Objective To perform an updated assessment of Fournier gangrene (FG) associated with sodium-glucose cotransporter-2 (SGLT2) inhibitors based on the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database, and to provide a reference for safe clinical medication.

Methods FG reports related to empagliflozin, dapagliflozin, canagliflozin, ertugliflozin, and their fixed-dose combinations from the first quarter of 2013 to the first quarter of 2026 were retrieved from the FAERS database. Adverse drug event signals were mined using the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS) methods. Descriptive analyses were performed for demographic characteristics, clinical outcomes, and time to onset.

Results A total of 1,814 SGLT2 inhibitor-related FG reports were identified, with empagliflozin having the largest number of reports (n = 1,142). Cases were predominantly male (60.00% to 73.26%). Hospitalization was the most common serious outcome (46.06% to 68.66%), and death reports accounted for 6.22% to 9.77% of cases. Positive signals were detected for all four SGLT2 inhibitors. Cases of FG were most prevalent among patients with a treatment duration > 360 days, which constituted the largest proportion ( > 40%), followed by those with 181 to 360 days; approximately 8%-14% of cases occurred within 30 days of treatment initiation.

Conclusion Significant disproportionality signals were observed between all four SGLT2 inhibitors and FG at the reporting level. Given the acute onset of FG, the relatively high proportion of fatal reports, and the persistence of risk throughout the treatment course, clinicians should enhance monitoring for symptoms of this adverse event throughout the entire treatment course.

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