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.

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Plendil:

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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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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)

Body System Adverse Events	Placebo N=334	2.5 mg N=255	5 mg N=581	10 mg N=408
Body as a Whole
Peripheral Edema	3.3 (0.0)	2.0 (0.0)	8.8 (2.2)	17.4 (2.5)
Asthenia	3.3 (0.0)	3.9 (0.0)	3.3 (0.0)	2.2 (0.0)
Warm Sensation	0.0 (0.0)	0.0 (0.0)	0.9 (0.2)	1.5 (0.0)
Cardiovascular
Palpitation	2.4 (0.0)	0.4 (0.0)	1.4 (0.3)	2.5 (0.5)
Digestive
Nausea	1.5 (0.9)	1.2 (0.0)	1.7 (0.3)	1.0 (0.7)
Dyspepsia	1.2 (0.0)	3.9 (0.0)	0.7 (0.0)	0.5 (0.0)
Constipation	0.9 (0.0)	1.2 (0.0)	0.3 (0.0)	1.5 (0.2)
Nervous
Headache	10.2 (0.9)	10.6 (0.4)	11.0 (1.7)	14.7 (2.0)
Dizziness	2.7 (0.3)	2.7 (0.0)	3.6 (0.5)	3.7 (0.5)
Paresthesia	1.5 (0.3)	1.6 (0.0)	1.2 (0.0)	1.2 (0.2)
Respiratory
Upper Respiratory Infection	1.8 (0.0)	3.9 (0.0)	1.9 (0.0)	0.7 (0.0)
Cough	0.3 (0.0)	0.8 (0.0)	1.2 (0.0)	1.7 (0.0)
Rhinorrhea	0.0 (0.0)	1.6 (0.0)	0.2 (0.0)	0.2 (0.0)
Sneezing	0.0 (0.0)	1.6 (0.0)	0.0 (0.0)	0.0 (0.0)
Skin
Rash	0.9 (0.0)	2.0 (0.0)	0.2 (0.0)	0.2 (0.0)
Flushing	0.9 (0.3)	3.9 (0.0)	5.3 (0.7)	6.9 (1.2)

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.

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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.

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Side Effects by Body System - for Healthcare Professionals

General

Side effects of felodipine 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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