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Xeljanz XR Side Effects

Generic name: tofacitinib

Medically reviewed by Drugs.com. Last updated on July 8, 2020.

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 XR.

In Summary

Common side effects of Xeljanz XR include: infection. Other side effects include: diarrhea and headache. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to tofacitinib: oral tablet, oral tablet extended release

Warning

Oral route (Tablet; Tablet, Extended Release; Solution)

Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred. If a serious infection develops, interrupt tofacitinib until the infection is controlled.Prior to starting tofacitinib and during therapy, perform a test for latent tuberculosis; if it is positive, start treatment for tuberculosis prior to starting tofacitinib. Monitor all patients active tuberculosis during treatment, even if the initial latent tuberculosis test is negative.Thrombosis, including pulmonary embolism, deep venous thrombosis and arterial thrombosis have occurred in patients treated with tofacitinib and other Janus kinase inhibitors. Rheumatoid arthritis patients with at least one cardiovascular (CV) risk factor had a higher rate of all-cause mortality and thrombosis with tofacitinib 10 mg twice daily vs 5 mg twice daily or TNF blockers.Lymphoma and other malignancies have been observed in patients treated with tofacitinib, including an increased rate of Epstein Barr Virus-associated posttransplant lymphoproliferative disorder.

Side effects requiring immediate medical attention

Along with its needed effects, tofacitinib (the active ingredient contained in Xeljanz XR) 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

  • Black, tarry stools
  • bladder pain
  • bloody or cloudy urine
  • blurred vision
  • body aches or pain
  • chest pain or tightness
  • chills
  • cough
  • difficult, burning, or painful urination
  • difficulty breathing
  • dizziness
  • ear congestion
  • fever
  • frequent urge to urinate
  • headache
  • itching, pain, redness, swelling, tenderness, warmth on the skin
  • 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
  • swollen glands
  • trouble breathing
  • unusual tiredness or weakness
  • weight loss
  • yellow eyes and skin

Incidence not known

  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • confusion
  • dark urine
  • decreased urination
  • dry mouth
  • fainting
  • hives or welts, rash
  • increase in heart rate
  • labored breathing
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  • light-colored stools
  • lightheadedness
  • nausea
  • pain, redness, swelling, or tenderness in the arms or legs
  • pale skin
  • persistent non-healing sore
  • rapid breathing
  • rapid weight gain
  • reddish patch or irritated area of the skin
  • sunken eyes
  • thirst
  • tingling of the hands or feet
  • unusual bleeding or bruising
  • unusual weight gain
  • upper right abdominal or stomach pain
  • vomiting
  • wrinkled skin

Side effects not requiring immediate medical attention

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

Incidence not known

  • Belching
  • burning feeling in the chest or stomach
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • difficulty with moving
  • heartburn
  • indigestion
  • 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

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, abdominal pain, dyspepsia, vomiting, gastritis, nausea, vomiting, constipation, gastritis, gastroenteritis[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

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]

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, bronchitis, cough

Frequency not reported: Dyspnea, sinus congestion, tuberculosis (TB)[Ref]

References

1. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

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

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.