Key result
Regadenoson FAERS analysis shows ~99% of adverse events occur on day 0, revealing new signals.
Why the study?
As the clinical use of regadenoson for myocardial perfusion imaging becomes more widespread, assessing its safety in real-world settings is essential.
What are the real-world adverse event safety signals and temporal risk profiles associated with regadenoson for myocardial perfusion imaging in the FAERS database?
Observational (n=4,408)
What are the real-world adverse event safety signals and temporal risk profiles associated with regadenoson for myocardial perfusion imaging in the FAERS database?
Real-world pharmacovigilance data from FAERS corroborate known cardiovascular and neurological adverse effects of regadenoson while identifying novel unlabeled safety signals (such as micturition urgency, mental status changes, conversion disorder, eye movement disorder, and genital paraesthesia) that predominantly occur immediately upon administration.
Answers are grounded in this paper and cite their sources.
May support closer monitoring for immediate events in MPI; extends real-world FAERS signal detection for regadenoson.
Background/Objectives: Regadenoson, a selective adenosine A2A 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.
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Xu et al. (2025) conducted an observational in Patients undergoing myocardial perfusion imaging (MPI) with reported adverse events to regadenoson (n=4,408). Regadenoson vs. Other drugs in the FAERS database (disproportionality analysis) was evaluated on Disproportionality signals of adverse events (using ROR, PRR, MGPS, and BCPNN) and time-to-onset of adverse events. Regadenoson was associated with 4,408 FAERS adverse event reports (99.18% occurring on day 0), confirming labeled risks and identifying unlabeled signals like micturition urgency.
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