Plendil Side Effects

Generic name: felodipine

Note: This document contains side effect information about felodipine. Some of the dosage forms listed on this page may not apply to the brand name Plendil.

Some side effects of Plendil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to felodipine: oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking felodipine (the active ingredient contained in Plendil) hives; difficult 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;

• feeling short of breath, swelling in your hands or feet;

• fast or pounding heartbeats;

• numbness or tingly feeling; or

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Less serious side effects of felodipine may include:

• headache, dizziness, drowsiness, weakness;

• feeling restless or nervous;

• nausea, upset stomach, constipation, diarrhea, stomach pain;

• sleep problems (insomnia);

• joint pain or muscle cramps;

• warmth, redness, or tingly feeling under your skin;

• mild rash;

• urinating more than usual; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to felodipine: oral tablet extended release

General

Side effects of felodipine (the active ingredient contained in Plendil) were generally mild and transient. The most common side effects reported with felodipine given at 2.5 to 10 mg per day were peripheral edema and headache. Therapy was discontinued due to adverse drug events in about 6% of patients, primarily for peripheral edema, headache or flushing.

A dose of 20 mg per day has been evaluated in some clinical trials. Although 20 mg per day increased the antihypertensive effect of felodipine, a disproportionate increase in side effects, especially those associated with vasodilatory effects, was reported.

Other

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

Other side effects have included peripheral edema (up to 17.4%), flushing (up to 6.9%), asthenia (up to 3.9%), warm sensation (up to 1.5%), chest pain, facial edema, and influenza-like illness.

Nervous system

Nervous system side effects have included headache (up to 14.7%), dizziness (up to 3.7%), paresthesia (up to 1.6%), syncope, insomnia, and somnolence.

Cardiovascular

Cardiovascular side effects have included palpitation (up to 2.5%), myocardial infarction, hypotension, angina pectoris, arrhythmia, tachycardia, premature beats, and leukocytoclastic vasculitis. A few rare cases of felodipine-induced telangiectasia have been reported.

Gastrointestinal

Gastrointestinal side effects have included dyspepsia (up to 3.9%), nausea (up to 1.7%), constipation (1.5%), abdominal pain, diarrhea, vomiting, dry mouth, flatulence, and acid regurgitation. Gingival hyperplasia, usually mild, has been reported in less than 0.5% of patients.

Gingival hyperplasia has been avoided or has regressed with good dental hygiene.

Respiratory

Respiratory side effects have included upper respiratory infection (up to 3.9%), cough (up to 1.7%), rhinorrhea (up to 1.6%), sneezing (up to 1.6%), dyspnea, pharyngitis, bronchitis, influenza, sinusitis, epistaxis, and respiratory infection.

Dermatologic

Dermatologic side effects have included rash (up to 2%), angioedema, contusion, erythema, and urticaria.

Hematologic

Hematologic side effects have included anemia.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, back pain, leg pain, foot pain, muscle cramps, myalgia, arm pain, knee pain, and hip pain.

Hepatic

Hepatic side effects have included elevated ALT (SGPT) and unspecified serum transaminases.

In clinical studies, one of two episodes of elevated serum transaminases decreased following drug discontinuation; no follow-up was available for the second patient.

Psychiatric

Psychiatric system side effects have included depression, anxiety disorders, irritability, nervousness, and decreased libido.

Genitourinary

Genitourinary side effects have included gynecomastia, impotence, urinary frequency, urinary urgency, dysuria, and polyuria.

Ocular

Ocular system side effects have included visual disturbances.

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