Selected Safety Information About Asacol

Important Precautions

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

• It is recommended that all people have their kidney function tested prior to starting Asacol® and periodically while on Asacol therapy.
• If you have a history of kidney impairment or kidney disease, you should tell your doctor before using Asacol.
• If you are pregnant, become pregnant or are a nursing mother, talk with your doctor before using Asacol.
• 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 people in clinical trials.
• If you have pyloric stenosis (a narrowing of the outlet from the stomach), you should tell your doctor before using Asacol.

Adverse Events

In clinical studies that compared people taking Asacol® to those taking a sugar pill (placebo), there was no significant difference in the number reporting side effects.

In studies of flare-ups, some people taking Asacol reported headache, abdominal pain, general pain, rash, upset stomach and worsening of colitis symptoms. In a maintenance study, some people reported headache, runny nose, general pain, sore throat, infection, and nervousness.

Talk with your doctor about your medical history and any questions about your medication. It's also important to visit your doctor periodically to monitor your condition and discuss your treatment plan.