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Safety and Side Effects of Cannabidiol, a Cannabis sativa Constituent
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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“Unlike THC, CBD does not produce psychotropic effects and this is probably because of its low affinity for CB1 receptors 55– 57.”
From Psychosocial and pharmacological interventions for the treatment of cannabis use disorder (2018) · cites this paper as [57]
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“According to comprehensive reviews, acute and chronic administration of CBD by various routes (oral, inhaled, intravenous) to healthy volunteers and patients with different clinical conditions did not induce significant adverse effects (50, 51), especially because a conversion of oral cannabidiol to THC seems not to occur in humans (52).”
From Translational investigation of the therapeutic potential of Cannabidiol (CBD): Toward a new age (2018) · cites this paper as [50]
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“This ability of CBD to modulate the endocannabinoid signalling pathway can explain why this compound may decrease the activity of CB1 receptors without inducing side effects [18,19].”
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Potential Adverse Drug Events with Tetrahydrocannabinol (THC) Due to Drug–Drug Interactions
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A Conversion of oral cannabidiol to delta9-tetrahydrocannabinol seems not to occur in humans
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“Although our list may still be incomplete, the conclusions of Bergamaschi et al.(20) have been confirmed by other recent reviews.”
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Kirkland, A. E., Fadus, M. C., Gruber, S. A., Gray, K. M., Wilens, T. E., & Squeglia, L. M. (2021) · Psychiatry Research · doi:10.1016/j.psychres.2021.114347 · Cited by 63
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“Indeed, CBD is a non-psychoactive compound with a better safety profile if compared with ∆9-THC: it seems to be well tolerated at high doses in both animal models and humans, it does not alter heart rate, blood pressure, or body temperature and has no effects on locomotor activity or superior cognitive functions [9].”
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Henson, J. D., Vitetta, L., & Hall, S. (2022) · Inflammopharmacology · doi:10.1007/s10787-022-01020-z · Cited by 62
“One placebo controlled study used the Simulation Public Speaking Test to induce anxiety in patients with social anxiety disorder (SAD) and found that a single dose of CBD (400–600 mg) significantly decreased symptoms of performance discomfort, anxiety and cognitive impairment (Bergamaschi et al. 2011; Crippa et al. 20…”
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New Targeted Treatments for Fragile X Syndrome
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“It has also been shown to be an inverse agonist of CB 2 receptors.(70,71) It has been tested extensively on animals and humans, and is just entering the clinical trial phase for cannabis use.”
Role of Cannabinoids in Gastrointestinal Mucosal Defense and Inflammation
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“toxicity [170], makes it a promising candidate for the treatment of IBD.”
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Cannabidiol (CBD) enhances lipopolysaccharide (LPS)-induced pulmonary inflammation in C57BL/6 mice
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“In another study, oral administration of 600 mg CBD (~9 mg/kg), CBD concentrations were 20 ng/ml at 2-h post-administration (Bhattacharyya et al., 2009).”
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“It must be also considered that CBD can inactivate or induce cytochrome P450 isozymes, depending on the drug regimen, which may lead to important drug interactions (Bergamaschi et al., 2011; Iffland and Grotenhermen, 2017).”
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“We might further adjust our perspective on the entourage effect through the observation that relatively low dose pure CBD is well tolerated and attended by little evidence of adverse outcomes [90].”
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The Impact of Cannabidiol on Psychiatric and Medical Conditions
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“Similar exacerbating effects are to be expected when CBD is no longer taken for depression or anxiety [12, 42].”
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“It has been reported that CBD possesses anxiolytic, antiinflammatory, anti-oxidative, and analgesic properties (Bergamaschi et al., 2011; Mechoulam&Hanus, 2002), as well as suggested that it improves sleep quality (Russo et al.”
BackgroundImmunomodulatory Potential of Cannabidiol in Multiple Sclerosis: a Systematic Review
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Potency and Therapeutic THC and CBD Ratios: U.S. Cannabis Markets Overshoot
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“, opioids or benzodiazepines), specifically referred to as pharmacodynamic drug–drug interactions [26,27].”
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“Importantly, CBD, even at high doses, has been shown to be well tolerated in humans [108].”
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In utero exposure to cannabidiol disrupts select early-life behaviors in a sex-specific manner
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“In particular, recent reviews and meta-analyses, concluded that evidence supporting clinical benefits of cannabis-based therapies in mood disorders is scarce, and limited to low-grade evidence supporting the beneficial effect of CBD in social anxiety (Bergamaschi et al., 2011) and of medical marijuana in PTSD (Walsh e…”
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“CBD presents no interaction with blood pressure or body temperature and no association with psychomotor psychological functions such as THC [111].”
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Is there a role for cannabidiol in psychiatry?
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“Bergamaschi et al. (2011b), in a systematic review of the safety and side effects of CBD, concluded that CBD is well tolerated and safe in humans at high doses and in the long term.”
