Felodipine Side Effects

ADVERSE REACTIONS In controlled studies in the United States and overseas, approximately 3000 patients were treated with felodipine as either the extended-release or the immediate-release formulation.

The most common clinical adverse events reported with felodipine extended-release administered as monotherapy at the recommended dosage range of 2.5 mg to 10 mg once a day were peripheral edema and headache.

Peripheral edema was generally mild, but it was age and dose related and resulted in discontinuation of therapy in about 3% of the enrolled patients.

Discontinuation of therapy due to any clinical adverse event occurred in about 6% of the patients receiving felodipine extended-release, principally for peripheral edema, headache, or flushing.

Adverse events that occurred with an incidence of 1.5% or greater at any of the recommended doses of 2.5 mg to 10 mg once a day (felodipine extended-release, N = 861;

Placebo, N = 334), without regard to causality, are compared to placebo and are listed by dose in the table below.

These events are reported from controlled clinical trials with patients who were randomized to a fixed dose of felodipine extended-release tablets, USP or titrated from an initial dose of 2.5 mg or 5 mg once a day.

A dose of 20 mg once a day has been evaluated in some clinical studies.

Although the antihypertensive effect of felodipine extended-release tablets, USP is increased at 20 mg once a day, there is a disproportionate increase in adverse events, especially those associated with vasodilatory effects (see DOSAGE AND ADMINISTRATION ).

Percent of Patients with Adverse Events in Controlled Trials* of Felodipine Extended-Release Tablets (N = 861) as Monotherapy without Regard to Causality (Incidence of discontinuations shown in parentheses) *Patients in titration studies may have been exposed to more than one dose level of felodipine extended-release tablets.