Empagliflozin → Acute kidney injury — Audit-grade candidate (class scan)

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Ledger entry · candidate

Empagliflozin → Acute kidney injury — Audit-grade candidate (class scan)

Drug: empagliflozin · AE: Acute kidney injury

Discovered via class scan of SGLT2 inhibitors. PRR = 3.05, n = 583 cases.

Disproportionality

PRR: 3.0510268567368217
Yates χ²: n/a
Cases (case-drug + AE): n = 583
Verdict: PASSES_ALL_GATES — PRR=3.05 (95% CI 2.82–3.31), n=583 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: a957247a913cd497e615c5880618f21f26fa46b6