(tofacitinib)

Medication Guide

Download Consumer Medicine Information

Health Professional Information

{{section_name_patient}}

{{section_body_html_patient}}

Prescribing Information

Download Prescribing Information

Health Professional Information

What are the possible side effects of XELJANZ/XELJANZ XR/XELJANZ Oral Solution?

What are the possible side effects of XELJANZ/XELJANZ XR/XELJANZ Oral Solution?

XELJANZ/XELJANZ XR/XELJANZ Oral Solution may cause serious side effects, including:

•
See "What is the most important information I should know about XELJANZ/XELJANZ XR/XELJANZ Oral Solution?"
•
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 XELJANZ/XELJANZ XR/XELJANZ Oral Solution. Your healthcare provider may do blood tests before you start treatment with XELJANZ/XELJANZ XR/XELJANZ Oral Solution and while you are taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B or C infection:
 
o
feel very tired
o
little or no appetite
o
clay-colored bowel movements
o
chills
o
muscle aches
o
skin rash
 
o
skin or eyes look yellow
o
vomiting
o
fevers
o
stomach discomfort
o
dark urine

Common side effects of XELJANZ/XELJANZ XR in people with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis include:

•
upper respiratory tract infections (common cold, sinus infections)
•
headache
•
diarrhea
•
nasal congestion, sore throat, and runny nose (nasopharyngitis)
•
high blood pressure (hypertension)
•
acne

Common side effects of XELJANZ/XELJANZ XR in people with ulcerative colitis include:

•
nasal congestion, sore throat, and runny nose (nasopharyngitis)
•
increased cholesterol levels
•
headache
•
upper respiratory tract infections (common cold, sinus infections)
•
increased muscle enzyme levels
•
rash
•
acne
•
diarrhea
•
shingles (herpes zoster)

Common side effects of XELJANZ/XELJANZ Oral Solution in people with polyarticular course juvenile arthritis include:

•
upper respiratory tract infections (common cold, sinus infections)
•
nasal congestion, sore throat, and runny nose (nasopharyngitis)
•
headache
•
fever
•
nausea
•
vomiting
•
acne

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of XELJANZ/XELJANZ XR/XELJANZ Oral Solution. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Pfizer at 1-800-438-1985.

Additional Resources

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine or vaccine.

Speak with a Pfizer Medical Information Professional regarding your Pfizer medicine or vaccine inquiry.

Available 9AM-5PM ET Monday to Friday; excluding holidays.

 

Submit a medical question for a Pfizer medicine or a vaccine. 

The submission will be reviewed during our standard business hours.

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this medication, click the link below to submit your information: 
Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer medication, please call (800) 438-1985.

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or by calling (800) 332-1088.