Table 1

Aggregate characteristics of reports for definite Fournier’s gangrene (FG) and severe genital adverse events (AEs), with SGLT2i as suspect or concomitant drugs

Definite FGSevere genital AEs
Total cases4717
Reporter country (US/non-US)29/1806/11/19
Age, years (mean/range)*58.9/38–7850.7/35–70
Sex (M/F/)††31/1112/03/19
Type of SGLT2i
 Empagliflozin143
 Dapagliflozin177
 Canagliflozin167†
Primary/secondary suspect47‡16†
Diabetes type
 Type 1 diabetes00
 Type 2 diabetes2510
 Not specified71
 Not reported156
Concomitant medications‡‡
 Glucose-lowering agents217
 Lipid-lowering agents73
 Cardiovascular agents (including ASA)63
 Systemic immunosuppressant drugs2§§1
 Systemic anti-infectives20
 Levothyroxine20
 Antiasthma1¶¶0
 Others113
 None/not reported2611
Mean time to onset, days (range)§434 (0–2508)291 (0–965)
Outcomes¶ 
 Hospitalisation3613
 Life-threatening190
 Disability52
 Requiring intervention50
 Death**20
 Other146

  • *Not reported in 20 cases.

  • †In one case canagliflozin was reported as concomitant.

  • ‡In one case dapagliflozin was reported as secondary suspect.

  • §Calculated for 27 reports with available data on ‘start date’ and ‘event date’. In case the specific day of start/event dates was not recorded, day 1 was imputed. Reports with incomplete data (both year and month of reporting) were excluded.

  • ¶A report may be coded with multiple outcomes.

  • **One death was reported in the case narrative.

  • ††Not reported in seven cases.

  • ‡‡A report may contain multiple medications. If more than one drug of a given therapeutic class was reported (eg, glucose-lowering agents), the case counted only once.

  • §§In one case, secukinumab was reported as primary suspect drug.

  • ¶¶Including a short-acting β2-adrenoreceptor agonist and a combination of inhaled corticosteroid and long-acting β2-adrenoreceptor agonist.

  • ASA, acetylsalicylic acid.