Amlodipine Side Effects

Brand Names: Norvasc

Please note - some side effects for Amlodipine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Amlodipine - for the Consumer

Amlodipine/Benazepril

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Amlodipine/Benazepril:

Dizziness or lightheadedness when sitting or standing; headache; persistent, dry cough; swelling of the hands or feet.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; infection (fever, sore throat); irregular or slow heartbeat; yellowing of the skin or eyes.

Amlodipine/Atorvastatin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Amlodipine/Atorvastatin:

Constipation; diarrhea; dizziness; drowsiness; flushing; gas; headache; nausea; stomach upset or pain; tiredness; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); change in the amount of urine produced or increased urination; changes in vision; dark urine; fainting; fast or irregular heartbeat; increased frequency, duration, or severity of chest pain; joint pain; muscle aches, pain, tenderness, or weakness, especially with fever, unusual tiredness, or general body discomfort; numbness of an arm or leg; pale stools; red, swollen, blistered, or peeling skin; severe or persistent stomach pain; sharp or crushing chest pain; sudden leg pain; sudden severe headache, vomiting, dizziness, or fainting; sudden shortness of breath; swelling of your feet or legs; tender, bleeding, or swollen gums; unexplained weight gain; yellowing of eyes or skin.

Amlodipine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Amlodipine:

Dizziness; drowsiness; fatigue; flushing; headache; muscle cramps; nausea; stomach pain; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; difficulty breathing; fast or irregular heartbeat; pounding in the chest; swelling of feet or legs; tender, bleeding, or swollen gums; worsening chest pain; yellowing of the eyes or skin.

Amlodipine/Valsartan

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Amlodipine/Valsartan:

Dizziness; dry cough; sore throat; stuffy nose; upper respiratory tract infection.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); change in the amount of urine produced; chest pain; fainting; fast or irregular heartbeat; numbness of an arm or leg; severe or persistent dizziness; severe or persistent muscle pain or aches; shortness of breath; sudden severe headache or vomiting; sudden unexplained weight gain; sudden vision changes; swelling of the feet, ankles, or hands; yellowing of the eyes or skin.

Amlodipine/Olmesartan

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Amlodipine/Olmesartan:

Dizziness; flushing.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); change in the amount of urine produced; chest pain; fainting; fast or irregular heartbeat; numbness of an arm or leg; severe or persistent dizziness; severe or persistent muscle pain or aches; shortness of breath; sudden severe headache or vomiting; sudden unexplained weight gain; sudden vision changes; swelling of the feet, ankles, or hands; yellowing of the eyes or skin.

Amlodipine/Valsartan/Hydrochlorothiazide

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Amlodipine/Valsartan/Hydrochlorothiazide:

Dizziness; dry cough; headache; indigestion; lightheadedness; muscle spasms; nausea; sore throat; stuffy nose; tiredness; upset stomach.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); back pain; blurred vision or other vision changes; change in the amount of urine produced; chest pain; confusion; dark urine; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; joint pain, swelling, warmth, or redness (especially of the big toe joint); loss of appetite; mental or mood changes; numbness of an arm or leg; pale stools; red, swollen, blistered, or peeling skin; seizures; severe or persistent dizziness, drowsiness, or lightheadedness; severe or persistent dry mouth; severe or persistent muscle pain, tenderness, or cramps; severe or persistent nausea, vomiting, or stomach pain; shortness of breath; sudden severe headache; sudden unexplained weight gain; sudden vision changes; swelling of the feet, ankles, or hands; unusual bruising or bleeding; unusual thirst, tiredness, or weakness; yellowing of the eyes or skin.

Amlodipine Side Effects - for the Professional

Amlodipine

Amlodipine has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with Amlodipine was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with Amlodipine were mild or moderate severity. In controlled clinical trials directly comparing Amlodipine (N=1730) in doses up to 10 mg to placebo (N=1250), discontinuation of Amlodipine due to adverse reactions was required in only about 1.5% of patinets and was not significantly different from placebo (about 1%). The most common side effects are headache and edema. The incidence (%) of side effects which occurred in a dose related manner are as follows:

Other adverse experiences which were not clearly dose related but which were reported with an incidence greater than 1.0% in placebo-controlled clinical trials include the following:

Placebo-Controlled Studies

For several adverse experiences that appear to be drug and dose related, there was a greater incidence in women than men associated with Amlodipine treatment as shown in the following table:

The following events occurred in <1% but >0.1% of patients in controlled clinical trials or under conditions of open trials or marketing experience where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship:

Cardiovascular: arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, hypotension, peripheral ischemia, syncope, tachycardia, postural dizziness, postural hypotension, vasculitis.

Central and Peripheral Nervous System: hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo.

Gastrointestinal: anorexia, constipation, dyspepsia,** dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia.

General: allergic reaction, asthenia,** back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease.

Musculoskeletal System: arthralgia, arthrosis, muscle cramps,** myalgia.

Psychiatric: sexual dysfunction (male** and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization.

Respiratory System: dyspnea,** epistaxis.

Skin and Appendages: angioedema, erythema multiforme, pruritus,** rash,** rash erythematous, rash maculopapular.

**These events occurred in less than 1% in placebo-controlled trials, but the incidence of these side effects was between 1% and 2% in all multiple dose studies.

Special Senses: abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus.

Urinary System: micturition frequency, micturition disorder, nocturia.

Autonomic Nervous System: dry mouth, sweating increased.

Metabolic and Nutritional: hyperglycemia, thirst.

Hemopoietic: leukopenia, purpura, thrombocytopenia.

