Beyond adrenal suppression: a comprehensive post-marketing safety profile of etomidate from real world data

Etomidate is a widely used intravenous anesthetic, yet concerns persist regarding its potential for adverse drug reactions (ADRs) beyond well-known adrenal suppression. Pre-marketing trials may not fully capture its long-term or rare safety profile, necessitating continuous post-marketing surveillance.

A retrospective pharmacovigilance study was performed based on the U.S. FDA Adverse Event Reporting System (FAERS) database (Q1 2004-Q2 2025). Disproportionality analysis using ROR, PRR, BCPNN and EBGM algorithms was conducted and the corresponding 95% CIs were calculated. ADRs meeting the criteria of all four algorithms were considered positive signals significantly associated with the target drug.

Totally 318 ADRs were acquired, of which 59 preferred terms (PTs) and two system organ classes (SOCs) met four algorithm criteria. In addition to known cardiovascular, muscular and adrenal related PTs, novel positive signals included cardiac arrest (n = 33), seizure (n = 12), drug abuse (n = 10), hypokalaemia (n = 9) and bruxism (n = 9) were found to be correlated with etomidate. As for SOCs, cardiac disorders (n = 100) remains significantly associated with etomidate while endocrine disorders (n = 38) was uncovered as a novel signal.

This study confirmed known risks and identified novel ADRs of etomidate. These findings underscore the need for heightened clinical vigilance and further investigation into its long-term safety profile.