Ledger entry · candidate

Isotretinoin → depression — Audit-grade candidate

Drug: isotretinoin · AE: depression

Caliper validation of the submitted claim (drug=isotretinoin, AE=depression). PRR = 6.04 (95% CI 5.79–6.31), n = 1943 cases. Pre-reg locked at submission; awaiting Adam's review before public ship.

Disproportionality

PRR: 6.044847730418311 (95% CI 5.79–6.31)
Yates χ²: 8213.904345936853
Cases (case-drug + AE): n = 1943
Verdict: PASSES_ALL_GATES — PRR=6.04 (95% CI 5.79–6.31), n=1943 cases; flagged for clinical expert review, NOT for external escalation without manual verification

Top reactions in cohort

MedDRA PT	n
Depression	1901
Suicidal ideation	317
Anxiety	241
Mood altered	144
Inflammatory bowel disease	98
Mood swings	83
Colitis ulcerative	82
Dry skin	81

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