Norvasc

[Amlodipine]

Side Effects & Drug Interactions
ADVERSE REACTIONS

NORVASC has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with NORVASC was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with NORVASC were of mild or moderate severity. In controlled clinical trials directly comparing NORVASC (N= 1730) in doses up to 10 mg to placebo (N= 1250), discontinuation of NORVASC due to adverse reactions was required in only about 1.5% of patients 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:

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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.

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