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Olumiant Side Effects

Generic name: baricitinib

Medically reviewed by Drugs.com. Last updated on Jun 15, 2023.

Note: This document contains side effect information about baricitinib. Some dosage forms listed on this page may not apply to the brand name Olumiant.

Applies to baricitinib: oral tablet.

Warning

Oral route (Tablet)

Serious InfectionsPatients treated with baricitinib are at risk for developing serious infections that may lead to hospitalization or death. Most patients with rheumatoid arthritis who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.If a serious infection develops, interrupt baricitinib until the infection is controlled.Reported infections include:Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Baricitinib should not be given to patients with active tuberculosis. Patients, except those with COVID-19, should be tested for latent tuberculosis before initiating baricitinib and during therapy. If positive, start treatment for latent infection prior to baricitinib use.Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.Bacterial, viral, and other infections due to opportunistic pathogens.The risks and benefits of treatment with baricitinib 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 baricitinib including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapyMortalityIn a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death ,was observed with the JAK inhibitorMalignancies Lymphoma and other malignancies have been observed in patients treated with baricitinib. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.Major Adverse Cardiovascular EventsIn RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue baricitinib in patients that have experienced a myocardial infarction or stroke.ThrombosisThrombosis, including deep venous thrombosis and pulmonary embolism, has been observed at an increased incidence in patients treated with baricitinib compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid baricitinib in patients at risk. Patients with symptoms of thrombosis should discontinue baricitinib and be promptly evaluated.

Serious side effects of Olumiant

Along with its needed effects, baricitinib (the active ingredient contained in Olumiant) 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 baricitinib:

More common

Less common

Rare

Incidence not known

For Healthcare Professionals

Applies to baricitinib: oral tablet.

Cardiovascular

Common (1% to 10%): Hypertension, coronary artery disease, deep vein thrombosis (DVT)

Frequency not reported: Venous thromboses/venous thromboembolism, arterial thrombosis, venous thromboembolic events, myocardial infarction

Venous thromboses, venous thromboembolism, and venous thromboembolic events included DVT and pulmonary embolism.

Dermatologic

Herpes simplex included eczema herpeticum, genital herpes, herpes simplex, ophthalmic herpes simplex, oral herpes, Kaposi's varicelliform eruption, and genital herpes simplex.

Acne included acne, acne varioliformis, and dermatitis acneiform.

Rash included rash, dermatitis, contact dermatitis, eczema, allergic dermatitis, maculopapular rash, pruritic rash, pustular rash, drug eruption, erythematous rash, and macular rash.

Folliculitis was most commonly localized in the scalp region associated with hair regrowth.

Common (1% to 10%): Herpes simplex, acne, rash, alopecia, onychomycosis, contact dermatitis, folliculitis, pruritus

Uncommon (0.1% to 1%): Urticaria

Frequency not reported: Fungal skin infections

Gastrointestinal

Common (1% to 10%): Nausea, gastroenteritis, diarrhea, dyspepsia, abdominal pain, constipation, vomiting, stomatitis, abdominal discomfort, gastroesophageal reflux disease, upper abdominal pain, oral herpes

Uncommon (0.1% to 1%): Diverticulitis

Frequency not reported: Gastrointestinal perforations

Abdominal pain included abdominal pain, lower abdominal pain, upper abdominal pain, and abdominal discomfort.

Genitourinary

Common (1% to 10%): Urinary tract infection, cystitis, benign prostatic hyperplasia, erectile dysfunction, vulvovaginal candidiasis, genital Candida infections, irregular menstruation

Urinary tract infection included cystitis, urinary tract infection, urine positive for WBCs, bacterial urinary tract infection, and pyelonephritis.

Genital Candida infections included vulvovaginal candidiasis, vulvovaginal mycotic infection, and genital fungal infection.

Hematologic

Common (1% to 10%): Thrombocytosis, neutropenia, anemia, iron deficiency anemia, increased platelet count, increased WBC count

Frequency not reported: Lymphopenia, lymphocytosis

Thrombocytosis (greater than 600,000 cells/mm3) and neutropenia (less than 1000 cells/mm3) were reported in up to 7.9% and 2.2% of patients, respectively.

Neutropenia included neutropenia and decreased neutrophil count.

Hepatic

Very common (10% or more): Increased ALT (up to 18.1%), increased AST (up to 11.8%)

Common (1% to 10%): Abnormal hepatic function, increased liver enzymes, increased transaminases

Increased ALT (at least 3 times the upper limit of normal [3 x ULN]) and increased AST (at least 3 x ULN) were reported in up to 18.1% and 11.8% of patients, respectively.

