openFDA
Cure8 regulatory brief
Tofacitinib FDA label update (2026-09-01)
Medications
Tofacitinib
Azathioprine
Methotrexate
Immunomodulators
JAK inhibitor
Regulatory Update
Adult patients
Why This Matters
This FDA drug-label update describes approved uses and safety warnings for tofacitinib, a JAK inhibitor used in immune-mediated diseases including ulcerative colitis. The boxed warnings highlight serious infection and cardiovascular/malignancy risks that can affect treatment choices for people with IBD.
Who Should Pay Attention
Adults with ulcerative colitis or other immune-mediated diseases considering or taking tofacitinib; clinicians prescribing JAK inhibitors; patients on or considering combination immunosuppressive therapy (eg, azathioprine); caregivers monitoring for infections or cardiovascular risk.
Study Snapshot
Story typeRegulatory
Evidence typeRegulatory update
Study statusHuman prescription drug
Source depthRegulatory record
What To Know
This is a U.S. prescribing information (label) update for tofacitinib tablets (a JAK inhibitor).
The label lists indications including moderately to severely active ulcerative colitis and other rheumatologic conditions, boxed warnings about serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis, and limitations of use advising against combining tofacitinib with biologic therapies or potent immunosuppressants (eg, azathioprine, cyclosporine).
Keep In Mind
This record is the official prescribing information (regulatory document). It summarizes indications, boxed warnings, and limitations of use; it is not treatment advice. Specific dosing, monitoring, and contraindications are detailed in the full label and should be discussed with a 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
SponsorNovadoz Pharmaceuticals LLC
Study typeDrug Label Update
Indexed viaopenFDA
Source typeRegulatory record
PublishedSep 1, 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 (2026-07-30)
FDA drug-label updates change how a medicine should be used and monitored. For people with ulcerative colitis and other immune-mediated diseases, this label highlights safety risks and limits on combining tofacitinib...
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.
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.