Cannabis and Cannabinoid-Related Suspected Adverse Drug Reactions: Global Patterns and Cross-National Analysis Based on VigiBase® Data

BACKGROUND AND OBJECTIVES: Despite increasing global use of cannabis and cannabinoids, comprehensive data on their safety profile remain limited. This study aimed to examine global patterns in pharmacovigilance reports associated with cannabis and cannabinoids, irrespective of regulatory status or context of use. METHODS: , the World Health Organisation's global database of individual case safety reports (ICSRs), was analysed in a retrospective cross-sectional study from 1 January 2020 to 31 December 2024 (data extraction: 19 February 2025). "Cannabis ICSRs" included at least one mention of Cannabis sativa or cannabinoids. Temporal and geographical distributions, reported substances, and suspected adverse drug reactions (ADRs) were assessed. A single ICSR may include multiple substance mentions and several suspected ADRs. RESULTS: Among 7,007,689 records, 9983 cannabis ICSRs were identified across 44 countries, comprising 12,538 cannabis or cannabinoid mentions and 27,593 suspected ADRs. The median age was 29 years, with 62.7% males. Most cases were serious (68.5%), including hospitalisation (45.9%) and death (28.6%). The highest reporting rates relative to national ICSR numbers were observed in France, Greece, and the USA. The most frequently reported substances were Cannabis sativa (n = 5951) and cannabidiol (n = 2967). Suspected ADRs were predominantly psychiatric (29.2%) and nervous system disorders (16.8%), with gastrointestinal, respiratory, and cardiac disorders less common (6.4%, 3.6%, and 2.8%). CONCLUSIONS: This study provides the first comprehensive global overview of suspected ADRs associated with cannabis and cannabinoids. The predominance of serious cases, particularly psychiatric and nervous system reactions, highlights important safety considerations, offering key insights to inform clinical practice and risk assessment worldwide.