Cited by 559Cannabis and Cannabinoid ResearchPhytochemistry Medicinal Plant ApplicationsForensic Toxicology and Drug Analysis

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Safety and Side Effects of Cannabidiol, a Cannabis sativa Constituent

Machado Bergamaschi, Mateus, Helena Costa Queiroz, Regina, Waldo Zuardi, Antonio, Alexandre S. Crippa, Jose·2011·Current Drug Safety

DOI 10.2174/157488611798280924

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Abstract

Cannabidiol (CBD), a major nonpsychotropic constituent of Cannabis, has multiple pharmacological actions, including anxiolytic, antipsychotic, antiemetic and anti-inflammatory properties. However, little is known about its safety and side effect profile in animals and humans. This review describes in vivo and in vitro reports of CBD administration across a wide range of concentrations, based on reports retrieved from Web of Science, Scielo and Medline. The keywords searched were "cannabinoids", "cannabidiol" and "side effects". Several studies suggest that CBD is non-toxic in non-transformed cells and does not induce changes on food intake, does not induce catalepsy, does not affect physiological parameters (heart rate, blood pressure and body temperature), does not affect gastrointestinal transit and does not alter psychomotor or psychological functions. Also, chronic use and high doses up to 1,500 mg/day of CBD are reportedly well tolerated in humans. Conversely, some studies reported that this cannabinoid can induce some side effects, including inhibition of hepatic drug metabolism, alterations of in vitro cell viability, decreased fertilization capacity, and decreased activities of p-glycoprotein and other drug transporters. Based on recent advances in cannabinoid administration in humans, controlled CBD may be safe in humans and animals. However, further studies are needed to clarify these reported in vitro and in vivo side effects.

