{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T02:33:09Z","timestamp":1760149989850,"version":"build-2065373602"},"reference-count":55,"publisher":"MDPI AG","issue":"10","license":[{"start":{"date-parts":[[2023,10,5]],"date-time":"2023-10-05T00:00:00Z","timestamp":1696464000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>Cannabidiol is the first cannabis-derived drug approved for the treatment of Lennox\u2013Gastaut syndrome, Dravet syndrome, and Tuberous Sclerosis Complex. In the current study, we performed a descriptive analysis followed by a disproportionality analysis of potential adverse events caused by CBD extracted from the VigiBase\u00ae database. Furthermore, the biological plausibility of the association between CBD and the serotonin 5-HT1A receptor as a possible cause of adverse events was analyzed and discussed. Data were extracted from the VigiBase\u00ae database using the VigiLyze\u00ae signal detection and signal management tool. Adverse events in VigiBase\u00ae reports were coded using MedDRA, version 19 of Preferred Terms (PTs). Data were uploaded into SPSS software and analyzed via a disproportionality analysis. Statistically significant disproportionality signals for CBD were found for \u201cweight decreased\u201d (5.19 (95% CI: 4.54\u20135.70)), \u201chypophagia\u201d (3.68 (95% CI: 3.22\u20135.27)), and \u201cinsomnia\u201d (1.6 (95% CI: 1.40\u20131.83)). Positive IC025 values were found for \u201cweight decreased\u201d (2.2), \u201chypophagia\u201d (1.3), and \u201cinsomnia\u201d (0.5), indicating a surplus of reported cases. CBD\u2019s interactions with 5-HT1A serotonin receptors may offer a potential biological explanation for the occurrence of insomnia in patients. It is noteworthy that the risk profiles mentioned in the information for prescribing CBD as an antiepileptic agent by regulatory agencies showed disparities specifically related to the adverse event \u201cinsomnia\u201d.<\/jats:p>","DOI":"10.3390\/ph16101420","type":"journal-article","created":{"date-parts":[[2023,10,6]],"date-time":"2023-10-06T01:07:13Z","timestamp":1696554433000},"page":"1420","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Pharmacological Evaluation of Signals of Disproportionality Reporting Related to Adverse Reactions to Antiepileptic Cannabidiol in VigiBase"],"prefix":"10.3390","volume":"16","author":[{"given":"Fabrizio","family":"Calapai","sequence":"first","affiliation":[{"name":"Department of Chemical, Biological, Pharmaceutical and Environmental Sciences, University of Messina, 98125 Messina, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carmen","family":"Mannucci","sequence":"additional","affiliation":[{"name":"Department of Biomedical and Dental Sciences and Morphological and Functional Imaging, University of Messina, 98125 Messina, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Liana","family":"McQuain","sequence":"additional","affiliation":[{"name":"Universit\u00e9 de Bordeaux, European Training Programme in Pharmacovigilance and Pharmacoepidemiology (Eu2P), F-33000 Bordeaux, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3210-7171","authenticated-orcid":false,"given":"Francesco","family":"Salvo","sequence":"additional","affiliation":[{"name":"CHU de Bordeaux, Service de Pharmacologie M\u00e9dicale, Centre R\u00e9gional de Pharmacovigilance de Bordeaux, F-33000 Bordeaux, France"},{"name":"Universit\u00e9 de Bordeaux, INSERM, Bordeaux Population Health, U1219, AHeaD Team, F-33000 Bordeaux, France"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2023,10,5]]},"reference":[{"key":"ref_1","first-page":"103","article-title":"Molecular Targets of the Phytocannabinoids: A Complex Picture","volume":"103","author":"Morales","year":"2017","journal-title":"Prog. 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