ArticleJournal of cannabis research2025
Trends in cannabis adverse reaction reports: A descriptive analysis of spontaneous reporting data submitted to the Canada Vigilance Program since legalization and regulation of cannabis for non-medical purposes in Canada.
Article in Journal of cannabis research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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Who cites it
4 citing papers in PubMed.
- International Policy Approaches for Higher THC Cannabis Products: Are They Applicable to the Australian Medicinal Cannabis Framework?Drug and alcohol review · 2026Review
- Age and Gender Heterogeneity in Adverse Drug Reactions Associated with Hemp Use: Evidence from the FDA Pharmacovigilance Data in the Last Two Decades.Drugs - real world outcomes · 2026Article
- Pharmacovigilance in medical cannabis therapy among physicians in Poland: pharmacovigilance knowledge, ADR reporting practice and cannabis-related safety reporting.Frontiers in public health · 2026Article
- Cannabis Use Disorder in the Era of Legalization: Implications for Addiction Treatment Systems.Substance abuse and rehabilitation · 2026Review
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe cannabis control framework implemented by Canada in October 2018 established a robust post-market surveillance system for cannabis products, adopting tools and practices from the existing pharmacovigilance system for pharmaceuticals and health products. The cannabis vigilance system relies on spontaneous reporting of adverse reactions, allowing Health Canada to collect, monitor and assess health effects involving cannabis. In this study, we examine trends in adverse reaction reports involving legal cannabis products since legalization and regulation in Canada.
methodsUnique case reports of adverse reactions involving cannabis were collected through the Canada Vigilance Program. Case details were extracted from each report involving legal cannabis as a suspected product. Each case was also assessed for causality to determine the likelihood of association between the cannabis product(s) and the reported event(s). The case data was then aggregated and descriptively analyzed to identify adverse reaction case patterns, including the demographic profiles and use patterns of individuals reporting adverse reactions to cannabis.
resultsOverall, individuals reporting an adverse reaction to a cannabis product (n = 698) were 56.0 ± 20.0 years of age. 45.4% of reporting individuals were female, and 67.5% of individuals self-reported using cannabis for medical purposes, with pain management as the most cited reason for medical use. Most cases were reported as serious (62.3%), citing "other medically important condition" as the primary reason for seriousness (58.6%), and 68.8% of all cases involved cannabis extracts. Frequently reported events included hallucination, headache, nausea, dizziness and dyspnea. Some events were more frequently reported with products containing a greater concentration of tetrahydrocannabinol to cannabidiol, whereas others were more frequently reported with products containing a greater concentration of cannabidiol to tetrahydrocannabinol. Causality was assessed for 668 events; most were assessed as being "possibly" associated with the reported cannabis product.
conclusionsThe post-market adverse reaction reporting system for cannabis products has provided valuable safety information about cannabis products available for legal retail sale in Canada. The data collected through this framework have helped identify emerging risks associated with legal cannabis products; contributed to international data about cannabis effects and risks; informed the development of communication materials related to new and emerging risks; and provided evidence to inform regulatory decisions.
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