Pharmacovigilance and toxicological studies on safety signals associated with the combined use of propofol and midazolam
Year: 2026
Type: article
Study design: Observational Study
Abstract: BACKGROUND: Propofol and midazolam are widely used in sedation and general anesthesia, but there has been a lack of systematic research on safety signals caused by the combination medication. METHODS: We collected data on drug safety signals related to propofol and midazolam from the FAERS database (2004Q1-2025Q1). Disproportionality analysis, Time-to-event, and Weibull distribution are performed for signal monitoring and risk assessment. We further analyze the potential mechanism of allergic reactions caused by the combination medication. RESULTS: A strong signal for Propofol Infusion Syndrome (PRIS) was detected with propofol alone (ROR: 4514.44, 95% CI: 3851.09–5292.06), whereas no risk reduction was observed with combination medication (ROR: 2219.2, 95% CI: 1753.85–2808.03). Anaphylactic Shock (ROR: 39.45, 95% CI: 30.49–51.04) had high signal values. Time-to-event onset analysis in the combination therapy group showed that the most common onset time for safety signals was 3–7 days (46.3%). The Scale Parameter α was the smallest in the combination medication group (6.37, 95% CI: 5.48–7.26). Further research is needed to determine whether the PI3K-Akt signaling pathway represents a potential mechanism underlying anaphylactic reactions induced by the combination medication. CONCLUSIONS: Early monitoring should be performed when propofol and midazolam are used in combination. At the same time, the occurrence of anaphylactic reactions should be taken seriously when combining medications.
Source: BMC Anesthesiology
Language: English
Subfield: Toxicology
Domain: Life Sciences
Open Access status: gold
Estimated APC paid: $3,190
OpenAlex ID: W7155105773