Abstract
Background: Chronic heart failure (CHF) is a prevalent condition characterized by the heart's inability to effectively pump blood, leading to significant morbidity and mortality. Ivabradine, a medication targeting heart rate regulation, has emerged as a valuable therapy for managing CHF symptoms. However, comprehensive real-world data on ivabradine's adverse reactions are lacking. Our study utilized FAERS data and statistical algorithms to identify and characterize ivabradine-related adverse events, providing insights crucial for enhancing medication safety and informing clinical practice.Methods: This study utilized the FDA's Adverse Event Reporting System (FAERS) to analyze adverse drug reaction (ADR) reports associated with ivabradine over an eight-year period. Four statistical methodologies, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EBGM), were employed to assess the association between ivabradine and ADRs. Disproportionality analysis at both the System Organ Class (SOC) and Preferred Terms (PTs) levels was conducted to identify potential safety signals.Results: Analysis of 1,860 ADR reports revealed notable associations between ivabradine and various ADRs across different organ systems. Common AEs included cardiovascular events such as bradycardia and atrial fibrillation, as well as visual disturbances and autonomic dysfunction. The study also highlighted the importance of monitoring off-label use and potential interactions with other medications.Conclusions: This comprehensive pharmacovigilance analysis identified and characterized ADRs associated with ivabradine, providing valuable insights for healthcare professionals and regulatory authorities. Despite limitations inherent in spontaneous reporting systems, these findings underscore the importance of ongoing surveillance to ensure the safe use of ivabradine in clinical practice.