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Indication

Lialda is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis.

Important Safety Information

• You should not take Lialda if you are allergic to salicylates (including mesalamine, aspirin, or aspirin-containing products) or to any of the ingredients of Lialda.
• Reports of problems with kidney function have been associated with mesalamine-containing products like Lialda. Tell your doctor if you have or have had problems with your kidneys. It is recommended that all patients have their kidney function checked before starting Lialda and periodically while on therapy.
• Products that contain mesalamine, like Lialda, have been associated with a condition that may be difficult to distinguish from an ulcerative colitis flare-up. Symptoms include cramping, stomach ache, bloody diarrhea, fever, headache, and rash. If you experience any of these symptoms, talk to your doctor immediately. Your doctor may decide to discontinue your medication.
• Tell your doctor if you are allergic to sulfasalazine, as you may also be allergic to Lialda or drugs that contain or are converted to mesalamine. Some patients taking Lialda or mesalamine-containing products have reported heart-related allergic reactions, such as inflammation of the heart muscle and inflammation of the lining of the heart. Tell your doctor if you have or have had a history of myocarditis or pericarditis as this may increase your likelihood of having these types of reactions.
• Reports of liver failure have been associated with mesalamine-containing products like Lialda in patients that have or have had liver disease. Tell your doctor if you have a problem with your liver.
• Tell your doctor if you have a stomach blockage, as this may delay the release of medication.
• In clinical trials, common side effects reported with Lialda included ulcerative colitis, headache, gas, abnormal liver function test results, and stomach ache. Inflammation of the pancreas was reported which led to discontinuation of Lialda therapy. Other side effects may occur.
• Before starting Lialda, tell your doctor about all medications you are taking. Mesalamine may increase the risk of kidney problems when used with non-steroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen). Mesalamine may increase the risk of blood disorders when used with azathioprine and 6-mercaptopurine.

Please see Full Prescribing Information.

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.

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