Adverse event signal analysis of remimazolam using the FDA adverse event reporting system database

Abstract Background Remimazolam, a novel ultra‐short‐acting benzodiazepine, has gained popularity in various anesthetic applications due to its pharmacokinetic advantages. However, as its use increases, safety concerns also rise, necessitating thorough examination. Additionally, the limited reports on its side effects require a broader investigation to better understand the drug's safety profile. Methods This observational study systematically investigated adverse drug events (ADEs) associated with remimazolam using the FAERS database from Q1 2020 to Q4 2023. The primary objective was to assess potential safety signals and provide comprehensive information for clinical and regulatory purposes. Results A total of 67 cases and 161 ADEs were identified. The incidence of ADEs was higher in patients aged >45 years, particularly those >65 years. Intravenous general anaesthesia was the most common administration method. Notable ADE signals included serious events such as allergic reactions, respiratory and cardiac arrest, and vascular access occlusion. Conclusion Clinicians should be vigilant about potential allergic reactions to remimazolam, especially in older patients, and avoid off‐label use until more data are available. Continuous monitoring of post‐market surveillance data is essential for uncovering undetected ADEs and ensuring the safe use of remimazolam. Editorial comment This study analyzed adverse drug events (ADEs) associated with remimazolam using the FAERS database, identifying serious safety signals like allergic reactions, respiratory and cardiac arrests, and vascular access site occlusions, especially in older patients. The findings highlight the need for vigilant monitoring, cautious off‐label use, and ongoing post‐marketing surveillance.