AGE AND GENDER HETEROGENEITY IN ADVERSE DRUG REACTIONS ASSOCIATED WITH HEMP USE: EVIDENCE FROM THE FDA PHARMACOVIGILANCE DATA IN THE LAST TWO DECADES
Author(s)
Chengwen Teng, MS, RPh, PharmD, PhD1, Jun Wu, PhD2, Jing Yuan, BSc, PhD3, Z. Kevin Lu, PhD4;
1University of South Carolina, Assistant Professor, Irmo, SC, USA, 2Nova Southeastern University College of Pharmacy, Fort Lauderdale, FL, USA, 3Fudan University, Shanghai, China, 4University of South Carolina, Columbia, SC, USA
1University of South Carolina, Assistant Professor, Irmo, SC, USA, 2Nova Southeastern University College of Pharmacy, Fort Lauderdale, FL, USA, 3Fudan University, Shanghai, China, 4University of South Carolina, Columbia, SC, USA
OBJECTIVES: Hemp-derived products, particularly cannabidiol (CBD), are increasingly consumed for medical and wellness purposes following legalization and commercialization. Despite their popularity, systematic safety data are sparse, and little is known about how adverse drug reactions (ADRs) differ across demographic groups. We aimed to identify the most common ADRs 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 January 1, 2004, to June 30, 2025. Hemp-related cases were identified using search terms including “hemp” and “CBD.” We conducted disproportionality analyses to estimate reporting odds ratios (RORs) with 95% confidence intervals (CIs) for hemp-associated ADRs compared with all other products in FAERS. Subgroup analyses examined differences by age (<65 vs. ≥65 years) and by gender.
RESULTS: Of 19,345,024 FAERS reports, 1,712 involved hemp products. The 20 most frequently reported ADRs included fatigue (n=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, 4.26-6.22), and depression (ROR 4.13, 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 ADRs except seizures, which were more strongly associated with men.
CONCLUSIONS: Hemp use is associated with a wide range of ADRs, including serious neurological and psychiatric events, with marked heterogeneity by age and gender.
METHODS: We analyzed adverse event reports submitted to the US Food and Drug Administration Adverse Event Reporting System (FAERS) from January 1, 2004, to June 30, 2025. Hemp-related cases were identified using search terms including “hemp” and “CBD.” We conducted disproportionality analyses to estimate reporting odds ratios (RORs) with 95% confidence intervals (CIs) for hemp-associated ADRs compared with all other products in FAERS. Subgroup analyses examined differences by age (<65 vs. ≥65 years) and by gender.
RESULTS: Of 19,345,024 FAERS reports, 1,712 involved hemp products. The 20 most frequently reported ADRs included fatigue (n=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, 4.26-6.22), and depression (ROR 4.13, 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 ADRs except seizures, which were more strongly associated with men.
CONCLUSIONS: Hemp use is associated with a wide range of ADRs, including serious neurological and psychiatric events, with marked heterogeneity by age and gender.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
EPH59
Topic
Epidemiology & Public Health
Topic Subcategory
Safety & Pharmacoepidemiology