Label Changes for:

Lialda (mesalamine) delayed-release tablet

October 2009

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2009

ADVERSE REACTIONS

Post Marketing Experience

The following adverse reactions have been identified during post-approval use of Lialda in clinical practice. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Cardiac Disorders: Myocarditis and pericarditis.
  • Hepatobiliary Disorders: Hepatitis
  • Renal Disorders: Interstitial nephritis
  • Respiratory, Thoracic and Mediastinal Disorders: Hypersensitivity pneumonitis (including interstitial pneumonitis, allergic alveolitis, eosinophilic pneumonitis).
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