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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.

For the Consumer

Applies to tofacitinib: oral tablet, oral tablet extended release

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
  • confusion
  • dark urine
  • decreased urination
  • difficult or labored breathing
  • dry mouth
  • fainting
  • increase in heart rate
  • light-colored stools
  • lightheadedness
  • nausea and vomiting
  • pale skin
  • persistent non-healing sore
  • rapid breathing
  • rapid weight gain
  • reddish patch or irritated area
  • 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
  • wrinkled skin
  • yellow eyes and skin

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
  • Diarrhea
Incidence not known
  • Acid or sour stomach
  • belching
  • burning feeling in the chest or stomach
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • difficulty with moving
  • flushing or redness of the skin
  • heartburn
  • indigestion
  • itching skin or rash
  • 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.

Some side effects of Xeljanz may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.