Adverse event signal analysis of remimazolam using the FDA adverse event reporting system database
Authors' 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.
Study context
- Population
- Reports of adverse drug events associated with remimazolam in the FAERS database, Q1 2020 to Q4 2023
- Participants
- 67 cases
- Outcome
- Potential safety signals (ADE signals) of remimazolam in FAERS
Methodological detailsobservational analysis of the FDA Adverse Event Reporting System database, FAERS database Q1 2020 to Q4 2023
- Observational analysis of the FDA Adverse Event Reporting System database
- FAERS database Q1 2020 to Q4 2023
Main finding
As reported in the abstract
ADE signals of remimazolam
- 161 adverse drug events (ADEs) identified in 67 cases
- Notable ADE signals included serious events: allergic reactions, respiratory and cardiac arrest, vascular access occlusion
Observational data: associations, not effects.
Further findings
ADE incidence by age
- Incidence of ADEs higher in patients aged >45 years, particularly >65 years
Administration method
- IV GA the most common administration method
Original publication
Adverse event signal analysis of remimazolam using the FDA adverse event reporting system database. Acta Anaesthesiol Scand. Published 13 February 2025. doi:10.
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