darifenacin Side Effects

What the FAERS Data Reveals About darifenacin Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 596 voluntary reports linked to darifenacin and its brand equivalents (Enablex), spanning 2005 through 2025. Of those, 56 (9.4%) listed death as an outcome and 174 (29.2%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 75% were female and 24% male; age distribution skews toward 75+, with 180 reports in that bracket. The single most reported reaction is drug ineffective with 99 submissions, followed by peripheral swelling and herpes zoster.

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.