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Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Dapagliflozin and Genital infection: 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.
Dapagliflozin ↔ Genital infection
n=130 co-reports · PRR 5.3 · ROR 5.3
Dapagliflozin is an SGLT2 inhibitor that increases urinary glucose, creating a favourable environment for genital mycotic infections and, less often, urinary infections (candida infection 130 co-reports here, PRR 5.3). The effect is dose- and glycosuria-related, typically mild, and managed with hygiene measures and topical antifungals.
Regulatory basis: dapagliflozin (Farxiga) prescribing information — genital mycotic infections.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Infection appears within weeks |
| Strength | met | PRR 5.3, modest |
| Consistency | met | Consistent across SGLT2 inhibitors |
| Specificity | partial | Shared across the class |
| Biological gradient | met | Worse with higher glycosuria |
| Plausibility | met | Glucose-rich environment favouring fungi |
| Coherence | met | Fits the mechanism |
| Experiment | met | Trials recorded genital infections |
| Analogy | met | Analogous to other SGLT2-inhibitor infections |
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.
✓ Trial evidence found — A Phase 2b Diabetic Kidney Disease Study (NCT04170543)
| Adverse event | Placebo (n=133) · MEDI3506 30 mg (n=95) · MEDI3506 60 mg (n=89) · MEDI3506 120 mg (n=93) | |||
|---|---|---|---|---|
| Candida infection | 0/133 | 0/95 | 0/89 | 1/93 |
| Genital infection fungal | 1/133 | 0/95 | 0/89 | 0/93 |
| Oesophageal candidiasis | 1/133 | 0/95 | 0/89 | 0/93 |
Post-marketing signal terms appear in this trial's posted adverse-event tables; per-arm counts shown as affected/at-risk. View on ClinicalTrials.gov →