Varenicline → Anxiety — Audit-grade candidate (scan)

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Ledger entry · candidate

Varenicline → Anxiety — Audit-grade candidate (scan)

Drug: varenicline · AE: Anxiety

Discovered via single-drug scan of varenicline. PRR = 2.80 (95% CI 2.63–2.97), n = 1030 cases. Pre-reg locked at submission time.

Disproportionality

PRR: 2.7950663456036153 (95% CI 2.63–2.97)
Yates χ²: 1198.3543204145435
Cases (case-drug + AE): n = 1030
Verdict: PASSES_ALL_GATES — PRR=2.80 (95% CI 2.63–2.97), n=1030 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: c90e100f9a16af947eb9676c4024fdf92655d466