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The most frequent adverse reactions observed with TRILISATE (choline magnesium trisalicylate) preparations in clinical trials (7- 12) are tinnitus and gastrointestinal complaints (including nausea, vomiting, gastric upset, indigestion, heartburn, diarrhea, constipation and epigastric pain). These occur in less than twenty percent (20%) of patients. Should tinnitus develop, reduction of daily dosage is recommended until the tinnitus is resolved. Less frequent adverse reactions, occurring in less than two percent (2%) of patients, are: hearing impairment, headache, lightheadedness, dizziness, drowsiness, and lethargy. Adverse reactions occurring in less than one percent (1%) of patients are: gastric ulceration, positive fecal occult blood, elevation in serum BUN and creatinine, rash, pruritus, anorexia, weight gain, edema, epistaxis and dysgeusia.

Spontaneous reporting has yielded isolated or rare reports of the following adverse experiences: duodenal ulceration, elevated hepatic transaminases, hepatitis, esophagitis, asthma, erythema multiforme, urticaria, ecchymoses, irreversible hearing loss and/ or tinnitus, mental confusion, hallucinations.

DRUG ABUSE AND DEPENDENCE

Drug abuse and dependence have not been reported with TRILISATE (choline magnesium trisalicylate) preparations.