Serious adverse effects of cannabidiol (CBD): a review of randomized controlled trials

• Published in: Expert opinion on drug metabolism & toxicology Vol. 16; no. 6; p. 517
• Main Authors: Dos Santos, Rafael G, Guimarães, Francisco S, Crippa, José Alexandre S, Hallak, Jaime E C, Rossi, Giordano Novak, Rocha, Juliana Mendes, Zuardi, Antônio W
• Format: Journal Article
• Language: English
• Published: England 02.06.2020
• Subjects: Administration, Oral; Anticonvulsants - administration & dosage; Anticonvulsants - adverse effects; Cannabidiol - administration & dosage; Cannabidiol - adverse effects; Drug Interactions; Drug Therapy, Combination; Epilepsy - drug therapy; Epilepsy - physiopathology; Humans; Randomized Controlled Trials as Topic; cannabidiol; Cannabinoids; serious adverse effects; safety
• ISSN: 1744-7607
• DOI: 10.1080/17425255.2020.1754793

Recent trials using cannabidiol (CBD) have shown that most acute and prolonged adverse effects of CBD are mild to moderate, with rare serious adverse effects (SAEs). This review focused on analyzing SAEs of CBD and their possible relation to drug-drug interactions. We systematically analyzed the SAEs reported in randomized controlled trials (RCTs) involving the administration of oral CBD for at least 1 week in both healthy volunteers and clinical samples. SAEs related to CBD in RCT are rare and include mainly elevated transaminases, convulsion, sedation, lethargy, and upper respiratory tract infections. Elevated transaminases are related to concomitant valproate use, while sedation, lethargy, and upper respiratory tract infections are related to concomitant clobazam use. Epileptic patients should be monitored when using CBD concomitantly with these and other antiepileptic drugs for other possible drug-drug interactions.