Pronunciation: zel-jans
Generic name: tofacitinib
Other brand names of tofacitinib include: Xeljanz, Xeljanz XR, Xeljanz Oral Solution
Dosage form: oral tablet, extended-release tablet, oral solution
Drug classes: Antirheumatics, Janus kinase (JAK) inhibitors (immunomodulatory)

Medically reviewed by Carmen Pope, Senior Medical Editor, B. Pharm. Last updated on Oct 1, 2026.

What is Xeljanz?

Xeljanz is used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and polyarticular-course juvenile arthritis. Xeljanz is available as an oral tablet, an extended-release tablet, and an oral solution.

Xeljanz (tofacitinib) works by decreasing the activity of the immune system. It does this by blocking the activity of JAK enzymes (JAK1, JAK2, JAK3, TYK2) inside the cell. These enzymes are responsible for sending inflammatory signals in the body, which are associated with cytokine release. Xeljanz helps to decrease the immune reaction that causes inflammatory conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and polyarticular-course juvenile arthritis. It belongs to the drug class called Janus kinase (JAK) inhibitors.

Xeljanz (tofacitinib) first received FDA approval on November 6, 2012, and was the first JAK inhibitor to be approved for rheumatoid arthritis. Generics are available.

FDA approvals and uses

Xeljanz is FDA-approved for:

• moderately to severely active rheumatoid arthritis in adults when 1 or more tumor necrosis factor (TNF) blockers have been used and did not work well or cannot be tolerated
• active psoriatic arthritis when 1 or more TNF blocker medicines have been used, and did not work well or cannot be tolerated. Xeljanz/Xeljanz XR is used to treat adults, and Xeljanz/Xeljanz oral solution is used to treat children 2 years and older
• active ankylosing spondylitis in adults when 1 or more TNF blocker medicines have been used and did not work well or cannot be tolerated
• moderately to severely active ulcerative colitis when 1 or more TNF blocker medicines have been used, and did not work well or cannot be tolerated
• active polyarticular course juvenile arthritis when 1 or more TNF blocker medicines have been used, and did not work well or cannot be tolerated. Xeljanz/Xeljanz oral solution is used in children 2 years of age and older.

It is not known if Xeljanz is safe and effective in people with Hepatitis B or C.

Xeljanz is not recommended for people with severe liver problems.

It is not known if Xeljanz/Xeljanz oral solution is safe and effective in children for treatment other than active polyarticular course juvenile arthritis and psoriatic arthritis.

It is not known if Xeljanz XR is safe and effective in children. Xeljanz XR is not approved for use in children.

Important information and warnings

Xeljanz may cause serious side effects, including:

• Serious infections. Xeljanz affects your immune system and can lower the ability of your immune system to fight infections. Some people can have serious infections while taking Xeljanz, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.

  • Your healthcare provider should test you for TB before starting Xeljanz and during treatment.
  • Your healthcare provider should monitor you closely for signs and symptoms of TB infection during treatment with Xeljanz.

  You should not start taking Xeljanz if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster).

  People with ulcerative colitis taking the higher dose of Xeljanz (10 mg twice daily) or Xeljanz XR (22 mg one time each day) have a higher risk of serious infections and shingles.

  Before starting Xeljanz, tell your healthcare provider if you:

  • think you have an infection or have symptoms of an infection such as:
    • fever, sweating, or chills
    • muscle aches
    • cough
    • shortness of breath
    • blood in phlegm
    • weight loss
    • warm, red, or painful skin or sores on your body
    • diarrhea or stomach pain
    • burning when you urinate or urinating more often than normal
    • feeling very tired
  • are being treated for an infection.
  • get a lot of infections or have infections that keep coming back.
  • have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance for infections.
  • have TB, or have been in close contact with someone with TB.
  • live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you take Xeljanz. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common.
  • have or have had hepatitis B or C.

  After starting Xeljanz, call your healthcare provider right away if you have any symptoms of an infection. Xeljanz can make you more likely to get infections or make any infection that you have worse.

  Call your healthcare provider right away if you, your partner, or your caregiver notice new or worsening neurological symptoms, such as general muscle weakness, vision changes, or changes in thinking, memory, and orientation leading to confusion and personality changes. These may be symptoms of a very rare, serious brain infection called progressive multifocal leukoencephalopathy (PML).

• Increased risk of death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking Xeljanz 5 mg or 10 mg twice daily.

