Xeljanz Oral Solution Side Effects
Generic name: tofacitinib
Medically reviewed by Drugs.com. Last updated on Apr 17, 2024.
Note: This document contains side effect information about tofacitinib. Some dosage forms listed on this page may not apply to the brand name Xeljanz Oral Solution.
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
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
- 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
- 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)?
- Is Xeljanz an immunosuppressant?
- Who makes Xeljanz and where is it made?
More about Xeljanz Oral Solution (tofacitinib)
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- Latest FDA alerts (4)
- Dosage information
- During pregnancy
- Drug class: antirheumatics
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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
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.