Felodipine side effects

List of side effects
Overview Occurrence in ≥ 1.5% of patients Occurrence in 0.5%-1.5% of patients Gingival hyperplasia Clinical lab test findings
 * Serum electrolytes
 * Serum glucose
 * Liver enzymes

Overview
In controlled studies in the United States and overseas, approximately 3,000 patients were treated with Felodipine as either the extended-release or the immediate-release formulation. The most common clinical adverse events reported with Felodipine 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, principally for peripheral edema, headache, or flushing. Return to top

Occurrence in ≥ 1.5% of patients
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, N = 861; Placebo, N = 334), without regard to causality, include the following: These events are reported from controlled clinical trials with patients who were randomized to a fixed dose of Felodipine 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 is increased at 20 mg once a day, there is a disproportionate increase in adverse events, especially those associated with vasodilatory effects. Return to top
 * Body as a whole: Peripheral edema, asthenia, warm sensation
 * Cardiovascular: Palpitation
 * Digestion: Nausea, dyspepsia, constipation
 * Nervous: Headache, dizziness, paresthesia
 * Respiratory: Upper respiratory infection, cough, rhinorrhea, sneezing
 * Skin: rash, flushing

Occurrence in 0.5%-1.5% of patients
Adverse events that occurred in 0.5 up to 1.5% of patients who received Felodipine 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 are listed below. These events are listed in order of decreasing severity within each category, and the relationship of these events to administration of Felodipine is uncertain:
 * Body as a whole: Chest pain, facial edema, flu-like illness
 * Cardiovascular: Myocardial infarction, hypotension, syncope, angina pectoris, 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
 * Special senses: Visual disturbances
 * Urogenital: Impotence, urinary frequency, urinary urgency, dysuria, polyuria. Return to top

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. Return to top

Serum electrolytes
No significant effects on serum electrolytes were observed during short- and long-term therapy. Return to top

Serum glucose
No significant effects on fasting serum glucose were observed in patients treated with Felodipine in the U.S. controlled study. Return to top

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. Return to top