BARICITINIB

N/A

Manufactured by Eli Lilly and Company

11,538 FDA adverse event reports analyzed

Last updated: 2026-04-14

About BARICITINIB

BARICITINIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Eli Lilly and Company. The most commonly reported adverse reactions for BARICITINIB include DRUG INEFFECTIVE, OFF LABEL USE, COVID-19, RHEUMATOID ARTHRITIS, PULMONARY EMBOLISM. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BARICITINIB.

Top Adverse Reactions

DRUG INEFFECTIVE709 reports
OFF LABEL USE655 reports
COVID 19439 reports
RHEUMATOID ARTHRITIS352 reports
PULMONARY EMBOLISM294 reports
PNEUMONIA264 reports
HEADACHE253 reports
HERPES ZOSTER237 reports
DEATH235 reports
NAUSEA226 reports
DEEP VEIN THROMBOSIS213 reports
FATIGUE183 reports
ARTHRALGIA179 reports
WEIGHT INCREASED179 reports
THERAPY INTERRUPTED178 reports
DYSPNOEA174 reports
URINARY TRACT INFECTION174 reports
PAIN173 reports
DIARRHOEA165 reports
RASH156 reports
ALOPECIA150 reports
CONDITION AGGRAVATED145 reports
VOMITING143 reports
INFECTION136 reports
PYREXIA134 reports
PAIN IN EXTREMITY124 reports
FALL123 reports
COUGH117 reports
DIZZINESS115 reports
SINUSITIS115 reports
ILLNESS109 reports
NASOPHARYNGITIS109 reports
ABDOMINAL PAIN108 reports
MALAISE105 reports
ARTHRITIS104 reports
ANAEMIA101 reports
RESPIRATORY FAILURE100 reports
ACUTE KIDNEY INJURY99 reports
SEPSIS99 reports
COVID 19 PNEUMONIA93 reports
INTERSTITIAL LUNG DISEASE90 reports
PERIPHERAL SWELLING90 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION89 reports
ALANINE AMINOTRANSFERASE INCREASED87 reports
PRURITUS83 reports
LEUKOPENIA82 reports
DIVERTICULITIS81 reports
HYPERTENSION81 reports
THERAPY CESSATION80 reports
ATRIAL FIBRILLATION77 reports
CHEST PAIN76 reports
BLOOD CHOLESTEROL INCREASED75 reports
CEREBROVASCULAR ACCIDENT75 reports
ACNE74 reports
NEOPLASM MALIGNANT74 reports
ASPARTATE AMINOTRANSFERASE INCREASED73 reports
WHITE BLOOD CELL COUNT DECREASED71 reports
INFLUENZA70 reports
MYOCARDIAL INFARCTION68 reports
BREAST CANCER67 reports
ABDOMINAL PAIN UPPER66 reports
HEPATIC ENZYME INCREASED64 reports
CONSTIPATION62 reports
JOINT SWELLING62 reports
STAPHYLOCOCCAL INFECTION62 reports
ASTHENIA61 reports
BRONCHITIS61 reports
ABDOMINAL DISCOMFORT60 reports
DEPRESSION59 reports
WEIGHT DECREASED59 reports
HYPERSENSITIVITY58 reports
LIVER FUNCTION TEST INCREASED58 reports
BACK PAIN57 reports
PNEUMOCYSTIS JIROVECII PNEUMONIA57 reports
PRODUCT USE IN UNAPPROVED INDICATION57 reports
BLOOD PRESSURE INCREASED56 reports
THROMBOSIS56 reports
PLATELET COUNT DECREASED55 reports
PNEUMONIA BACTERIAL55 reports
BRONCHOPULMONARY ASPERGILLOSIS54 reports
SEPTIC SHOCK54 reports
SWELLING54 reports
ANXIETY53 reports
DRUG INTERACTION53 reports
HAEMOGLOBIN DECREASED53 reports
UPPER RESPIRATORY TRACT INFECTION53 reports
CARDIAC ARREST52 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION52 reports
TACHYCARDIA52 reports
THERAPY NON RESPONDER52 reports
GASTROINTESTINAL DISORDER51 reports
OSTEOARTHRITIS51 reports
RENAL IMPAIRMENT51 reports
ANAPHYLACTIC REACTION50 reports
CARDIAC FAILURE50 reports
MATERNAL EXPOSURE DURING PREGNANCY50 reports
MUSCULOSKELETAL STIFFNESS50 reports
OXYGEN SATURATION DECREASED50 reports
ALOPECIA AREATA49 reports
LUNG DISORDER49 reports

Report Outcomes

Out of 9,257 classified reports for BARICITINIB:

Serious 68.8%Non-Serious 31.2%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female5,641 (67.3%)
Male2,741 (32.7%)
Unknown1 (0.0%)

Reports by Age

Age 65222 reports
Age 61211 reports
Age 68186 reports
Age 69185 reports
Age 64181 reports
Age 60177 reports
Age 55176 reports
Age 67171 reports
Age 75170 reports
Age 66161 reports
Age 63155 reports
Age 57151 reports
Age 62147 reports
Age 70147 reports
Age 71146 reports
Age 72146 reports
Age 73138 reports
Age 58136 reports
Age 59136 reports
Age 56133 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with BARICITINIB?

This profile reflects 11,538 FDA FAERS reports that mention BARICITINIB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BARICITINIB?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, OFF LABEL USE, COVID-19, RHEUMATOID ARTHRITIS, PULMONARY EMBOLISM, PNEUMONIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BARICITINIB?

Labeling and FAERS entries often list Eli Lilly and Company in connection with BARICITINIB. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.