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Background
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BackgroundInfluential
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“Compared to other known cannabinoids, CBD exhibits superior antipsychotic efficiency and is associated with limited side effects and low toxicity in humans and animals (Bergamaschi et al., 2011).”
Background
A Warning against the Negligent Use of Cannabidiol in Professional and Amateur Athletes
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“119 In addition, the therapeutic potential of CBD has been evaluated in diabetes and its complications, acute and chronic pain, cardiovascular disease, cancer, and epilepsy, 120 which are usually accompanied by oxidative stress and inflammation.”
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“Levin et al., 2014 Acute administration of AM 404 (1, 5, or 10 mg/kg) does not alter the PPI of SHRs or Wistar rats.”
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“, THC), as exemplified by the tolerance of high doses up to 1500 mg/day in humans, and no changes in heart rate, blood pressure, and body temperature after CBD intake in humans and rodents [2,6].”
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“It has a low adverse effect profile, including when chronically used [22].”
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“Both CPA and cannabinoids are processed by similar enzymes in the liver [50,51], which may alter drug excretion.”
Background
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Astray, G., Mejuto, J. C., Xiao, J., & Simal‐Gándara, J. (2022) · Critical Reviews in Food Science and Nutrition · doi:10.1080/10408398.2021.2024493 · Cited by 30
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“CBD is a promising candidate since as far as known it does not promote side effects and it is well tolerated (Bergamaschi et al., 2011).”
Background
Enhancing Endocannabinoid Control of Stress with Cannabidiol
Henson, J. D., Vitetta, L., Quezada, M., & Hall, S. (2021) · Journal of Clinical Medicine · doi:10.3390/jcm10245852 · Cited by 32
“The first study used the Simulation Public Speaking Test in individuals diagnosed with SAD, to show that a 400–600 mg single dose of CBD significantly reduced subjective symptoms of anxiety, cognitive impairment, and performance discomfort, relative to the placebo group [77,101].”
BackgroundMethod
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O’Reilly, E., Khalifa, K., Cosgrave, J. M., Azam, H., Prencipe, M., Simpson, J. C., Gallagher, W. M., & Perry, A. S. (2023) · Journal of Natural Products · doi:10.1021/acs.jnatprod.3c00363 · Cited by 26
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“, 2015), and accumulating evidence indicates that CBD has a number of medical benefits, including antipsychotic and anxiolytic effects (Bergamaschi et al., 2011; Martin-Santos et al., 2012; Morgan and Curran, 2008), thereby possibly counteracting psychotic symptoms and cognitive impairment associated with cannabis and…”
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“However, concomitant medication use and drugs-of-abuse tests were not reported in several papers (Bergamaschi et al., 2011b; Crippa et al., 2004, 2011, 2021; Crockett et al., 2020; Hosseini et al., 2020; Izgelov et al., 2020a; Knaub et al., 2019; Linares et al., 2019; Patrician et al., 2019;…”
BackgroundResultInfluential
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“Despite these potential side effects, research has indicated that controlled administration of CBD in humans and animals is generally safe [63].”
Background
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Genetic advances, biochemical and clinical features and critical approach to treatment of patients with X-linked hypophosphatemic rickets.
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“In this context, one promising avenue of research has been the discovery of THC and CBD as anticancer agents.”
BackgroundInfluential
SCN1A-Related Seizure Disorders
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“This cannabinoid has shown a favorable safety profile in humans (15).”
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“Given the lack of data, an upper permissible dose cannot be defined and CBD doses up to 50 mg/kg were found to be safe (8, 28).”
Background
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“Humans can tolerate high dose of CBD [89].”
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“Bergamaschi et al [18] reviewed in vivo and in vitro reports on CBD administration across a wide range of concentrations, based on reports retrieved from the Web of Science, SciELO, and Medline.”
Background
A Palmitoylethanolamide Producing Lactobacillus paracasei Improves Clostridium difficile Toxin A-Induced Colitis
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“58–60 In a prospective cohort study of 131 chronic pain patients, 97 patients completed an 8-week course of 15 mg CBD soft gels.”
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Novel biotherapies are needed in youth mental health
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Medicinal plants and plant-based traditional medicine: Alternative treatments for depression and their potential mechanisms of action
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Influence of short-term chronic oral cannabidiol application on muscle recovery and performance after an intensive training protocol - a randomized double-blind crossover study
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“Therefore, psycho-tropic effects are absent even at very high doses [11,14].”
Background
Cannabinoids as Antibacterial Agents: A Systematic and Critical Review of In Vitro Efficacy Against Streptococcus and Staphylococcus
Niyangoda, D., Aung, M. L., Qader, M., Tesfaye, W. H., Bushell, M., Chiong, F. J. K., Tsai, D., Ahmad, D., Samarawickrema, I., Sinnollareddy, M., et al. (2024) · Antibiotics · doi:10.3390/antibiotics13111023 · Cited by 24
“Chronic CBD administration in humans up to 1500 mg/day was well tolerated [98,99].”
Cannabinoid treats as adjunctive therapy for pets: gaps in our knowledge
Greb, A. C., & Puschner, B. (2018) · Toxicology Communications · doi:10.1080/24734306.2018.1434470 · Cited by 19
“While CBD may have attractive therapeutic properties such as anti-emetic, analgesic, anti-inflammatory and immunosuppressant effects [24], long-term cannabis use has deleterious immune and cognitive effects in humans, including visual processing and executive functioning [33].”
Background
Determination of cannabinoids in hair of CBD rich extracts consumers using gas chromatography with tandem mass spectrometry (GC/MS–MS)
Rodrigues, A., Yegles, M., Elsué, N. V., & Schneider, S. (2018) · Forensic Science International · doi:10.1016/j.forsciint.2018.09.015 · Cited by 19
Herbal medicines and phytochemicals for obsessive–compulsive disorder
Ayati, Z., Sarris, J. J., Chang, D., Emami, S. A., & Rahimi, R. (2020) · Phytotherapy Research · doi:10.1002/ptr.6656 · Cited by 19
