Safety / Side Effects
If you are considering asking your doctor about XELJANZ or
Possible Side Effects
XELJANZ/XELJANZ XR (tofacitinib) may cause serious side effects.
XELJANZ/XELJANZ XR can lower the ability of your immune system to fight infections. Some people can have serious infections while taking
- 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
Before starting
- 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
These are not all of the possible side effects of
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
These are not all of the possible side effects of
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
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
These are not all of the possible side effects of
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
- 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
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
These are not all of the possible side effects of
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
These are not all of the possible side effects of
Your healthcare provider should do blood tests before you start receiving
- 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
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
These are not all of the possible side effects of
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
Common side effects of
Common side effects of
These are not all of the possible side effects of
Before taking
- 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 receivenon-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 stoppingXELJANZ/XELJANZ XR . It is not known ifXELJANZ/XELJANZ XR will harm an unborn baby.



Questions About 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
- 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
Take XELJANZ/XELJANZ XR exactly as your healthcare provider tells you to take it.
Contact your healthcare provider if you miss a dose or forget to take
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.
Before taking
- 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 stoppingXELJANZ/XELJANZ XR . It is not known ifXELJANZ/XELJANZ XR will harm an unborn baby.
Before taking
- 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 withXELJANZ/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
- 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

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

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

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