openFDA
Cure8 regulatory brief
Sulfasalazine FDA label update (2026-08-25)
Medications
Sulfasalazine
Aminosalicylates
Anemia
Regulatory Update
Adult patients
Pediatric Patients
Clinicians
Why This Matters
This label update confirms current FDA prescribing information for sulfasalazine delayed‑release tablets, which many people with ulcerative colitis may be prescribed for induction and maintenance of remission.
It includes dosing, precautions about gastrointestinal intolerance, and guidance relevant to both adults and children.
Who Should Pay Attention
Patients with ulcerative colitis, caregivers of pediatric IBD patients, clinicians prescribing sulfasalazine, and pharmacists.
Study Snapshot
Story typeRegulatory
Evidence typeRegulatory update
Study statusHuman prescription drug
Source depthRegulatory record
What To Know
This is an FDA dailymed drug-label record for sulfasalazine delayed‑release tablets (label update).
The label lists approved indications (notably treatment and maintenance of ulcerative colitis, and certain arthritis indications), dosing guidance for adults and children, recommendations for dose adjustments and reintroduction after intolerance, and monitoring considerations. The record is a regulatory-label document, not a clinical study report.
The label gives specific adult and pediatric dosing ranges for induction and maintenance of ulcerative colitis, notes slower onset in rheumatoid conditions, and includes advice about starting at lower doses to reduce gastrointestinal intolerance and steps for desensitization or reintroduction when sensitivity occurs.
Readers should consult their clinician or pharmacist for personalized dosing and safety advice; this summary reports what the official label text states and does not replace medical advice.
Keep In Mind
This is an official dailymed (FDA) drug-label record (regulatory-document). It reflects the product label language and dosing recommendations rather than new clinical trial results. For individual medical decisions, follow clinicians' guidance and consult the full label or pharmacist for detailed safety information.
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
SponsorMylan Pharmaceuticals Inc.
Study typeDrug Label Update
Indexed viaopenFDA
Source typeRegulatory record
PublishedAug 25, 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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