Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
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)
Post marketing Experience
- anaphylactic reaction, Steven-Johnson syndrome (SJS), and drug reaction with eosinophilia and systematic symptoms (DRESS)
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.