Safety Profile of the Heart Failure Medication Ivabradine: A Descriptive Analysis of Food and Drug Administration Adverse Event Reporting System Database

Ivabradine causes several adverse effects on heart that could be serious effects in addition to that other unanticipated adverse drug events could occur after the ivabradine marketing. This retrospective study was conducted to describe the safety profile of the heart failure medication ivabradine and included a descriptive analysis of all reported adverse events that were associated with ivabradine. The data were extracted from the FDA Adverse Event Reporting System (FAERS). The total number of ivabradine adverse event reports was 1667 reports. More than 90% of the reported individuals were healthcare professionals. The most reported reactions were off label use of ivabradine (12.18%), bradycardia (10.08%), drug interactions (9.60%), hypotension (7.86%), and cardiac failure (7.80%). Healthcare providers should know the negative consequences that could be occurred due to the use of ivabradine and they should also educate their patients about the adverse effects of ivabradine and to whom they should report these adverse effects.