TOFACITINIB FDA label update (2026-07-06)

2 min read Jul 13, 2026, 4:55 PM

Medications Tofacitinib Azathioprine Immunomodulators JAK inhibitor Regulatory Update Adult patients Clinicians

Why This Matters

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.

Who Should Pay Attention

Adult patients with ulcerative colitis or other inflammatory conditions considering or taking tofacitinib; clinicians who prescribe JAK inhibitors; patients on or considering combination immunosuppression.

Study Snapshot

Story typeRegulatory

Evidence typeRegulatory update

Study statusHuman prescription drug

Source depthRegulatory record

What To Know

This is the FDA (DailyMed) prescribing information for tofacitinib, a JAK inhibitor, updated as a regulatory record.

The label lists approved indications including moderately to severely active ulcerative colitis and other immune-mediated diseases, and includes boxed warnings about serious infections, increased mortality in older RA patients with cardiovascular risk factors, malignancy, major adverse cardiovascular events, and thrombosis.

The label states testing for latent tuberculosis before starting tofacitinib and monitoring during therapy, and it recommends against combining tofacitinib with biologic therapies or potent immunosuppressants (for example azathioprine or cyclosporine) for UC and other indications.

It also notes pediatric indications for certain conditions and dosage cautions (10 mg twice daily not recommended for several indications). Read the actual DailyMed label for details on boxed warnings, contraindications, dosing, and full safety information.

This curator note summarizes the source-provided regulatory record and does not replace professional medical advice.

Keep In Mind

This classification and brief are grounded in the DailyMed / FDA prescribing information (regulatory record). Patients should consult their clinician and review the full label for individualized risks, dosing, and monitoring requirements.

Source Details

Review the original publication for the complete reporting, methods, and context.

Read Original Source

Regulatory update Evidence type derived from source or registry metadata.

PublicationopenFDA

Study typeDrug Label Update

Indexed viaopenFDA

Source typeRegulatory record

PublishedJul 6, 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.