Baricitinib Side Effects

Medically reviewed by Drugs.com. Last updated on May 29, 2023.

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 Baricitinib

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 [PE]), arterial thrombosis, venous thromboembolic events (including DVT, PE)

Dermatologic

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

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

Uncommon (0.1% to 1%): Urticaria

Frequency not reported: Fungal skin infections

Gastrointestinal

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

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

Frequency not reported: Gastrointestinal perforations

Genitourinary

Common (1% to 10%): Urinary tract infection (includes cystitis, urinary tract infection, urine positive for WBCs, bacterial urinary tract infection, pyelonephritis), cystitis, benign prostatic hyperplasia, erectile dysfunction, vulvovaginal candidiasis, genital Candida infections (includes vulvovaginal candidiasis, vulvovaginal mycotic infection, fungal genital infection)

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.

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

Frequency not reported: Lymphopenia, lymphocytosis

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 (includes increased transaminases, increased AST, increased ALT, increased hepatic enzyme, increased GGT, abnormal hepatic function)

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.

Hypersensitivity

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

Metabolic

Very common (10% or more): Hypercholesterolemia

Common (1% to 10%): Hyperlipidemia (includes hyperlipidemia, hypercholesterolemia, hypertriglyceridemia, dyslipidemia, increased lipids, increased low-density lipoprotein, increased blood cholesterol, increased blood triglycerides), dyslipidemia

Uncommon (0.1% to 1%): Hypertriglyceridemia

Musculoskeletal

Increased creatine phosphokinase (greater than 5 x ULN) was reported in up to 4.5% 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

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.

Very common (10% or more): Increased low-density lipoprotein (LDL) cholesterol (up to 33.7%), infections (includes 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, herpes zoster, weight increased

Uncommon (0.1% to 1%): Opportunistic infections (includes tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystis pneumonia/pneumocystosis, acute histoplasmosis, cryptococcosis, CMV, BK virus), tuberculosis, swelling of the face (includes 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])

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 (includes 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, adenoiditis; up to 21.3%)

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, lower respiratory tract infections (includes bronchitis, bronchiolitis, lower respiratory tract infection, pneumonia, COVID-19 pneumonia, respiratory tract infection)