This study represents the most comprehensive pharmacovigilance analysis of hemp-associated ADRs to date, examining over two decades of data from FAERS. Several important and novel findings emerged. Hemp was not only associated with gastrointestinal ADRs such as nausea and diarrhea, which have been described previously [3], but also with a broader range of neuropsychiatric and neurological outcomes. Particularly striking were the strong associations with anxiety, depression, insomnia, and especially seizures, which exhibited the highest ROR. These findings extend beyond what has been reported in clinical trials of CBD, which are often narrow in scope and underpowered to capture rare or serious events [9]. By reframing hemp as a substance with clinically meaningful adverse risks, our study challenges the prevailing perception that products that come from hemp are uniformly safe. The term “hemp” or “hemp-derived products” does not indicate the actual ingredients in these types of products, and it is likely the case that such products can contain various types of cannabinoids, whether natural or semi-synthetic, including tetrahydrocannabinol and other psychoactive cannabinoids. Therefore, it would be expected that these types of products would be associated with such ADRs.

An innovative contribution of this work is the explicit assessment of heterogeneity by age and gender, an area that has been largely neglected in cannabis research. We found that older adults more often involved physical vulnerabilities (e.g., falls, dizziness, appetite loss), while younger adults showed higher rates of neuropsychiatric outcomes including anxiety, depression, insomnia, and seizures. These findings align with the broader pharmacological literature showing that aging populations are more susceptible to drug-related harms because of polypharmacy, comorbidities, and altered drug metabolism [16, 17], while younger adults are more prone to psychiatric complications associated with cannabis exposure [26]. The observed gender differences were equally striking. Women showed increased reporting of nearly all ADRs, aligning with prior findings that female individuals are generally more susceptible to drug-related adverse effects [12, 13]. By contrast, male patients showed a uniquely elevated risk for seizures, which may reflect gender-related differences in neurophysiology and cannabinoid pharmacodynamics [27]. Together, these observations indicate that hemp use cannot be understood in isolation from the demographic context and highlight the importance of incorporating gender- and age-stratified analyses in future safety evaluations.

The implications of these findings extend beyond individual patient care to broader public health and policy. Clinicians must be aware that hemp, despite its marketing as a benign “wellness” product, carries risks that disproportionately affect certain groups, and that the moniker “hemp” is somewhat meaningless because in many cases, the actual ingredients and their amounts are unknown or falsely labeled. Screening for hemp use should be integrated into routine practice, and age- and gender-specific risks should inform clinical counseling. At the population level, public health practitioners must recognize that the harms of hemp are unlikely to be evenly distributed, with older adults and women at a higher risk for a wide spectrum of ADRs and men at a particular risk for seizures. Such disparities have implications for health equity, as vulnerable groups may face a disproportionate burden of preventable morbidity [28]. Without targeted interventions, legalization and commercialization could amplify inequities rather than reduce them.

From a policy perspective, these findings arrive at a pivotal time as countries around the world move toward the legalization of hemp and cannabis products. The public health consequences of these policy changes are not confined to the USA, where FAERS data are collected, but are globally relevant. Patterns of legalization in Canada, Europe, and Latin America suggest that consumer exposure will continue to grow, making it essential to anticipate potential harms. Regulatory oversight must therefore extend beyond ensuring product availability to protecting population health. This includes mandating accurate labeling and dosing, strengthening AE reporting mechanisms, and integrating demographic-specific warnings on hemp products, akin to gender- and age-specific labeling already applied to pharmaceuticals [4]. Public health messaging should avoid oversimplified portrayals of hemp as safe for all users; instead, campaigns must emphasize that risks vary by demographic characteristics. Canada has a very robust federal cannabis pharmacovigilance program [29–31].

This study is not without limitations. As a spontaneous reporting system, FAERS is subject to reporting biases, underreporting, and differential reporting by gender and age. The lack of denominator data precludes incidence estimates, and causality cannot be established from disproportionality analyses [32]. Key exposure details such as dosage, formulation, duration of use, and concomitant use of other substances are often missing, limiting the ability to assess dose–response or interaction effects. In addition, ADRs may reflect underlying conditions for which hemp was used, complicating causal interpretation. Reports are also disproportionately submitted by healthcare-engaged populations in the USA, limiting global generalizability. Nevertheless, FAERS provides unparalleled breadth and temporal coverage, allowing the detection of rare ADRs and systematic exploration of demographic heterogeneity. These strengths make pharmacovigilance data an essential complement to clinical trials and observational cohorts.

Future research should build on these findings by pursuing three directions. First, prospective population-based studies are needed to quantify incidence and establish causality, particularly in high-risk groups such as older adults and women. In addition, seizure in male individuals is highly concerning and should be investigated further. Second, mechanistic research is required to elucidate biological pathways underlying gender- and age-specific vulnerabilities, including hormonal, pharmacokinetic, and neurophysiological factors. Third, improved international pharmacovigilance systems with harmonized reporting standards would facilitate cross-country comparisons and help evaluate the impact of global legalization trends. Ensuring robust product standards, including reliable information on the label about ingredients and formulations and concentration/amount of cannabinoids would be key to understand causality. Together, these efforts can close the current evidence gap and provide the robust demographic-specific data needed to inform safer clinical practice, regulatory oversight, and equitable public health policy.