openFDA
Cure8 regulatory brief
Why This Matters
Label updates list safety warnings and monitoring steps that can affect people taking APRISO (mesalamine) for ulcerative colitis. Knowing these helps patients and clinicians watch for serious side effects and manage risks like kidney injury, allergic reactions, and interactions with lab tests.
Who Should Pay Attention
Adults with ulcerative colitis on or considering APRISO/mesalamine; prescribing clinicians; pharmacists; caregivers.
Study Snapshot
Story typeRegulatory
Evidence typeRegulatory update
Study statusHuman prescription drug
Source depthRegulatory record
What To Know
This is an FDA (DailyMed) label update for APRISO (mesalamine), an aminosalicylate used for maintenance of remission in adults with ulcerative colitis.
The label emphasizes warnings and monitoring recommendations including renal impairment, mesalamine-induced acute intolerance syndrome, hypersensitivity (including myocarditis/pericarditis), hepatic failure, severe cutaneous adverse reactions, photosensitivity, nephrolithiasis, phenylketonuria risk, and possible lab-test interference.
The label advises assessing and periodically monitoring renal function before and during treatment and discontinuing APRISO if renal function deteriorates. It also recommends promptly discontinuing APRISO if acute intolerance syndrome or hypersensitivity is suspected.
Patients with PKU should have phenylalanine exposure considered because the formulation contains phenylalanine. If you take APRISO or care for someone who does, discuss renal monitoring, signs of allergic or intolerance reactions, and sun protection with your clinician. Do not stop or change medications without medical advice.
Keep In Mind
This is the official drug label (DailyMed/FDA) summarizing approved indications, warnings, and monitoring recommendations. It is not a clinical study or new efficacy result. Follow your clinician’s advice for monitoring and any changes in treatment.
Source Details
Review the original publication for the complete reporting, methods, and context.
Regulatory update
Evidence type derived from source or registry metadata.
PublicationopenFDA
PublisherU.S. Food and Drug Administration
SponsorSalix Pharmaceuticals, Inc.
Study typeDrug Label Update
Indexed viaopenFDA
Source typeRegulatory record
PublishedAug 27, 2026, 12:00 AM
Content availableRegulatory record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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