baricitinib Side Effects
Also known as: Olumiant
Analysis of 9,259 adverse event reports submitted to the FDA from 2012 to 2025.
Total Reports
9,259
Death-Related
866
9.4% of reports
Hospitalizations
3,011
32.5% of reports
Top Indication
Rheumatoid Arthritis
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 866 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 229 |
| COVID-19 | 80 |
| OFF LABEL USE | 70 |
| RESPIRATORY FAILURE | 48 |
| CARDIAC ARREST | 45 |
| DRUG INEFFECTIVE | 42 |
| COVID-19 PNEUMONIA | 41 |
| SEPSIS | 41 |
| PULMONARY EMBOLISM | 39 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 34 |
| PNEUMONIA | 33 |
| SEPTIC SHOCK | 28 |
| ACUTE KIDNEY INJURY | 27 |
| ACUTE RESPIRATORY DISTRESS SYNDROME | 25 |
| CARDIO-RESPIRATORY ARREST | 24 |
| CARDIAC FAILURE | 22 |
| ACUTE RESPIRATORY FAILURE | 21 |
| ISCHAEMIC STROKE | 21 |
| BRONCHOPULMONARY ASPERGILLOSIS | 20 |
| DYSPNOEA | 20 |
Reactions in Hospitalization Reports
Top reactions in 3,011 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| OFF LABEL USE | 256 |
| COVID-19 | 227 |
| PNEUMONIA | 185 |
| RHEUMATOID ARTHRITIS | 181 |
| PULMONARY EMBOLISM | 154 |
| DRUG INEFFECTIVE | 143 |
| DEEP VEIN THROMBOSIS | 109 |
| DYSPNOEA | 99 |
| HERPES ZOSTER | 88 |
| PYREXIA | 83 |
| ARTHRALGIA | 77 |
| URINARY TRACT INFECTION | 75 |
| ARTHRITIS | 73 |
| ACUTE KIDNEY INJURY | 72 |
| FALL | 71 |
| RESPIRATORY FAILURE | 70 |
| VOMITING | 69 |
| COVID-19 PNEUMONIA | 65 |
| SEPSIS | 63 |
| ANAEMIA | 62 |
Nearby — Related Medications
What the FAERS Data Reveals About baricitinib Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 9,259 voluntary reports linked to baricitinib and its brand equivalents (Olumiant), spanning 2012 through 2025. Of those, 866 (9.4%) listed death as an outcome and 3,011 (32.5%) involved hospitalization. The most common indication reported alongside adverse events was Rheumatoid Arthritis.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 67% were female and 33% male; age distribution skews toward 45-64, with 2,625 reports in that bracket. The single most reported reaction is drug ineffective with 709 submissions, followed by off label use and covid-19.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.