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Side Effects

Safety Information about Lialda

Lialda—approved for the induction of remission in patients with active, mild to moderate UC—has the same active ingredient (mesalamine) as some other UC medications. It contains more medication per tablet compared with other drugs in the same class.

Lialda is a new formulation of mesalamine. Mesalamine has a well-established safety profile. Lialda is generally well tolerated.

The most common side effects are:

  • Headache
  • Flatulence

Mesalamine has been associated with a condition that may be difficult to distinguish from a flare of UC. Symptoms may include abdominal pain, cramping, bloody diarrhea, headache and rash. Tell your doctor immediately if you experience these symptoms.

Tell your doctor if you have a stomach blockage, or are allergic to sulfasalazine.

It's also important to talk to your doctor if you have kidney disease or a related illness, since use of Lialda may cause such conditions to become worse.

Safety and effectiveness of Lialda has been established for up to 8 weeks.

If you have any questions about Lialda, please talk to your doctor.

See additional Important Safety Information below.

 

next Working with Your Doctor

 

 

Important Safety Information

You should not take Lialda if you are allergic to salicylates (including mesalamine or aspirin) or to any of the ingredients of Lialda. Tell your doctor if you have a stomach blockage or are allergic to sulfasalazine. Mesalamine has been associated with a syndrome that may be difficult to distinguish from an ulcerative colitis flare-up. If you experience cramping, abdominal pain, bloody diarrhea, fever, headache or rash, talk to your doctor immediately. Some patients taking mesalamine have reported heart-related hypersensitivity reactions, such as inflammation of the heart muscle and inflammation of the lining of the heart. Tell your doctor if you have problems with your liver or kidneys.

In worldwide clinical trials, Lialda was generally well tolerated. The most common adverse events were headache and flatulence. As with other medications, some serious side effects may occur. Less than 1% of patients experienced inflammation of the pancreas, which led to discontinuation of therapy with Lialda.

Please see Lialda Full Prescribing Information

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