openFDA
Cure8 regulatory brief
Why This Matters
Label changes affect how balsalazide is prescribed and monitored for people with ulcerative colitis. The update highlights safety risks—especially kidney, liver, and hypersensitivity concerns—and reinforces age- and duration-related limits on use.
Who Should Pay Attention
Patients with ulcerative colitis (adults and pediatric patients ages 5+); caregivers of children on balsalazide; gastroenterologists and prescribing clinicians; clinicians monitoring renal or hepatic function.
Study Snapshot
Story typeRegulatory
Evidence typeRegulatory update
Study statusHuman prescription drug
Source depthRegulatory record
What To Know
This is an FDA label update (DailyMed) for balsalazide disodium capsules, an aminosalicylate indicated for mildly to moderately active ulcerative colitis in patients 5 years and older.
The label emphasizes monitoring renal function before and during treatment, warns about mesalamine-induced acute intolerance and hypersensitivity (including myocarditis/pericarditis), photosensitivity, hepatotoxicity, and rare severe cutaneous reactions. It also notes limits on established safety durations (≤8 weeks in children 5–17 and ≤12 weeks in adults).
Keep In Mind
This entry is a regulatory drug-label record (DailyMed/ FDA). It summarizes official prescribing information and safety warnings. It does not present new clinical trial results. Medication-specific monitoring and duration recommendations reflect label language; discuss individual treatment decisions with your clinician.
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
SponsorApotex Corp.
Study typeDrug Label Update
Indexed viaopenFDA
Source typeRegulatory record
PublishedSep 9, 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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