Norvasc Side Effects

Generic name: amlodipine

Note: This document contains side effect information about amlodipine. Some of the dosage forms listed on this page may not apply to the brand name Norvasc.

Some side effects of Norvasc 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 amlodipine: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking amlodipine (the active ingredient contained in Norvasc) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• feeling like you might pass out;

• swelling in your hands, ankles, or feet;

• pounding heartbeats or fluttering in your chest; or

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Less serious side effects of amlodipine may include:

• headache;

• dizziness, drowsiness;

• tired feeling;

• stomach pain; or

• flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to amlodipine: oral tablet

General

Amlodipine (the active ingredient contained in Norvasc) 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.

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.

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%). During studies in patients with documented coronary artery disease, the most common side effect was peripheral edema. Asthenia, hot flushes, malaise, pain, and rigors 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.

Cardiovascular

Cardiovascular side effects have included palpitation (up to 4.5%). Arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, hypotension, peripheral ischemia, postural hypotension, 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. Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine (the active ingredient contained in Norvasc) especially in patients with severe obstructive coronary artery disease.

Nervous system

Nervous system side effects have included headache (7.3%), dizziness (up to 3.4%), and somnolence (up to 1.6%). Hypoesthesia, paresthesia, peripheral neuropathy, postural dizziness, syncope, tinnitus, 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

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

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.

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.

Metabolic

Metabolic side effects have included hyperglycemia, thirst, weight decrease, and weight gain in less than 1% but greater than 0.1% of patients. New-onset diabetes has been reported. A single case of acute porphyria exacerbation has been associated with the use of amlodipine (the active ingredient contained in Norvasc) and confirmed upon rechallenge in the same patient. Calcium channel blockers have been suggested as possibly unsafe in patients with this condition.

Musculoskeletal

Musculoskeletal side effects have included myalgia (up to 2%). Arthralgia, arthrosis, and muscle cramps have been reported in less than 1% but greater than 0.1% of patients. Hypertonia, muscle weakness, and twitching have been reported in less than 0.1% of patients.

Psychiatric

Psychiatric side effects have included male sexual dysfunction (up to 2%). Abnormal dreams, anxiety, depersonalization, depression, female sexual dysfunction, insomnia, and nervousness have been reported in less than 1% but greater than 0.1% of patients. Agitation, amnesia, and apathy have been reported in less than 0.1% of patients.

Dermatologic

A 62-year-old man with hypertension and psoriasis developed erythema multiforme within three days after starting amlodipine (the active ingredient contained in Norvasc) The rash resolved upon substitution with nifedipine.

Dermatologic side effects have included rash and erythematous rash in up to 2% of patients. Angioedema, erythema multiforme, increased sweating, maculopapular rash, and pruritus have been reported 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. At least one case of amlodipine-associated bullous pemphigoid (with erythema multiforme-like clinical features) has been reported.

Ocular

Ocular side effects have included abnormal vision, conjunctivitis, diplopia, and eye pain in less than 1% but greater than 0.1% of patients. Abnormal visual accommodation and xerophthalmia have been reported in less than 0.1% of patients.

Respiratory

Respiratory side effects have included epistaxis (up to 2%) and dyspnea (less than 1% but greater than 0.1%). Coughing and rhinitis have been reported in less than 0.1% of patients. Pulmonary edema was reported during a study of patients with NYHA Class III or IV heart failure without clinical symptoms or objective evidence of underlying ischemic disease.

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 allergic reaction (less than 1% but greater than 0.1%).

Endocrine

In one case, a patient's gynecomastia resolved upon substitution of amlodipine (the active ingredient contained in Norvasc) 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 (the active ingredient contained in Norvasc) therapy.

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