Global safety data reveals serious psychiatric risks from cannabis use

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

CNS drugs • • Moderately Relevant
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AI Summary

This groundbreaking World Health Organisation study analyzed nearly 10,000 safety reports from 44 countries involving cannabis and cannabinoids, revealing critical patterns in adverse drug reactions. The research examined real-world reports from VigiBase®, the WHO's global pharmacovigilance database, covering cases from 2020 to 2024. The findings paint a sobering picture: 68.5% of reported cases were serious, with 45.9% requiring hospitalization and 28.6% resulting in death. The typical affected individual was around 29 years old and predominantly male (62.7%), highlighting that adverse reactions span across cannabis users globally regardless of whether products were obtained legally or illicitly.

The most striking finding concerns the types of adverse reactions reported. Psychiatric disorders dominated at 29.2% of all suspected adverse drug reactions, followed closely by nervous system disorders at 16.8%. These mental health and neurological complications vastly outnumbered other serious conditions like cardiac problems (2.8%), respiratory issues (3.6%), and gastrointestinal problems (6.4%). Cannabidiol (CBD) and Cannabis sativa products were the most frequently reported substances, challenging the common perception that CBD is risk-free. France, Greece, and the USA reported the highest rates relative to their national surveillance data, suggesting either higher use rates or better reporting infrastructure in these countries.

This comprehensive safety analysis underscores an important public health message: while cannabis use continues expanding globally, our understanding of its potential psychiatric and neurological risks remains incomplete. The predominance of serious, hospitalization-requiring cases—not minor side effects—suggests that vulnerable populations may face significant health risks that warrant medical attention. Healthcare providers and policymakers now have concrete global data to inform counseling about cannabis safety, particularly regarding mental health consequences, challenging the assumption that cannabis is universally safe or that CBD products are risk-free alternatives.

📄 Original Abstract

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. VigiBase®, 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. 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%). 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.

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