The complete official prescribing information should always be consulted for authoritative prescribing instructions. The following is a structured summary of the current U.S. XELJANZ/XELJANZ XR label revised in June 2026.
Indications
Current U.S. labeling includes:
- Moderately to severely active rheumatoid arthritis in specified adults.
- Active psoriatic arthritis in specified adults.
- Active ankylosing spondylitis in specified adults.
- Moderately to severely active ulcerative colitis in specified adults.
- Active psoriatic arthritis in specified pediatric patients aged 2 years and older.
- Polyarticular-course juvenile idiopathic arthritis in specified pediatric patients aged 2 years and older.
Dosage forms
Current U.S. reference-product presentations include:
- 5 mg and 10 mg tablets.
- 11 mg and 22 mg extended-release tablets.
- 1 mg/mL oral solution.
Contraindications
The current U.S. label lists no contraindications. This does not mean that tofacitinib is appropriate for every patient; the boxed warning and numerous precautions remain applicable.
Major warnings
The boxed warning addresses serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis. Other warnings include gastrointestinal perforation, hypoglycemia in patients with diabetes, laboratory abnormalities and vaccination considerations.
Drug interactions
Clinically significant interactions include medicines affecting CYP3A4 and CYP2C19 activity, with dosage modifications required in specified circumstances.
Complete label
Readers should consult the current official label for complete dosing tables, clinical pharmacology, adverse-reaction frequencies, drug interactions and special-population information.