Asacol Safety and Tolerability

There are some important precautions one should be aware of regarding Asacol therapy, including:

• It is recommended that all patients have an evaluation of renal function prior to initiation of Asacol tablets and periodically while on Asacol therapy.
• Caution should be exercised when using Asacol in patients with known renal dysfunction or history of renal disease.
• Pregnancy Category B: This drug should be used during pregnancy only if clearly needed.
• Some people who have had a reaction to sulfasalazine may have a similar reaction to Asacol or other products that contain mesalamine. Such a reaction may include worsening of colitis symptoms (i.e., cramping, abdominal pain, and bloody diarrhea) and occasionally fever, headache, general discomfort, itching, rash, and conjunctivitis (an inflammation of part of the eye).
• There was a worsening of the symptoms of colitis as reported in 3% of Asacol-treated patients in clinical trials.
• Patients with pyloric stenosis may have prolonged gastric retention of Asacol tablets which could delay release of mesalamine in the colon.

In pivotal clinical studies of mildly to moderately active Ulcerative Colitis, 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%).

In clinical studies for the maintenance of remission of Ulcerative Colitis, 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.

Please see accompanying full prescribing information by clicking the link above.