Label Changes for:
Lialda (mesalamine) delayed-release tablet
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
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).