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.
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.
For the Consumer
Applies to tofacitinib: oral tablet
Get emergency medical help if you have any of these signs of an allergic reaction while taking tofacitinib (the active ingredient contained in Xeljanz) hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Serious and sometimes fatal infections may occur during treatment with tofacitinib. Stop using this medicine and call your doctor right away if you have signs of infection such as:
fever, chills, tired feeling, night sweats;
stomach pain, loss of appetite, diarrhea, weight loss, or a change in your bowel habits;
pain or burning when you urinate;
body aches, sore throat, flu symptoms, sores in your mouth and throat;
stabbing chest pain, wheezing, feeling short of breath, cough with mucus or blood; or
skin redness and swelling.
Tofacitinib may also cause severe liver symptoms. Call your doctor at once if you have any of these liver symptoms:
low fever, itching;
upper stomach pain, loss of appetite;
dark urine, clay-colored stools; or
jaundice (yellowing of the skin or eyes).
Common side effects may include:
mild cold symptoms such as runny or stuffy nose.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to tofacitinib: oral tablet
The most common serious adverse reactions were serious infections.
Common (1% to 10%): Hypertension
Frequency not reported: Rash, erythema, pruritus
Common (1% to 10%): Diarrhea
Frequency not reported: Abdominal pain, dyspepsia, vomiting, gastritis, nausea
Frequency not reported: Anemia, neutropenia, lymphopenia
Common (1% to 10%): AST elevation, ALT elevation
Frequency not reported: Hepatic steatosis, elevated bilirubin
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
Frequency not reported: Dehydration, increased total cholesterol, increased LDL cholesterol, increased HDL cholesterol, increased triglycerides
Frequency not reported: Musculoskeletal pain, arthralgia, tendonitis, joint swelling
Common (1% to 10%): Headache
Frequency not reported: Paresthesia
Frequency not reported: Lung cancer, breast cancer, gastric cancer, colorectal cancer, renal cell cancer, prostate cancer, lymphoma, malignant melanoma, non-melanoma skin cancer
Frequency not reported: Pyrexia, fatigue, peripheral edema
Frequency not reported: Insomnia
Common (1% to 10%): Increased serum creatinine
Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection
Frequency not reported: Dyspnea, cough, sinus congestion, tuberculosis (TB)
More Xeljanz resources
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