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Indication

AMITIZA is approved to treat Chronic Idiopathic Constipation in adults including those over 65 years. “Idiopathic” means the cause of the constipation is unknown and not due to an underlying illness or medication. AMITIZA is approved to treat Irritable Bowel Syndrome with Constipation (IBS-C) in women 18 years of age and older.

Important Safety Information

AMITIZA is not for everyone. If you know or suspect you have a bowel obstruction, do not take AMITIZA. If you are unsure, your doctor should evaluate your condition before starting AMITIZA. You should not take AMITIZA if you have severe diarrhea.

AMITIZA has not been studied in pregnant women and should only be used during a pregnancy if the potential benefits justify the potential risk to the fetus. Women should have a negative pregnancy test before beginning treatment with AMITIZA and need to practice effective birth control measures. If you are pregnant or become pregnant while being treated with AMITIZA, talk to your doctor to evaluate the risks.

Within an hour of taking AMITIZA, shortness of breath may occur. This symptom usually goes away within three hours, but may recur with repeated use. Tell your doctor if you have shortness of breath.

The most common side effects of taking AMITIZA (24 mcg) orange capsules for Chronic Idiopathic Constipation are nausea, diarrhea, and headache. The most common side effects of taking AMITIZA (8 mcg) pink capsules for IBS-C are nausea, diarrhea, and abdominal pain. If nausea occurs, take AMITIZA with food. If your diarrhea or nausea becomes severe, tell your doctor. These are not all the side effects associated with AMITIZA.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.