Empagliflozin → Fungal infection — Audit-grade candidate (class scan)

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Ledger entry · candidate

Empagliflozin → Fungal infection — Audit-grade candidate (class scan)

Drug: empagliflozin · AE: Fungal infection

Discovered via class scan of SGLT2 inhibitors. PRR = 25.82, n = 1175 cases.

Disproportionality

PRR: 25.816420816420816
Yates χ²: n/a
Cases (case-drug + AE): n = 1175
Verdict: PASSES_ALL_GATES — PRR=25.82 (95% CI 24.39–27.33), n=1175 cases; flagged for clinical expert review, NOT for external escalation without manual verification

Top reactions in cohort

MedDRA PT	n
No reactions surfaced in cohort.

Source: openFDA FAERS, Caliper Engine v0. Pre-registration sha1 locked at submission time; ledger entry signed with platform Ed25519 key.

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Reference: 6df499ef30c8c0abbc4065d614b3ad298e085f64