openFDA
Cure8 regulatory brief
Tofacitinib FDA label update (2026-08-13)
Medications
Tofacitinib
Immunomodulators
JAK inhibitor
Regulatory Update
Adult patients
Clinicians
Patients On Biologics
Why This Matters
The FDA label defines who may be prescribed tofacitinib and highlights important safety warnings (serious infections, increased mortality signal, and malignancy risk) relevant to people with IBD and other autoimmune diseases. It also restricts combining tofacitinib with biologic therapies or potent immunosuppressants.
Who Should Pay Attention
Adults with moderately to severely active ulcerative colitis and other labeled autoimmune conditions; patients currently on or considering tofacitinib; clinicians who prescribe JAK inhibitors; patients on combination immunosuppression.
Study Snapshot
Story typeRegulatory
Evidence typeRegulatory update
Study statusHuman prescription drug
Source depthRegulatory record
What To Know
This is the FDA drug label/update for tofacitinib (a JAK inhibitor).
The label lists approved indications including moderately to severely active ulcerative colitis in adults and several rheumatologic and pediatric indications, describes boxed warnings (serious infections, mortality signal from a postmarketing safety study, malignancy risk), and notes limitations on combining tofacitinib with biologics or strong immunosuppressants.
The update is a regulatory record: it reports approved uses, safety warnings, and prescribing limitations rather than new trial results or guidance. Patients currently taking or considering tofacitinib should consult their clinicians to discuss how label warnings apply to their individual cardiovascular risk, infection risk, and concurrent medications.
If you are pregnant, planning pregnancy, or immunocompromised, talk with your clinician because the label includes safety and use restrictions relevant to those situations.
Keep In Mind
This entry is the official prescribing information (regulatory drug label) posted on DailyMed. It reports approved uses and boxed warnings — not new trial data. Treatment decisions should be made 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
SponsorGolden State Medical Supply, Inc.
Study typeDrug Label Update
Indexed viaopenFDA
Source typeRegulatory record
PublishedAug 13, 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 (2026-07-31)
This is an updated FDA drug label for tofacitinib, a JAK inhibitor that is approved for ulcerative colitis and other immune conditions.
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.
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...