Safety

Lialda (Mesalamine) Delayed-release Tablets

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

October 2014

Summary View

6 ADVERSE REACTIONS

6.2 Postmarketing Experience
  • ...angioedema added...
  • Immune System Disorders: anaphylactic reaction, angioedema,Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS)

 

December 2013

Summary View

ADVERSE REACTIONS

Post marketing Experience
  • anaphylactic reaction, Steven-Johnson syndrome (SJS), and drug reaction with eosinophilia and systematic symptoms (DRESS) 
      

August 2013

Summary View

WARNINGS AND PRECAUTIONS

  • Interference with Laboratory Tests - Use of mesalamine may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection because of the similarity in the chromatograms of normetanephrine and mesalamine’s main metabolite, N-acetylaminosalicylic acid (N-Ac-5-ASA). An alternative, selective assay for normetanephrine should be considered.

Page Last Updated: 11/17/2014
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