Analysis of drug-induced pulmonary embolism risk based on the Food and Drug Administration Adverse Event Reporting System database

Abstract

Background: Drug-induced pulmonary embolism (PE) is a serious adverse drug reaction. While the risk of PE associated with specific medications, such as certain antipsychotics, has been preliminarily investigated, the risks of PE across multiple drug classes in real-world settings are yet to be systematically elucidated. This study utilizes the Food and Drug Administration Adverse Event (AE) Reporting System (FAERS) database, covering data from the first quarter of 2004 to the fourth quarter of 2024, with the objective of identifying drug risk signals that are significantly associated with PE. The findings aim to provide a scientific basis for subsequent clinical medication safety. Methods: This study retrieved AE reports related to ‘‘PE’’ from the FAERS database and conducted a disproportionality analysis using the reporting odds ratio (ROR) and Bayesian confidence propagation neural network (BCPNN). The Preferred Terms (PTs) involved in the study process were standardized using the 27.1 version of the Medical Dictionary for Regulatory Activities (MedDRA). Furthermore, this study systematically classified all drugs involved based on the anatomical therapeutic chemical (ATC) classification standards established by the World Health Organization. Results: This study identified 1,459 drugs associated with the AE of PE, affecting a total of 86,810 patients. Notably, the proportion of female patients was higher than that of male patients. Common drug categories, including antineoplastic and immunomodulating agents, blood and blood-forming organ medications, and nervous system drugs, exhibited strong reporting association signals with PE. The highest number of PE cases was reported for drospirenone/ethinylestradiol, rivaroxaban, and ethinylestradiol/etonogestrel. Conclusions: Through a comprehensive analysis of the FAERS database, this study identified multiple drug categories that exhibit significant positive associations with PE. These findings suggest that clinicians should be vigilant about these potential risk signals, particularly when prescribing long-term treatments to patients with underlying thrombotic risk factors.