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Xeljanz Side Effects

Generic Name: tofacitinib

Note: This document contains side effect information about tofacitinib. Some of the dosage forms listed on this page may not apply to the brand name Xeljanz.

In Summary

Common side effects of Xeljanz include: infection. Other side effects include: diarrhea and headache. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to tofacitinib: oral tablet, oral tablet extended release


Oral route (Tablet; Tablet, Extended Release)

Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred in patients receiving tofacitinib. If a serious infection develops, interrupt tofacitinib until the infection is controlled. Prior to starting tofacitinib and during therapy, perform a test for latent tuberculosis; if it is positive, start treatment for tuberculosis prior to starting tofacitinib. Monitor all patients for the development of signs and symptoms of infection during and after treatment with tofacitinib, including active tuberculosis during treatment, even if the initial latent tuberculosis test is negative. Rheumatoid arthritis patients with at least one cardiovascular (CV) risk factor had a higher rate of all-cause mortality and thrombosis with tofacitinib 10 mg twice daily vs 5 mg twice daily or TNF blockers. Lymphoma and other malignancies have been observed in patients treated with tofacitinib. Epstein Barr virus-associated posttransplant lymphoproliferative disorder has been observed at an increased rate in renal transplant patients treated with tofacitinib and concomitant immunosuppressive medications.

Side effects requiring immediate medical attention

Along with its needed effects, tofacitinib (the active ingredient contained in Xeljanz) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking tofacitinib:

Less common

  • Bladder pain
  • bloody or cloudy urine
  • blurred vision
  • body aches or pain
  • chills
  • cough
  • difficult, burning, or painful urination
  • difficulty breathing
  • dizziness
  • ear congestion
  • fever
  • frequent urge to urinate
  • headache
  • loss of voice
  • lower back or side pain
  • muscle aches
  • nervousness
  • pounding in the ears
  • slow or fast heartbeat
  • sneezing
  • sore throat
  • stuffy or runny nose
  • unusual tiredness or weakness

Incidence not known

  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • chest pain
  • confusion
  • dark urine
  • decreased urination
  • dry mouth
  • fainting
  • hives or welts, itching skin, rash
  • increase in heart rate
  • labored breathing
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  • light-colored stools
  • lightheadedness
  • nausea
  • pain, redness, swelling, or tenderness in the arms or legs
  • pale skin
  • persistent non-healing sore
  • rapid breathing
  • rapid weight gain
  • reddish patch or irritated area of the skin
  • redness of the skin
  • sunken eyes
  • thirst
  • tightness in the chest
  • tingling of the hands or feet
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual weight gain or loss
  • upper right abdominal or stomach pain
  • vomiting
  • wrinkled skin
  • yellow eyes and skin

Side effects not requiring immediate medical attention

Some side effects of tofacitinib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Incidence not known

  • Belching
  • burning feeling in the chest or stomach
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • difficulty with moving
  • heartburn
  • indigestion
  • muscle pain or stiffness
  • pain in the joints
  • stomach discomfort, upset, or pain
  • tenderness in the stomach area
  • trouble sleeping
  • unusually warm skin

For Healthcare Professionals

Applies to tofacitinib: oral tablet, oral tablet extended release


The most common serious adverse reactions were serious infections.[Ref]


Common (1% to 10%): Hypertension[Ref]


Frequency not reported: Rash, erythema, pruritus[Ref]


Common (1% to 10%): Diarrhea, abdominal pain, dyspepsia, vomiting, gastritis, nausea, vomiting, constipation, gastritis, gastroenteritis[Ref]


Frequency not reported: Anemia, neutropenia, lymphopenia[Ref]


Common (1% to 10%): AST elevation, ALT elevation

Frequency not reported: Hepatic steatosis, elevated bilirubin[Ref]


Very common (10% or more): Overall infections (up to 22%)

Frequency not reported: Serious infection (most commonly pneumonia, cellulitis, herpes zoster and urinary tract infection), other non-TB opportunistic infection[Ref]


Frequency not reported: Dehydration, increased total cholesterol, increased LDL cholesterol, increased HDL cholesterol, increased triglycerides[Ref]


Common (1% to 10%): Rheumatoid arthritis, back pain, arthralgia

Frequency not reported: Musculoskeletal pain, tendonitis, joint swelling[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness

Frequency not reported: Paresthesia[Ref]


Frequency not reported: Lung cancer, breast cancer, gastric cancer, colorectal cancer, renal cell cancer, prostate cancer, lymphoma, malignant melanoma, non-melanoma skin cancer[Ref]


Frequency not reported: Pyrexia, fatigue, peripheral edema[Ref]


Frequency not reported: Insomnia[Ref]


Common (1% to 10%): Increased serum creatinine[Ref]


Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection, bronchitis, cough

Frequency not reported: Dyspnea, sinus congestion, tuberculosis (TB)[Ref]


1. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL:" ([2006]):

2. "Product Information. Xeljanz (tofacitinib)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

Further information

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

Some side effects may not be reported. You may report them to the FDA.

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