ADVERSE REACTIONS
Adverse reaction information was derived from blinded-controlled and open-labelled clinical trials and from worldwide marketing experience. In the description below, rates of the more common events (greater than 1%) and many of the less common events (less than 1%) represent results of US clinical studies.
Of the 1,677 patients who received RELAFEN during US clinical trials, 1,524 were treated for at least 1 month, 1,327 for at least 3 months, 929 for at least a year, and 750 for at least 2 years. More than 300 patients have been treated for 5 years or longer.
The most frequently reported adverse reactions were related to the gastrointestinal tract and included diarrhea, dyspepsia, and abdominal pain.
Incidence≥1%—Probably Causally Related
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Gastrointestinal: Diarrhea (14%), dyspepsia (13%), abdominal pain (12%), constipation*, flatulence*, nausea*, positive stool guaiac*, dry mouth, gastritis, stomatitis, vomiting.
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Central Nervous System: Dizziness*, headache*, fatigue, increased sweating, insomnia, nervousness, somnolence.
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Dermatologic: Pruritus*, rash*.
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Special Senses: Tinnitus*.
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Miscellaneous: Edema*.
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*Incidence of reported reaction between 3% and 9%. Reactions occurring in 1% to 3% of the patients are unmarked.
Incidence <1%—Probably Causally Related †
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Gastrointestinal: Anorexia, jaundice, duodenal ulcer, dysphagia, gastric ulcer, gastroenteritis, gastrointestinal bleeding, increased appetite, liver function abnormalities, melena, hepatic failure.
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Central Nervous System: Asthenia, agitation, anxiety, confusion, depression, malaise, paresthesia, tremor, vertigo.
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Dermatologic: Bullous eruptions, photosensitivity, urticaria, pseudoporphyria cutanea tarda, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome.
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Cardiovascular: Vasculitis.
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Metabolic: Weight gain.
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Respiratory: Dyspnea, eosinophilic pneumonia, hypersensitivity pneumonitis, idiopathic interstitial pneumonitis.
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Genitourinary: Albuminuria, azotemia, hyperuricemia, interstitial nephritis, nephrotic syndrome, vaginal bleeding, renal failure.
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Special Senses: Abnormal vision.
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Hematologic/Lymphatic: Thrombocytopenia.
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Hypersensitivity: Anaphylactoid reaction, anaphylaxis, angioneurotic edema.
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†Adverse reactions reported only in worldwide postmarketing experience or in the literature, not seen in clinical trials, are considered rarer and are italicized.
Incidence <1%—Causal Relationship Unknown
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Gastrointestinal: Bilirubinuria, duodenitis, eructation, gallstones, gingivitis, glossitis, pancreatitis, rectal bleeding.
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Central Nervous System: Nightmares.
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Dermatologic: Acne, alopecia.
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Cardiovascular: Angina, arrhythmia, hypertension, myocardial infarction, palpitations, syncope, thrombophlebitis.
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Respiratory: Asthma, cough.
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Genitourinary: Dysuria, hematuria, impotence, renal stones.
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Special Senses: Taste disorder.
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Body as a Whole: Fever, chills.
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Hematologic/Lymphatic: Anemia, leukopenia, granulocytopenia.
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Metabolic/Nutritional: Hyperglycemia, hypokalemia, weight loss.
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