• Cancer and immune system problems. Xeljanz may increase your risk of certain cancers by changing the way your immune system works.

  • Lymphoma and other cancers, including skin cancers, can happen in people taking Xeljanz. People taking Xeljanz 5 mg twice daily or Xeljanz 10 mg twice daily have a higher risk of certain cancers, including lymphoma and lung cancer, especially if you are a current or past smoker. People with ulcerative colitis taking the higher dose of Xeljanz (10 mg twice daily) or Xeljanz XR (22 mg one time each day) have a higher risk of skin cancers. Tell your healthcare provider if you have ever had any type of cancer.

• Increased risk of major cardiovascular events such as heart attack, stroke, or death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking Xeljanz 5 mg or 10 mg twice daily, especially if you are a current or past smoker.

  Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Xeljanz, including:

  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded
  • weakness in one part or on one side of your body
  • slurred speech

• Blood clots in the lungs, veins of the legs or arms, and arteries. Blood clots in the lungs (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT), and arteries (arterial thrombosis) have happened more often in people who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking Xeljanz 5 mg or 10 mg twice daily. Blood clots in the lungs have also happened in people with ulcerative colitis. Some people have died from these blood clots.

  • Stop taking Xeljanz and tell your healthcare provider right away if you develop signs and symptoms of a blood clot, such as sudden shortness of breath or difficulty breathing, chest pain, swelling of the leg or arm, leg pain or tenderness, or redness or discoloration in the leg or arm.

• Tears (perforation) in the stomach or intestines.

  • Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking Xeljanz can get tears in their stomach or intestines. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.

  Tell your healthcare provider right away if you have a fever and stomach-area pain that does not go away, and a change in your bowel habits.

• Allergic reactions. Symptoms such as swelling of your lips, tongue, or throat, or hives (raised, red patches of skin that are often very itchy) that may mean you are having an allergic reaction have been seen in people taking Xeljanz/Xeljanz XR. Some of these reactions were serious. If any of these symptoms occur while you are taking Xeljanz, stop Xeljanz and call your healthcare provider right away.

• Low blood sugar (hypoglycemia) in people with diabetes. If you have diabetes, your healthcare provider may tell you to check your blood sugar (glucose) more often during treatment with Xeljanz. Call your healthcare provider if you have any problems with low blood sugar.

• Changes in certain laboratory test results. Your healthcare provider should do blood tests before you start taking Xeljanz and while you take Xeljanz to check for the following side effects:

  • changes in lymphocyte counts. Lymphocytes are white blood cells that help the body fight off infections.
  • low neutrophil counts. Neutrophils are white blood cells that help the body fight off infections.
  • low red blood cell count. This may mean that you have anemia, which may make you feel weak and tired.

  Your healthcare provider should routinely check certain liver tests.

  You should not take Xeljanz if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver tests are too high.

  Your healthcare provider may stop your Xeljanz treatment for a period of time if needed because of changes in these blood test results.

  You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start taking Xeljanz, and as needed after that. Normal cholesterol levels are important to good heart health.

What are the possible side effects of Xeljanz?

Xeljanz may cause serious side effects (see also Important information above), including:

• 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. Your healthcare provider may do blood tests before you start treatment with Xeljanz and while you are taking Xeljanz. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B or C infection:
  • feel very tired
  • skin or eyes look yellow
  • little or no appetite
  • vomiting
  • clay-colored bowel movements
  • fevers
  • chills
  • stomach discomfort
  • muscle aches
  • dark urine
  • skin rash.

Common side effects

Common side effects of Xeljanz in people with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis include:

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

Common side effects of Xeljanz/Xeljanz XR in people with ulcerative colitis 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
• acne
• diarrhea
• shingles (herpes zoster).

Common side effects of Xeljanz/Xeljanz oral solution in children with polyarticular course juvenile arthritis and psoriatic arthritis include:

• upper respiratory tract infections (common cold, sinus infections)
• nasal congestion, sore throat, and runny nose (nasopharyngitis)
• headache
• fever
• nausea
• vomiting
• acne.

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. 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.

