Drug-induced pulmonary edema: a real-world pharmacovigilance study using the FDA Adverse Event Reporting System...

This study aimed to systematically evaluate the risk of drug-induced pulmonary edema (DIPE) using the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. This retrospective pharmacovigilance study utilized FAERS data from the first quarter of 2004 to the second quarter of 2024. We identified drugs with at least 10 reported DIPE cases as primary suspects (PS). The DIPE signals were assessed using four methods: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EBGM). Multivariate logistic regression was employed to control for confounding factors, and the timing of DIPE onset was statistically analyzed. Out of 173 target drugs, 37 were identified with DIPE risk. The top five drugs were naloxone, dasatinib, nifedipine, anti-thymocyte globulin, and pioglitazone. Multivariate logistic regression indicated that all except pioglitazone were independent risk factors for DIPE. The onset time of DIPE varied by age and gender for some drugs. This study is the first to identify the DIPE risk systematically associated with multiple drugs. It highlights the need for clinicians and pharmacists to be aware of these high-risk drugs and to monitor high-risk populations closely to ensure medication safety.