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Baricitinib Side Effects

For the Consumer

Applies to baricitinib: oral tablet

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Change in color or size of a mole.
  • A skin lump or growth.
  • Night sweats.
  • Feeling very tired or weak.
  • Tears in the stomach or bowel wall have happened in certain people taking this drug. Call your doctor right away if you have swelling or pain in your stomach that is very bad, gets worse, or does not go away. Call your doctor right away if you throw up blood or have throw up that looks like coffee grounds; upset stomach or throwing up that does not go away; or black, tarry, or bloody stools.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to baricitinib: oral tablet

Hematologic

Common (1% to 10%): Thrombocytosis, anemia

Uncommon (0.1% to 1%): Neutropenia

Frequency not reported: Lymphocytosis (occurs at higher rates in the elderly)[Ref]

Immunologic

Common (1% to 10%): Herpes zoster, herpes simplex (e.g., eczema herpeticum, herpes simplex, ophthalmic herpes simplex, oral herpes), influenza[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, rheumatoid arthritis, back pain, muscle spasm, myalgia[Ref]

Ocular

Common (1% to 10%): Blurred vision

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

Metabolic

Very common (10% or more): Hypercholesterolemia (34%)

Uncommon (0.1% to 1%): Hypertriglyceridemia, weight gain, creatine phosphokinase increased to greater than 5 times the upper limit of normal (ULN)[Ref]

Psychiatric

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

Genitourinary

Common (1% to 10%): Urinary tract infection, benign prostatic hyperplasia

Uncommon (0.1% to 1%): Cystitis, erectile dysfunction, vulvovaginal candidiasis[Ref]

Hepatic

Common (1% to 10%): ALT increased greater than or equal to 3 times the upper limit of normal (ULN)

Uncommon (0.1% to 1%): AST increased greater than or equal to 3 times the upper limit of normal (ULN), abnormal hepatic function[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infections (e.g., sinusitis, epiglottitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, tonsillitis, tracheitis) (15%)

Common (1% to 10%): Bronchitis, sinusitis, rhinitis, cough

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

Other

Common (1% to 10%): Fatigue, pyrexia, peripheral edema[Ref]

Nervous system

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

Cardiovascular

Common (1% to 10%): Hypertension, coronary artery disease[Ref]

Dermatologic

Uncommon (0.1% to 1%): Acne, alopecia, rash[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, gastroenteritis, dyspepsia, upper abdominal pain, constipation, vomiting, oropharyngeal pain, stomatitis, abdominal discomfort, gastroesophageal reflux disease[Ref]

References

1. "Product Information. Olumiant (baricitinib)." Lilly, Eli and Company, Indianapolis, IN.

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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