Safety / Side Effects

If you are considering asking your doctor about XELJANZ or XELJANZ XR, it’s important to learn more about the risks and benefits. The tools below can provide helpful information about taking XELJANZ and the safety and side effects of treatment.

Possible Side Effects

XELJANZ/XELJANZ XR (tofacitinib) may cause serious side effects.

Serious Infections

XELJANZ/XELJANZ XR can lower the ability of your immune system to fight infections. Some people can have serious infections while taking XELJANZ/XELJANZ XR, 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 and during XELJANZ/XELJANZ XR treatment, and monitor you closely for signs and symptoms of TB infection during treatment.

You should not start taking XELJANZ/XELJANZ XR 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 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/XELJANZ XR, tell your healthcare provider if you:

  • think you have an infection or have symptoms of an infection, such as fever, sweating, or chills; cough; blood in phlegm; warm, red, or painful skin or sores on your body; burning when you urinate or urinating more often than normal; muscle aches; shortness of breath; weight loss; diarrhea or stomach pain; or 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 use XELJANZ/XELJANZ XR. 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/XELJANZ XR, call your healthcare provider right away if you have any symptoms of an infection. XELJANZ/XELJANZ XR can make you more likely to get infections or make worse any infection that you have.

These are not all of the possible side effects of XELJANZ/XELJANZ XR. Learn more and read the Medication Guide.

Increased Risk Of Death In Rheumatoid Arthritis Patients Age 50+ With At Least One Heart Disease Risk Factor Who Take A Higher Than Recommended Dose

Increased risk of death in people 50 years of age and older with rheumatoid arthritis who have at least 1 heart disease (cardiovascular) risk factor and who are taking a higher than recommended dose of XELJANZ/XELJANZ XR. The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is XELJANZ 5 mg twice daily or XELJANZ XR 11 mg one time each day.

These are not all of the possible side effects of XELJANZ/XELJANZ XR. Learn more and read the Medication Guide.

Cancer And Immune System Problems

XELJANZ/XELJANZ XR 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 patients taking XELJANZ/XELJANZ XR. People taking the higher dose of XELJANZ (10 mg twice daily) of 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.

Some people who have taken XELJANZ with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr Virus–associated post-transplant lymphoproliferative disorder).

These are not all of the possible side effects of XELJANZ/XELJANZ XR. Learn more and read the Medication Guide.

Blood Clots In The Lungs, Veins Of The Legs, And Arteries In Rheumatoid Arthritis Patients Age 50+ Who Take A Higher Than Recommended Dose

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 patients with rheumatoid arthritis who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a higher than recommended dose of XELJANZ/XELJANZ XR. The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is XELJANZ 5 mg twice daily or XELJANZ XR 11 mg one time each day. Blood clots in the lungs have also happened in patients with ulcerative colitis. Some people have died from these blood clots.

  • Stop taking XELJANZ/XELJANZ XR and tell your healthcare provider right away if you have any signs and symptoms of a blood clot such as sudden shortness of breath, difficulty breathing, chest pain, swelling of a leg or arm, leg pain or tenderness, or red or discolored skin in the leg or arm.

These are not all of the possible side effects of XELJANZ/XELJANZ XR. Learn more and read the Medication Guide.

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/XELJANZ XR can get tears in their stomach or intestine. 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 fever and stomach-area pain that does not go away and a change in your bowel habits.

These are not all of the possible side effects of XELJANZ/XELJANZ XR. Learn more and read the Medication Guide.

Serious 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 patients taking XELJANZ/XELJANZ XR. Some of these reactions were serious. If any of these symptoms occur while you are taking XELJANZ/XELJANZ XR, stop XELJANZ/XELJANZ XR and call your healthcare provider right away.

These are not all of the possible side effects of XELJANZ/XELJANZ XR. Learn more and read the Medication Guide.

Changes In Certain Lab Test Results

Your healthcare provider should do blood tests before you start receiving XELJANZ/XELJANZ XR, and while you take XELJANZ/XELJANZ XR, 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 receive XELJANZ/XELJANZ XR 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/XELJANZ XR 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 XELJANZ/XELJANZ XR, and as needed after that.

These are not all of the possible side effects of XELJANZ/XELJANZ XR. Learn more and read the Medication Guide.

What Are Other Possible Side Effects Of XELJANZ/XELJANZ XR?

