ustekinumab Side Effects

What the FAERS Data Reveals About ustekinumab Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 98,899 voluntary reports linked to ustekinumab and its brand equivalents (Stelara), spanning 2009 through 2025. Of those, 5,465 (5.5%) listed death as an outcome and 21,428 (21.7%) involved hospitalization. The most common indication reported alongside adverse events was Psoriasis.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 60% were female and 40% male; age distribution skews toward 18-44, with 21,364 reports in that bracket. The single most reported reaction is drug ineffective with 14,436 submissions, followed by off label use and product dose omission issue.

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.