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Xeljanz Oral Solution Side Effects

Generic name: tofacitinib

Medically reviewed by Drugs.com. Last updated on Apr 17, 2024.

Note: This document provides detailed information about Xeljanz Oral Solution Side Effects associated with tofacitinib. Some dosage forms listed on this page may not apply specifically to the brand name Xeljanz Oral Solution.

Applies to tofacitinib: oral solution, oral tablet, oral tablet extended release.

Important warnings This medicine can cause some serious health issues

Oral route (tablet; tablet, extended release; solution)

Serious Infections. Patients treated with tofacitinib are at increased risk for developing serious infections that may lead to hospitalization or death.

Most patients who develop these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.If a serious infection develops, interrupt tofacitinib until the infection is controlled.Reported infections include:Active tuberculosis, which may present with pulmonary or extrapulmonary disease.

Patients should be tested for latent tuberculosis before tofacitinib use and during therapy.

Treatment for latent infection should be initiated prior to tofacitinib use.Invasive fungal infections, including cryptococcosis and pneumocystosis.

Patients with invasive fungal infections may present with disseminated, rather than localized, disease.Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.The risks and benefits of treatment with tofacitinib should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with tofacitinib, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.Mortality. In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular (CV) risk factor comparing tofacitinib 5 mg twice a day or tofacitinib 10 mg twice a day to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with tofacitinib 5 mg twice a day or tofacitinib 10 mg twice a day.

Tofacitinib oral tablets/oral solution 10 mg twice daily (or a tofacitinib extended-release tablet 22 mg once daily) dosage is not recommended for the treatment of RA or PsA.Malignancies. Malignancies, including lymphomas and solid tumors, have occurred in patients treated with tofacitinib and other Janus kinase inhibitors used to treat inflammatory conditions.

In RA patients, a higher rate of malignancies (excluding NMSC) was observed in patients treated with tofacitinib 5 mg twice a day or tofacitinib 10 mg twice a day compared with TNF blockers.Lymphomas and lung cancers were observed at a higher rate in patients treated with tofacitinib 5 mg twice a day or tofacitinib 10 mg twice a day in RA patients compared to those treated with TNF blockers.

Patients who are current or past smokers are at additional increased risk.Epstein Barr virus-associated posttransplant lymphoproliferative disorder has been observed at an increased rate in renal transplant patients treated with tofacitinib and concomitant immunosuppressive medications.Major Adverse Cardiovascular EventsRA patients 50 years of age and older with at least one cardiovascular risk factor, treated with tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily, had a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), compared to those treated with TNF blockers.

Patients who are current or past smokers are at additional increased risk.

Discontinue tofacitinib in patients that have experienced a myocardial infarction or stroke.Thrombosis. Thrombosis, including pulmonary embolism, deep venous thrombosis and arterial thrombosis have occurred in patients treated with tofacitinib and other Janus kinase inhibitors.

Many of these events were serious and some resulted in death.

RA patients 50 years of age and older with at least one cardiovascular risk factor treated with tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily compared to TNF blockers had an observed increase in incidence of these events.

Avoid tofacitinib in patients at risk.

Discontinue tofacitinib and promptly evaluate patients with symptoms of thrombosis.

Serious side effects

Along with its needed effects, tofacitinib (the active ingredient contained in Xeljanz Oral Solution) 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 side effects

  • 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
  • double vision
  • dry mouth
  • fainting
  • hives or welts, rash
  • inability to move the arms, legs, or facial muscles
  • 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
  • no blood pressure or pulse
  • pain or discomfort in the arms, jaw, back, or neck
  • pain, redness, swelling, or tenderness in the arms or legs
  • pale skin
  • pink growth
  • persistent non-healing sore
  • rapid breathing
  • rapid weight gain
  • reddish patch or irritated area of the skin
  • shiny bump
  • slow speech
  • stopping of heart
  • sunken eyes
  • sweating
  • thirst
  • tingling of the hands or feet
  • unconsciousness
  • unusual bleeding or bruising
  • unusual weight gain
  • upper right abdominal or stomach pain
  • vomiting
  • white, yellow or waxy scar-like area
  • wrinkled skin

Other side effects

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 side effects

  • diarrhea

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 solution, oral tablet, oral tablet extended release.

General adverse events

In rheumatoid arthritis clinical trials, the most common serious adverse reactions were serious infections; the most common serious infections included pneumonia, cellulitis, herpes zoster, urinary tract infection, diverticulitis, and appendicitis. In ulcerative colitis induction and maintenance trials, the most common serious adverse reaction was worsening of ulcerative colitis.[Ref]

Cardiovascular

Dermatologic

Gastrointestinal

Genitourinary

Hematologic

Hepatic

Hypersensitivity

Metabolic

Musculoskeletal

Nervous system

Oncologic

Other

A patient had dissemination of the vaccine strain of varicella zoster virus, 16 days after vaccination with live attenuated virus vaccine and 2 days after starting therapy with 5 mg twice a day; the patient was varicella virus naive, as shown by no history of varicella infection and no anti-varicella antibodies at baseline. This drug was discontinued and the patient recovered after treatment with standard doses of antiviral therapy.

Psychiatric

Renal

Respiratory

References

1. (2021) "Product Information. Xeljanz (tofacitinib)." Pfizer U.S. Pharmaceuticals Group, SUPPL-28

2. (2021) "Product Information. Xeljanz XR (tofacitinib)." Pfizer U.S. Pharmaceuticals Group, SUPPL-13

3. (2021) "Product Information. Xeljanz (tOFACitinib)." Pfizer Australia Pty Ltd, pfpxeljt11021

4. (2022) "Product Information. Xeljanz (tofacitinib)." Pfizer Ltd, XJ 5mg 26_0 GB

Frequently asked questions

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Further information

Xeljanz Oral Solution side effects can vary depending on the individual. 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.