XELJANZ/XELJANZ XR may cause serious side effects, 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/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, or dark urine.

Common side effects of XELJANZ/XELJANZ XR in rheumatoid arthritis and psoriatic arthritis patients include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, runny nose (nasopharyngitis), and high blood pressure (hypertension).

Common side effects of XELJANZ/XELJANZ XR in ulcerative colitis patients include nasal congestion, sore throat, runny nose (nasopharyngitis), increased cholesterol levels, headache, upper respiratory tract infections (common cold, sinus infections), increased muscle enzyme levels, rash, diarrhea, and shingles (herpes zoster).

These are not all of the possible side effects of XELJANZ/XELJANZ XR. Learn more and read the Medication Guide.

What Should I Tell My Healthcare Provider Before Taking XELJANZ/XELJANZ XR?

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

  • have an infection
  • 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 had a reaction to tofacitinib or any of the ingredients in XELJANZ/XELJANZ XR
  • have recently received or are scheduled to receive a vaccine. People taking XELJANZ/XELJANZ XR should not receive live vaccines but can receive non-live vaccines
  • plan to become pregnant or are pregnant. XELJANZ/XELJANZ XR may affect the ability of females to get pregnant. It is not known if this will change after stopping XELJANZ/XELJANZ XR. It is not known if XELJANZ/XELJANZ XR will harm an unborn baby.
    pregnancy registry

    Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ/XELJANZ XR. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking XELJANZ/XELJANZ XR, talk to your healthcare provider about how you can join this pregnancy registry or you may contact the registry at 1-877-311-8972 to enroll

  • plan to breastfeed or are breastfeeding. You and your healthcare provider should decide if you will take XELJANZ/XELJANZ XR or breastfeed. You should not do both. After you stop your treatment with XELJANZ/XELJANZ XR do not start breastfeeding again until 18 hours after your last dose of XELJANZ 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. Especially tell your healthcare provider about any other medicines to treat your rheumatoid arthritis, psoriatic arthritis, or ulcerative colitis. 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®), azathioprine, cyclosporine, or other immunosuppressive drugs while you are taking XELJANZ or XELJANZ XR. Taking XELJANZ or XELJANZ XR with these medicines may increase your risk of infection.
  • Tell your healthcare provider if you are taking 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.

These are not all of the possible side effects of XELJANZ/XELJANZ XR. Learn more and read the Medication Guide.

Patients should always ask their doctors for medical advice about adverse events. You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.

Questions About XELJANZ/XELJANZ XR

What Should I Know Before Starting On XELJANZ/XELJANZ XR?

XELJANZ/XELJANZ XR can lower the ability of your immune system to fight infections. Some people can have serious infections while taking XELJANZ/XELJANZ XR, 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 and during XELJANZ/XELJANZ XR treatment, and monitor you closely for signs and symptoms of TB infection during treatment.

You should not start taking XELJANZ/XELJANZ XR 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 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.

How Should I Take XELJANZ/XELJANZ XR?

Take XELJANZ/XELJANZ XR exactly as your healthcare provider tells you to take it. XELJANZ/XELJANZ XR is a pill that can be taken with or without food. XELJANZ is available in 5 mg and 10 mg tablets and is taken twice daily. XELJANZ XR is available in 11 mg and 22 mg extended-release tablets, and is taken once a day. XELJANZ XR tablets should be swallowed whole and intact. Do not crush, split, or chew.

What Should I Do If I Miss A Dose?

Contact your healthcare provider if you miss a dose or forget to take XELJANZ/XELJANZ XR for an extended period of time.

If I’m Taking XELJANZ XR, Will I See Something In My Stool?

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.

What Should I Do If I Plan To Become Pregnant Or Am Pregnant?

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

  • plan to become pregnant or are pregnant. XELJANZ/XELJANZ XR may affect the ability of females to get pregnant. It is not known if this will change after stopping XELJANZ/XELJANZ XR. It is not known if XELJANZ/XELJANZ XR will harm an unborn baby.
    • pregnancy registry

    Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ/XELJANZ XR. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking XELJANZ/XELJANZ XR, talk to your healthcare provider about how you can join this pregnancy registry or you may contact the registry at 1-877-311-8972 to enroll

What Should I Do If I Plan To Breastfeed Or Am Breastfeeding?

