Perioperative Medications Associated with Delayed Recovery from Anaesthesia: A Two-Decade Pharmacovigilance Study Based on the FAERS

Background: Drug-induced delayed recovery from anaesthesia (DRA) represents a serious postoperative adverse drug reaction characterized by prolonged unconsciousness or respiratory depression following the cessation of anaesthetic agents. Objective: To systematically identify drugs significantly associated with DRA using the U.S. FDA Adverse Event Reporting System (FAERS). Methods: Pharmacovigilance disproportionality analysis was conducted with FAERS data (2003–2024), applying the Reporting Odds Ratio (ROR) to quantify drug-event associations. Results: A total of 1,831 reports related to DRA were included for disproportionality analysis, yielding 1,239 significant signals. The strong associations were observed for thiamylal (n = 4, ROR = 1273.21; 95% CI: 465.82–3480.02), sevoflurane (n = 111, ROR = 887.24; 95% CI: 715.31–1100.49), methohexital (n = 4, ROR = 715.20; 95% CI: 264.09–1936.83), remifentanil (n = 49, ROR = 584.70; 95% CI: 433.77–788.15), rocuronium (n = 86, ROR = 553.14; 95% CI: 436.93–700.25), desflurane (n = 15, ROR = 524.97; 95% CI: 312.45–882.04), isoflurane (n = 15, ROR = 473.59; 95% CI: 281.99–795.36), propofol (n = 171, ROR = 460.29; 95% CI: 380.80–556.37), and succinylcholine (n = 20, ROR = 287.47; 95% CI: 183.27–450.91). In our results, only midazolam (n = 57, ROR = 120.62; 95% CI: 91.37–159.25) and remifentanil (n = 49, ROR = 584.70; 95% CI: 433.77–788.15) were mentioned in FDA labeling as associated with delayed recovery, while the others were not. Conclusions: This pharmacovigilance analysis identified multiple agents with strong associations with DRA. Most lacked corresponding warnings in official drug labeling, underscoring the need for improved risk communication.