Objective  To identify potential adverse event signals associated with vericiguat through the Food and Drug Administration Adverse Event Reporting System (FAERS) database, and to provide early warning of potential drug risks for clinical practice.

Methods  The reports were aggregated from the first quarter of 2021, when vericiguat was introduced to the market, to the third quarter of 2024 in the FAERS database. Reports in which vericiguat was identified as the primary suspect (PS) drug for adverse drug events (ADEs) were selected. Adverse events were standardized using the system organ classes (SOC) and preferred terms (PT) from the Medical Dictionary for Regulatory Activities (MedDRA). The reporting odds ratio (ROR) method and the proportional reporting ratio (PRR) method, which were commonly employed in pharmacovigilance, were utilized for risk signal mining.

Results  A total of 755 ADE reports identified vericiguat as the PS drug. The elderly population aged 75 and above accounted for 21.55%. The indications for the reported ADEs were predominantly chronic heart failure. By calculating using ROR and PRR methods, 127 positive signals were identified. According to SOC, the adverse event terms with stronger signals were primarily concentrated in the category of cardiac organ diseases. According to PT classification, the incidence of hypotension, dizziness, and anemia was prominent, which was consistent with the description in the drug label. Among the elderly patients, the signals for anemia and renal failure were particularly prominent.

Conclusion  This article explores and analyzes the ADE signals of vericiguat in the FAERS database, which is consistent with the drug description. It is overall safe and controllable. Hypotension, dizziness, and anemia are adverse events with significant positive signals, which are consistent with previous clinical research conclusions. For elderly people aged 75 and above, anemia signals are particularly evident, and positive signals appear in renal function impairment, indicating clinical attention to medication monitoring for the elderly and further ensuring medication safety.

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