Nifedipine Extended-Release Tablets Side Effects

Please note - some side effects for Nifedipine Extended-Release Tablets 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).

Nifedipine Extended-Release Tablets Side Effects - for the Professional

Nifedipine Extended-Release Tablets

The incidence of adverse events during treatment with Nifedipine Extended-Release Tablets in doses up to 90 mg daily were derived from multi-center placebo-controlled clinical trials in 370 hypertensive patients. Atenolol 50 mg once daily was used concomitantly in 187 of the 370 patients on Nifedipine Extended-Release Tablets and in 64 of the 126 patients on placebo. All adverse events reported during Nifedipine Extended-Release Tablets therapy were tabulated independently of their causal relationship to medication.

The most common adverse event reported with Nifedipine Extended-Release Tablets was peripheral edema. This was dose related and the frequency was 18% on Nifedipine Extended-Release Tablets 30 mg daily and 22% on Nifedipine Extended-Release Tablets 60 mg daily versus 10% on placebo.

Other common adverse events reported in the above placebo-controlled trials include:

Where the frequency of adverse events with Nifedipine Extended-Release Tablets and placebo is similar, causal relationship cannot be established.

The following adverse events were reported with an incidence of 3% or less in daily doses up to 90 mg:

Body as a Whole/Systemic: chest pain, leg pain
Central Nervous System: paresthesia, vertigo
Dermatologic: rash
Gastrointestinal: constipation
Musculoskeletal: leg cramps
Respiratory: epistaxis, rhinitis
Urogenital: impotence, urinary frequency
Other adverse events reported with an incidence of less than 1.0% were:

Body as a Whole/Systemic: allergic reaction, asthenia, cellulitis, substernal chest pain, chills, facial edema, lab test abnormal, malaise, neck pain, pelvic pain, pain, photosensitivity reaction
Cardiovascular: atrial fibrillation, bradycardia, cardiac arrest, extrasystole, hypotension, migraine, palpitations, phlebitis, postural hypotension, tachycardia, cutaneous angiectases
Central Nervous System: anxiety, confusion, decreased libido, depression, hypertonia, hypesthesia, insomnia, somnolence
Dermatologic: angioedema, petechial rash, pruritus, sweating
Gastrointestinal: abdominal pain, diarrhea, dry mouth, dysphagia, dyspepsia, eructation, esophagitis, flatulence, gastrointestinal disorder, gastrointestinal hemorrhage, GGT increased, gum disorder, gum hemorrhage, vomiting
Hematologic: eosinophilia, lymphadenopathy
Metabolic: gout, weight loss
Musculoskeletal: arthralgia, arthritis, joint disorder, myalgia, myasthenia
Respiratory: dyspnea, increased cough, rales, pharyngitis, stridor
Special Senses: abnormal vision, amblyopia, conjunctivitis, diplopia, eye disorder, eye hemorrhage, tinnitus
Urogenital/Reproductive: dysuria, kidney calculus, nocturia, breast engorgement, polyuria, urogenital disorder The following adverse events have been reported rarely in patients given nifedipine in coat core or other formulations: allergenic hepatitis, alopecia, anaphylactic reaction, anemia, arthritis with ANA (+), depression, erythromelalgia, exfoliative dermatitis, fever, gingival hyperplasia, gynecomastia, hyperglycemia, jaundice, leukopenia, mood changes, muscle cramps, nervousness, paranoid syndrome, purpura, shakiness, sleep disturbances, Stevens-Johnson syndrome, syncope, taste perversion, thrombocytopenia, toxic epidermal necrolysis, transient blindness at the peak of plasma level, tremor and urticaria.

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