in patients with cardiovascular disease.
Cardiovascular side effects have included orthostatic hypotension, tachycardia, QRS widening, conduction abnormalities,
malignant arrhythmias, and malignant hypertension. Very rare cases of cardiomyopathy have also been reported.
Psychiatric
Psychiatric side effects associated with the use of amitriptyline have included hypomania and visual hallucinations. Suicidal
ideation, paradoxical aggressiveness, and mental status changes have also been reported with use of this and other tricyclic
antidepressants.
Gastrointestinal
A study of 26,005 antidepressant users has reported 2.3 times more upper GI bleeding episodes with the use of non-SSRI's.
Upper gastrointestinal tract bleeding was observed in 2.5 times more frequently in patients receiving amitriptyline.
Gastrointestinal side effects are most likely due to the anticholinergic properties of the drug and commonly include dry mouth
(79%) and constipation (55%). Nausea, vomiting, and diarrhea have also been reported. In addition, ischemic colitis has been
associated with the use of amitriptyline.
General
Increased appetite and weight gain have been associated with use of amitriptyline.
Other
Withdrawal symptoms, including nervousness, anxiety, restlessness, akathisia, nausea, malaise, sweating and salivation have
been reported after abrupt discontinuation of other tricyclic antidepressants.
Genitourinary
Genitourinary side effects have included urinary retention and sexual dysfunction (including decreased penile circumference and
decreased amplitude and duration of nocturnal erections).
Hematologic
Hematologic side effects are rare. Cases of reversible agranulocytosis and eosinophilia have been rarely associated with use of
tricyclic antidepressants.
Endocrine
Endocrinologic problems associated with the use of amitriptyline are rare, and include hyponatremia in association with the
syndrome of inappropriate secretion of antidiuretic hormone.
Hepatic
Hepatic side effects are rare. Elevated liver function tests, drug-induced hepatitis, and acute hepatic necrosis have been rarely
reported.
Dermatologic
Dermatologic side effects have included rare cases of rashes and a single report of erythema annulare centrifigum.
Immunologic
Immunologic side effects of amitriptyline have included rare associated cases of a lupoid- like reaction.
UPDATE OF REPEAT-PRESCRIPTIONS: 18-05-2016;
FELODIPINE 10mg
FELODIPINE 5mg
FERROUS SULPHATE 200mg
FUROSEMIDE 40mg
HYDRALAZINE 50mg
RANITIDINE 150mg
SITAGLIPTIN 25mg
FELODIPINE
http://www.drugs.com/sfx/felodipine-side-effects.html
In Summary
More frequently reported side effects include: peripheral edema and headache. See below for a comprehensive
list of adverse effects.
For the Consumer

Applies to felodipine: oral tablet extended release
In addition to its needed effects, some unwanted effects may be caused by felodipine. In the event that any of
these side effects do occur, they may require medical attention.
Severity: Major
You should check with your doctor immediately if any of these side effects occur when taking felodipine:
More common:
 Bloating or swelling of face, arms, hands, lower legs, or feet
 rapid weight gain
 tingling of hands or feet

 unusual weight gain or loss
Less common:
 Body aches or pain
 chills
 cough
 difficulty in breathing
 ear congestion
 fever
 headache
 loss of voice
 nasal congestion
 runny nose
 sneezing
 sore throat
 unusual tiredness or weakness
Incidence not known:

 Blurred vision
 chest pain, tightness, or heaviness
 confusion
 congestion
 cough producing mucus
 diarrhea
 dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
 fast, slow, or irregular heartbeat
 general feeling of discomfort or illness
 hoarseness
 joint pain
 large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
 loss of appetite
 muscle aches and pains
 nausea
 pain or discomfort in arms, jaw, back, or neck
 pale skin
 shivering
 shortness of breath
 sweating
 swelling or puffiness of face
 tender or swollen glands in neck
 trouble in swallowing
 trouble sleeping
 troubled breathing with exertion
 unusual bleeding or bruising
 voice changes
 wheezing
If any of the following symptoms of overdose occur while taking felodipine, get emergency help
immediately:
Symptoms of overdose:
 Feeling of warmth
 redness of the face, neck, arms and occasionally, upper chest
Severity: Minor
Some of the side effects that can occur with felodipine may not need medical attention. As your body adjusts to
the medicine during treatment these side effects may go away. Your health care professional may also be able to
tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue,
are bothersome or if you have any questions about them, check with your health care professional:
Less common:
 Acid or sour stomach
 belching
 burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
 constipation
 heartburn
 indigestion
 lack or loss of strength
 skin rash
 stomach discomfort, upset, or pain
Rare:
 Bleeding gums
 irritation in mouth
 redness and swelling of gums

 Bloated or full feeling
 bloody nose
 burning while urinating

 decreased interest in sexual intercourse
 difficult or painful urination
 difficulty in moving
 discouragement
 disturbed color perception
 double vision
 dry mouth
 excess air or gas in stomach or intestines
 feeling sad or empty
 fear or nervousness
 frequent strong or increased urge to urinate
 halos around lights
 hives or welts
 inability to have or keep an erection
 increased need to urinate
 increased volume of pale or dilute urine
 irritability
 itching
 loss in sexual ability, desire, drive, or performance
 loss of interest or pleasure
 muscle cramps or stiffness
 night blindness
 overbright appearance of lights
 pain or tenderness around eyes and cheekbones
 passing gas
 passing urine more often
 redness of skin
 sleepiness or unusual drowsiness
 sleeplessness
 sores, welting, or blisters
 swelling of the breasts or breast soreness in both females and males
 swollen joints
 tiredness
 trouble concentrating
 tunnel vision
 unable to sleep

Applies to felodipine: oral tablet extended release
General
Side effects of felodipine were generally mild and transient. The most common side effects reported with
felodipine given at 2.5 to 10 mg per day were peripheral edema and headache. Therapy was discontinued due to
adverse drug events in about 6% of patients, primarily for peripheral edema, headache or flushing.
A dose of 20 mg per day has been evaluated in some clinical trials. Although 20 mg per day increased the
antihypertensive effect of felodipine, a disproportionate increase in side effects, especially those associated with
vasodilatory effects, was reported.[Ref]
Other
Peripheral edema was generally mild, but it was age and dose related. It resulted in treatment discontinuation in
about 3% of patients.
Other side effects have included peripheral edema (up to 17.4%), flushing (up to 6.9%), asthenia (up to 3.9%),
warm sensation (up to 1.5%), chest pain, facial edema, and influenza-like illness.
Nervous system
Nervous system side effects have included headache (up to 14.7%), dizziness (up to 3.7%), paresthesia (up to
1.6%), syncope, insomnia, and somnolence.[Ref]
Cardiovascular
Cardiovascular side effects have included palpitation (up to 2.5%), myocardial infarction, hypotension, angina
pectoris, arrhythmia, tachycardia, premature beats, and leukocytoclastic vasculitis. A few rare cases of
felodipine-induced telangiectasia have been reported.[Ref]
Gastrointestinal
Gingival hyperplasia has been avoided or has regressed with good dental hygiene.[Ref]
Gastrointestinal side effects have included dyspepsia (up to 3.9%), nausea (up to 1.7%), constipation (1.5%),
abdominal pain, diarrhea, vomiting, dry mouth, flatulence, and acid regurgitation. Gingival hyperplasia, usually
mild, has been reported in less than 0.5% of patients.[Ref]
Respiratory
Respiratory side effects have included upper respiratory infection (up to 3.9%), cough (up to 1.7%), rhinorrhea
(up to 1.6%), sneezing (up to 1.6%), dyspnea, pharyngitis, bronchitis, influenza, sinusitis, epistaxis, and
respiratory infection.
Dermatologic
Dermatologic side effects have included rash (up to 2%), angioedema, contusion, erythema, and urticaria.
Hematologic
Hematologic side effects have included anemia.
Musculoskeletal
Musculoskeletal side effects have included arthralgia, back pain, leg pain, foot pain, muscle cramps, myalgia,
arm pain, knee pain, and hip pain.[Ref]
Hepatic
Hepatic side effects have included elevated ALT (SGPT) and unspecified serum transaminases.
In clinical studies, one of two episodes of elevated serum transaminases decreased following drug
discontinuation; no follow-up was available for the second patient.
Psychiatric
Psychiatric system side effects have included depression, anxiety disorders, irritability, nervousness, and
decreased libido.
Genitourinary
Genitourinary side effects have included gynecomastia, impotence, urinary frequency, urinary urgency, dysuria,
and polyuria.
Ocular
Ocular system side effects have included visual disturbances.
References
1. Yedinak KC, Lopez LM "Felodipine: a new dihydropyridine calcium-channel antagonist." DICP 25 (1991):
1193-206
2. "Felodipine--another calcium-channel blocker for hypertension." Med Lett Drugs Ther 33 (1991): 115-6
3. Todd PA, Faulds D "Felodipine: a review of the pharmacology and therapeutic use of the extended release
formulation in cardiovascular disorders." Drugs 44 (1992): 251-77
4. "Product Information. Plendil (felodipine)." Merck & Co, Inc, West Point, PA.
5. Schaefer RM, Aldons PM, Burgess ED, Tilvis R, Singh GP, Rehn L, Morgan TO "Improved tolerability of
felodipine compared with amlodipine in elderly hypertensives: A randomised, double-blind study in 535 patients,
focusing on vasodilatory adverse events." Int J Clin Pract 52 (1998): 381
6. Carruthers SG, Vintreed C "Antihypertensive effect and tolerability of felodipine extended release (er) tablets
in comparison with felodipine plain tablets (pt) and placebo in hypertensives on a diuretic." Clin Invest Med 16
(1993): 386-94
7. Weber MA, Goldberg AI, Faison EP, Lipschutz K, Shapiro DA, Nelson EB, Irvin JD "Extended-release
felodipine in patients with mild to moderate hypertension." Clin Pharmacol Ther 55 (1994): 346-52
8. Wiklund I, Dimenas E, Partridge S "Effects of felodipine extended release on quality of life - an analysis of
four clinical trials." Curr Ther Res Clin Exp 56 (1995): 81-94
9. Cutler SA, Hammond JJ "A multicenter comparison of isradipine and felodipine in the treatment of mild-to-
moderate hypertension. The Physician's Study Group." Am J Hypertens 6 (1993): s44-8
10. Cambell LM, Ross JR, Goves JR, Lees CT, McCullagh A, Barnes P, Timerick SJ, Richardson PD "A dose-
finding, placebo-controlled study on extended-release felodipine once daily in treatment of hypertension." J
Cardiovasc Pharmacol 14 (1989): 869-73
11. Achilli F, Buono G, Difraia S, Dolara A, Raffo M, Montereggi A, Ravera E, Valagussa F "Acute and chronic
effects of felodipine extended release and amlodipine in patients with exertional angina: a double-masked,
clinical comparison." Curr Ther Res Clin Exp 57 (1996): 523-36
12. Fagan TC, Haggert BE, Liss C "Efficacy and tolerability of extended-release felodipine and extended-release
nifedipine in patients with mild-to-moderate essential hypertension." Clin Ther 16 (1994): 634-46
13. Vanderkrogt KP, Brand R, Dawson EC "Amlodipine versus extended-release felodipine in general practice: a
randomized, parallel-group study in patients with mild-to-moderate hypertension." Curr Ther Res Clin Exp 57
(1996): 145-58
14. Goudie AW, Gupta OP, Gray PL, Ross JRM, Goves JR, Mckenna BJ, Blomfield IA, Bramley KW, Sharp
RW, Jones DF, Hadley RJ "A comparison of felodipine and nifedipine as monotherapy in patients with mild-to-
moderate hypertension." Curr Ther Res Clin Exp 55 (1994): 625-31
15. Walton T, Symes LR "Felodipine and isradipine: new calcium-channel-blocking agents for the treatment of
hypertension." Clin Pharm 12 (1993): 261-75
16. Welin L, Elvelin L, Niklasson A, Olsson G, Elmfeldt D "Overview of the safety of felodipine based on
clinical trials in patients with hypertension." Am J Cardiol 79 (1997): 996
17. Al-Niaimi F, Lyon C "Felodipine-induced eruptive telangiectasia following mastectomy and radiotherapy."
Br J Dermatol (2009):
18. Hasselgren B, Edgar B, Johnsson G, Ronn O "The acute haemodynamic and renal effects of oral felodipine
and ramipril in healthy subjects." Eur J Clin Pharmacol 45 (1993): 327-32
19. Silvestre JF, Albares MP, Carnero L, Botella R "Photodistributed felodipine-induced facial telangiectasia." J
Am Acad Dermatol 45 (2001): 323-4
20. Lorimer AR, Pringle SD "The safety of felodipine." J Cardiovasc Pharmacol 15 (1990): s85-9
21. Young PC, Turiansky GW, Sau P, Liebman MD, Benson PM "Felodipine-induced gingival hyperplasia."
Cutis 62 (1998): 41-3
Ferrous sulfate Side Effects

