Published: 5 March 2026
Publications
Update: Fournier’s gangrene can occur in patients treated with empagliflozin who do not have type 2 diabetes mellitus
Published: 5 March 2026
Prescriber Update 47(1): 7–8
March 2026
We have received two case reports of Fournier’s gangrene in patients
taking empagliflozin for heart failure. These cases highlight that Fournier’s
gangrene not only occurs in patients taking empagliflozin for type 2
diabetes but can occur in patients taking empagliflozin for any indication.1,2
The data sheets for empagliflozin-containing products were recently
updated to reflect this.
Jardiance (empagliflozin) and Jardiamet (empagliflozin + metformin) are both indicated for use in type 2 diabetes mellitus.1,2 Jardiance is also indicated for use in heart failure and chronic kidney disease in patients with or without type 2 diabetes mellitus.1
Fournier’s gangrene is a rapidly progressive necrotising fasciitis of the external genitalia, perineum and perianal region. It is more common in males than females.3
Promptly evaluate patients treated with empagliflozin for any indication who present with pain or tenderness, erythema (redness), swelling in the genital or perineal area, fever or malaise for Fournier’s gangrene.1,2
Discontinue empagliflozin treatment immediately if Fournier’s gangrene is suspected and promptly treat the patient, including broad-spectrum antibiotics and surgical debridement if necessary.1,2
New Zealand case reports
As of 31 December 2025, there were 44 case reports of Fournier’s gangrene/necrotising fasciitis associated with empagliflozin. Age was reported in 32 cases with a median of 57.5 years (range: 35 to 81 years). All cases were serious, including 3 cases with a fatal outcome.
See Table 1 for a summary of these 44 cases.
Table 1: Summary of the 44 Fournier’s gangrene/necrotising fasciitis cases reported in association with empagliflozin in the New Zealand Pharmacovigilance Database, 1 January 2021 to 31 December 2025
| Subgroup | Number of cases |
|---|---|
| Medicine | |
| Empagliflozin | 38 |
| Empagliflozin + metformin | 6 |
| Indication | |
| Type 2 diabetes mellitus | 30 |
| Heart failure | 2 |
| Unknown/not reported | 12 |
| Gender | |
| Male | 27 |
| Female | 14 |
| Unknown/not reported | 3 |
| Ethnicity | |
| Māori | 10 |
| European or Other | 8 |
| Pacific Peoples | 6 |
| Asian | 2 |
| Unknown/not reported | 18 |
Source: New Zealand Pharmacovigilance Database, accessed 19 February 2026.
Further information
For prescribers:
- Spotlight on empagliflozin (Prescriber Update December 2020)
- Empagliflozin: advise patients on the risk of ketoacidosis and Fournier’s gangrene (Prescriber Update September 2021)
- Reminder: Flozins and the risks of diabetic ketoacidosis and Fournier’s gangrene (Prescriber Update December 2022)
For patients:
- Watch out for Fournier’s gangrene (infection) when taking SGLT-2 inhibitors like empagliflozin (Medsafe consumer information leaflet November 2022)
- Empagliflozin (also called Jardiance) and Jardiamet (also called empagliflozin + metformin) (Healthify medicine information)
References
- Boehringer Ingelheim (N.Z.) Limited. Jardiance New Zealand Data Sheet 23 January 2025. URL: www.medsafe.govt.nz/profs/Datasheet/j/jardiancetab.pdf (accessed 7 January 2026).
- Boehringer Ingelheim (N.Z.) Limited. Jardiamet New Zealand Data Sheet 29 January 2025. URL: www.medsafe.govt.nz/profs/Datasheet/j/jardiamettab.pdf (accessed 7 January 2026).
- Singh A and Oakley A. 2022. Fournier gangrene. In: DermNet March 2022. URL: https://dermnetnz.org/topics/fournier-gangrene (accessed 7 January 2026).
