Tolerability of Amlodipine

Summary

We examined the tolerability and safety of amlodipine in a large population of patients (n = 12 831) by performing a meta-analysis of 16 consecutive studies in which this drug was used for treatment of hypertension (n = 9638; 75%) or ischaemic heart disease (n = 3193; 25%) and data were standardised and referred to a central core laboratory. Adverse events were reported by patients in response to an open questionnaire and completed at standardised times after starting amlodipine.

Overall, the percentage of patients who experienced amlodipine-related adverse effects was about 15%, and only 3% of patients were withdrawn from amlodipine therapy because of drug intolerance.

Four adverse events (peripheral oedema, headache, flushing and altered heart rate) occurred in 1% or more of amlodipine recipients; these are typical of dihydropyridines and are predominantly related to arteriolar vasodilation.

Rare adverse events attributable to idiosyncratic or allergic response (skin rash) were reported.

Other adverse events (gastrointestinal disorders, tremor, polyuria, cough, etc.) were ill defined, and their nature was unclear.

Finally, the percentage of patients with amlodipine-related adverse effects was not influenced by drug dosage or disease status, and a comparison of amlodipine’s tolerability with that of alternative calcium antagonists, β-blockers or ACE inhibitors showed a significantly lower occurrence (17.3 vs 39.7% of patients, p < 0.001).