openFDA
Cure8 regulatory brief
TOFACITINIB FDA label update (2026-07-31)
Medications
Tofacitinib
Steroids
Immunomodulators
JAK inhibitor
Regulatory Update
Adult patients
Clinicians
Why This Matters
This is an updated FDA drug label for tofacitinib, a JAK inhibitor that is approved for ulcerative colitis and other immune conditions.
The label emphasizes serious safety risks and limits on combining tofacitinib with other immunosuppressants—information directly relevant to people with IBD who are considering or using this medicine.
Who Should Pay Attention
Adults with ulcerative colitis or other inflammatory conditions considering or taking tofacitinib; clinicians who prescribe JAK inhibitors; patients on biologics or other immunosuppressants who may be considering treatment changes.
Study Snapshot
Story typeRegulatory
Evidence typeRegulatory update
Study statusHuman prescription drug
Source depthRegulatory record
What To Know
This is a FDA/dailymed drug label record for tofacitinib (a JAK inhibitor) describing approved indications, boxed warnings, and limitations of use.
The label lists approved indications including moderately to severely active ulcerative colitis in adults, and summarizes serious risks such as serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
The label also states testing recommendations (for example, testing for latent tuberculosis before and during treatment) and advises against combining tofacitinib with biologic therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine.
It notes pediatric and other non-IBD indications and dosing cautions (10 mg twice daily not recommended for several conditions). If you are taking or considering tofacitinib for UC or another condition, this label update is a regulatory document that explains FDA-required safety information and prescribing limits.
It is not a clinical guideline or individualized medical advice; talk with your prescribing clinician about how the updated label affects your care.
Keep In Mind
This entry is a regulatory drug-label record (DailyMed / FDA). It summarizes approved indications and boxed warnings required by the FDA. It does not provide individualized treatment recommendations. For personal clinical decisions, consult your clinician and the full prescribing 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
SponsorMicro Labs Limited
Study typeDrug Label Update
Indexed viaopenFDA
Source typeRegulatory record
PublishedJul 31, 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.
Tofacitinib FDA label update (2026-07-27)
This DailyMed/FDA label update affects adults with moderately to severely active ulcerative colitis because it states approved use of tofacitinib extended‑release and highlights important safety warnings and recommended...
A Case of Elderly-Onset Ulcerative Colitis with Large-Vessel Giant Cell Arteritis Treated Successfully with Tofocitinib.
Older adults with ulcerative colitis can rarely develop large-vessel giant cell arteritis as an extraintestinal complication.
TOFACITINIB FDA label update (2026-07-06)
The FDA label update for tofacitinib lists ulcerative colitis among approved uses and highlights serious safety warnings that are directly relevant to people with IBD considering or taking this oral JAK inhibitor.