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

  • plan to breastfeed or are breastfeeding. You and your healthcare provider should decide if you will take XELJANZ/XELJANZ XR or breastfeed. You should not do both. After you stop your treatment with XELJANZ/XELJANZ XR do not start breastfeeding again until:
  • 18 hours after your last dose of XELJANZ or
  • 36 hours after your last dose of XELJANZ XR

Taking XELJANZ/XELJANZ XR

Depending on your diagnosis and other factors, your doctor may prescribe you a different dosage of XELJANZ or XELJANZ XR—which affects how many times a day you take your medication. In the meantime, learn more about the options you may have by selecting your condition.

  • Moderate to SevereRheumatoid Arthritis
  • ActivePsoriatic Arthritis
  • Moderate to SevereUlcerative Colitis

What are my options?

XELJANZ (5 mg)

How It’s Taken

Twice a day with or without food

How It’s Delivered

Immediate release into the bloodstream over the course of several hours

XELJANZ XR (11 mg)

How It’s Taken

Once a day with or without food*

How It’s Delivered

Extended release into the bloodstream over the course of a day

*XELJANZ XR tablets should be swallowed whole and intact. Do not crush, split, or chew.

What are my options?

XELJANZ (5 mg)*

How It’s Taken

Twice a day with or without food

How It’s Delivered

Immediate release into the bloodstream over the course of several hours

XELJANZ XR (11 mg)*

How It’s Taken

Once a day with or without food†

How It’s Delivered

Extended release into the bloodstream over the course of a day

*For active psoriatic arthritis (PsA), XELJANZ and XELJANZ XR should be taken with a disease-modifying antirheumatic drug (DMARD) such as methotrexate.
†XELJANZ XR tablets should be swallowed whole and intact. Do not crush, split, or chew.

What are my options?

XELJANZ (5 mg)*

How It’s Taken

Twice a day with or without food

How It’s Delivered

Immediate release into the bloodstream over the course of several hours

XELJANZ (10 mg)*

How It’s Taken

Twice a day with or without food

How It’s Delivered

Immediate release into the bloodstream over the course of several hours

XELJANZ XR (11 mg)*

How It’s Taken

Once a day with or without food†

How It’s Delivered

Extended release into the bloodstream over the course of a day

XELJANZ XR (22 mg)*

How It’s Taken

Once a day with or without food†

How It’s Delivered

Extended release into the bloodstream over the course of a day

*For moderate to severe UC, the recommended starting dose of XELJANZ/XELJANZ XR is 10 mg twice daily or 22 mg once daily for 8 weeks. Depending on your doctor’s assessment of your progress, your maintenance dose may be 5 mg or 10 mg twice daily, or 11 mg or 22 mg once a day if you are taking XELJANZ XR. You should use the lowest effective dose to maintain response. Therapy should be discontinued after 16 weeks of 22 mg once daily or 10 mg twice daily if adequate symptom improvement is not achieved.
†XELJANZ XR tablets should be swallowed whole and intact. Do not crush, split, or chew.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit http://fda.gov/MedWatch or call 1-800-FDA-1088.

If your doctor has prescribed XELJANZ and you need help paying for it, XELSOURCE may be able to assist, depending on eligibility, terms and conditions.

Call 1-844-935-5269 Monday through Friday, 8:00 AM–8:00 PM ET, for more information.

This site is intended only for U.S. residents. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only and is not intended to replace discussions with a healthcare provider.

XELJANZ is a registered trademark of Pfizer Inc. The brand names included throughout are the properties of their respective owners.

XELJANZ (tofacitinib) is available in 5 mg and 10 mg tablets.

XELJANZ XR (tofacitinib) is available in 11 mg and 22 mg extended-release tablets.

XELJANZ Oral Solution 1 mg/mL is anticipated to be available in first quarter 2021.

PP-XEL-USA-5895-01
PP-XEL-USA-5895-01
Indications Indaication Modal

XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults with:

  • Moderately to severely active rheumatoid arthritis in whom methotrexate did not work well or cannot be tolerated
  • Active psoriatic arthritis in which methotrexate or other similar medicines called nonbiologic disease-modifying antirheumatic drugs (DMARDs) did not work well or cannot be tolerated
  • Moderately to severely active ulcerative colitis when medicines called tumor necrosis factor (TNF) blockers did not work well or cannot be tolerated

XELJANZ/XELJANZ Oral Solution is used to treat patients 2 years of age and older with active polyarticular juvenile arthritis.

