Varenicline → Abnormal dreams — Audit-grade candidate (scan)

Drug: varenicline · AE: Abnormal dreams

Discovered via single-drug scan of varenicline. PRR = 56.87 (95% CI 54.36–59.51), n = 1876 cases. Pre-reg locked at submission time.

Disproportionality

• PRR: 56.874543136421586 (95% CI 54.36–59.51)
• Yates χ²: 95957.87140188785
• Cases (case-drug + AE): n = 1876
• Verdict: PASSES_ALL_GATES — PRR=56.87 (95% CI 54.36–59.51), n=1876 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.