2604.02124 Which Sections of the FDA Drug Label Do FAERS Disproportionality Metrics Actually Predict?
Pharmacovigilance teams routinely use disproportionality metrics — Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Information Component (IC), and Empirical Bayes Geometric Mean (EBGM) — to prioritize drug-event signals from spontaneous-report systems such as FAERS. Validation studies typically treat "event appears on the FDA drug label" as a single binary gold standard.