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

XELJANZ/XELJANZ XR/XELJANZ Oral Solution 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 juvenile arthritis.

It is not known if XELJANZ XR is safe and effective in children.

XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults with:

  • Moderately to severely active » Read More
Important Safety Information ISI Modal

The safety information below applies to all marketed formulations of XELJANZ. Specific risks associated with certain dosing is noted.

Serious Infections. XELJANZ can lower the ability of your immune system to fight infections. Do not start taking XELJANZ if you have any kind of infection unless your healthcare provider tells you it is okay. Serious Infections have happened in people taking XELJANZ. These serious infections include 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 and during treatment with XELJANZ.

Before and after starting XELJANZ, tell your doctor if you have an infection or symptoms of an infection, including:

  • Fever, sweating, or chills
  • Cough
  • Blood in phlegm
  • Warm, red, or painful skin or sores on your body
  • Burning when you urinate
  • Urinating more often than normal
  • Muscle aches
  • Shortness of breath
  • Weight loss
  • Diarrhea or stomach pain
  • Feeling very tired

Increased risk of death in people 50 years of age and older with rheumatoid arthritis who have at least 1 heart disease (cardiovascular) risk factor and who are taking a higher than recommended dose of XELJANZ/XELJANZ XR. The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is XELJANZ 5 mg twice daily or XELJANZ XR 11 mg one time each day.

Cancer. 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. Tell your healthcare provider if you have ever had any type of cancer.

Higher dose.  People 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, shingles, or skin cancers.

Immune System Problem. Some people who have taken XELJANZ with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr Virus–associated post-transplant lymphoproliferative disorder).

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 patients with rheumatoid arthritis who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a higher than recommended dose of XELJANZ/XELJANZ XR. Blood clots in the lungs have also happened in patients with ulcerative colitis. Some people have died from these blood clots.

• Stop taking XELJANZ and tell your healthcare provider right away if you have any signs and symptoms of blood clots such as sudden shortness of breath, difficulty breathing, chest pain, swelling of a leg or arm, leg pain or tenderness, or red or discolored skin 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 intestine. 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 fever, stomach-area pain that does not go away, and a change in your bowel habits.

Serious allergic reactions can occur. Stop using XELJANZ and call your healthcare provider right away if you have swelling of your lips, tongue, throat, or get hives.

Changes in certain lab test results. Your doctor should do blood tests to check your white and red blood cells before and while you are taking XELJANZ. Your doctor should also check certain liver tests. You should not receive XELJANZ if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver function test levels are too high. Changes in lab test results may cause your healthcare provider to stop your XELJANZ treatment for a time. Your cholesterol levels should be checked 4 to 8 weeks after you start receiving XELJANZ.

Before you use XELJANZ, tell your healthcare provider if you:

  • Are being treated for an infection, have an infection that won’t go away or keeps coming back, or think you have symptoms of an infection
  • Have TB, or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB
  • Have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance for infections
  • Live or have lived in certain areas (such as Ohio and Mississippi River Valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections
  • Have or have had Hepatitis B or C
  • Have had blood clots
  • Have liver or kidney problems
  • Have any stomach area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines
  • Have recently received or plan to receive a vaccine. People taking XELJANZ should not receive live vaccines but can receive non-live vaccines
  • Are pregnant, planning to become pregnant, breastfeeding or planning to breastfeed. You should not take XELJANZ and breastfeed
  • Have had a reaction to tofacitinib or any of the ingredients
  • Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take any of the following medicines while taking XELJANZ since this may increase your risk of infection:
    • tocilizumab (Actemra®)
    • etanercept (Enbrel®)
    • adalimumab (Humira®)
    • infliximab (Remicade®)
    • rituximab (Rituxan®)
    • abatacept (Orencia®)
    • anakinra (Kineret®)
    • certolizumab (Cimzia®)
    • golimumab (Simponi®)
    • ustekinumab (Stelara®)
    • secukinumab (Cosentyx®)
    • vedolizumab (Entyvio®)
    • sarilumab (Kevzara®)
    • azathioprine, cyclosporine, or other immunosuppressive drugs
  • Tell your healthcare provider if you are taking 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.

