Age and Gender Heterogeneity in Adverse Drug Reactions Associated with Hemp Use: Evidence from the FDA Pharmacovigilance Data in the Last Two Decades

BACKGROUND: Hemp-derived products are increasingly used for medical and wellness purposes following legalization, yet systematic safety data remain limited. OBJECTIVE: We aimed to identify the most common adverse drug reactions associated with hemp use and to evaluate age- and gender-specific differences in risk. METHODS: We analyzed adverse event reports submitted to the US Food and Drug Administration Adverse Event Reporting System (FAERS) from 1 January, 2004 to 30 June, 2025. Reporting odds ratios (RORs) with 95% confidence intervals (CIs) for hemp-associated adverse drug reactions were calculated. RESULTS: Among 19,345,024 FAERS reports, 1712 involved hemp products. The most frequently reported adverse drug reactions included fatigue (180), nausea (152), diarrhea (138), headache (126), dizziness (119), pain (119), anxiety (115), dyspnea (86), arthralgia (82), vomiting (82), insomnia (79), depression (76), weight decreased (70), asthenia (68), feeling abnormal (68), fall (67), decreased appetite (60), pain in extremity (60), seizure (60), and somnolence (58). Seizures (ROR 6.76, 95% CI 5.22-8.75), anxiety (ROR 5.15, 95% CI 4.26-6.22), and depression (ROR 4.13, 95% CI 3.28-5.19) were most strongly associated with hemp. Older adults exhibited higher RORs for diarrhea, dizziness, arthralgia, asthenia, fall, decreased appetite, and pain in extremity, whereas younger adults showed stronger associations with fatigue, nausea, headache, pain, anxiety, dyspnea, vomiting, insomnia, depression, weight decreased, feeling abnormal, seizure, and somnolence. Women demonstrated higher RORs across nearly all adverse drug reactions except seizures, which were more strongly associated with men. CONCLUSIONS: Use of hemp-derived products are associated with adverse drug reactions, including serious neurological and psychiatric events, with marked heterogeneity by age and gender.