adalimumab Side Effects

What the FAERS Data Reveals About adalimumab Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 695,825 voluntary reports linked to adalimumab and its brand equivalents (Humira), spanning 2004 through 2025. Of those, 28,962 (4.2%) listed death as an outcome and 146,638 (21.1%) 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, 68% were female and 32% male; age distribution skews toward 45-64, with 160,251 reports in that bracket. The single most reported reaction is drug ineffective with 90,715 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.