What are other possible side effects of XELJANZ?

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 starting and while using treatment with XELJANZ. Tell your healthcare provider if you have any signs of these symptoms: 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, or dark urine.

Common side effects in adults with rheumatoid arthritis and psoriatic arthritis include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, runny nose (nasopharyngitis), and high blood pressure (hypertension).

Common side effects in adults with ulcerative colitis include nasal congestion, sore throat, runny nose (nasopharyngitis), increased cholesterol levels, headache, upper respiratory tract infections (common cold, sinus infections), increased muscle enzyme levels, rash, diarrhea, and shingles (herpes zoster).

Common side effects in children (2 & older) with polyarticular juvenile idiopathic arthritis include upper respiratory tract infections (common cold, sinus infections), nasal congestion, sore throat, and runny nose (nasopharyngitis), headache, fever, nausea, and vomiting.

XELJANZ & Pregnancy

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.

  • Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking XELJANZ, talk to your healthcare provider about how you can join this pregnancy registry or you may contact the registry at 1-877-311-8972 to enroll.

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 or 36 hours after your last dose of XELJANZ XR.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

IndicationsIndaication Modal

XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults with:

  • Moderately to severely active rheumatoid arthritis in whom methotrexate did not work well or cannot be tolerated
  • Active psoriatic arthritis in which methotrexate or other similar medicines called nonbiologic disease-modifying antirheumatic drugs (DMARDs) did not work well or cannot be tolerated
  • Moderately to severely active ulcerative colitis when medicines called tumor necrosis factor (TNF) blockers did not work well or cannot be tolerated

XELJANZ/XELJANZ Oral Solution is used to treat patients 2 years of age and older with active polyarticular juvenile arthritis.

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

XELJANZ/XELJANZ XR/XELJANZ Oral Solution 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 juvenile arthritis.

It is not known if XELJANZ XR is safe and effective in children.

XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults with:

  • Moderately to severely active rheumatoid arthritis in whom methotrexate did not work well or cannot be tolerated...Read More

XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults with:

  • Moderately to severely active » Read More
Important Safety InformationISI Modal

The safety information below applies to all marketed formulations of XELJANZ. Specific risks associated with certain dosing is noted.

Serious Infections. XELJANZ can lower the ability of your immune system to fight infections. Do not start taking XELJANZ if you have any kind of infection unless your healthcare provider tells you it is okay. Serious Infections have happened in people taking XELJANZ. These serious infections include 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 and during treatment with XELJANZ.

Before and after starting XELJANZ, tell your doctor if you have an infection or symptoms of an infection, including:

  • Fever, sweating, or chills
  • Cough
  • Blood in phlegm
  • Warm, red, or painful skin or sores on your body
  • Burning when you urinate
  • Urinating more often than normal
  • Muscle aches
  • Shortness of breath
  • Weight loss
  • Diarrhea or stomach pain
  • Feeling very tired

Increased risk of death in people 50 years of age and older with rheumatoid arthritis who have at least 1 heart disease (cardiovascular) risk factor and who are taking a higher than recommended dose of XELJANZ/XELJANZ XR. The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is XELJANZ 5 mg twice daily or XELJANZ XR 11 mg one time each day.

Cancer. 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. Tell your healthcare provider if you have ever had any type of cancer.

Higher dose.  People 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, shingles, or skin cancers.

Immune System Problem. Some people who have taken XELJANZ with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr Virus–associated post-transplant lymphoproliferative disorder).

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 patients with rheumatoid arthritis who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a higher than recommended dose of XELJANZ/XELJANZ XR. Blood clots in the lungs have also happened in patients with ulcerative colitis. Some people have died from these blood clots.

• Stop taking XELJANZ and tell your healthcare provider right away if you have any signs and symptoms of blood clots such as sudden shortness of breath, difficulty breathing, chest pain, swelling of a leg or arm, leg pain or tenderness, or red or discolored skin 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 intestine. 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 fever, stomach-area pain that does not go away, and a change in your bowel habits.

Serious allergic reactions can occur. Stop using XELJANZ and call your healthcare provider right away if you have swelling of your lips, tongue, throat, or get hives.

