abatacept Side Effects
Also known as: Orencia
Analysis of 133,227 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
133,227
Death-Related
8,659
6.5% of reports
Hospitalizations
24,589
18.5% 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 8,659 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 3,005 |
| JOINT SWELLING | 2,016 |
| RHEUMATOID ARTHRITIS | 2,013 |
| INFUSION RELATED REACTION | 1,966 |
| PAIN | 1,954 |
| RASH | 1,943 |
| OFF LABEL USE | 1,914 |
| FATIGUE | 1,892 |
| HYPERTENSION | 1,886 |
| GLOSSODYNIA | 1,883 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 1,857 |
| TYPE 2 DIABETES MELLITUS | 1,857 |
| HEPATIC ENZYME INCREASED | 1,853 |
| SYNOVITIS | 1,832 |
| WOUND | 1,824 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 1,820 |
| HAND DEFORMITY | 1,814 |
| FIBROMYALGIA | 1,813 |
| PSORIATIC ARTHROPATHY | 1,785 |
| HYPOAESTHESIA | 1,776 |
Reactions in Hospitalization Reports
Top reactions in 24,589 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DRUG INEFFECTIVE | 6,476 |
| RHEUMATOID ARTHRITIS | 5,521 |
| PAIN | 4,980 |
| ARTHRALGIA | 4,253 |
| ARTHROPATHY | 4,191 |
| FATIGUE | 4,089 |
| RASH | 4,069 |
| OFF LABEL USE | 4,017 |
| SYNOVITIS | 3,911 |
| JOINT SWELLING | 3,897 |
| DRUG INTOLERANCE | 3,597 |
| HYPERSENSITIVITY | 3,446 |
| DRUG HYPERSENSITIVITY | 3,391 |
| CONDITION AGGRAVATED | 3,328 |
| CONTRAINDICATED PRODUCT ADMINISTERED | 3,293 |
| INFECTION | 3,189 |
| NAUSEA | 3,172 |
| PERIPHERAL SWELLING | 3,114 |
| INFUSION RELATED REACTION | 3,080 |
| DIARRHOEA | 3,018 |
Nearby — Related Medications
What the FAERS Data Reveals About abatacept Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 133,227 voluntary reports linked to abatacept and its brand equivalents (Orencia), spanning 2004 through 2025. Of those, 8,659 (6.5%) listed death as an outcome and 24,589 (18.5%) 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, 85% were female and 15% male; age distribution skews toward 45-64, with 37,860 reports in that bracket. The single most reported reaction is drug ineffective with 38,612 submissions, followed by rheumatoid arthritis and pain.
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.