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Baricitinib Side Effects

Medically reviewed by Drugs.com. Last updated on Jun 5, 2022.

For the Consumer

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.

Side effects requiring immediate medical attention

Along with its needed effects, baricitinib 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

  • Body aches or pain
  • chest tightness
  • chills
  • cough
  • difficulty in breathing
  • ear congestion
  • fever
  • headache
  • hoarseness
  • loss of voice
  • muscle aches
  • pain or tenderness around the eyes and cheekbones
  • runny or stuffy nose
  • sneezing
  • sore throat
  • trouble in swallowing
  • unusual tiredness or weakness

Less common

  • Black, tarry stools
  • bladder pain
  • blemishes on the skin
  • bloody or cloudy urine
  • burning, itching, and pain in hairy areas, pus at the root of the hair
  • chest pain or tightness
  • cough producing mucus
  • difficult, burning, or painful urination
  • frequent urge to urinate
  • itching of the vagina or outside genitals
  • lower back or side pain
  • pain, redness, or swelling in the arm or leg
  • pain during sexual intercourse
  • pains in the chest, groin, or legs, especially calves of the legs
  • pale skin
  • pimples
  • severe headaches of sudden onset
  • stomach pain
  • sudden loss of coordination
  • sudden onset of slurred speech
  • sudden vision changes
  • thick, white curd-like vaginal discharge without odor or with mild odor
  • trouble breathing
  • unusual bleeding or bruising

Rare

  • Anxiety
  • burning or stinging of the skin
  • coughing or spitting up blood
  • dizziness or lightheadedness
  • increased weight
  • night sweats
  • painful blisters on the trunk of body
  • painful cold sores or blisters on the lips, nose, eyes, or genitals
  • sudden high fever or low-grade fever for months

Incidence not known

  • Chest discomfort
  • confusion
  • difficulty in speaking
  • double vision
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • nausea
  • no blood pressure or pulse
  • pain or discomfort in the arms, jaw, back or neck
  • persistent non-healing sore
  • pink growth
  • reddish patch or irritated area
  • shiny bump
  • stopping of heart
  • sweating
  • unconsciousness
  • white, yellow, or waxy scar-like area

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 (DVT, pulmonary embolism), arterial thrombosis[Ref]

Dermatologic

Common (1% to 10%): Herpes simplex (included eczema herpeticum, genital herpes, herpes simplex, ophthalmic herpes simplex, oral herpes, Kaposi's varicelliform eruption, genital herpes simplex), acne (included acne, acne varioliformis, dermatitis acneiform), rash (included rash, dermatitis, contact dermatitis, eczema, allergic dermatitis, maculopapular rash, pruritic rash, pustular rash, drug eruption, erythematous rash, macular rash), alopecia, onychomycosis, contact dermatitis

Uncommon (0.1% to 1%): Urticaria[Ref]

Gastrointestinal

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

Uncommon (0.1% to 1%): Diverticulitis, oral herpes

Frequency not reported: Gastrointestinal perforations[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, cystitis, benign prostatic hyperplasia, erectile dysfunction, vulvovaginal candidiasis[Ref]

Hematologic

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.[Ref]

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

Frequency not reported: Lymphopenia, lymphocytosis[Ref]

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, abnormal liver function test

Frequency not reported: Increased liver enzymes[Ref]

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.[Ref]

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[Ref]

Musculoskeletal

Increased creatine phosphokinase (greater than 5 x ULN) was reported in up to 4.5% of patients.[Ref]

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

Uncommon (0.1% to 1%): Myalgia[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness, herpes zoster, sciatica[Ref]

Ocular

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

Oncologic

Frequency not reported: Malignancies, nonmelanoma skin cancers

Other

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.

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.

In the integrated data from rheumatoid arthritis and atopic dermatitis clinical trials, this drug was associated with dose-related increases in lipid parameters (including total cholesterol, LDL cholesterol, and HDL 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.[Ref]

Very common (10% or more): Increased low-density lipoprotein (LDL) cholesterol (up to 33.7%), infections (included bacterial, mycobacterial, invasive fungal, viral, opportunistic; 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, weight increased

Uncommon (0.1% to 1%): Opportunistic infections (included tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystis pneumonia/pneumocystosis, acute histoplasmosis, cryptococcosis, CMV, BK virus), tuberculosis, swelling of the face (included eye swelling, eyelid edema, face edema, lip swelling, swelling face, swelling of eyelid), increased triglycerides

Frequency not reported: Increased lipid parameters (including total cholesterol, triglycerides, LDL cholesterol, high-density lipoprotein [HDL] cholesterol), viral reactivation (including herpes virus reactivation [e.g., herpes zoster, herpes simplex])[Ref]

Psychiatric

Common (1% to 10%): Depression

Uncommon (0.1% to 1%): Insomnia[Ref]

Renal

Frequency not reported: Increased serum creatinine

Respiratory

Very common (10% or more): 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; up to 17.5%)

Common (1% to 10%): Bronchitis, nasopharyngitis, pharyngitis, sinusitis, rhinitis, cough, pneumonia, oropharyngeal pain, influenza, coronavirus disease 2019 (COVID-19) pneumonia, pulmonary embolism, tonsillitis, dyspnea, rhinorrhea[Ref]

Frequently asked questions

References

1. "Product Information. Olumiant (baricitinib)." Lilly, Eli and Company (2018):

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.