http://www.drugs.com/sfx/ferrous-sulfate-side-effects.html
For the Consumer
Applies to ferrous sulfate: drops, elixir, liquid, tablets
Other dosage forms:
 controlled-release capsules, delayed-release tablets, enteric-coated tablets, tablets
Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; darkened or green stools; diarrhea; loss of appetite; nausea; stomach cramps, pain, or upset;
vomiting.
Seek medical attention right away if any of these SEVERE side effects occur while taking ferrous sulfate:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth,
face, lips, or tongue); black, tarry stools; blood or streaks of blood in the stool; fever; severe or persistent nausea,
stomach pain, or vomiting; vomit that looks like blood or coffee grounds.

Applies to ferrous sulfate: compounding powder, oral capsule extended release, oral delayed release tablet, oral
elixir, oral liquid, oral syrup, oral tablet, oral tablet extended release
Gastrointestinal
Gastrointestinal side effects are generally dose-related and have included nausea, constipation, anorexia,
heartburn, vomiting, and diarrhea. In addition, stools may appear darker in color in patients taking ferrous
sulfate.
Oral preparations of ferrous sulfate may rarely cause Hemoccult-positive stools, patients with positive tests
generally require further work-up.[Ref]
Gastrointestinal side effects are dose-related with approximately 25% of patients experiencing side effects at a
dosage of 325 mg three times a day.
Gastrointestinal discomfort may be minimized by initiating ferrous sulfate therapy at smaller doses and gradually
titrating upwards until the desired dose is achieved.
Administering each dose with food may also minimize gastrointestinal discomfort. However, concurrent
administration of ferrous sulfate with food may decrease the amount of iron absorbed.
Due to the small amount of iron released and absorbed, the use of enteric-coated or delayed release ferrous
sulfate preparations may reduce gastrointestinal side effects; however, these products are not recommended for
use.
Constipation may be relieved by administering docusate sodium 100 mg to 200 mg per day in addition to
increasing the intake of oral fluids, such as water.[Ref]
Other
Other side effects have included stained teeth and iron overload (hemosiderosis). Secondary hemochromatosis
due to prolonged iron ingestion has been reported rarely.[Ref]
Stained teeth have primarily occurred following ingestion of ferrous sulfate liquid preparation. Liquid dosage
forms should be diluted in juice or water and sipped through a straw to aid in prevention of staining.
Iron overload (i.e., hemosiderosis) has been reported in patients genetically predisposed, or have underlying
disorders, that augment the absorption of iron. It has also occurred following administration of excessive
parenteral iron therapy, combination of oral and parenteral iron, or in patients with hemoglobinopathies that were
erroneously diagnosed as iron deficiency anemia. Hemosiderosis is treated with repeated phlebotomy or long-
term administration of deferoxamine. The liver is particularly susceptible to toxicity in iron-overload states.[Ref]
Immunologic
Immunologic side effects have rarely included gastroenteritis associated with Yersinia enterocolitica and Listeria
monocytogenes in patients with iron overload status receiving treatment with deferoxamine.[Ref]
It has been hypothesized that gastroenteritis is caused by bacteria that become virulent in the presence of iron
overload resulting in a systemic infection. Treatment consists of discontinuing deferoxamine and initiating
appropriate antimicrobial therapy.[Ref]
Local
Local side effects have included gangrene.[Ref]
Localized corrosion has been reported in a pregnant woman taking ferrous sulfate (tablet) that lodged in a
Meckels diverticulum.
There have also been reports of wax-matrix ferrous sulfate tablets (delayed-release) lodging in the bowels of
patients with strictures.[Ref]
Metabolic
Metabolic side effects have included decreased absorption of thyroxine (T4).[Ref]
References
1. Hutchins L, Lipschitz D "Iron and folate metabolism in renal failure." Semin Nephrol 5 (1985): 142-6
2. Brock C, Curry H, Hanna C, Knipfer M, Taylor L "Adverse effects of iron supplementation: a comparative
trial of a wax- matrix iron preparation and conventional ferrous sulfate tablets." Clin Ther 7 (1985): 568-73
3. Bacon BR "Causes of iron overload." N Engl J Med 326 (1992): 126-7
4. M'Seffar A, Fornasier VL, Fox IH "Arthropathy as the major clinical indicator of occult iron storage disease."
JAMA 238 (1977): 1825-8
5. Falk RJ, Mattern WD, Lamanna RW, Gitelman HJ, Parker NC, Cross RE, Rastall JR "Iron removal during
continuous ambulatory peritoneal dialysis using deferoxamine." Kidney Int 24 (1983): 110-2
6. Pollycove M "Iron overload syndromes." Clin Physiol Biochem 4 (1986): 61-77

7. Laine LA, Bentley E, Chandrasoma P "Effect of oral iron therapy on the upper gastrointestinal tract. A
prospective evaluation." Dig Dis Sci 33 (1988): 172-7
8. Leighton PM, MacSween HM "Yersinia hepatic abscesses subsequent to long-term iron therapy." JAMA 257
(1987): 964-5
9. Boelaert JR, van Landuyt HW, Valcke YJ, Cantinieaux B, Lornoy WF, Vanherweghem JL, Moreillon P,
Vandepitte JM "The role of iron overload in Yersinia enterocolitica and Yersinia pseudotuberculosis bacteremia
in hemodialysis patients." J Infect Dis 156 (1987): 384-7
10. Mofenson HC, Caraccio TR, Sharieff N "Iron sepsis: Yersinia enterocolitica septicemia possibly caused by
an overdose of iron." N Engl J Med 316 (1987): 1092-3
11. Abcarian PW, Demas BE "Systemic Yersinia enterocolitica infection associated with iron overload and
deferoxamine therapy." AJR Am J Roentgenol 157 (1991): 773-5
12. Fakir M, Saison C, Wong T, Matta B, Hardin JM "Septicemia due to Yersinia enterocolitica in a
hemodialyzed depleted patient receiving omeprazole and oral iron supplementation." Am J Kidney Dis 19
(1992): 282-4
13. Mazzoleni G, deSa D, Gately J, Riddell RH "Yersinia enterocolitica infection with ileal perforation
associated with iron overload and deferoxamine therapy." Dig Dis Sci 36 (1991): 1154-60
14. Mossey RT, Sondheimer J "Listeriosis in patients with long-term hemodialysis and transfusional iron
overload." Am J Med 79 (1985): 397-400
15. Shaffer JL, Higham C, Turnberg LA "Hazards of slow-release preparations in patients with bowel strictures."
Lancet 2 (1980): 487
16. Alaily AB "Gangrene of Meckel's diverticulum in pregnancy due to iron tablet." Br Med J 1 (1974): 103
17. Surks MI, Sievert R "Drugs and thyroid function." N Engl J Med 333 (1995): 1688-94
FUROSEMIDE
http://www.drugs.com/sfx/furosemide-side-effects.html
For the Consumer

