Global pharmacovigilance overview of adverse drug reactions associated with propofol: A descriptive pharmacovigilance study using WHO-VigiAccess data.

Propofol is an intravenous anesthetic widely used for induction and maintenance of anesthesia and sedation. Despite its well-established efficacy and routine clinical use, multiple reports have described adverse reactions ranging from mild events to life-threatening complications. Pharmacovigilance databases provide valuable insight into such real-world experiences. This study provides an updated global overview of adverse drug reactions (ADRs) associated with propofol using data from the World Health Organization (WHO) VigiAccess platform. A retrospective descriptive study was performed using publicly available data from the WHO-VigiAccess database, retrieved on October 26,2025, covering all spontaneous reports available from the inception of WHO pharmacovigilance reporting through the search date. ADRs were summarized according to the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class and analyzed by geographical region, sex, and age group. No individual case review, disproportionality analysis, or causality assessment was performed. VigiAccess listed 45 354 ADR reports for propofol. Of the 45,354 ADR reports, skin and subcutaneous tissue disorders (12%), vascular disorders (12%), general disorders and administration site conditions (11%), nervous system disorders (9%), respiratory disorders (9%), immune disorders (8%), and cardiac disorders (8%) were most frequently reported. Europe and the Americas accounted for the largest proportion of reports. Male patients represented a slightly higher proportion than females, and adults aged 45 to 64 years constituted the most frequently reported age group. Temporal analysis revealed a continuous increase in reporting over the past 2 decades. This descriptive pharmacovigilance overview highlights the broad spectrum of spontaneously reported ADRs associated with propofol and emphasizes the importance of continued pharmacovigilance and post-marketing safety monitoring.