Applies to baricitinib: oral tablet.

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)