A real-world pharmacovigilance study of FDA adverse event reporting system events for cefazolin

Cefazolin, a first-generation cephalosporin, is critical for treating infections and preventing orthopedic perioperative infections, but its real-world adverse event (AE) spectrum remains unclear. This study identifies safety signals using data from the U.S. Food and Drug Administration AE Reporting System (FAERS). A retrospective pharmacovigilance study analyzed FAERS data (Q1 2004-Q1 2024). Disproportionality analysis was performed using a case/non-case design, calculating the reporting odds ratio (ROR), proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma poisson shrinker (MGPS) to assess the frequency and disproportionality of AEs. The "cases" were reports listing cefazolin as the primary suspect drug, while the "non-cases" comprised all other reports in FAERS. 1896 cefazolin-related AE reports were included (50.45% male; 45-65 age group dominant). 70.08% occurred within 1 week, mainly "serious events" (39.13%) and "hospitalization" (34.04%). Key SOCs: immune system disorders (488 cases, ROR = 8.72), skin disorders (815 cases, ROR = 2.95), hepatobiliary disorders (137 cases, ROR = 2.7). Significant signals: anaphylactic shock (ROR = 48.37) and acute generalized exanthematous pustulosis (ROR = 51.8). Critical safety risks of cefazolin are identified, highlighting the need for enhanced AE monitoring. Further research is required to clarify mechanisms and improve safety evaluation.