Dipyridamole-associated pulmonary edema: discovery of a new potential adverse reaction signal based on the FAERS...

To analyze adverse events signals linked to dipyridamole using the FDA Adverse Event Reporting System, informing safety protocols for clinical use.

We retrospectively extracted AE reports linked to dipyridamole from the FAERS database, covering the period from Q1 2004 to Q4 2024. Signal detection was rigorously performed using a combination of statistical methods, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS).

A total of 1235 patients experienced adverse events related to dipyridamole, with these events occurring 3371 times in total. The signal for Acquired von Willebrand's Disease emerged as particularly prominent, followed by Steal syndrome and Peritoneal hematoma. Additionally, signals indicating increased risks of pulmonary edema, myocardial ischemia and ischemic stroke were detected. Adverse events were common in patients aged ≥65 years, with the most prominent signal being Catheter site hematoma and Blood creatine phosphokinase MB increased. The combination of dipyridamole and other drugs was prone to bleeding adverse events, suggesting a multifaceted safety profile that warrants careful clinical consideration.

These findings underscore the need for tailored safety monitoring strategies and more nuanced risk-benefit assessments in the clinical use of dipyridamole.