An Exploratory Research to Evaluate the 30 Most Common Pulmonary Embolism Drugs in the Food and Drug Administration Adverse Event Reporting System

Clin Respir J. 2025 Jun;19(6):e70054. doi: 10.1111/crj.70054.

Abstract

Backgrounds: Pulmonary embolism (PE) is a common disease and a common cause of death. However, it is currently unclear which clinically common drugs can lead to PE.

Methods: We collected, organized, and analyzed reports from the first quarter of 2018 to the fourth quarter of 2022. We performed disproportionality analysis algorithms to calculate reporting odds ratio (ROR), which could quantify the signal values of different adverse events (AEs).

Results: We have screened a total of 3091 drugs, with AE containing "PE" and calculated the ROR signal values of the top 30 drugs reported and ranked them. TESTIM (ROR = 32.03[28.77-35.66]), BARICITINIB (ROR = 23.48[20.55-26.83]), and NUVARIANG (ROR = 19.89[17.13-23.10]) are the drugs with the strongest correlation with PE. In addition, among the 30 drugs with the strongest correlation with PE, most of which are Biologics & Immunomodulators. Therefore, when using these 30 drugs, it is necessary to be alert to the possible risk of PE.

Conclusion: In our study, we filtered 30 common drugs that could cause PE through the FAERS public database, which provides theoretical support for drug selection in the treatment of malignant tumors and IMID.

Keywords: FDA adverse event reporting system; adverse events; drugs; molecular targeted agents; pulmonary embolism.

MeSH terms

  • Adverse Drug Reaction Reporting Systems* / statistics & numerical data
  • Algorithms
  • Drug-Related Side Effects and Adverse Reactions* / epidemiology
  • Humans
  • Pulmonary Embolism* / chemically induced
  • Pulmonary Embolism* / epidemiology
  • United States / epidemiology
  • United States Food and Drug Administration*