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

(tofacitinib)

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.

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Find XELJANZ / XELJANZ XR medical information:

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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.
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.

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Report Adverse Event

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

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

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 call (800) 822-7967.