tofacitinib Side Effects
Also known as: Xeljanz
Analysis of 181,998 adverse event reports submitted to the FDA from 2008 to 2025.
Total Reports
181,998
Death-Related
8,655
4.8% of reports
Hospitalizations
24,557
13.5% 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 8,655 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 3,491 |
| OFF LABEL USE | 2,002 |
| JOINT SWELLING | 1,969 |
| RHEUMATOID ARTHRITIS | 1,950 |
| PAIN | 1,933 |
| RASH | 1,899 |
| INFUSION RELATED REACTION | 1,889 |
| FATIGUE | 1,860 |
| SYNOVITIS | 1,848 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 1,844 |
| GLOSSODYNIA | 1,840 |
| TYPE 2 DIABETES MELLITUS | 1,836 |
| WOUND | 1,826 |
| HEPATIC ENZYME INCREASED | 1,796 |
| HYPERTENSION | 1,796 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 1,768 |
| HAND DEFORMITY | 1,768 |
| PSORIATIC ARTHROPATHY | 1,732 |
| HYPOAESTHESIA | 1,729 |
| SWELLING | 1,719 |
Reactions in Hospitalization Reports
Top reactions in 24,557 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DRUG INEFFECTIVE | 5,640 |
| PAIN | 5,294 |
| RHEUMATOID ARTHRITIS | 4,484 |
| CONDITION AGGRAVATED | 4,373 |
| ARTHRALGIA | 4,344 |
| FATIGUE | 4,196 |
| OFF LABEL USE | 4,018 |
| RASH | 3,865 |
| JOINT SWELLING | 3,732 |
| ARTHROPATHY | 3,429 |
| SYNOVITIS | 3,310 |
| PERIPHERAL SWELLING | 3,152 |
| PNEUMONIA | 3,053 |
| MALAISE | 3,046 |
| DRUG INTOLERANCE | 3,044 |
| DRUG HYPERSENSITIVITY | 3,037 |
| HYPERSENSITIVITY | 3,027 |
| ABDOMINAL DISCOMFORT | 2,985 |
| INFECTION | 2,974 |
| HEADACHE | 2,923 |
Nearby — Related Medications
What the FAERS Data Reveals About tofacitinib Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 181,998 voluntary reports linked to tofacitinib and its brand equivalents (Xeljanz), spanning 2008 through 2025. Of those, 8,655 (4.8%) listed death as an outcome and 24,557 (13.5%) 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, 80% were female and 20% male; age distribution skews toward 45-64, with 69,765 reports in that bracket. The single most reported reaction is drug ineffective with 43,542 submissions, followed by pain and arthralgia.
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.