Varenicline → Nightmare — Audit-grade candidate (scan)

Drug: varenicline · AE: Nightmare

Discovered via single-drug scan of varenicline. PRR = 24.24 (95% CI 22.81–25.75), n = 1037 cases. Pre-reg locked at submission time.

Disproportionality

• PRR: 24.24023452585753 (95% CI 22.81–25.75)
• Yates χ²: 22414.578060197033
• Cases (case-drug + AE): n = 1037
• Verdict: PASSES_ALL_GATES — PRR=24.24 (95% CI 22.81–25.75), n=1037 cases; flagged for clinical expert review, NOT for external escalation without manual verification

Top reactions in cohort

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