Amlodipine (Norvasc) Adverse Reactions
- abdominal pain
- angina
- angioedema
- anorexia
- blurred vision
- bradycardia
- constipation
- diarrhea
- dizziness
- drowsiness
- dysphagia
- edema
- elevated hepatic enzymes
- erythema multiforme
- fatigue
- flatulence
- flushing
- gynecomastia
- headache
- hepatitis
- hypotension
- jaundice
- leukopenia
- nausea/vomiting
- orthostatic hypotension
- palpitations
- pancreatitis
- paresthesias
- peripheral edema
- sinus tachycardia
- syncope
- thrombocytopenia
- tremor
- vertigo
Amlodipine (Norvasc) Adverse Reactions
Amlodipine therapy is generally well tolerated at doses of up to 10 mg/day. Most of the reported reactions are of mild to moderate severity and are related to the drug’s vasodilatory effect on the periphery. Dose-related headache and edema (e.g., peripheral edema) are reported most frequently. Dizziness, flushing, and palpitations also occur and also appear to be dose-related. Since the vasodilation induced by amlodipine is gradual in onset, acute hypotension has rarely been reported after oral administration. Nonetheless, caution, as with any other peripheral vasodilator, should be exercised when administering amlodipine to patients at risk for hypotension (see Contraindications/Precautions). Other adverse reactions that have been reported and do not appear to be dose-related include fatigue, nausea/vomiting, abdominal pain, and drowsiness. Although calcium-channel blockers are effective drugs for treating angina, worsening of angina has occurred in as many as 10% of patients receiving nifedipine for angina pectoris. This may be a result of excessive hypotension, myocardial steal, reflex sinus tachycardia, or a reflex increase in myocardial contractility. Since amlodipine is similar to nifedipine in structure and actions, patients with angina should be observed for worsening symptoms when amlodipine therapy is begun. Amlodipine overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex sinus tachycardia.
In post-marketing experience with amlodipine, jaundice and elevated hepatic enzymes (mostly consistent with cholestasis or hepatitis) in some cases severe enough to require hospitalization have been reported. Patients who develop jaundice should discontinue amlodipine therapy and receive appropriate therapy. Pancreatitis has also been reported rarely.
Rare adverse reactions associated with amlodipine therapy include angioedema, allergic reactions, erythema multiforme, leukopenia and thrombocytopenia. During post-marketing surveillance, gynecomastia was infrequently reported during amlodipine therapy; however, a causal relationship is uncertain.
The following adverse effects have been reported during amlodipine administration, but a causal relationship has not been established: vasculitis, sinus bradycardia, angina, peripheral ischemia, peripheral neuropathy, syncope, postural dizziness, orthostatic hypotension, paresthesias, tremor, vertigo, blurred vision, anorexia, constipation, diarrhea, dysphagia, and flatulence.
Animal models have reported no adverse effects of amlodipine on fertility.
[ Last revised: 8/9/2005 12:54:00 PM ]
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