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Tofacitinib Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Apr 27, 2022.

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

Warning

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

Serious InfectionsPatients 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.MortalityIn 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.MalignanciesMalignancies, 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.ThrombosisThrombosis, 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 Tofacitinib

Along with its needed effects, tofacitinib 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

Incidence not known

Other side effects of Tofacitinib

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

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

References

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

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

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

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

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.

Medical Disclaimer