golimumab Side Effects

What the FAERS Data Reveals About golimumab Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 82,622 voluntary reports linked to golimumab and its brand equivalents (Simponi), spanning 2006 through 2025. Of those, 5,919 (7.2%) listed death as an outcome and 19,695 (23.8%) 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, 77% were female and 23% male; age distribution skews toward 45-64, with 20,890 reports in that bracket. The single most reported reaction is drug ineffective with 21,070 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.