Postmarketing safety analysis of remimazolam: Identifying unlabelled serious events
Authors' conclusion
While remimazolam shows a generally acceptable safety profile, our pharmacovigilance analysis identified serious unlabelled reactions requiring clinical vigilance.
Study context
- Population
- Patients with remimazolam-related adverse event (AEs) reported in FDA Adverse Event Reporting System (FAERS) and JADER, January 2020 to December 2023reports
- Participants
- 199 patients
- Outcome
- Significant AEs identified by reporting OR, proportional reporting ratio, Bayesian confidence propagation neural network and multiitem gamma Poisson shrinker; categorised by IME list (version 26.1)
Methodological detailsdisproportionality analysis, FAERS and JADER databases
- Disproportionality analysis
- FAERS and JADER databases
Main finding
As reported in the abstract
Significant remimazolam-related AEs
- Remimazolam-related reports from FAERS
- 69
- Remimazolam-related reports from JADER
- 130
- Significant AEs
- 20
- Events classified as Important Medical Events, including hypotension and anaphylaxis
- 9
- AEs not in current Food and Drug Administration (FDA) labelling
- 4
Observational data: associations, not effects.
Original publication
Postmarketing safety analysis of remimazolam: Identifying unlabelled serious events. Eur J Anaesthesiol. Published 23 June 2025. doi:10.
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