FDA label
What is Xeljanz used for?
Xeljanz contains tofacitinib. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Xeljanz lists 5 uses: Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Polyarticular Course Juvenile Idiopathic Arthritis; and 1 more.
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Xeljanz, tablet, film coated
Indications and Usage, quoted from the label by U.S. Pharmaceuticals (NDA203214). Cross-references to other label sections are left out.
Rheumatoid Arthritis
XELJANZ tablets and XELJANZ XR (extended-release tablets) are indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers.
Limitations of Use
Use of XELJANZ tablets or XELJANZ XR in combination with biologic disease-modifying antirheumatic drugs (DMARDs) or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
Psoriatic Arthritis
XELJANZ (tablets and oral solution) is indicated for the treatment of adult and pediatric patients 2 years of age and older with active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers.
XELJANZ XR (extended-release tablets) is indicated for the treatment of adults with active PsA who have had an inadequate response or intolerance to one or more TNF blockers.
Limitations of Use
Use of XELJANZ or XELJANZ XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
Ankylosing Spondylitis
XELJANZ tablets and XELJANZ XR (extended-release tablets) are indicated for the treatment of adult patients with active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers.
Limitations of Use
Use of XELJANZ tablets or XELJANZ XR in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
Polyarticular Course Juvenile Idiopathic Arthritis
XELJANZ (tablets and oral solution) are indicated for the treatment of pediatric patients 2 years of age and older with of active polyarticular course juvenile idiopathic arthritis (pcJIA), who have had an inadequate response or intolerance to one or more TNF blockers.
Limitations of Use
Use of XELJANZ in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
Ulcerative Colitis
XELJANZ tablets and XELJANZ XR (extended-release tablets) are indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have an inadequate response or intolerance to one or more TNF blockers.
Limitations of Use
Use of XELJANZ tablets or XELJANZ XR in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
Source: DailyMed label, set id 68e3d6b2-7838-4d2d-a417-09d919b43e13, version 19, effective October 6, 2026. NDC 63539-012, one of 4 listings for this product.
Questions
What is Xeljanz used for?
The FDA label for Xeljanz lists 5 uses: Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Polyarticular Course Juvenile Idiopathic Arthritis; and 1 more.
What drug class is Xeljanz?
FDA lists tofacitinib in the Janus Kinase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Xeljanz
- Is Xeljanz a controlled substance?Federal schedule
- Generic for XeljanzFDA Orange Book
- What is Tofacitinib used for?FDA label uses
- Is Tofacitinib a controlled substance?Federal schedule
- Generic for Xeljanz XRFDA Orange Book
- Janus Kinase Inhibitors listFDA drug class
- Xeljanz Medicare Part D coverageBy plan and state
- NDC 0069-0501Xeljanz NDC record
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- NDC 0069-1001Xeljanz NDC record