Full Prescribing Information
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Important Safety Information
- PENTASA is indicated for the induction of remission and for the treatment of patients with mildly to moderately active ulcerative colitis.
- PENTASA is generally well tolerated. In worldwide clinical trials (N>2100), the most common adverse events were diarrhea (3.4%), headache (2.0%), nausea (1.8%), abdominal pain (1.7%), dyspepsia (1.6%), vomiting (1.5%), and rash (1.0%). As with other mesalamine products, serious adverse events may occur. PENTASA is contraindicated in patients with a hypersensitivity to salicylates. Caution should be used in patients with impaired hepatic or renal function. Patients with pre-existing renal disease, increased BUN or serum creatinine, or proteinuria should be monitored during PENTASA therapy.