Related/similar drugs

Before taking

Before taking Xeljanz, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection. See "What is the most important information I should know about Xeljanz?"
• are a current or past smoker
• have had any type of cancer
• have had a heart attack, other heart problems or stroke
• have had blood clots in the veins of your legs, arms, or lungs, or clots in the arteries in the past
• have liver problems
• have kidney problems
• have any stomach-area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines
• have diabetes
• have had a reaction to tofacitinib or any of the ingredients in Xeljanz
• have recently received or are scheduled to receive a vaccine. People who take Xeljanz should not receive live vaccines. People taking Xeljanz can receive non-live vaccines
• plan to become pregnant or are pregnant. Xeljanz may affect the ability of females to get pregnant. It is not known if this will change after stopping Xeljanz. It is not known if Xeljanz will harm an unborn baby
• plan to breastfeed or are breastfeeding. You and your healthcare provider should decide if you will take Xeljanz or breastfeed. You should not do both. After you stop your treatment with Xeljanz, do not start breastfeeding again until:
  • 18 hours after your last dose of Xeljanz/Xeljanz oral solution or
  • 36 hours after your last dose of Xeljanz XR.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take Xeljanz?

Take Xeljanz exactly as your healthcare provider tells you to take it.

• Take Xeljanz/Xeljanz oral solution 2 times a day with or without food.
• Take Xeljanz XR 1 time a day with or without food.
• Swallow Xeljanz XR tablets whole and intact. Do not crush, split, or chew.
• When you take Xeljanz XR, you may see something in your stool that looks like a tablet. This is the empty shell from the tablet after the medicine has been absorbed by your body.
• If you take too much Xeljanz, call your healthcare provider or go to the nearest hospital emergency room right away.
• For the treatment of psoriatic arthritis, take Xeljanz in combination with methotrexate, sulfasalazine or leflunomide as instructed by your healthcare provider.
• Xeljanz XR should not be used instead of Xeljanz oral solution.

What other drugs will affect Xeljanz?

Xeljanz and other medicines may affect each other, causing side effects. Especially tell your healthcare provider if you take:

• any other medicines to treat your rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, or polyarticular course juvenile arthritis. You should not take tocilizumab (Actemra), etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), rituximab (Rituxan), abatacept (Orencia), anakinra (Kineret), certolizumab (Cimzia), golimumab (Simponi), ustekinumab (Stelara), secukinumab (Cosentyx), vedolizumab (Entyvio), ixekizumab (Taltz), azathioprine, cyclosporine, or other immunosuppressive drugs while you are taking Xeljanz. Taking Xeljanz with these medicines may increase your risk of infection.
• medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I store Xeljanz?

• Store Xeljanz/Xeljanz XR at room temperature between 68°F and 77°F (20°C and 25°C).
• Store Xeljanz oral solution at room temperature between 68°F and 77°F (20°C and 25°C) in the original bottle and carton to protect from light.
• Safely throw away Xeljanz oral solution that is out of date or no longer needed. Use Xeljanz oral solution within 60 days of opening the bottle. Throw away (discard) the remaining oral solution after 60 days.

Keep Xeljanz and all medicines out of the reach of children.

What are the ingredients in Xeljanz?

Active ingredient: tofacitinib citrate

Inactive ingredients (5 mg tablets): croscarmellose sodium, HPMC 2910/Hypromellose 6cP, lactose monohydrate, macrogol/PEG3350, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.

Inactive ingredients (10 mg tablets): croscarmellose sodium, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, FD&C Blue #2/Indigo Carmine Aluminum Lake, HPMC 2910/Hypromellose 6cP, lactose monohydrate, macrogol/PEG3350, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.

Inactive ingredients (11 mg XR tablets): cellulose acetate, copovidone, hydroxyethyl cellulose, hydroxypropyl cellulose, HPMC 2910/Hypromellose, magnesium stearate, red iron oxide, sorbitol, titanium dioxide, and triacetin. Printing ink contains ammonium hydroxide, ferrosoferric oxide/black iron, propylene glycol, and shellac glaze.

Inactive ingredients (22 mg XR tablets): cellulose acetate, copovidone, FD&C Blue #2 Aluminum Lake, hydroxyethyl cellulose, hydroxypropyl cellulose, HPMC 2910/Hypromellose, magnesium stearate, red iron oxide, sorbitol, titanium dioxide, triacetin, and yellow iron oxide. Printing ink contains ammonium hydroxide, ferrosoferric oxide/black iron oxide, propylene glycol, and shellac glaze.

Inactive ingredients (oral solution 1 mg/mL): grape flavor (natural), hydrochloric acid, lactic acid, purified water, sodium benzoate, sucralose, and xylitol.

Manufacturer

Xeljanz is distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10001.

Common questions about Xeljanz

More FAQ

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer