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Causality: well established
Causality assessment · Causality: well established
Empagliflozin and Necrotising fasciitis (Fournier's gangrene): is the FAERS signal real?
A written Bradford Hill assessment of one drug–event pair. The grade is a judgement about the signal, not a statement that this drug causes this event in any one person; FAERS counts are reports, not rates.
Empagliflozin ↔ Necrotising fasciitis (Fournier's gangrene)
n=251 co-reports · PRR 24.0 · ROR 24.1
Empagliflozin is an SGLT2 inhibitor; heavy glycosuria and impaired host defence make perineal necrotising fasciitis (Fournier's gangrene) a rare but life-threatening complication, carried here as 251 co-reports (PRR 24.0). The label carries a warning for necrotising fasciitis of the perineum and advises urgent treatment; the reaction is strongly disproportionate even though it is rare in absolute terms.
Regulatory basis: empagliflozin (Jardiance) prescribing information — warning for necrotising fasciitis of the perineum (Fournier's gangrene).
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Onset within days to weeks |
| Strength | met | PRR 24.0, large |
| Consistency | met | Reproduced across SGLT2 inhibitors |
| Specificity | partial | Shared across the class |
| Biological gradient | not established | Not clearly dose-related |
| Plausibility | met | Glycosuria and impaired host defence |
| Coherence | met | Fits the mechanism |
| Experiment | n/a | Too rare for trial detection |
| Analogy | met | Analogous to other SGLT2-inhibitor Fournier's gangrene |
This table is this page's own qualitative read of the literature cited above, not an automated or citation-gated assessment — see the note at the bottom of this page.
✗ No ClinicalTrials.gov results-posting trial in the top search hits for empagliflozin captured necrotising fasciitis (fournier's gangrene) as a tracked adverse event in a usable structure. Perineal necrotising fasciitis is very rare, so the diabetes outcome trials did not capture it as a coded event.