Assessing the Real-World Safety of Regadenoson for Myocardial Perfusion Imaging: Insights from a Comprehensive...

Background/Objectives: Regadenoson, a selective adenosine A_2A receptor agonist, is primarily prescribed for myocardial perfusion imaging (MPI). As its clinical use becomes more widespread in practice, assessing its safety in real-world settings is essential. Methods: In this research, disproportionality analysis was applied to evaluate the safety of Regadenoson by examining all adverse event (AE) reports since 2004 in the FDA Adverse Event Reporting System (FAERS), in which Regadenoson was identified as the primary suspected drug. The reporting odds ratio (ROR), proportional reporting ratio (PRR), multi-item gamma Poisson shrinker (MGPS), and Bayesian confidence propagation neural network (BCPNN) were used to analyze AEs associated with Regadenoson. The Weibull distribution was utilized to model the temporal risk of AEs. Results: The results confirmed some known adverse reactions, such as nausea, shortness of breath (dyspnea), palpitations/vomiting, headache, dizziness, chest pain, and flushing (facial redness or warmth), which were also listed on the drug's label. New potential adverse reactions not mentioned in the label were identified, including micturition urgency, mental status changes, conversion disorder, eye movement disorder, and genital paraesthesia. This study highlighted the significance of monitoring AEs, particularly right after the start of Regadenoson administration. Conclusions: This study provides preliminary safety data on Regadenoson's real-world use, corroborating known adverse effects while uncovering new potential risks. These findings offer valuable safety insights for clinicians when prescribing Regadenoson for the use of MPI.