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Tolerance
The overall incidence of bad events for Asacol was comparable to placebo.
Patients who received either the active or maintenance dose of Asacol had
discontinuation rates due to adverse events comparable to placebo.
According to clinical studies of mildly to moderately active UC, headache,
abdominal pain, and eructation, are the most frequent adverse events reported
for Asacol and placebo, and for the maintenance of remission of UC, the
most frequent adverse events reported were headache, rhinitis, and diarrhea.
Asacol is contraindicated in patients with a hypersensitivity to salicylates.
Caution is required when using Asacol in patients with known renal dysfunction
or history of renal disease. Evaluation of renal function is recommended
before initiation of Asacol tablets and periodically while on Asacol therapy.
As with other mesalamine-containing products, serious adverse events may
occur with Asacol.
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