Increased liver enzymes included increased transaminases, increased AST, increased ALT, increased hepatic enzyme, increased GGT, and abnormal hepatic function.

Hypersensitivity

Postmarketing reports: Drug hypersensitivity (e.g., rash, urticaria, angioedema)

Metabolic

Very common (10% or more): Hypercholesterolemia

Common (1% to 10%): Hyperlipidemia, dyslipidemia

Uncommon (0.1% to 1%): Hypertriglyceridemia

Hyperlipidemia included hyperlipidemia, hypercholesterolemia, hypertriglyceridemia, dyslipidemia, increased lipids, increased low-density lipoprotein, increased blood cholesterol, and increased blood triglycerides.

Musculoskeletal

Increased creatine phosphokinase (greater than 5 x ULN) was reported in up to 5.1% of patients.

Common (1% to 10%): Arthralgia, rheumatoid arthritis, back pain, muscle spasms, increased creatine phosphokinase, osteoarthritis

Uncommon (0.1% to 1%): Myalgia

Nervous system

Common (1% to 10%): Headache, dizziness, sciatica

Ocular

Common (1% to 10%): Blurred vision, cataract

Oncologic

Frequency not reported: Malignancies, nonmelanoma skin cancers, B-cell lymphoma

Other

Very common (10% or more): Increased low-density lipoprotein (LDL) cholesterol (up to 33.7%), infections (up to 31.5%)

Common (1% to 10%): Fatigue, pyrexia, peripheral edema, serious infections, septic shock, contusion, drug intolerance, increased blood alkaline phosphatase, increased blood cholesterol, herpes zoster, increased weight

Uncommon (0.1% to 1%): Opportunistic infections, tuberculosis, swelling of the face, increased triglycerides

Frequency not reported: Increased lipid parameters, viral reactivation

During 12 weeks of therapy, up to 33.7% of patients developed LDL cholesterol at least 130 mg/dL (3.36 mmol/L). Increased triglycerides (at least 500 mg/dL [5.65 mmol/L]) was reported in at least 0.7% of patients.

Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in rheumatoid arthritis patients receiving this drug; the most common serious infections reported included pneumonia, herpes zoster, cellulitis, and urinary tract infection.

Infections included bacterial, mycobacterial, invasive fungal, viral, and opportunistic.

Opportunistic infections included tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystis pneumonia/pneumocystosis, acute histoplasmosis, cryptococcosis, CMV, and BK virus.

Swelling of the face included eye swelling, eyelid edema, face edema, lip swelling, swelling face, and swelling of eyelid.

In the integrated data from rheumatoid arthritis, atopic dermatitis, and alopecia areata clinical trials, this drug was associated with dose-related increases in lipid parameters (including total cholesterol, LDL cholesterol, and high-density lipoprotein cholesterol); in rheumatoid arthritis trials, this drug was also associated with dose-related increases in triglycerides. Elevations were observed at 12 weeks and remained stable thereafter at a higher value than baseline in rheumatoid arthritis trials; total and LDL cholesterol increased through week 52 in atopic dermatitis patients and alopecia areata patients.

Viral reactivation (including herpes virus reactivation [e.g., herpes zoster, herpes simplex]) has been reported.

Psychiatric

Common (1% to 10%): Depression

Uncommon (0.1% to 1%): Insomnia

Renal

Frequency not reported: Increased serum creatinine, decreased cystatin C

Respiratory

Very common (10% or more): Upper respiratory tract infections (up to 21.3%)

Common (1% to 10%): Bronchitis, nasopharyngitis, pharyngitis, sinusitis, rhinitis, cough, pneumonia, oropharyngeal pain, influenza, COVID-19 pneumonia, pulmonary embolism, tonsillitis, dyspnea, rhinorrhea, lower respiratory tract infections, viral upper respiratory tract infection

Upper respiratory tract infections included acute sinusitis, chronic sinusitis, acute tonsillitis, chronic tonsillitis, epiglottitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinobronchitis, sinusitis, tonsillitis, tracheitis, upper respiratory tract infection, influenza, viral upper respiratory tract infection, viral sinusitis, viral pharyngitis, viral respiratory tract infection, rhinovirus infection, and adenoiditis.

Lower respiratory tract infections included bronchitis, bronchiolitis, lower respiratory tract infection, pneumonia, COVID-19 pneumonia, and respiratory tract infection.

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.

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