Plendil Side Effects

Generic Name: felodipine

Please note - some side effects for Plendil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Plendil - for the Consumer

Plendil

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Plendil:

Diarrhea; dizziness; flushing; headache; mild swelling of gums; nausea; weakness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breathing problems; chest pain; enlarged breasts in men; fast or irregular heartbeat; heart problems; impotence; lightheadedness and fainting; swelling of the ankles or hands.

Plendil Side Effects - for the Professional

Plendil

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 Plendil 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 Plendil, 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 (Plendil, 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 Plendil 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 Plendil is increased at 20 mg once a day, there is a disproportionate increase in adverse events, especially those associated with vasodilatory effects.

Percent of Patients with Adverse Events in Controlled Trials3 of Plendil (N=861) as Monotherapy without Regard to Causality (Incidence of discontinuations shown in parentheses)

Adverse events that occurred in 0.5 up to 1.5% of patients who received Plendil in all controlled clinical trials at the recommended dosage range of 2.5 mg to 10 mg once a day, and serious adverse events that occurred at a lower rate, or events reported during marketing experience (those lower rate events are in italics) are listed below. These events are listed in order of decreasing severity within each category, and the relationship of these events to administration of Plendil is uncertain: Body as a Whole: Chest pain, facial edema, flu-like illness; Cardiovascular:Myocardial infarction, hypotension, syncope, anginapectoris, arrhythmia, tachycardia, premature beats; Digestive: Abdominal pain, diarrhea, vomiting, dry mouth, flatulence, acid regurgitation; Endocrine: Gynecomastia; Hematologic:Anemia; Metabolic: ALT (SGPT) increased; Musculoskeletal: Arthralgia, back pain, leg pain, foot pain, muscle cramps, myalgia, arm pain, knee pain, hip pain; Nervous/Psychiatric: Insomnia, depression, anxiety disorders, irritability, nervousness, somnolence, decreased libido; Respiratory: Dyspnea, pharyngitis, bronchitis, influenza, sinusitis, epistaxis, respiratory infection; Skin:Angioedema, contusion, erythema, urticaria, leukocytoclastic vasculitis; SpecialSenses: Visual disturbances; Urogenital: Impotence, urinary frequency, urinary urgency, dysuria, polyuria.

Gingival Hyperplasia – Gingival hyperplasia, usually mild, occurred in < 0.5% of patients in controlled studies. This condition may be avoided or may regress with improved dental hygiene.

3

Patients in titration studies may have been exposed to more than one dose level of Plendil.

Clinical Laboratory Test Findings

Serum Electrolytes– No significant effects on serum electrolytes were observed during short- and long-term therapy.

Serum Glucose– No significant effects on fasting serum glucose were observed in patients treated with Plendil in the U.S. controlled study.

Liver Enzymes– 1 of 2 episodes of elevated serum transaminases decreased once drug was discontinued in clinical studies; no follow-up was available for the other patient.

Side Effects by Body System

General

Side effects of felodipine are generally mild and transient. The overall frequency of side effects ranges from 40% to 80%; 8% of patients withdraw from felodipine therapy due to adverse drug events.

Cardiovascular

Most adverse effects of felodipine related to vasodilation are transient and decrease in frequency with continued administration. Ankle edema, however, tends to be persistent and dose-related.

Cardiovascular side effects are the most common, and are related to the vasodilatory properties of felodipine. Peripheral edema occurs in up to 30%, flushing in 10%, tachycardia in less than 15%, dizziness in 2%, and palpitations in 2%. A few rare cases of felodipine-induced telangiectasia have been reported.

Nervous system

Nervous system side effects are probably related to the vasodilatory properties of felodipine, and include headache in up to 30% of patients.

Gastrointestinal

Gastrointestinal intolerance may occur in up to 3% of patients. Nausea and constipation occur in approximately 1% of patients. Gingival hyperplasia has occasionally been associated with felodipine. This can be minimized by good dental hygiene.

Musculoskeletal

Musculoskeletal cramps may occur in 1% to 3% of patients.

Endocrine

There are no known endocrinologic complications from the use of felodipine. Data have shown that the use of felodipine in hypertensive patients with type II diabetes mellitus has a neutral effect on glucose metabolism and serum lipids.

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