XELJANZ/XELJANZ XR may cause serious side effects including:
1. Serious infections. XELJANZ/XELJANZ XR is a medicine that affects your immune system. 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 XELJANZ/XELJANZ XR and during treatment.
- Your healthcare provider should monitor you closely for signs and symptoms of TB infection during treatment with XELJANZ/XELJANZ XR.
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
- 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
- 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.
2. 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.
3. 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) 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.
- 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).
4. 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 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 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.
5. 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 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 fever and stomach-area pain that does not go away, and a change in your bowel habits.
6. 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.
7. Changes in certain laboratory 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 receiving XELJANZ/XELJANZ XR, and as needed after that. Normal cholesterol levels are important to good heart health.
See "What are the possible side effects of XELJANZ/XELJANZ XR?" for more information about side effects.