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Norvasc

Last reviewed on RxList: 3/15/2017
Norvasc Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 03/15/2017

Norvasc (amlodipine) is a calcium channel blocker (CCB) prescribed for the prevention and treatment of heart pain or chest pain from angina, and for the treatment of high blood pressure. Norvasc is available as a generic drug. Common side effects of Norvasc include:

  • headache,
  • swelling (edema) of the ankles or feet,
  • dizziness,
  • lightheadedness,
  • drowsiness,
  • tired feeling,
  • nausea,
  • abdominal or stomach pain, or
  • flushing (warmth, redness, or tingly feeling).

Excessive lowering of blood pressure during initiation of Norvasc treatment can occur (especially in patients taking another blood pressure medication with Norvasc).

The usual initial antihypertensive oral dose of Norvasc is 5 mg once daily, and the maximum dose is 10 mg once daily. Norvasc dosages may need to be lowered in patients with liver dysfunction. Drug interactions and warnings in patients with severe coronary artery disease can increase the frequency and severity of angina or actually cause a heart attack on rare occasions. Norvasc may interact with simvastatin, ketoconazole, itraconazole, ritonavir, diltiazem, and cyclosporine. Norvasc is generally avoided during pregnancy and is not recommended for use while breastfeeding.

Our Norvasc Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Norvasc Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Norvasc (Amlodipine Besylate)

Norvasc Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

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) at doses up to 10 mg to placebo (N=1250), discontinuation of NORVASC because of adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%). The most commonly reported side effects more frequent than placebo are reflected in the table below. The incidence (%) of side effects that occurred in a dose related manner are as follows:

  2.5 mg Amlodipine 5 mg 10 mg Placebo
N=275 N=296 N=268 N=520
Edema 1.8 3.0 10.8 0.6
Dizziness 1.1 3.4 3.4 1.5
Flushing 0.7 1.4 2.6 0.0
Palpitation 0.7 1.4 4.5 0.6

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

  NORVASC (%)
(N=1730)
Placebo (%)
(N=1250)
Fatigue 4.5 2.8
Nausea 2.9 1.9
Abdominal Pain 1.6 0.3
Somnolence 1.4 0.6

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:

  NORVASC Placebo
Male=%
(N=1218)
Female=%
(N=512)
Male=%
(N=914)
Female=%
(N=336)
Edema 5.6 14.6 1.4 5.1
Flushing 1.5 4.5 0.3 0.9
Palpitations 1.4 3.3 0.9 0.9
Somnolence 1.3 1.6 0.8 0.3

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, peripheral ischemia, syncope, tachycardia, vasculitis.

Central And Peripheral Nervous System

hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo.

Gastrointestinal

anorexia, constipation, 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,1 myalgia.

Psychiatric

sexual dysfunction (male1 and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization.

Respiratory System

dyspnea,1 epistaxis.

Skin And Appendages

angioedema, erythema multiforme, pruritus,1 rash,1 rash erythematous, rash maculopapular.

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.

NORVASC 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 [see Clinical Studies], the adverse event profile was similar to that reported previously (see above), with the most common adverse event being peripheral edema.

Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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.

Postmarketing reporting has also revealed a possible association between extrapyramidal disorder and amlodipine.

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

1These 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.

Read the entire FDA prescribing information for Norvasc (Amlodipine Besylate)

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