Xeljanz XR Side Effects

Generic name: tofacitinib

Medically reviewed by Philip Thornton, DipPharm. Last updated on Apr 17, 2024.

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

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 of Xeljanz XR

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
• 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 of Xeljanz XR

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

• 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

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

• Common (1% to 10%): Hypertension
• Uncommon (0.1% to 1%): Venous thromboembolism (includes pulmonary embolism, deep vein thrombosis), myocardial infarction
• Frequency not reported: Deep vein thrombosis, nonfatal myocardial infarction, fatal myocardial infarction, arterial thromboembolism, major adverse cardiovascular events (includes nonfatal myocardial infarction, nonfatal stroke, cardiovascular death [excluding fatal pulmonary embolism]), thrombosis (including pulmonary embolism, deep venous thrombosis, arterial thrombosis), decreased heart rate, prolonged PR interval

Dermatologic

• Common (1% to 10%): Rash, acne
• Uncommon (0.1% to 1%): Erythema, pruritus, cellulitis, herpes simplex
• Frequency not reported: Multidermatomal herpes zoster, pilonidal cyst
• Postmarketing reports: Angioedema, urticaria

Gastrointestinal

• Common (1% to 10%): Diarrhea, abdominal pain, dyspepsia, vomiting, gastritis, nausea, constipation, gastroenteritis, upper abdominal pain, ulcerative colitis
• Uncommon (0.1% to 1%): Diverticulitis, viral gastroenteritis, appendicitis
• Frequency not reported: Esophageal candidiasis, worsening of ulcerative colitis, gastrointestinal perforation, gastrointestinal obstruction

Genitourinary

• Common (1% to 10%): Urinary tract infection
• Uncommon (0.1% to 1%): Pyelonephritis
• Rare (0.01% to 0.1%): Urosepsis

Hematologic

• Common (1% to 10%): Anemia, decreased absolute lymphocyte count
• Uncommon (0.1% to 1%): Leukopenia, neutropenia, lymphopenia
• Rare (0.01% to 0.1%): Decreased absolute neutrophil count
• Frequency not reported: Lymphocytosis

Hepatic

• Common (1% to 10%): Increased AST, increased ALT, increased GGT
• Uncommon (0.1% to 1%): Hepatic steatosis, increased hepatic enzymes, increased transaminases, abnormal liver function test
• Frequency not reported: Drug-induced liver injury, increased bilirubin
• Postmarketing reports: Hepatitis B reactivation

Hypersensitivity

• Postmarketing reports: Hypersensitivity/allergic reactions, drug hypersensitivity (e.g., angioedema, urticaria)

Metabolic

• Common (1% to 10%): Hypercholesterolemia
• Uncommon (0.1% to 1%): Dehydration, dyslipidemia, hyperlipidemia

Musculoskeletal

• Common (1% to 10%): Rheumatoid arthritis, back pain, arthralgia, increased blood creatine phosphokinase
• Uncommon (0.1% to 1%): Musculoskeletal pain, tendonitis, joint swelling, ligament sprain, muscle strain
• Rare (0.01% to 0.1%): Necrotizing fasciitis, bacterial arthritis
• Frequency not reported: Limb abscess, fractures

Nervous system

• Common (1% to 10%): Headache, dizziness
• Uncommon (0.1% to 1%): Paresthesia
• Rare (0.01% to 0.1%): Tuberculosis of central nervous system, encephalitis, cryptococcal meningitis
• Frequency not reported: Aseptic meningitis, epidural empyema (with sinusitis and subperiosteal abscess)

Oncologic

• Common (1% to 10%): Epstein Barr Virus-associated posttransplant lymphoproliferative disorder
• Uncommon (0.1% to 1%): Lung cancer, nonmelanoma skin cancer (includes basal cell carcinoma, squamous cell carcinoma)
• Rare (0.01% to 0.1%): Lymphoma
• Frequency not reported: Solid cancers, malignancies (including solid cancers, lymphomas, nonmelanoma skin cancer, lung cancer, breast cancer, gastric cancer, colorectal cancer, renal cell cancer, prostate cancer, malignant melanoma), basal cell carcinoma, cutaneous squamous cell carcinoma, breast cancer, melanoma, prostate cancer, pancreatic cancer

Other

• Very common (10% or more): Infections (up to 49.4%)
• Common (1% to 10%): Pyrexia, fatigue, peripheral edema, herpes zoster, increased weight, fall, increased cholesterol levels (includes hypercholesterolemia, hyperlipidemia, increased blood cholesterol, dyslipidemia, increased blood triglycerides, increased low-density lipoprotein [LDL], abnormal LDL, increased lipids), increased blood cholesterol, serious infections
• Uncommon (0.1% to 1%): Tuberculosis, viral infection, increased LDL
• Rare (0.01% to 0.1%): Sepsis, disseminated tuberculosis, bacteremia, staphylococcal bacteremia, atypical mycobacterial infection, CMV infection, Mycobacterium avium complex infection
• Frequency not reported: Opportunistic infections, other mycobacterial infections, cryptococcus, histoplasmosis, BK virus infection, listeriosis, increased lipid parameters (total cholesterol, LDL cholesterol, high-density lipoprotein [HDL] cholesterol, triglycerides), increased LDL cholesterol, increased HDL cholesterol, septic shock, opportunistic herpes zoster infections (including meningoencephalitis, ophthalmologic, disseminated cutaneous), viral reactivation (including herpes virus reactivation [e.g., herpes zoster]), all-cause mortality (including sudden cardiovascular death), deaths associated with infection, deaths associated with cardiovascular events, deaths associated with malignancies, deaths associated with other causes (excluding infections, cardiovascular events, malignancies), dissemination of the vaccine strain of varicella zoster virus

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

• Uncommon (0.1% to 1%): Insomnia

Renal

• Uncommon (0.1% to 1%): Increased blood creatinine
• Frequency not reported: Escherichia pyelonephritis

Respiratory

• Very common (10% or more): Nasopharyngitis (up to 18.2%)
• Common (1% to 10%): Pneumonia, influenza, sinusitis, pharyngitis, upper respiratory tract infections, bronchitis, cough, viral upper respiratory tract infection
• Uncommon (0.1% to 1%): Dyspnea, sinus congestion
• Rare (0.01% to 0.1%): Pneumocystis jirovecii pneumonia, pneumococcal pneumonia, bacterial pneumonia
• Frequency not reported: Pulmonary embolism, interstitial lung disease

Frequently asked questions

• What are the new drugs for rheumatoid arthritis (RA)?
• What are JAK inhibitors and how do they work?
• Which JAK inhibitors are approved in the U.S?
• Is Xeljanz an immunosuppressant?
• Who makes Xeljanz and where is it made?

Further information

Xeljanz XR 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.

Medical Disclaimer