Applies to furosemide: oral solution, oral tablet
Other dosage forms:
 injection injectable, injection solution
In addition to its needed effects, some unwanted effects may be caused by furosemide. In the event that any of
Severity: Major
You should check with your doctor immediately if any of these side effects occur when taking furosemide:
Rare:
 Chest pain
 chills
 cough or hoarseness
 fever
 general feeling of tiredness or weakness
 headache
 lower back or side pain
 painful or difficult urination
 sore throat
 sores, ulcers, or white spots on the lips or in the mouth
 swollen or painful glands
 tightness in the chest
 wheezing

 Back or leg pains
 black, tarry stools
 bleeding gums
 blistering, peeling, or loosening of the skin
 bloating
 blood in the urine or stools
 blurred vision
 burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
 changes in skin color, pain, tenderness, or swelling of the foot or leg
 clay-colored stools
 cloudy urine
 cold sweats
 confusion
 constipation
 continuing ringing or buzzing or other unexplained noise in the ears
 coughing up blood
 cracks in the skin
 darkened urine
 diarrhea
 difficulty breathing
 dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
 dry mouth
 fast heartbeat
 flushed, dry skin
 fruit-like breath odor
 greatly decreased frequency of urination or amount of urine
 hearing loss
 increased hunger
 increased thirst
 indigestion
 itching
 nausea or vomiting
 nosebleeds
 pain in the joints or muscles
 pains in the stomach, side, or abdomen, possibly radiating to the back
 pale skin
 pinpoint red spots on the skin
 red, irritated eyes
 red, swollen skin
 skin rash
 spots on your skin resembling a blister or pimple
 sweating
 swelling of the feet or lower legs
 trouble breathing with exertion
 unusual weight loss
 vomiting of blood
 yellow eyes or skin

If any of the following symptoms of overdose occur while taking furosemide, get emergency help
immediately:
 Decreased urination
 drowsiness
 increase in heart rate
 irregular heartbeat
 irritability
 mood changes
 muscle cramps
 numbness, tingling, pain, or weakness in the hands, feet, or lips
 rapid breathing
 seizures
 sunken eyes
 thirst
 trembling
 weak pulse
 weakness and heaviness of the legs
 wrinkled skin
Severity: Minor
Some of the side effects that can occur with furosemide may not need medical attention. As your body adjusts to
 Feeling of constant movement of self or surroundings

 hives or welts
 increased sensitivity of the skin to sunlight
 muscle spasm
 redness or other discoloration of the skin
 restlessness
 sensation of spinning
 severe sunburn
 weakness

Applies to furosemide: compounding powder, injectable solution, intravenous solution, oral liquid, oral solution,
oral tablet
Cardiovascular
Volume depletion may predispose some patients to deep venous thrombosis.
In a study of patients with congestive heart failure (CHF) due to myocardial infarction, furosemide has been
shown to decrease left ventricular end diastolic pressure and decrease peripheral vascular resistance before a
significant increase in urine output or decrease in arterial blood pressure is observed.
However, in patients with advanced, chronic CHF, the IV administration of furosemide may result in an acute
vasoconstrictor response associated with an acute increase in vasoconstrictive hormones, such as norepinephrine,
renin, and arginine vasopressin (AVP).
After central venous catheter administration of furosemide 125 mg, 3rd degree AV heart block was observed in a
very ill patient (one case report). Because no other etiology was found, it was believed that the relatively high pH
of furosemide and/or the rapid rate of administration caused the arrhythmia.
Furosemide may increase cholesterol and triglyceride serum levels.[Ref]
Cardiovascular side effects have commonly included intravascular volume depletion and hypotension. Signs and
symptoms of furosemide-induced volume depletion have included thirst, muscle cramps, weakness, dizziness,
lightheadedness, syncope, tachycardia, palpitations, and dry skin. In addition, these signs and symptoms have
often been associated with a hypochloremic metabolic alkalosis and increased serum BUN and creatinine.[Ref]
Metabolic
Hyperuricemia is usually a benign side effect, but may be important in some patients with a history of gout.
Although less so than with thiazide diuretics, furosemide may induce a relative glucose intolerance, which may
be important in some patients, such as diabetics.
Rare instances of hypocalcemia have been reported in patients with latent hypoparathyroidism, in which case
both calcium and magnesium replacement may be helpful.
Metabolic abnormalities may be more likely and severe in patients with liver disease. If a patient has severe liver
disease, frequent monitoring of the patient's electrolytes is recommended.
Calcium balance appears to remain neutral during treatment with a loop diuretic (i.e., furosemide, bumetanide).
Although loop diuretics cause an increase in renal calcium excretion, this appears to be compensated for by a
parathyroid-dependent increase in 1,25-dihydroxyvitamin D levels, which increases intestinal calcium
absorption. Bone metabolism does not appear to be significantly affected by loop diuretics.[Ref]
Metabolic side effects including hypokalemia, hypomagnesemia, and an increase in serum uric acid, have been
relatively common especially with higher doses. Although less common than with thiazide diuretics, mild
hyperlipidemia and hypercholesterolemia have been associated with the use of furosemide. A single study
suggests that chronic furosemide therapy is associated with clinically significant thiamine deficiency via urinary
thiamine loss. This may be important in patients with congestive heart failure since thiamine deficiency may
impair cardiac performance.
Furosemide has been reported to displace thyroxine (T4) from protein-binding sites. When administered in large
intravenous doses (above 80 mg), a transient increase in serum free T4 concentrations and decrease in serum
total T4 concentrations have been reported.[Ref]
Hypersensitivity
Hypersensitivity reactions to furosemide have been uncommon. Rashes, fever, malaise, interstitial nephritis, and
eosinophilia have been reported. Severe anaphylactic or anaphylactoid reactions (e.g., with shock) have been
reported.[Ref]
Furosemide contains a sulfur moiety, and may induce an allergic reaction in some patients with a history of sulfa
sensitivity.
Rare cases of interstitial nephritis and hypersensitivity angiitis associated with furosemide have been reported.[Ref]
Nervous system
Nervous system side effects have included headaches and dizziness. Cases of tinnitus and reversible or
irreversible hearing impairment and deafness have been reported.[Ref]
The doses of furosemide in cases of tinnitus, vertigo, or deafness ranged from 0.24 grams IV given over 40
minutes to 3 grams IV in divided doses over 9 hours and 2 grams IV in a single dose. It is recommended that
infusion rates not exceed 4 mg/min to minimize the risk of ototoxicity.
Ototoxicity may be more likely and more severe due in patients with renal insufficiency.[Ref]
Gastrointestinal
Gastrointestinal side effects have included hepatic encephalopathy in patients with hepatocellular insufficiency,
pancreatitis, jaundice (intrahepatic cholestatic jaundice), anorexia, oral and gastric irritation, cramping, diarrhea,
constipation, nausea, and vomiting.[Ref]
Hepatic
Cholestatic jaundice may be important in patients with liver disease.[Ref]
Hepatic side effects have included rare cases of cholestatic jaundice and increased liver enzymes.[Ref]
Hematologic
Hematologic side effects have included eosinophilia. Thrombocytopenia, aplastic anemia, and leukopenia have
been very rare.[Ref]
Dermatologic
Dermatologic reactions, such as bullous pemphigoid have been reported in rare cases. Exfoliative dermatitis,
erythema multiforme, purpura, photosensitivity, urticaria, rash, Stevens-Johnson Syndrome, toxic epidermal
necrolysis, and pruritus have also been reported.
At least two cases of Sweet syndrome related to use of furosemide have been reported. In one case, Sweet
syndrome was characterized by low-grade fever, tender, papular, erythematous, nonpruritic skin lesions on the
arms and thighs, and redness in the eyes with photophobia. Papuloerythroderma of Ofuji has also been associated
with furosemide use.
Dermatologic side effects reported postmarketing have included drug rash with eosinophilia and systemic
symptoms and acute generalized exanthematous pustulosis.[Ref]
One patient experienced acute generalized exanthematic pustulosis a few hours after receiving intravenous
furosemide.[Ref]
Renal
Renal side effects have included nephrocalcinosis/nephrolithiasis in premature infants treated with furosemide,
therefore renal function should be monitored and renal ultrasonography performed.[Ref]
References
1. Roesner M "The loop diuretics: focus on furosemide and ethacrynic acid." N C Med J 47 (1986): 93-6
2. Ponto LL, Schoenwald RD "Furosemide (frusemide): a pharmacokinetic/pharmacodynamic review." Clin

Pharmacokinet 18 (1990): 381-408
3. Massari P, Moore N, Bonmarchand G, et al "Complete atrio-ventricular block after furosemide." Intensive

