Xeljanz Side Effects

Generic Name: tofacitinib

Note: This page contains side effects data for the generic drug tofacitinib. It is possible that some of the dosage forms included below may not apply to the brand name Xeljanz.

It is possible that some side effects of Xeljanz may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to tofacitinib: oral tablet

As well as its needed effects, tofacitinib (the active ingredient contained in Xeljanz) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking tofacitinib, check with your doctor immediately:

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 tofacitinib side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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

General

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

Cardiovascular

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

Dermatologic

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

Gastrointestinal

Common (1% to 10%): Diarrhea
Frequency not reported: Abdominal pain, dyspepsia, vomiting, gastritis, nausea[Ref]

Hematologic

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

Hepatic

Common (1% to 10%): AST elevation, ALT elevation
Frequency not reported: Hepatic steatosis, elevated bilirubin[Ref]

Immunologic

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]

Metabolic

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

Musculoskeletal

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

Nervous system

Common (1% to 10%): Headache
Frequency not reported: Paresthesia[Ref]

Oncologic

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

Other

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

Psychiatric

Frequency not reported: Insomnia[Ref]

Renal

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

Respiratory

Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection
Frequency not reported: Dyspnea, cough, sinus congestion, tuberculosis (TB)[Ref]

References

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

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. Drugs.com 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.

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