Safety assessment of ezetimibe: real-world adverse event analysis from the FAERS database.

Background: Ezetimibe is known for its lipid-lowering safety and tolerability, but its real-world adverse effects have not been fully evaluated. In this study, adverse events associated with ezetimibe were investigated using the FAERS database for the period 2004 to 2023.

Research design and methods: Adverse events data for ezetimibe, spanning from the first quarter of 2004 to the fourth quarter of 2023, were standardized and analyzed using signal quantification methods like Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (EBGM).

Results: Among 11,550 adverse drug events reports with ezetimibe as the primary suspect drug, 211 preferred terms (PTs) were identified across 24 different system organ classes (SOCs).Notably, in addition to the adverse reactions already specified in the instruction manual, unstable angina (n = 120, ROR 30.53(25.47-36.58), PRR 30.41(25.49-36.28), IC 4.9(4.64), EBGM 29.85(25.66)), crush syndrome(n = 19,ROR 298.83(182.95-488.09), PRR 298.65(182.96-487.49), IC 7.97(7.29),EBGM 251.12(166.57)), and autoscopy (n = 7, ROR 28.81(13.64-60.85), PRR 28.80(13.68-60.65), IC 4.82(3.81), EBGM 28.30(15.14))were new adverse reactions that emerged as strong signals.

Conclusions: Ezetimibe is effective in lowering blood lipids, but there is a risk of adverse reactions such as unstable angina, rhabdomyolysis and autoscopy, which require careful monitoring by physicians.