Drug-associated Kounis Syndrome: A Retrospective, Disproportionate Analysis Study of FAERS Database

Background

Kounis syndrome (KS), or allergic acute coronary syndrome, remains an under-recognized clinical entity precipitated by mast-cell activation [1, 3]. While various triggers exist, drug-specific patterns and signal strengths across therapeutic classes remain incompletely characterized.

Methods

A retrospective pharmacovigilance study was conducted using the FDA Adverse Event Reporting System (FAERS) database (2003–2025). Disproportionality analysis was performed using frequentist (ROR, PRR) and Bayesian (IC, EBGM) metrics to identify medications with significant reporting signals for KS.

Results