The following events occurred in <0.1% of patients: cardiac failure, pulse irregularity, extrasystoles, skin discoloration, urticaria, skin dryness, alopecia, dermatitis, muscle weakness, twitching, ataxia, hypertonia, migraine, cold and clammy skin, apathy, agitation, amnesia, gastritis, increased appetite, loose stools, coughing, rhinitis, dysuria, polyuria, parosmia, taste perversion, abnormal visual accommodation, and xerophthalmia.

Other reactions occurred sporadically and cannot be distinguished from medications or concurrent disease states such as myocardial infarction and angina.

Amlodipine therapy has not been associated with clinically significant changes in routine laboratory tests. No clinically relevant changes were noted in serum potassium, serum glucose, total triglycerides, total cholesterol, HDL cholesterol, uric acid, blood urea nitrogen, or creatinine.

In the CAMELOT and PREVENT studies the adverse event profile was similar to that reported previously, with the most common adverse event being peripheral edema.

The following postmarketing event has been reported infrequently where a causal relationship is uncertain: gynecomastia. In postmarketing experience, jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis) in some cases severe enough to require hospitalization have been reported in association with use of Amlodipine.

Amlodipine has been used safely in patients with chronic obstructive pulmonary disease, well-compensated congestive heart failure, coronary artery disease, peripheral vascular disease, diabetes mellitus, and abnormal lipid profiles.

Side Effects by Body System

General

Amlodipine is generally well-tolerated at dosages up to 10 mg per day. Most side effects reported were of mild or moderate severity and were dose-related. Headache and edema are the most common side effects.

Other

Other side effects have included edema (up to 14.6%), flushing (up to 4.5%), fatigue (4.5%), and back pain (up to 2%). Allergic reaction, asthenia, hot flushes, malaise, pain, rigors, tinnitus, weight decrease, and weight gain have been reported in less than 1% but greater than 0.1% of patients. Cold and clammy skin and parosmia have been reported in less than 0.1% of patients. A single case of acute porphyria exacerbation has been associated with the use of amlodipine, and confirmed upon rechallenge in the same patient. Calcium channel blockers have been suggested as possibly unsafe in patients with this condition.

Cardiovascular

Cardiovascular side effects have included palpitation (up to 4.5%) and peripheral edema (2%). Peripheral edema may become a chronic problem, and may occur in up to 10% of patients who are receiving 10 mg doses. Arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, hypotension, peripheral ischemia, postural dizziness, postural hypotension, syncope, tachycardia, and vasculitis have been reported in less than 1% but greater than 0.1% of patients. Cardiac failure, extrasystoles, and pulse irregularity have been reported in less than 0.1% of patients. Angina and myocardial infarction have occasionally been reported; however, these reactions could not be distinguished from coexisting disease states or medications. Worsened angina has been rarely associated with the use of amlodipine (as with other calcium channel blockers).

Recent data have shown that the use of amlodipine in patients with NYHA Class III or IV heart failure is not associated with worsened heart failure.

Nervous system

Nervous system side effects have included headache (7.3%), dizziness (up to 3.4%), and somnolence (1.6%). Hypoesthesia, paresthesia, peripheral neuropathy, tremor, and vertigo have been reported in less than 1% but greater than 0.1% of patients. Ataxia and migraine have been reported in less than 0.1% of patients. Myoclonus has been reported.

Gastrointestinal

Gastrointestinal side effects have included nausea (2.9%), dysphagia (up to 2%), and abdominal pain (1.6%). Anorexia, constipation, diarrhea, dry mouth, dyspepsia, flatulence, gingival hyperplasia, pancreatitis, and vomiting have been reported in less than 1% but greater than 0.1% of patients. Gastritis, increased appetite, loose stools, and taste perversion have been reported in less than 0.1% of patients. At least one case of amlodipine-associated dysgeusia has been reported and confirmed upon rechallenge.

Hematologic

A case study reports a 34-year-old woman with a history of chronic renal failure secondary to glomerulonephritis, who was started on amlodipine for uncontrolled hypertension. Three days later the patient developed severe thrombocytopenia. After discontinuation of the drug, the platelet count returned to normal.

Hematologic side effects have included leukopenia, purpura, and thrombocytopenia in less than 1% but greater than 0.1% of patients.

Hepatic

Hepatic side effects have included jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis) during postmarketing experience. In some instances, these cases were severe enough to require hospitalization.

Dermatologic

Dermatologic side effects have included rash and erythematous rash in up to 2% of patients and angioedema, erythema multiforme, increased sweating, maculopapular rash, and pruritus in less than 1% but greater than 0.1% of patients. Alopecia, dermatitis, skin discoloration, skin dryness, and urticaria have been reported in less than 0.1% of patients. Amlodipine-associated lichen planus and telangiectasia have been rarely reported.

Genitourinary

Genitourinary side effects have included micturition disorder, micturition frequency, and nocturia in less than 1% but greater than 0.1% of patients. Dysuria and polyuria have been reported in less than 0.1% of patients.

Hypersensitivity

Hypersensitivity side effects have included at least one case of erythema multiforme. Hypersensitivity reactions have rarely been reported, although experience with amlodipine is limited.

A 62-year-old man with hypertension and psoriasis developed erythema multiforme within three days after starting amlodipine. The rash resolved upon substitution with nifedipine.

Endocrine

In one case, a patient's gynecomastia resolved upon substitution of amlodipine with an unrelated antihypertensive agent.

Endocrine side effects have included gynecomastia during postmarketing experience.

Renal

Renal side effects have been reported rarely. At least one case of interstitial nephritis has been associated with amlodipine therapy.

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