pioglitazone Side Effects

What the FAERS Data Reveals About pioglitazone Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 42,504 voluntary reports linked to pioglitazone and its brand equivalents (Actos), spanning 2004 through 2025. Of those, 4,296 (10.1%) listed death as an outcome and 11,530 (27.1%) involved hospitalization. The most common indication reported alongside adverse events was Type 2 Diabetes Mellitus.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 46% were female and 53% male; age distribution skews toward 45-64, with 9,898 reports in that bracket. The single most reported reaction is bladder cancer with 8,736 submissions, followed by blood glucose increased and nausea.

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.