ADVERSE REACTIONS
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 tablet was peripheral edema. This was dose related and the frequency was 18% on nifedipine extended-release tablet 30 mg daily, 22% on nifedipine extended-release tablets 60 mg daily and 29% on nifedipine extended-release tablets 90 mg daily versus 10% on placebo.
Other common adverse events reported in the above placebo-controlled trials include:
| Adverse Event | NIFEDIPINE
EXTENDED-RELEASE
TABLETS (%)
(n=370) | PLACEBO
(%)
(n=126) |
|---|
| Headache | 19 | 13 |
| Flushing/heat sensation | 4 | 0 |
| Dizziness | 4 | 2 |
| Fatigue/asthenia | 4 | 4 |
| Nausea | 2 | 1 |
| Constipation | 1 | 0 |
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: cellulitis, chills, facial edema, neck pain, pelvic pain, pain
Cardiovascular: atrial fibrillation, bradycardia, cardiac arrest, extrasystole, hypotension, palpitations, phlebitis, postural hypotension, tachycardia, cutaneous angiectases
Central Nervous System: anxiety, confusion, decreased libido, depression, hypertonia, insomnia, somnolence
Dermatologic: pruritus, sweating
Gastrointestinal: abdominal pain, diarrhea, dry mouth, dyspepsia, esophagitis, flatulence, gastrointestinal hemorrhage, vomiting
Hematologic: lymphadenopathy
Metabolic: gout, weight loss
Musculoskeletal: arthralgia, arthritis, myalgia
Respiratory: dyspnea, increase cough, rales, pharyngitis
Special Senses: abnormal vision, amblyopia, conjunctivitis, diplopia, tinnitus
Urogenital/Reproductive: kidney calculus, nocturia, breast engorgement
The following adverse events have been reported rarely in patients given nifedipine in other formulations: allergenic hepatitis, alopecia, anemia, arthritis with ANA (+), depression, erythromelalagia, exfoliative dermatitis, fever, gingival hyperplasia, gynecomastia, leukopenia, mood changes, muscle cramps, nervousness, paranoid syndrome, purpura, shakiness, sleep disturbances, syncope, taste perversion, thrombocytopenia, transient blindness at the peak plasma level, tremor and urticaria.
There have been rare reports of exfoliative or bullous skin adverse events (such as erythema multiforme, Stevens-Johnson Syndrome, and toxic epidermal necrolysis) and photosensitivity reactions.
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