Changes in certain lab test results. Your doctor should do blood tests to check your white and red blood cells before and while you are taking XELJANZ. Your doctor should also check certain liver tests. You should not receive XELJANZ if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver function test levels are too high. Changes in lab test results may cause your healthcare provider to stop your XELJANZ treatment for a time. Your cholesterol levels should be checked 4 to 8 weeks after you start receiving XELJANZ.

Before you use XELJANZ, tell your healthcare provider if you:

  • Are being treated for an infection, have an infection that won’t go away or keeps coming back, or think you have symptoms of an infection
  • Have TB, or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB
  • Have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance for infections
  • Live or have lived in certain areas (such as Ohio and Mississippi River Valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections
  • Have or have had Hepatitis B or C
  • Have had blood clots
  • Have liver or kidney problems
  • Have any stomach area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines
  • Have recently received or plan to receive a vaccine. People taking XELJANZ should not receive live vaccines but can receive non-live vaccines
  • Are pregnant, planning to become pregnant, breastfeeding or planning to breastfeed. You should not take XELJANZ and breastfeed
  • Have had a reaction to tofacitinib or any of the ingredients
  • Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take any of the following medicines while taking XELJANZ since this may increase your risk of infection:
    • tocilizumab (Actemra®)
    • etanercept (Enbrel®)
    • adalimumab (Humira®)
    • infliximab (Remicade®)
    • rituximab (Rituxan®)
    • abatacept (Orencia®)
    • anakinra (Kineret®)
    • certolizumab (Cimzia®)
    • golimumab (Simponi®)
    • ustekinumab (Stelara®)
    • secukinumab (Cosentyx®)
    • vedolizumab (Entyvio®)
    • sarilumab (Kevzara®)
    • azathioprine, cyclosporine, or other immunosuppressive drugs
  • Tell your healthcare provider if you are taking 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.

What are other possible side effects of XELJANZ?

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 starting and while using treatment with XELJANZ. Tell your healthcare provider if you have any signs of these symptoms: 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, or dark urine.

Common side effects in adults with rheumatoid arthritis and psoriatic arthritis include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, runny nose (nasopharyngitis), and high blood pressure (hypertension).

Common side effects in adults with ulcerative colitis include nasal congestion, sore throat, runny nose (nasopharyngitis), increased cholesterol levels, headache, upper respiratory tract infections (common cold, sinus infections), increased muscle enzyme levels, rash, diarrhea, and shingles (herpes zoster).

Common side effects in children (2 & older) with polyarticular juvenile idiopathic arthritis include upper respiratory tract infections (common cold, sinus infections), nasal congestion, sore throat, and runny nose (nasopharyngitis), headache, fever, nausea, and vomiting.

XELJANZ & Pregnancy

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.

  • Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking XELJANZ, talk to your healthcare provider about how you can join this pregnancy registry or you may contact the registry at 1-877-311-8972 to enroll.

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 or 36 hours after your last dose of XELJANZ XR.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

Indications

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XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults with:

  • Moderately to severely active rheumatoid arthritis in whom methotrexate did not work well or cannot be tolerated
  • Active psoriatic arthritis in which methotrexate or other similar medicines called nonbiologic disease-modifying antirheumatic drugs (DMARDs) did not work well or cannot be tolerated
  • Moderately to severely active ulcerative colitis when medicines called tumor necrosis factor (TNF) blockers did not work well or cannot be tolerated

XELJANZ/XELJANZ Oral Solution is used to treat patients 2 years of age and older with active polyarticular juvenile arthritis.

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

XELJANZ/XELJANZ XR/XELJANZ Oral Solution 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 juvenile arthritis.

It is not known if XELJANZ XR is safe and effective in children.

Important Safety Information

Close

The safety information below applies to all marketed formulations of XELJANZ. Specific risks associated with certain dosing is noted.

Serious Infections. XELJANZ can lower the ability of your immune system to fight infections. Do not start taking XELJANZ if you have any kind of infection unless your healthcare provider tells you it is okay. Serious Infections have happened in people taking XELJANZ. These serious infections include 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 and during treatment with XELJANZ.