Care Med 12 (1986): 54-5
4. Dikshit K, Vyden JK, Forrester JS, et al "Renal and extrarenal hemodynamic effects of furemoside in
congestive heart failure after acute myocardial infarction." N Engl J Med 288 (1973): 1087-90
5. Sommers SC, Higgins TE, Kimelblatt BJ "Chronic aortitis following furosemide therapy." Arch Pathol Lab
Med 108 (1984): 293-4
6. Seligmann H, Halkin H, Rauchfleisch S, et al "Thiamine deficiency in patients with congestive heart failure
receiving long-term furosemide therapy: a pilot study." Am J Med 91 (1991): 151-5
7. Campbell N, Brant R, Stalts H, Stone J, Mahallati H "Fluctuations in blood lipid levels during furosemide
therapy: A randomized, double-blind, placebo-controlled crossover study." Arch Intern Med 158 (1998): 1461-3
8. Dimitriadis G, Tegos C, Golfinopoulou L, Roboti C, Raptis S "Furosemide-induced hyperglycaemia - the

implication of glycolytic kinases." Horm Metab Res 25 (1993): 557-9
9. Rejnmark L, Vestergaard P, Heickendorff L, Andreasen F, Mosekilde L "Effects of thiazide- and loop-

diuretics, alone or in combination, on calcitropic hormones and biochemical bone markers: a randomized
controlled study." J Intern Med 250 (2001): 144-53
10. Bashey A, MacNee W "Tetany induced by frusemide in latent hypoparathyroidism." Br Med J 295 (1987):
960-1
11. vanderHeijden M, Donders SH, Cleophas TJ, Niemeyer MG, vanderMeulen J, Bernink PJ, dePlanque BA,
vanderWall EE "A randomized, placebo-controlled study of loop diuretics in patients with essential
hypertension: The bumetanide and furosemide on lipid profile (BUFUL) clinical study report." J Clin Pharmacol
38 (1998): 630-5
12. Donatucci CF, Deshon GE, Wade CE, Hunt M "Furosemide-induced disturbances of renal function in
patients undergoing TURP." Urology 35 (1990): 295-300
13. Campbell NRC, Wickert WA, Shumak SL "Frusemide causes acute increases in lipid concentrations." Br J
Clin Pharmacol 36 (1993): 607-9
14. Rejnmark L, Vestergaard P, Heickendorff L, Andreasen F, Mosekilde L "Effects of long-term treatment with
loop diuretics on bone mineral density, calcitropic hormones and bone turnover." J Intern Med 257 (2005): 176-
84
15. Surks MI, Sievert R "Drugs and thyroid function." N Engl J Med 333 (1995): 1688-94
16. Tambyah JA, Lim MK "Effect of furesomide on calcium excretion." Br Med J 03/22/69 (1969): 751-2
17. Lin RY "Unusual autoimmune manifestations in furosemide-associated hypersensitivity angiitis." N Y State J

Med 88 (1988): 439-40
18. Clegg HW, Riopel DA "Furosemide-associated fever." J Pediatr 126 (1995): 817-8
19. Amir J, Varsano I "Furosemide-associated fever." J Pediatr 128 (1996): 163-4
20. Siddiqui MA, Zaman MN "Recurrent and chronic leg ulcers secondary to furosemide-induced bullous
pemphigoid." J Am Geriatr Soc 43 (1995): 1183-4
21. Clegg HW, Riopel DA "Furosemide-associated fever: Drug fever or dehydration fever? - Reply." J Pediatr
130 (1997): 500
22. Garty BZ "Furosemide-associated fever: Drug fever or dehydration fever?" J Pediatr 130 (1997): 499
23. Hansbrough JR, Wedner HJ, Chaplin DD "Anaphylaxis to intravenous furosemide." J Allergy Clin Immunol
80 (1987): 538-41
24. David D, Hitzig P "Diuretics and ototoxicity." N Engl J Med 284 (1971): 1328
25. Schwartz G "Ototoxicity induced by furosemide." N Engl J Med 282 (1970): 1413
26. Quick CA, Hoppe W "Permanent deafness associated with furosemide administration." Ann Otol Rhinol
Laryngol 84 (1975): 94-101
27. Vargish T, Benjamin R, Shenkman L "Deafness from furosemide." Ann Intern Med 72 (1970): 761
28. Heidland A, Wigand N "Influence of high doses of furosemide on hearing of uremic patients." Klin
Wochenschr 48 (1970): 1052
29. Venkateswaran P "Transient deafness from high doses of furosemide." Br Med J 4 (1971): 113
30. Lloyd-Mostyn R, Lord I "Ototoxicity of intravenous furosemide." Lancet 2 (1971): 1156
31. "Product Information. Lasix (furosemide)." sanofi-aventis , Bridgewater, NJ.
32. Braithwaite PA "Long-term high-dose mebendazole for cystic hydatid disease of liver: failure in two cases."
Aust N Z J Surg 51 (1981): 23-6
33. Noce R, Paredes BE, Pichler WJ, Krahenbuhl S "Acute generalized exanthematic pustulosis (AGEP) in a
patient treated with furosemide." Am J Med Sci 320 (2000): 331-3
34. Govindarajan G, Bashir Q, Kuppuswamy S, Brooks C "Sweet syndrome associated with furosemide." South
Med J 98 (2005): 570-2
35. Castel T, Gratacos R, Castro J, et al "Bullous pemphigold induced by frusemide." Clin Exp Dermatol 6
(1981): 635-8
36. Sugita K, Kabashima K, Nakashima D, Tokura Y "Papuloerythroderma of Ofuji induced by furosemide." J

Am Acad Dermatol 58(2 Suppl) (2008): S54-5
37. Koch CA, Mazzaferri EL, Larry JA, Fanning TS "Bullous pemphigoid after treatment with furosemide."
Cutis 58 (1996): 340-4
38. Jennings M, Maddocks JL "Interstitial nephritis associated with frusemide." J R Soc Med 79 (1986): 239-40
HYDRALAZINE
http://www.drugs.com/sfx/hydralazine-side-effects.html
For the Consumer

Applies to hydralazine: oral tablet
Other dosage forms:
 injection solution
In addition to its needed effects, some unwanted effects may be caused by hydralazine. In the event that any of
Severity: Major
You should check with your doctor immediately if any of these side effects occur when taking hydralazine:
More common:
 Arm, back, or jaw pain

 chest pain or discomfort
 chest tightness or heaviness
 fast, pounding, or irregular heartbeat or pulse
 nausea
 sweating
Less common:
 Black, tarry stools
 blindness or vision changes
 blisters on the skin

 blurred vision
 burning of the face or mouth
 burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings
 chills
 clumsiness or unsteadiness
 confusion
 cough
 difficult or labored breathing
 dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
 fever and sore throat
 general feeling of discomfort or illness or weakness
 joint pain
 lower back or side pain
 muscle pain
 numbness, tingling, pain, or weakness in the hands or feet
 painful or difficult urination
 pale skin
 shakiness in the legs, arms, hands, or feet
 skin rash or itching
 swelling of the feet or lower legs
 swollen, painful, or tender lymph glands in the neck, armpit, or groin
 tightness in the chest
 trembling or shaking of the hands or feet
 ulcers, sores, or white spots in the mouth
 weakness in hands or feet
Rare:
 Dark urine
 light-colored stools
 upper right abdominal or stomach pain
 yellow eyes and skin

If any of the following symptoms of overdose occur while taking hydralazine, get emergency help
immediately:
 Feeling of warmth
 headache
 redness of the face, neck, arms, and occasionally, upper chest
Severity: Minor
Some of the side effects that can occur with hydralazine may not need medical attention. As your body adjusts to
More common:
 Diarrhea
 weight loss
Less common:
 Constipation
 difficulty with moving
 dizziness
 feeling anxious or depressed
 muscle cramps, pain, or stiffness
 pain in the joints
 rash, hives, welts, or itching
 stuffy nose
 watery eyes

Applies to hydralazine: compounding powder, injectable solution, oral tablet
Immunologic
Because up to 20% of patients who receive 400 mg per day or more develop a systemic lupus erythematosus
syndrome, some experts recommend checking a patient's acetylator status before giving higher doses. Up to 70%
of "resistant" patients are fast acetylators, in whom the dose can be relatively safely increased.
Data suggest that hydralazine lupus may represent a unique hypersensitivity reaction in which antibodies to
native DNA occur. These antibodies are believed to account for the clinical similarities between hydralazine-
induced lupus and systemic lupus erythematosus.[Ref]
Immunologic side effects including the development of a lupus-like syndrome has been reported. It is more likely
in patients who receive 400 mg or more of hydralazine per day, in female patients, or in patients who are slow
acetylators. Of patients who receive less than 200 mg or 400 mg or more per day of hydralazine, 40% and 50%,
respectively, develop a positive ANA titer, and up to 6% and 14%, respectively, develop a lupus-like syndrome.
The lupus syndrome may present as arthralgias (most common), myalgias, lethargy, malaise, a typical
erythematous rash, weight loss, or dyspnea, but may be found incidentally in asymptomatic patients by urinalysis
(proteinuria, hematuria), blood chemistry (elevated ESR, antinuclear antibody), or chest X-ray (interstitial lung
disease, rare). Hypocomplementemia is an extremely rare finding in hydralazine-induced lupus.
Alternative therapy is recommended for patients who develop the clinical appearance of a lupus syndrome,
sustained rises in the antinuclear antibody titer, or the presence of LE cells. The syndrome is reversible, but may
take months to years to resolve.[Ref]
Cardiovascular
Cardiovascular side effects are related to the vasodilatory properties of hydralazine. Reflex tachycardia is
commonly observed. Palpitations, flushing, edema, or chest pain have been reported in less than 5% of patients.
The use of hydralazine in patients with severe chronic heart failure has been associated with ischemia, including
episodes of myocardial infarction.
In patients with pulmonary hypertension (PH) and chronic obstructive pulmonary disease (COPD), hydralazine
may increase pulmonary artery hypertension, especially during periods of hypoxia. The use of hydralazine in
these patients may, on rare occasions, result in profound hypotension, tachycardia, and even death.
Rare cases of bradycardia or cardiac tamponade (associated with hydralazine-induced lupus) have been reported.
Hydralazine does not have a deleterious effect on the lipid profile, and, in fact, has been shown to decrease total
and LDL cholesterol.[Ref]
Provocation of ischemia in patients with compromised left ventricular systolic dysfunction may be due to the
inability of hydralazine to decrease preload, or left ventricular filling pressures.
The mechanism of increased pulmonary hypertension in patients with PH or COPD is a decrease of systemic
vascular resistance accompanied by an increase in cardiac output without a fall in the pulmonary vascular
resistance. In case reports and small series of patients, the use of hydralazine in such patients resulted in
palpitations, chest tightness, unchanged pulmonary vascular resistance, increased pulmonary artery pressure,
decreased systemic vascular resistance, and increased heart rate and cardiac output. For this reason, if
hydralazine must be used, many experts recommend hemodynamic monitoring during hydralazine therapy in
such patients.[Ref]
Nervous system
Nervous system side effects including peripheral neuropathy is dose-related and is more common in slow
acetylators. The neuropathy usually first presents as paresthesias, numbness, and tingling in the extremities. It is
probably the result of pyridoxine deficiency, perhaps because formation of a pyridoxal-hydralazine complex
inactivates the coenzyme, and can, therefore, be treated by administration of pyridoxine. Headache or dizziness
have been reported in approximately 5% of patients.[Ref]
A 61-year-old man with hypertension developed ataxia, numbness, and lower extremity weakness approximately
six months after beginning hydralazine (up to 300 mg per day) and reserpine therapy. The neuropathy partially
resolved after reduction of the hydralazine dosage to 60 mg daily. A complete evaluation revealed that this man
was a slow acetylator of hydralazine.[Ref]
Respiratory
Respiratory side effects include nasal stuffiness, seen in approximately 3% of patients. A case of "hydralazine
lung", associated with hydralazine-induced lupus has been reported.[Ref]
A 48-year-old woman with hypertension developed dyspnea, hemoptysis, pleurisy, proteinuria, and hematuria
one year after beginning hydralazine (150 mg per day), polythiazide, and atenolol therapy. Other associated
findings included an elevated ESR, antinuclear factor, anti-DNA titer, a positive LE test, and radiographic
findings of diffuse interstitial lung disease. Two weeks after stopping hydralazine, the signs and symptoms of
lupus with pulmonary involvement disappeared.
At least one fatal case of hydralazine-induced lupus pneumonitis has been reported. The patient had been taking
hydralazine for more than a year prior to developing symptoms.
A rare case of hydralazine-induced lupus presenting as laryngeal edema and right vocal fold paralysis has been
reported. The patient had been taking hydralazine 50 mg three times daily and exhibited hoarseness of voice and
inspiratory stridor. Discontinuation of hydralazine resulted in reversal of paralysis.[Ref]
Hematologic
A 71-year-old man with hypertension developed anorexia, weight loss, petechiae, and a microcytic anemia
during therapy with hydralazine and oxprenolol. Evaluation for iron deficiency, hemolysis, or marrow depression
was negative. The patient was found to have fecal blood loss, anti-DNA antibodies, decreased complement
levels, a normal upper GI series, and biopsy-proven vasculitis. The syndrome resolved within two weeks after
discontinuation of hydralazine.[Ref]
Hematologic abnormalities have been associated with the hydralazine-induced lupus-like syndrome. Anemia
may be caused by one of at least four hydralazine-associated problems; hemolysis, the formation of a circulating
anticoagulant, thrombocytopenia, and vasculitis. Rare cases of leukopenia and agranulocytosis have been
reported.[Ref]
Renal
Renal side effects are common in idiopathic systemic lupus erythematosus; however, immune complex
glomerulonephritis is rare in drug-induced lupus. Rare cases of rapidly progressive and focal glomerulonephritis
associated with the hydralazine-induced lupus syndrome are often accompanied by anemia, a positive anti-DNA
antibody titer, and a positive ANA titer.[Ref]
In one study, rapidly progressive glomerulonephritis (RPGN) is described in 4 of 444 patients, all of whom were
men who were treated for 5 to 11 years with daily doses of 100 to 250 mg. In three of the four cases, biopsy
revealed a focal and segmental glomerular necrosis with crescents and positive immunofluorescence. The
antinuclear antibody titer became positive in three. Renal function improved in all but one after the withdrawal of
hydralazine and institution of corticosteroid therapy. A number of other cases of RPGN are reported. It appears
to be far more common in patients who are slow acetylators.[Ref]
Dermatologic
A 65-year-old man with ischemic cardiomyopathy developed a pruritic, erythematous, generalized rash within
two months after beginning hydralazine (200 mg per day) therapy. There were no clinical or laboratory signs of
lupus. The rash persisted upon gradual withdrawal of the patient's other medications, but cleared only after
discontinuation of hydralazine. Rechallenge resulted in a recurrent pruritic rash.[Ref]
Dermatologic manifestations of the hydralazine-induced lupus-like syndrome include cutaneous vasculitis. A
generalized, pruritic rash without evidence of lupus has been associated with hydralazine. Rare cases of Sweet's
syndrome (neutrophilic dermatosis) have been associated with hydralazine.[Ref]
Hepatic
A 59-year-old woman with hypertension and cholecystic gallbladder disease developed abdominal pain, nausea,
vomiting, painful hepatomegaly, elevated serum transaminases, direct hyperbilirubinemia, and liver biopsy
findings of subacute hepatitis (with bridging necrosis) within two days after hydralazine was added to her
medical regimen. The signs and symptoms of hepatitis resolved after all medications were withheld, but returned
upon rechallenge with hydralazine.[Ref]
Hepatic reactions are rare. Less than ten cases of hepatitis have been reported, many of which were believed to
be due to hypersensitivity. Histological findings include hepatocellular, cholestatic, mixed hepatocellular-
cholestatic, and granulomatous patterns.[Ref]
Hypersensitivity
A 44-year-old woman with hypertension and acute sinusitis developed acute renal failure, edema, and a
generalized maculopapular erythematous rash during therapy with ampicillin (for sinusitis), hydrochlorothiazide,
and hydralazine. A complete evaluation revealed bilateral hydronephrosis and hydroureters secondary to ureteral
obstruction due to retroperitoneal fibrosis. Renal function returned to baseline after oral prednisone therapy. It is
unclear whether this problem was due to one or more of her medications.[Ref]
Hypersensitivity reactions are rare. Many of the rare cases of hepatitis are believed to be due to hypersensitivity.
A case of retroperitoneal fibrosis and of occupational asthma are believed to be due to hypersensitivity.[Ref]
Genitourinary
Genitourinary side effects including impotence in male patients have been reported rarely.[Ref]
At least two cases of male impotence associated with hydralazine are reported. The mechanism is unclear. There
was no evidence of a neuropathy in either case.[Ref]
Musculoskeletal
Musculoskeletal manifestations of hydralazine-induced lupus include joint pain, arthralgias, and myalgias.
Arthritis in the hands and wrists is a particularly common clinical manifestation.[Ref]
General
The incidence of hydralazine-induced systemic lupus erythematosus (SLE) is estimated at 5.4% for patients
receiving 100 mg daily, 10.4% for those receiving 200 mg daily, and 10% to 20% for those receiving 400 mg or
more daily. It should be noted that hydralazine-induced SLE has occurred at doses as low as 50 mg daily. Risk
factors associated with development of hydralazine-induced SLE include slow acetylator status, HLA-DRw4
phenotype, female gender, high daily dose, therapy longer than 3 months, and a family history of autoimmune
disease. Black patients appear to develop hydralazine-induced SLE less frequently than other populations.
Musculoskeletal symptoms appear to be the most common clinical manifestation of hydralazine-induced SLE;
however, it appears that any organ system can be involved. Laboratory findings that may aid in the diagnosis of
hydralazine-induced SLE include antinuclear antibody (ANA), lupus erythematosus cells, rheumatoid factor, and
antihistone antibodies.[Ref]
References
1. Pirmohamed M "Hydralazine-induced lupus: yet another autoantibody! triplex-DNA stabilization by

hydralazine and the presence of anti-(triplex DNA) antibodies in patients treated with hydralazine - comment."
Hum Exp Toxicol 15 (1996): 361-2
2. Bernstein RM, Egerton-Vernon J, Webster J "Hydrallazine-induced cutaneous vasculitis." Br Med J 280

(1980): 156-7
3. Darwaza A, Lamey P-J, Connell JM "Hydrallazine-induced Sjogren's syndrome." Int J Oral Maxillofac Surg
17 (1988): 92-3
4. Freestone S, Ramsay LE "Transient monoclonal gammopathy in hydralazine-induced lupus erythematosus."

Br Med J 285 (1982): 1536-7
5. Sturman SG, Kumararatne D, Beevers DG "Fatal hydralazine-induced systemic lupus erythematosus." Lancet
12/03/88 (1988): 1304
6. Sequeira W, Polisky RB, Alrenga DP "Neutrophilic dermatosis (Sweet's Syndrome)." Am J Med 81 (1986):
558-60
7. Kincaid-Smith P, Whitworth JA "Hydralazine-associated glomerulonephritis." Lancet 2 (1983): 348
8. Naparstek Y, Kopolovic J, Tur-Kaspa R, Rubinger D "Focal glumerulonephritis in the course of hydralazine-

induced lupus syndrome." Arthritis Rheum 27 (1984): 822-5
9. Cameron HA, Ramsay LE "The lupus syndrome induced by hydralazine: a common complication with low
dose treatment." Br Med J 289 (1984): 410-12
10. Shapiro KS, Pinn VW, Harrington JT, Levey AS "Immune complex glomerulonephritis in hydralazine-
induced SLE." Am J Kidney Dis 3 (1984): 270-4
11. Bass BH "Hydralazine lung." Thorax 36 (1981): 695-6
12. Weinstein J "Hypocomplementemia in hydralazine-associated systemic lupus erythematosus." Am J Med 65

(1978): 553-6
13. Finlay AY, Statham B, Knight AG "Hydrallazine-induced necrotising vasculitis." Br Med J 282 (1981):
1703-4
14. Fleming MG, Bergfeld WF, Tomecki KJ, et al "Bullous systemic lupus erythematosus." Int J Dermatol 28
(1989): 321-6
15. Bjorck S, Svalander C, Westberg G "Hydralazine-associated glomerulonephritis." Acta Med Scand 218
(1985): 261-9
16. Hahn BH, Sharp GC, Irvin WS, et al "Immune responses to hydralazine and nuclear antigens in hydralazine-
induced lupus erythematosus." Ann Intern Med 76 (1972): 365-74
17. Carey RM, Coleman M, Feder A "Pericardial tamponade: a major presenting manifestation of hydralazine-
induced lupus syndrome." Am J Med 54 (1973): 84-7
18. Ludmerer KM, Kissane JM "Clinopathologic conference: renal failure, dyspnea and anemia in a 57 year old
woman." Am J Med 71 (1981): 876-86
19. Ramsey-Goldman R, Franz T, Solano FX, Medsger TA "Hydralazine induced lupus and sweet's syndrome:
report and review of the literature." J Rheumatol 17 (1990): 682-4
20. Koch-Weser J "Hydralazine." N Engl J Med 295 (1976): 320-3
21. Lunde PK, Frislid K, Hansteen V "Disease and acetylation polymorphism." Clin Pharmacokinet 2 (1977):
182-97
22. Blumenkrantz N, Christiansen AH, Ullman S, Asboe-Hansen G "Hydralazine-induced lupoid syndrome."

Acta Med Scand 195 (1974): 443-9
23. Perry HM "Late toxicity to hydralazine resembling systemic lupus erythematosus or rheumatoid arthritis."
Am J Med 54 (1973): 58-72
24. Widgren B, Berglund G, Andersson OK "Side-effects in long-term treatment with hydralazine." Acta Med
Scand 714 (1986): 193-6
25. Brooks AP, Paulley JW "Cutaneous manifestations of hydrallazine toxicity." Br Med J 02/16/80 (1980): 482
26. Peacock A, Weatherall D "Hydralazine-induced necrotising vasculitis." Br Med J 282 (1981): 1121-2
27. Cush JJ, Goldings EA "Southwestern internal medicine conference: drug-induced lupus: clinical spectrum
and pathogenesis." Am J Med Sci 290 (1985): 36-45
28. Timbrell JA, Facchini V, Harland SJ, Mansilla-Tinoco R "Hydralazine-induced lupus: is there a toxic
metabolic pathway?" Eur J Clin Pharmacol 27 (1984): 555-9
29. Ihle BU, Whitworth JA, Dowling JP, Kincaid-Smith P "Hydralazine and lupus nephritis." Clin Nephrol 22
(1984): 230-8
30. Innes A, Rennie JA, Cato GR "Drug-induced lupus caused by very-low-dose hydralazine." Br J Rheumatol
25 (1986): 225-31
31. Packer M, Greenberg B, Massie B, Dash H "Deleterious effects of hydralazine in patients with pulmonary
hypertension." N Engl J Med 306 (1982): 1326-31
32. Danielson M, Kjellberg J, Ohman P, Wernersson B "Evaluation of once daily hydralazine in inadequately
controlled hypertension." Acta Med Scand 214 (1983): 373-80
33. Hammond TG, Mosesson MW "Fatal small-bowel necrosis and pulmonary hypertension in sickle cell
disease." Arch Intern Med 149 (1989): 447-8
34. Miller AJ, Abrams DL, Kaplan BM "Persistent reversal of severe systemic hypertension after prolonged toxic
reaction to hydralazine." Cardiology 60 (1975): 251-6
35. Wehner RJ, Romanauskas VS "An adverse reaction with hydralazine: a case study." AANA J June (1981):
274-5
36. Frontera Y, Piecuch JF "Multiple episodes of angioedema associated with lisinopril, an ACE inhibitor." J Am
Dent Assoc 126 (1995): 217-20
37. Lodeiro JG, Feinstein SJ, Lodeiro SB "Fetal premature atrial contractions associated with hydralazine." Am J
Obstet Gynecol 160 (1989): 105-7
38. Keller CA, Shepard JW, Chun DS, et al "Effects of hydralazine on hemodynamics, ventilation, and gas
exchange in patients with chronic obstructive pulmonary disease and pulmonary hypertension." Am Rev Respir
Dis 129 (1984): 606-11
39. Tuxen DV, Powles AC, Mathur PN, et al "Detrimental effects of hydralazine in patients with chronic air-flow
obstruction and pulmonary hypertension." Am Rev Respir Dis 129 (1984): 388-95
40. Laslett LJ, DeMaria AN, Amsterdam EA, Mason DT "Hydralazine-induced tachycardia and sodium retention
in heart failure: hemodynamic and symptomatic correlation by prazosin therapy." Arch Intern Med 138 (1978):
819-20
41. Lins L-E, Berglund J, Eliasson K, Wernersson B "Efficacy and tolerability of hydralazine, in conventional
and slow-release preparations, during long-term treatment of primary hypertension." Clin Ther 5 (1983): 251-9
42. Fagan TC, Sternleib C, Vlachakis N, et al "Efficacy and safety comparison of nitrendipine and hydralazine as
antihypertensive monotherapy." J Cardiovasc Pharmacol 6 (1984): s1109-13
43. Kronzon I, Cohen M, Winer HE "Adverse effect of hydralazine in patients with primary pulmonary
hypertension." JAMA 247 (1982): 3112-4
44. Williams LL, Lopez LM, Thorman AD, et al "Plasma lipid profiles and antihypertensive agents: effects of
lisinopril, enalapril, nitrendipine, hydralazine, and hydrochlorothiazide." Drug Intell Clin Pharm 22 (1988): 546-
50
45. Packer M, Meller J, Medina N, et al "Provocation of myocardial ischemic events during initiation of
vasodilator therapy for severe chronic heart failure." Am J Cardiol 48 (1981): 939-46
46. Aylward PE, Tonkin AM "Cardiac tamponade in hydrallazine-induced systemic lupus erythematosus." Aust
N Z J Med 12 (1982): 546
47. Tsujimoto G, Horai Y, Ishizaki T, Itoh K "Hydralazine-induced peripheral neuropathy seen in a Japanese
slow acetylator patient." Br J Clin Pharmacol 11 (1981): 622-5
48. Hari CK, Raza SA, Clayton MI "Hydralazine-induced lupus and vocal fold paralysis." J Laryngol Otol 112
(1998): 875-7
49. Perrin B, Malo J-L, Cartier A, et al "Occupational asthma in a pharmaceutical worker exposed to
hydralazine." Thorax 45 (1990): 980-1
50. Birnbaum B, Sidhu GS, Smith RL, Pillinger MH, Tagoe CE "Fulminating hydralazine-induced lupus
pneumonitis." Arthritis Rheum 55 (2006): 501-506
51. Finks SW, Finks AL, Self TH "Hydralazine-induced lupus: maintaining vigilance with increased use in
patients with heart failure." South Med J 99 (2006): 18-22
52. Singh S "Hydralazine-induced lupus." South Med J 99 (2006): 6-7
53. Macleod WN "Anaemia in the hydrallazine-induced lupus syndrome." Scott Med J 28 (1983): 181-2
54. Widerlov E, Karlman I, Storsater J "Hydralazine-induced neonatal thrombocytopenia." N Engl J Med 303
(1980): 1235
55. Orenstein AA, Yakulis V, Eipe J, Costea N "Immune hemolysis due to hydralazine." Ann Intern Med 86
(1977): 450-1
56. Harrison BD, Laidlaw ST, Reilly JT "Fatal aplastic anaemia associated with lisinopril." Lancet 346 (1995):
247-8
57. Gilmour E, Chalmers RJG, Rowlands DJ "Drug-induced sweet's syndrome (acute febrile neutrophilic
dermatosis) associated with hydralazine." Br J Dermatol 133 (1995): 490-1
58. Schapel GJ "Skin rash and hydralazine." Med J Aust 141 (1984): 765-6
59. Young EJ, Fainstein V, Musher DM "Drug-induced fever: cases seen in the evaluation of unexplained fever
in a general hospital population." Rev Infect Dis 4 (1982): 69-77
60. Itoh S, Yamaba Y, Ichinoe A, Tsukada Y "Hydralazine-induced liver injury." Dig Dis Sci 25 (1980): 884-7
61. Stewart GW, Peart WS, Boylston AW "Obstructive jaundice, pancytopenia and hydralazine." Lancet
05/30/81 (1981): 1207
62. Bartoli E, Massarelli G, Solinas A, et al "Acute hepatitis with bridging necrosis due to hydralazine intake."
Arch Intern Med 139 (1979): 698-9
63. Myers JL, Augur NA "Hydralazine-induced cholangitis." Gastroenterology 87 (1984): 1185-8
64. Podevin P, Biour M "Drug-induced ''allergic hepatitis''." Clin Rev Allergy Immunol 13 (1995): 223-44
65. Forster HS "Hepatitis from hydralazine." N Engl J Med 303 (1980): 1362
66. Barnett DB, Hudson SA, Golightly PW "Hydralazine-induced hepatitis." Br Med J 05/10/80 (1980): 1165-6
67. Rice D, Burdick CO "Granulomatous hepatitis from hydralazine therapy." Arch Intern Med 143 (1983): 1077
68. Jori GP, Peschle C "Hydralazine disease associated with transient granulomas in the liver." Gastroenterology
64 (1973): 1163-7
69. Waters VV "Hydralazine, hydrochlorothiazide and ampicillin associated with retroperitoneal fibrosis: case
report." J Urol 141 (1989): 936-7
70. Marinella MA, Billi JE "Lisinopril therapy associated with acute pancreatitis." West J Med 163 (1995): 77-8
71. Keidan H "Impotence during antihypertensive treatment." Can Med Assoc J 114 (1976): 874
RANITIDINE
http://www.drugs.com/sfx/ranitidine-side-effects.html
For the Consumer

Applies to ranitidine: oral solution, oral tablets and tablets for, oral tablets effervescent for solution, parenteral
injection, parenteral injection for iv infusion only
Side effects include:
Oral or parenteral therapy: Headache, sometimes severe.
IM therapy: Transient pain at injection site.
IV therapy: Transient local burning or itching.

Applies to ranitidine: compounding powder, injectable solution, intravenous solution, oral capsule, oral granule
effervescent, oral syrup, oral tablet, oral tablet effervescent
General
Ranitidine is generally well tolerated.[Ref]
Gastrointestinal
Gastrointestinal side effects have included constipation, nausea/vomiting, diarrhea, abdominal pain, and rare
reports of pancreatitis. Rebound acid hypersecretion has been reported after discontinuation of therapy. A case
report of coinfection with Giardia lamblia and Clostridium difficile has been attributed to the achlorhydria
induced by ranitidine predisposing the patient to the enteric infection.[Ref]
Hepatic
Hepatic side effects have included transient and minor increases in serum transaminases, which may be
important in patients with liver disease. There are rare reports of ranitidine-induced hepatitis with or without
jaundice, one case of subfulminant hepatitis with a fatal outcome, and very rare cases of acute interstitial
nephritis.[Ref]
Overall, serious hepatotoxicity due to ranitidine is rare. Hepatocellular, hepatocanalicular, and mixed-type injury
have been reported. In most cases, hepatotoxicity has been associated with fever, chills, nausea, and occasionally
rash and eosinophilia, with onset of symptoms early in the course of therapy. Such symptomatology is suggestive
of a hypersensitivity etiology. The majority of cases resolve following discontinuation of ranitidine therapy
although, at least two fatalities have been reported.
In a study with healthy volunteers , SGPT values were increased to at least twice the pretreatment levels in 6 of
12 subjects receiving 100 mg intravenously four times daily for 7 days, and in 4 of 24 subjects receiving 50 mg
intravenously four times daily for 5 days.[Ref]
Hypersensitivity
Hypersensitivity side effects have included rash, urticaria, bronchospasm, fever, eosinophilia, angioneurotic
edema, acute eosinophilic pneumonia and anaphylaxis. Vasculitis associated with immune complexes has also
been reported.[Ref]
Hematologic
Serious hematologic abnormalities are rare. Patients with renal dysfunction or those who are critically ill may be
at increased risk. While the mechanism of bone marrow toxicity is unknown, ranitidine concentration-dependent
inhibition of hematopoietic progenitor cell activity and hypersensitivity have both been proposed. Hematologic
abnormalities typically resolve upon discontinuation of ranitidine therapy.
Cases of ranitidine-induced thrombocytopenia are typically immune-mediated.[Ref]
Hematologic side effects have included leukopenia, granulocytopenia, and thrombocytopenia in a few patients.
These were usually reversible. Rare cases of agranulocytosis, pancytopenia, sometimes with marrow hypoplasia,
aplastic anemia, and acquired immune hemolytic anemia have been reported.[Ref]
Endocrine
Endocrine side effects have been reported rarely. These have included gynecomastia, impotence, and loss of
libido in male patients, although, the incidence was similar to that in the general population. Hyperprolactinemia,
amenorrhea, reductions in circulating levothyroxine and hypergastrinemia have also been reported.[Ref]
Ranitidine does not possess antiandrogenic properties nor has it been associated with significant changes in
pituitary hormone concentrations under study conditions. However, increases in prolactin serum concentrations
following administration of high doses as well as decreases in levothyroxine serum concentrations during short-
term therapy have been reported. Thyroid hormone levels are not affected during long-term therapy.[Ref]
Nervous system
The mechanism by which ranitidine induces mental status changes is not well established but appears to involve
increased serum concentrations of ranitidine. Renal dysfunction, advanced age, and critical illness appear to be
associated with an increased risk of central nervous system toxicity. Onset of symptoms is typically within the
first few weeks of therapy, but may be delayed. Following discontinuation of ranitidine, mental status usually
normalizes over several days.[Ref]
Nervous system side effects have been reported rarely. These have included headache (sometimes severe),
somnolence, dizziness, malaise, and vertigo. Reversible mental confusion, agitation, depression, and
hallucinations have been reported, predominantly in severely ill elderly patients. Hostility, mania, mental status
changes, dystonia, reversible involuntary motor disturbances have also been reported.[Ref]
Renal
Renal side effects have included mild elevations in serum creatinine. Rare cases of interstitial nephritis and
Fanconi's syndrome have been reported.[Ref]
Dermatologic
Dermatologic side effects have included alopecia, rash, pruritus, contact dermatitis, erythema multiforme,
cutaneous vasculitis, and toxic epidermal necrolysis.[Ref]
Two cases of toxic epidermal necrolysis have been reported in patients with underlying idiopathic
thrombocytopenia purpura. A 72-year-old male also experienced a photosensitivity reaction that resolved after
ranitidine was discontinued.[Ref]
Ocular
Ocular side effects have included blurred vision and increased intraocular pressure in a patient with a history of
glaucoma.[Ref]
Other
Other reported side effects have included tiredness and one case of aseptic meningitis.[Ref]
Cardiovascular
Cardiovascular side effects have rarely included tachycardia, bradycardia, atrioventricular block, and premature
ventricular beats. Several cases of bradycardia following intravenous administration of ranitidine have been
reported. Ranitidine-induced bradycardia may be due to a rise in the serum histamine concentration or due to a
direct effect of ranitidine on cardiac H2 receptors.[Ref]
Musculoskeletal
Musculoskeletal side effects have included arthralgias and myalgias.[Ref]
Respiratory
Respiratory side effects have included an increased risk of developing pneumonia in patients taking H2 receptor
antagonists versus those who had stopped treatment. However, a causal relationship has not been established.
References
1. Wormsley KG "Safety profile of ranitidine - a review." Drugs 46 (1993): 976-85
2. "Product Information. Zantac (ranitidine)." Glaxo Wellcome, Research Triangle Park, NC.
3. Elomar E, Banerjee S, Wirz A, Penman I, Ardill JES, Mccoll KEL "Marked rebound acid hypersecretion after
treatment with ranitidine." Am J Gastroenterol 91 (1996): 355-9
4. Herrmann R, Shaw RG, Fone DJ "Ranitidine-associated recurrent acute pancreatitis." Aust N Z J Med 20
(1990): 243-4
5. Khatami SS, Mukunda B, Ravakhah K "Coinfection with Giardia lamblia and Clostridium difficile after Use
of Ranitidine." Am J Med Sci 327 (2004): 91-3
6. Koch-Weser J, Zeldis JB, Friedman LS, Isselbacher KJ "Ranitidine: a new H2-receptor antagonist." N Engl J
Med 309 (1983): 1368-73
7. Beaugerie L, Patey N, Brousse N "Ranitidine, diarrhoea, and lymphocytic colitis." Gut 37 (1995): 708-11
8. Souza-Lima MA "Hepatitis associated with ranitidine." Ann Intern Med 101 (1984): 207-8
9. Brogden RN, Carmine AA, Heel RC, et al "Ranitidine: a review of its pharmacology and therapeutic use in
peptic ulcer disease and other allied diseases." Drugs 24 (1982): 267-303
10. Ramrakhiani S, Brunt EM, Bacon BR "Possible cholestatic injury from ranitidine with a review of the
literature." Am J Gastroenterol 93 (1998): 822-6
11. Ribeiro JM, Lucas M, Baptista A, Victorino RMM "Fatal hepatitis associated with ranitidine." Am J
Gastroenterol 95 (2000): 559-60
12. Hiesse C, Cantarovich M, Santelli C, et al "Ranitidine hepatotoxicity in renal transplant patient." Lancet
06/01/85 (1985): 1280
13. Black M, Scott WE Jr, Kanter R "Possible ranitidine hepatotoxicity." Ann Intern Med 101 (1984): 208-10
14. Khandheria BK "Hypersensitivity associated with ranitidine ." JAMA 252 (1984): 3252
15. Greer IA, Fellows K "Anaphalactoid reaction to ranitidine in labour." Br J Clin Pract 44 (1990): 78
16. Picardo M, Santucci B "Urticaria from ranitidine." Contact Dermatitis 9 (1983): 327
17. Kavanagh GM, Warwick JA, Burton JL "Ranitidine fever." Lancet 341 (1993): 1422
18. Haboubi N, Asquith P "Rash mediated by immune complexes associated with ranitidine treatment." Br Med J
296 (1988): 897
19. Andreu V, Bataller R, Caballeria J, Rodes J "Acute eosinophilic pneumonia associated with ranitidine." J
Clin Gastroenterol 23 (1996): 160-2
20. Gafter U, Komlos L, Weinstein T, et al "Thrombocytopenia, eosinophilia, and ranitidine ." Ann Intern Med
106 (1987): 477
21. Gibson PR, Pidcock ME "Immune-mediated thrombocytopenia associated with ranitidine therapy ." Med J
Aust 145 (1986): 661-2
22. Brenner LO "Agranulocytosis and ranitidine ." Ann Intern Med 104 (1986): 896-7
23. Spychal RT, Wickham NW "Thrombocytopenia associated with ranitidine." Br Med J 291 (1985): 1687
24. Lane GP, Speed B "Agranulocytosis after ranitidine administration." Med J Aust 150 (1989): 595-6
25. Pixley JS, MacKintosh FR, Sahr EA, Zanjani ED "Mechanism of ranitidine associated anemia." Am J Med
Sci 297 (1988): 369-71
26. Corinaldesi R, Pasquali R, Paternico A, et al "Effects of short- and long-term administrations of famotidine
and ranitidine on some pituitary, sexual and thyroid hormones." Drugs Exp Clin Res 13 (1987): 647-54
27. Berner BD, Conner CS, Sawyer DR, Siepler JK "Ranitidine: a new H2-receptor antagonist." Clin Pharm 1
(1982): 499-509
28. Knigge U, Thuesen B, Dejgaard A, et al "Plasma concentrations of pituitary and peripheral hormones during
ranitidine treatment for two years in men with duodenal ulcer." Eur J Clin Pharmacol 37 (1989): 305-7
29. Fiore CE, Lunetta M, Kanis JA "Long-term effects of histamine H2-receptor antagonists on serum
parathyroid hormone in chronic renal failure." Clin Endocrinol (Oxf) 23 (1985): 277-82
30. Chisholm JC, Jr "Ranitidine hydrochloride-induced hypergastrinemia." J Natl Med Assoc 77 (1985): 303-4
31. Billings RF, Stein MB "Depression associated with ranitidine." Am J Psychiatry 143 (1986): 915-6
32. Marinella MA "Ranitidine associated visual hallucinations." J Clin Gastroenterol 23 (1996): 238
33. Patterson JF "Mania associated with intravenous ranitidine therapy ." South Med J 80 (1987): 1467
34. Durand JM, Suchet L, Morange S, Michel B "Ranitidine and aseptic meningitis (vol 312, pg 886, 1996)."
BMJ 312 (1996): 1392
35. Sonnenblick M, Yinnon A "Mental confusion as a side effect of ranitidine ." Am J Psychiatry 143 (1986):
257
36. Delerue O, Muller JP, Destee A, Warot P "Mania-like episodes associated with ranitidine ." Am J Psychiatry
145 (1988): 271
37. Slugg PH, Haug MT, Pippenger CE "Ranitidine pharmacokinetics and adverse central nervous system
reactions." Arch Intern Med 152 (1992): 2325-9
38. Picotte-Pillmayer D, DiMaggio JR, Baile WF "H-2 blocker delirium." Psychosomatics 36 (1995): 74-7
39. Cantu TG, Korek JS "Central nervous system reactions to histamine-2 receptor blockers." Ann Intern Med
114 (1991): 1027-34
40. Davis BJ, Aul EA, Granner MA, Rodnitzky RL "Ranitidine-induced cranial dystonia." Clin Neuropharmacol
17 (1994): 489-91
41. Gaughan WJ, Sheth VR, Francos GC, Michael HJ, Burke JF "Ranitidine-induced acute interstitial nephritis
with epithelial cell foot process fusion." Am J Kidney Dis 22 (1993): 337-40
42. Neelakantappa K, Gallo GR, Lowenstein J "Ranitidine-associated interstitial nephritis and Fanconi
syndrome." Am J Kidney Dis 22 (1993): 333-6
43. Miralles ES, Nunez M, Delolmo N, Ledo A "Ranitidine-related toxic epidermal necrolysis in a patient with
idiopathic thrombocytopenic purpura." J Am Acad Dermatol 32 (1995): 133-4
44. Velez A, Moreno JC "Second case of ranitidine-related toxic epidermal necrolysis in a patient with idiopathic
thrombocytopenic purpura." J Am Acad Dermatol 42 (2000): 305
45. Todd P, Norris P, Hawk JLM, Duvivier AWP "Ranitidine-induced photosensitivity." Clin Exp Dermatol 20
(1995): 146-8
46. Goh CL, Ng SK "Allergic contact dermatitis to ranitidine." Contact Dermatitis 11 (1984): 252
47. Alomar A, Puig L, Vilaltella I "Allergic contact dermatitis due to ranitidine." Contact Dermatitis 17 (1987):
54-5
48. Khera DC, Smith SL, Slabic SF "Ranitidine-induced bradycardia ." Am J Gastroenterol 83 (1988): 332-3
49. Nault MA, Milne B, Parlow JL "Effects of the Selective H1 and H2 Histamine Receptor Antagonists
Loratadine and Ranitidine on Autonomic Control of the Heart." Anesthesiology 96 (2002): 336-341
50. Alliet P, Devos E "Ranitidine-induced bradycardia in a neonate - secondary to congenital long QT interval
syndrome?" Eur J Pediatr 153 (1994): 781
51. Allegri G, Pellegrini K, Dobrilla G "First-degree atrioventricular block in a young duodenal ulcer patient
treated with a standard oral dose of ranitidine." Agents Actions 24 (1988): 237-42
SITAGLIPTIN
http://www.drugs.com/sfx/sitagliptin-side-effects.html
For the Consumer

