The guanylate cyclase stimulator vericiguat: Insights and adverse events from a FAERS-based pharmacovigilance study

Since its approval by the U.S. Food and Drug Administration in January 2021, vericiguat, a novel soluble guanylate cyclase stimulator, has been increasingly utilized in the treatment of heart failure with reduced ejection fraction. However, comprehensive long-term safety data on vericiguat in large populations are lacking.

This study analyzed the adverse events reported to the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) to assess the safety profile of vericiguat.

We selected four algorithms to evaluate the signals of adverse events related to vericiguat: Multi-item Gamma Poisson Shrinker, Bayesian Confidence Propagation Neural Network, Proportional Reporting Ratio, and Reporting Odds Ratio.

We conducted a retrospective analysis of the FAERS database from January 19, 2021, to December 31, 2024, encompassing 6, 981, 085 reports. Among these, 1,863 adverse events from 886 reports were identified with vericiguat as the primary suspect. After applying all four algorithms at the preferred term level, 64 preferred terms were recognized, encompassing 853 signals. The most common adverse events, such as hypotension, dizziness, dyspepsia, and anemia, were consistent with findings of clinical trials. Additionally, we identified new adverse events, including gastrointestinal hemorrhage and renal impairment.

Our analysis provides a comprehensive safety assessment of vericiguat. Most of these results align with findings from previous studies. In addition, our data revealed several new adverse events. This study provides valuable insights that can inform future research and clinical practice.