Before and after starting XELJANZ, tell your doctor if you have an infection or symptoms of an infection, including:

  • Fever, sweating, or chills
  • Cough
  • Blood in phlegm
  • Warm, red, or painful skin or sores on your body
  • Burning when you urinate
  • Urinating more often than normal
  • Muscle aches
  • Shortness of breath
  • Weight loss
  • Diarrhea or stomach pain
  • Feeling very tired

Increased risk of death in people 50 years of age and older with rheumatoid arthritis who have at least 1 heart disease (cardiovascular) risk factor and who are taking a higher than recommended dose of XELJANZ/XELJANZ XR. The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is XELJANZ 5 mg twice daily or XELJANZ XR 11 mg one time each day.

Cancer. 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. Tell your healthcare provider if you have ever had any type of cancer.

Higher dose.  People 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, shingles, or skin cancers.

Immune System Problem. Some people who have taken XELJANZ with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr Virus–associated post-transplant lymphoproliferative disorder).

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 patients with rheumatoid arthritis who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a higher than recommended dose of XELJANZ/XELJANZ XR. Blood clots in the lungs have also happened in patients with ulcerative colitis. Some people have died from these blood clots.

• Stop taking XELJANZ and tell your healthcare provider right away if you have any signs and symptoms of blood clots such as sudden shortness of breath, difficulty breathing, chest pain, swelling of a leg or arm, leg pain or tenderness, or red or discolored skin 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 intestine. 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 fever, stomach-area pain that does not go away, and a change in your bowel habits.

Serious allergic reactions can occur. Stop using XELJANZ and call your healthcare provider right away if you have swelling of your lips, tongue, throat, or get hives.

Changes in certain lab test results. Your doctor should do blood tests to check your white and red blood cells before and while you are taking XELJANZ. Your doctor should also check certain liver tests. You should not receive XELJANZ if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver function test levels are too high. Changes in lab test results may cause your healthcare provider to stop your XELJANZ treatment for a time. Your cholesterol levels should be checked 4 to 8 weeks after you start receiving XELJANZ.

Before you use XELJANZ, tell your healthcare provider if you:

  • Are being treated for an infection, have an infection that won’t go away or keeps coming back, or think you have symptoms of an infection
  • Have TB, or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB
  • Have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance for infections
  • Live or have lived in certain areas (such as Ohio and Mississippi River Valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections
  • Have or have had Hepatitis B or C
  • Have had blood clots
  • Have liver or kidney problems
  • Have any stomach area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines
  • Have recently received or plan to receive a vaccine. People taking XELJANZ should not receive live vaccines but can receive non-live vaccines
  • Are pregnant, planning to become pregnant, breastfeeding or planning to breastfeed. You should not take XELJANZ and breastfeed
  • Have had a reaction to tofacitinib or any of the ingredients
  • Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take any of the following medicines while taking XELJANZ since this may increase your risk of infection:
    • tocilizumab (Actemra®)
    • etanercept (Enbrel®)
    • adalimumab (Humira®)
    • infliximab (Remicade®)
    • rituximab (Rituxan®)
    • abatacept (Orencia®)
    • anakinra (Kineret®)
    • certolizumab (Cimzia®)
    • golimumab (Simponi®)
    • ustekinumab (Stelara®)
    • secukinumab (Cosentyx®)
    • vedolizumab (Entyvio®)
    • sarilumab (Kevzara®)
    • azathioprine, cyclosporine, or other immunosuppressive drugs
  • Tell your healthcare provider if you are taking 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.

What are other possible side effects of XELJANZ?

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 starting and while using treatment with XELJANZ. Tell your healthcare provider if you have any signs of these symptoms: 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, or dark urine.

Common side effects in adults with rheumatoid arthritis and psoriatic arthritis include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, runny nose (nasopharyngitis), and high blood pressure (hypertension).

Common side effects in adults with ulcerative colitis include nasal congestion, sore throat, runny nose (nasopharyngitis), increased cholesterol levels, headache, upper respiratory tract infections (common cold, sinus infections), increased muscle enzyme levels, rash, diarrhea, and shingles (herpes zoster).

Common side effects in children (2 & older) with polyarticular juvenile idiopathic arthritis include upper respiratory tract infections (common cold, sinus infections), nasal congestion, sore throat, and runny nose (nasopharyngitis), headache, fever, nausea, and vomiting.

XELJANZ & Pregnancy

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.

  • Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking XELJANZ, talk to your healthcare provider about how you can join this pregnancy registry or you may contact the registry at 1-877-311-8972 to enroll.

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 or 36 hours after your last dose of XELJANZ XR.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.