Medical Cannabis in Oncology: a Valuable Unappreciated Remedy or an Undesirable Risk?
Abu-Amna, M., Salti, T., Khoury, M., Cohen, I., & Bar‐Sela, G. (2021) · Current Treatment Options in Oncology · doi:10.1007/s11864-020-00811-2 · Cited by 20
The Potential Role of Cannabidiol in Cosmetic Dermatology: A Literature Review
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Potential therapeutic targets and the role of technology in developing novel cannabinoid drugs from cyanobacteria
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Oral lipid-based formulations alter delivery of cannabidiol to different anatomical regions in the brain
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Subchronic oral toxicity assessment of a cannabis extract
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Therapeutic potentials of cannabidiol: Focus on the Nrf2 signaling pathway
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Ethical Implications for Providers Regarding Cannabis Use in Children With Autism Spectrum Disorders
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Development of cannabidiol as a treatment for severe childhood epilepsies
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Cannabidiol preferentially binds TRPV2: a novel mechanism of action
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“In any case, very high doses of CBD (up to 1500 mg/d) are safe and welltolerated both in animals and humans (Bergamaschi et al., 2011).”
BackgroundInfluential
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Effects of Cannabidiol on Parkinson’s Disease in a Transgenic Mouse Model by Gut-Brain Metabolic Analysis
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“Some studies reported that CBD could inhibit hepatic drug metabolism, alter in vitro cell viability, and decrease fertilization capacity, which all remain further clarified [23].”
Background
Does acute cannabidiol (CBD) use impair performance? A meta-analysis and comparison with placebo and delta-9-tetrahydrocannabinol (THC)
Lo, L. A., Christiansen, A. L., Strickland, J. C., Pistawka, C. A., Eadie, L., Vandrey, R. G., & MacCallum, C. A. (2024) · Neuropsychopharmacology · doi:10.1038/s41386-024-01847-w · Cited by 22
Potential of CBD Acting on Cannabinoid Receptors CB1 and CB2 in Ischemic Stroke
Raïch, I., Lillo, J., Rivas‐Santisteban, R., Rebassa, J. B., Capó, T., Santandreu, M., Cubeles-Juberias, E., Reyes‐Resina, I., & Navarro, G. (2024) · International Journal of Molecular Sciences · doi:10.3390/ijms25126708 · Cited by 18
“While CBD seems to be safe for both and animals [112,113], adverse effects have been documented when it was administered at relatively high doses (up to 50 mg kg − 1 d The prevailing occurrences (observed in >10% of patients receiving CBD treatment) included somnolence, diarrhea, diminished…”
Background
Screening Medications for the Treatment of Cannabis Use Disorder
Panlilio, L. V., Justinová, Z., Trigo, J. M., & Foll, B. L. (2016) · International review of neurobiology · doi:10.1016/bs.irn.2016.02.005 · Cited by 18
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Systematic literature review of human studies assessing the efficacy of cannabidiol for social anxiety
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Interaction Between the Cannabinoid and Vanilloid Systems on Anxiety in Male Rats
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Cannabinoid disposition in oral fluid after controlled vaporizer administration with and without alcohol
Hartman, R. L., Anizan, S., Jang, M., Brown, T. L., Yun, K., Gorelick, D. A., Milavetz, G., Spurgin, A. L., Gaffney, G., & Huestis, M. A. (2015) · Forensic Toxicology · doi:10.1007/s11419-015-0269-6 · Cited by 16
“CBD potency in particular may become more variable as medical and recreational cannabis decriminalization increase, because of its other pharmacological properties (antiemetic, antipsychotic, anti-inflammatory, antiepileptic) [40–42].”
BackgroundInfluential
Does cannabidiol reduce severe behavioural problems in children with intellectual disability? Study protocol for a pilot single-site phase I/II randomised placebo controlled trial
Efron, D., Taylor, K., Payne, J. M., Freeman, J. L., Cranswick, N., Mulraney, M., Prakash, C., Lee, K. J., & Williams, K. J. (2020) · BMJ Open · doi:10.1136/bmjopen-2019-034362 · Cited by 18
“Light cannabis” consumption in a sample of young adults: Preliminary pharmacokinetic data and psychomotor impairment evaluation
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Cannabis, Cannabinoids, and Cerebral Metabolism: Potential Applications in Stroke and Disorders of the Central Nervous System
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Cannabidiol: a potential treatment for post Ebola syndrome?
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“A small number of people who take anti-seizure drugs for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems (Bergamaschi et al. 2011).”
Background
The effects of pelleted cannabidiol supplementation on heart rate and reaction scores in horses
Draeger, A. L., Thomas, E. P., Jones, K. A., Davis, A. J., & Porr, C. A. S. (2021) · Journal of Veterinary Behavior · doi:10.1016/j.jveb.2021.09.003 · Cited by 19
Exotic ancient plant introductions: part of Indian ‘Ayurveda’ medicinal system
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“Additionally, it contains cannabidiol (Grlie, 1976), which has multiple pharmacological actions, including anxiolytic, antipsychotic, antiemetic and anti-inflammatory (Bergamaschi et al., 2011).”
Background
Cannabinoid concentrations in Canada's regulated medical cannabis industry
Mammen, G., de Freitas, L., Rehm, J. T., & Rueda, S. (2017) · Addiction · doi:10.1111/add.13738 · Cited by 16
Targeting the Endocannabinoid System in Borderline Personality Disorder: Corticolimbic and Hypothalamic Perspectives
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The Use of Cannabidiol in Metabolic Syndrome—An Opportunity to Improve the Patient’s Health or Much Ado about Nothing?
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“In contrast to ∆9-THC, administration of CBD in a wide range of doses by various routes does not cause serious side effects or toxicity in humans [5], therefore it has the potential to be a safe drug for many disorders.”
Background
A narrative review of the therapeutic and remedial prospects of cannabidiol with emphasis on neurological and neuropsychiatric disorders
Omotayo, O. P., Lemmer, Y., & Mason, S. (2024) · Journal of Cannabis Research · doi:10.1186/s42238-024-00222-2 · Cited by 21
Cannabidiol and its application in the treatment of oral diseases: therapeutic potentials, routes of administration and prospects
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Exploring the safety of cannabidiol (CBD): A comprehensive in vitro evaluation of the genotoxic and mutagenic potential of a CBD isolate and extract from Cannabis sativa L
Štern, A., Novak, M., Kološa, K., Trontelj, J., Žabkar, S., Šentjurc, T., Filipič, M., & Žegura, B. (2024) · Biomedicine & Pharmacotherapy · doi:10.1016/j.biopha.2024.116969 · Cited by 15