Applies to sitagliptin: oral tablet
As well as its needed effects, sitagliptin may cause unwanted side effects that require medical attention.
Severity: Major
If any of the following side effects occur while taking sitagliptin, check with your doctor immediately:
Less common:
 Anxiety
 blurred vision
 chills
 cold sweats
 confusion
 cool, pale skin
 depression
 dizziness
 fast heartbeat
 headache
 increased hunger
 loss of consciousness
 nausea
 nervousness
 nightmares
 seizures
 shakiness
 slurred speech
Severity: Minor
Some sitagliptin side effects may not need any medical attention. As your body gets used to the medicine these
side effects may disappear. Your health care professional may be able to help you prevent or reduce these side
effects, but do check with them if any of the following side effects continue, or if you are concerned about them:
More common:
 Body aches or pain
 cough
 difficulty with breathing

 ear congestion
 fever
 loss of voice
 muscle aches
 sneezing
 sore throat
 stuffy or runny nose
Less common:
 Abdominal or stomach pain
 diarrhea

Applies to sitagliptin: oral tablet
Metabolic
Common (1% to 10%): Hypoglycemia (when used in combination with insulin or sulfonylurea)[Ref]
Gastrointestinal
In a pooled analysis of 19 trials (sitagliptin 100 mg/day, n=5429; active control or placebo, n=4817), the
incidence of acute pancreatitis was in 0.1 per 100 patient-years in each group (4 patients in each group)[Ref]
Common (1% to 10%): Abdominal pain, nausea, diarrhea, constipation, gastroenteritis

Postmarketing reports: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis,
vomiting[Ref]
Respiratory
Common (1% to 10%): Nasopharyngitis, upper respiratory infection, pharyngitis,

Postmarketing reports: Interstitial lung disease[Ref]
Nervous system
Common (1% to 10%): Headache

Uncommon (0.1% to 1%): Dizziness[Ref]
Hypersensitivity
There have been postmarketing reports of serious hypersensitivity reactions in patients treated with this drug.
Reactions have occurred within the first 3 months of therapy initiation, with some reports occurring after the first
dose.[Ref]
Postmarketing reports: Serious hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria,
cutaneous vasculitis, and exfoliative skin conditions including Stevens-Johnson syndrome[Ref]
Hepatic
Postmarketing reports: Hepatic enzyme elevations[Ref]

Renal
There have been postmarketing reports of worsening renal function, including acute renal failure, sometime
requiring dialysis. A subset of these reports involved patients with renal insufficiency, some who were prescribed
inappropriate doses of this drug. With drug discontinuation, supportive treatment and discontinuation of
potentially causative agents, a return to baseline levels of renal insufficiency occurred.[Ref]
Postmarketing reports: Worsening renal function[Ref]
Musculoskeletal
Postmarketing reports: Arthralgia, myalgia, extremity pain, back pain, osteoarthritis[Ref]
Between October 2006 and December 2013, thirty-three cases of severe arthralgia have been reported to the FDA
Adverse Event Reporting System Database. Each case involved the use of 1 or more dipeptidyl peptidase-4
(DPP-4) inhibitors. In all cases, substantial reduction in prior activity level was reported, 10 patients were
hospitalized due to disabling joint pain. In 22 cases, symptoms appeared within 1 month of starting therapy. In 23
cases symptoms resolved less than 1 month after discontinuation. A positive rechallenge was reported in 8 cases,
with 6 cases involving use of a different DPP-4 inhibitor. Sitagliptin had the greatest number of cases reported
(n=28) followed by saxagliptin (n=5), linagliptin (n=2), alogliptin (n=1), and vildagliptin (n=2).[Ref]
Cardiovascular
Common (1% to 10%): Hypertension[Ref]
Dermatologic
Postmarketing reports: Pruritus[Ref]
General
The most commonly reported adverse events included upper respiratory tract infection, nasopharyngitis, and
headache. As add-on to insulin studies, hypoglycemia was commonly reported.[Ref]
References
1. "Product Information. Januvia (sitagliptin)." Merck & Company Inc, West Point, PA.
2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
3. Cerner Multum, Inc. "Australian Product Information." O 0
4. US Food and Drug Administration "FDA Drug Safety Communication: FDA warns that DPP-4 inhibitors for
type 2 diabetes may cause severe joint pain. Available from: URL:
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM460038.pdf." ([2015, Aug 28]):

Chemical Toxins & Effects of Pharmaceuticals

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Chemical Toxins & Effects of Pharmaceuticals

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CHEMICAL TOXINS & EFFECTS OF PHARMACEUTICALS

Omeprazole Side Effects

OverviewSide EffectsDosageInteractionsFor ProfessionalsMore...

For Healthcare Professionals

Isosorbide mononitrate Side Effects

For the Consumer

Ezetimibe Side Effects

For the Consumer

Doxazosin [Side] Effects

For the Consumer

Blurred vision has been reported in postmarketing studies.

For the Consumer

For the Consumer

For the Consumer

 tingling of hands or feet

Incidence not known:

Incidence not known:

 burning while urinating

For Healthcare Professionals

Hematologic side effects have included anemia.

Ocular system side effects have included visual disturbances.

Ferrous sulfate Side Effects

Other dosage forms:

 controlled-release capsules, delayed-release tablets, enteric-coated tablets, tablets

For Healthcare Professionals

Local side effects have included gangrene.[Ref]

Metabolic side effects have included decreased absorption of thyroxine (T4).[Ref]

3. Bacon BR "Causes of iron overload." N Engl J Med 326 (1992): 126-7

6. Pollycove M "Iron overload syndromes." Clin Physiol Biochem 4 (1986): 61-77

For the Consumer

Other dosage forms:

 injection injectable, injection solution

 general feeling of tiredness or weakness

 lower back or side pain

 painful or difficult urination

 sores, ulcers, or white spots on the lips or in the mouth

 swollen or painful glands

 tightness in the chest

 unusual bleeding or bruising

 unusual tiredness or weakness

Incidence not known:

 blistering, peeling, or loosening of the skin

 blood in the urine or stools

 changes in skin color, pain, tenderness, or swelling of the foot or leg

 continuing ringing or buzzing or other unexplained noise in the ears

 dizziness, faintness, or lightheadedness when getting up from a lying or sitting position

 flushed, dry skin

 fruit-like breath odor

 greatly decreased frequency of urination or amount of urine

 pain in the joints or muscles

 pains in the stomach, side, or abdomen, possibly radiating to the back

 pinpoint red spots on the skin

 red, irritated eyes

 red, swollen skin

 spots on your skin resembling a blister or pimple

 swelling of the feet or lower legs

 trouble breathing with exertion

 unusual weight loss