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What is XELJANZ/XELJANZ XR?

XELJANZ/XELJANZ XR (tofacitinib) is a prescription medicine called a Janus kinase (JAK) inhibitor used to treat:

  • Adults with active psoriatic arthritis in which methotrexate or other similar medicines called nonbiologic disease-modifying antirheumatic drugs (DMARDs) did not work well.

It is not known if XELJANZ/XELJANZ XR is safe and effective in children or in people with Hepatitis B or C.

XELJANZ/XELJANZ XR is not recommended for people with severe liver problems.

XELJANZ/XELJANZ XR may cause serious side effects, including:

  • See "What is the most important information I should know about XELJANZ/XELJANZ XR?”
  • Hepatitis B or C activation infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B or C virus (viruses that affect the liver), the virus may become active while you use XELJANZ/XELJANZ XR. Your healthcare provider may do blood tests before you start treatment with XELJANZ/XELJANZ XR and while you are using XELJANZ/XELJANZ XR. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B or C infection:
    • feel very tired
    • little or no appetite
    • clay-colored bowel movements
    • chills
    • muscle aches
    • skin rash
    • skin or eyes look yellow
    • vomiting
    • fevers
    • stomach discomfort
    • dark urine

Common side effects of XELJANZ/XELJANZ XR in rheumatoid arthritis patients and psoriatic arthritis patients include:

  • upper respiratory tract infections (common cold, sinus infections)
  • headache
  • diarrhea
  • nasal congestion, sore throat, and runny nose (nasopharyngitis)
  • high blood pressure (hypertension)

Common side effects of XELJANZ in ulcerative colitis patients include:

  • nasal congestion, sore throat, and runny nose (nasopharyngitis)
  • increased cholesterol levels
  • headache
  • upper respiratory tract infections (common cold, sinus infections)
  • increased muscle enzyme levels
  • rash
  • diarrhea
  • shingles (herpes zoster)

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of XELJANZ/XELJANZ XR. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Pfizer at 1-800-438-1985.

Questions: 
WHAT ARE POSSIBLE SIDE EFFECTS OF XELJANZ/XELJANZ XR?
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