openFDA
Cure8 regulatory brief
Why This Matters
Prednisone is a commonly used steroid for short-term control of IBD flares; changes or reaffirmations in its FDA label affect prescribing and safety guidance that patients and clinicians rely on.
The label explicitly lists ulcerative colitis and regional enteritis (Crohn’s disease) among indications, so IBD patients may see guidance relevant to dosing and tapering.
Who Should Pay Attention
Patients with ulcerative colitis or Crohn’s disease on prednisone, caregivers, and prescribing clinicians.
Study Snapshot
Story typeRegulatory
Evidence typeRegulatory update
Study statusHuman prescription drug
Source depthRegulatory record
What To Know
This is an FDA drug label page for prednisone (PredniSONE) with updated prescribing information and the full indications, dosing guidance, and administration details.
The label lists many approved uses including gastrointestinal diseases such as ulcerative colitis and regional enteritis (Crohn’s disease), general dosing ranges, timing recommendations (morning dosing), advice on tapering and avoiding abrupt withdrawal, and cautions about dosage individualization and dietary salt.
The content is a regulatory drug-label record (U.S. FDA / DailyMed). It summarizes official prescribing information rather than reporting new clinical study results. It is intended as reference information for clinicians and patients about indications, dosing, and safety.
If you use prednisone for IBD, this label is a primary source for official dosing language and general safety warnings, but individual treatment decisions (dose, tapering, monitoring) should come from your prescribing clinician.
Keep In Mind
This is an FDA/DailyMed drug-label record (regulatory update). It provides authoritative prescribing information but is not individualized medical advice. For personal treatment changes, consult your healthcare provider.
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
SponsorAtlantic Biologicals Corps
Study typeDrug Label Update
Indexed viaopenFDA
Source typeRegulatory record
PublishedJul 10, 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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