Selected Safety Information
Asacol is indicated for the treatment of mildly to moderately active UC (the indicated dosage is two 400 mg tablets tid for 6 weeks) and for the maintenance of remission of UC (the indicated dosage is 1.6 g/day in divided doses).In pivotal clinical studies of mildly to moderately active UC, the most frequent adverse events reported for Asacol and placebo, respectively, were headache (35% vs 36%), abdominal pain (18% vs 14%), and eructation (16% vs 15%); for the maintenance of remission of UC, the most frequent adverse events were headache (50% vs 50%), rhinitis (42% vs 36%) , and diarrhea (35% vs 50%).
Asacol is contraindicated in patients with hypersensitivity to salicylates. Caution should be exercised when using Asacol in patients with known renal dysfunction or history of renal disease. It is recommended that all patients have an evaluation of renal function prior to initiation of Asacol tablets and periodically while on Asacol therapy. Serious adverse events may occur with Asacol.
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