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Label Changes for:

Pentasa (mesalamine) Controlled-Release Capsules

December 2013

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)


December 2013


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



July 2013


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, Nacetylaminosalicylic acid (N-Ac-5-ASA). An alternative, selective assay for normetanephrine should be considered.