Authors: Machado Bergamaschi, M., Helena Costa Queiroz, R., Waldo Zuardi, A., & Alexandre S. Crippa, J.
Venue: Current Drug Safety
Publisher: Bentham Science Publishers Ltd.
Published: 2011-09-01
Volume: 6
Issue: 4
Pages: 237-249
ISSN: 1574-8863 (ISSN-L)
DOI: 10.2174/157488611798280924
OpenAlex: W2128076336
Cited by: 558
References: 122
Citations by year: 2026: 17 · 2025: 39 · 2024: 47 · 2023: 58 · 2022: 51 · 2021: 67 · 2020: 84 · 2019: 48 · 2018: 37 · 2017: 37 · 2016: 23 · 2015: 18 · 2014: 11 · 2013: 9 · 2012: 11
FWCI: 7.23
Type: journal article
Language: en
Open access: closed
Locations: Current Drug Safety (publishedVersion)
PubMed (publishedVersion)
Funders: Fundação de Amparo à Pesquisa do Estado de São Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Topics: Health Sciences › Medicine › Pharmacology (medical) › Cannabis and Cannabinoid Research
Life Sciences › Agricultural and Biological Sciences › Plant Science › Phytochemistry Medicinal Plant Applications
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Forensic Toxicology and Drug Analysis
Keywords: cannabidiol, Cannabis sativa, drug safety, adverse effects, toxicity, hepatotoxicity, drug metabolism inhibition, P-glycoprotein, fertility, cell viability, tolerability
MeSH terms: Animals, Anti-Inflammatory Agents, Antiemetics, Cannabidiol, Cannabis, Cell Survival, Eating, Humans, Antipsychotic Agents, Anti-Anxiety Agents

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Safety and Side Effects of Cannabidiol, a Cannabis sativa Constituent

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