etanercept Side Effects
Also known as: Enbrel
Analysis of 591,578 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
591,578
Death-Related
16,504
2.8% of reports
Hospitalizations
65,552
11.1% 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 16,504 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 6,230 |
| OFF LABEL USE | 2,290 |
| FATIGUE | 2,250 |
| RHEUMATOID ARTHRITIS | 2,104 |
| JOINT SWELLING | 2,030 |
| ARTHRALGIA | 2,003 |
| PAIN | 1,998 |
| RASH | 1,975 |
| HYPERTENSION | 1,973 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 1,935 |
| INFUSION RELATED REACTION | 1,928 |
| HEPATIC ENZYME INCREASED | 1,903 |
| HEADACHE | 1,879 |
| GLOSSODYNIA | 1,869 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 1,867 |
| HAND DEFORMITY | 1,856 |
| DIARRHOEA | 1,836 |
| PNEUMONIA | 1,819 |
| TYPE 2 DIABETES MELLITUS | 1,818 |
| VOMITING | 1,811 |
Reactions in Hospitalization Reports
Top reactions in 65,552 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DRUG INEFFECTIVE | 8,262 |
| RHEUMATOID ARTHRITIS | 8,061 |
| ARTHRALGIA | 7,585 |
| PAIN | 7,345 |
| PNEUMONIA | 5,567 |
| FATIGUE | 5,526 |
| CONDITION AGGRAVATED | 5,316 |
| JOINT SWELLING | 5,191 |
| OFF LABEL USE | 4,981 |
| ARTHROPATHY | 4,798 |
| RASH | 4,702 |
| NAUSEA | 4,305 |
| INFECTION | 4,275 |
| HEADACHE | 4,133 |
| MALAISE | 4,057 |
| DYSPNOEA | 4,028 |
| PYREXIA | 4,016 |
| SYNOVITIS | 3,999 |
| PAIN IN EXTREMITY | 3,991 |
| HYPERSENSITIVITY | 3,974 |
Nearby — Related Medications
What the FAERS Data Reveals About etanercept Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 591,578 voluntary reports linked to etanercept and its brand equivalents (Enbrel), spanning 2004 through 2025. Of those, 16,504 (2.8%) listed death as an outcome and 65,552 (11.1%) 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, 74% were female and 25% male; age distribution skews toward 45-64, with 205,107 reports in that bracket. The single most reported reaction is drug ineffective with 75,052 submissions, followed by injection site pain and rheumatoid arthritis.
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.