InfluentialMarx, T. K., Reddeman, R. A., Clewell, A. E., Endres, J. R., Béres, E., Vértesi, A., Glávits, R., Hirka, G., & Szakonyiné, I. P. (2018) · Journal of Toxicology · doi:10.1155/2018/8143582 · Cited by 45
The growing trend of cannabidiol in skincare products
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Pharmacologic Effects of Cannabidiol on Acute Reperfused Myocardial Infarction in Rabbits
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Impact of enzymatic and alkaline hydrolysis on CBD concentration in urine
Bergamaschi, M. M., Barnes, A. J., Queiróz, R. H. C., Hurd, Y. L., & Huestis, M. A. (2013) · Analytical and Bioanalytical Chemistry · doi:10.1007/s00216-013-6837-x · Cited by 43
“Cannabidiol (CBD) is proposed as oral or oromucosal pharmacotherapy for diverse conditions including dementias, cerebral ischemia, diabetes, inflammatory diseases, nausea, and psychiatric disorders [1–3] over a wide dosage range [4].”
BackgroundAntitumorigenic targets of cannabinoids – current status and implications
Ramer, R., & Hinz, B. (2016) · Expert Opinion on Therapeutic Targets · doi:10.1080/14728222.2016.1177512 · Cited by 44
“profile when used chronically with even high doses up to 1500 mg/day being well tolerated.[187] In addition to this remarkable safety profile, a study by Ligresti et al.”
BackgroundRobinson, J. D., Cinciripini, P. M., Karam‐Hage, M., Aubin, H., Dale, L. C., NIAURA, R. S., Anthenelli, R. M., & the STRATUS Group (2017) · Addiction Biology · doi:10.1111/adb.12508 · Cited by 43
“For example, cannabidiol, a weak CB1 inverse agonist with demonstrated neuroprotective properties, including anxiolysis (Bergamaschi et al., 2011), has been found to reduce smoking (Morgan et al.”
BackgroundCannabidiol and substance use disorder: Dream or reality
Karimi‐Haghighi, S., Razavi, Y., Iezzi, D., Scheyer, A. F., Manzoni, O. J., & Haghparast, A. (2022) · Neuropharmacology · doi:10.1016/j.neuropharm.2022.108948 · Cited by 46
Cannabidiol's neuroprotective properties and potential treatment of traumatic brain injuries
Aychman, M. M., Goldman, D. L., & Kaplan, J. S. (2023) · Frontiers in Neurology · doi:10.3389/fneur.2023.1087011 · Cited by 52
Potential Effects of Cannabidiol as a Wake-Promoting Agent
Murillo‐Rodríguez, E., Sarro-Ramírez, A., Sanchez, D., Mijangos-Moreno, S., Tejeda-Padrón, A., Poot-Aké, A., Guzmán, K., Pacheco-Pantoja, E. L., & Arias-Carrión, Ó. (2014) · Current Neuropharmacology · doi:10.2174/1570159x11666131204235805 · Cited by 42
Cannabinoids as therapeutic for PTSD
Loflin, M., Babson, K. A., & Bonn‐Miller, M. O. (2016) · Current Opinion in Psychology · doi:10.1016/j.copsyc.2016.12.001 · Cited by 44
Effects of cannabidiol on alcohol-related outcomes: A review of preclinical and human research.
Nona, C. N., Hendershot, C. S., & Foll, B. L. (2019) · Experimental and Clinical Psychopharmacology · doi:10.1037/pha0000272 · Cited by 41
Safety and tolerability of escalating cannabinoid doses in healthy cats
Kulpa, J., Paulionis, L. J., Eglit, G. M., & Vaughn, D. M. (2021) · Journal of Feline Medicine and Surgery · doi:10.1177/1098612x211004215 · Cited by 42
Li, J., Carvajal, R., Bruner, L. H., & Kaminski, N. E. (2021) · Food and Chemical Toxicology · doi:10.1016/j.fct.2021.112600 · Cited by 49
Gigli, S., Seguella, L., Pesce, M., Bruzzese, E., D’Alessandro, A., Cuomo, R., Steardo, L., Sarnelli, G., & Esposito, G. (2017) · United European Gastroenterology Journal · doi:10.1177/2050640617698622 · Cited by 42
“Remarkably, CBD is a non-psychotropic cannabinoid (unlike 9-THC) and does not interfere with psychomotor learning and psychological functions.(28) In this study we have demonstrated, for the first time, that CBD is able to preserve mucosal integrity and to reduce cellular permeability in in vitro cultured Caco-2 cells…”
BackgroundPharmacological Modulators of Autophagy as a Potential Strategy for the Treatment of COVID-19
Pereira, G. J. S., Leão, A. H. F. F., Erustes, A. G., Morais, I. B. D. M., Vrechi, T. A. D. M., Zamarioli, L. D. S., Pereira, C. A. S., Marchioro, L. D. O., Sperandio, L. P., Lins, Í. V. F., et al. (2021) · International Journal of Molecular Sciences · doi:10.3390/ijms22084067 · Cited by 43
“Additionally, cannabidiol can act as an antioxidant at several receptor sites, including the peroxisome proliferator-activated γ (PPARγ) and adenosine 2 receptors [253].”
BackgroundMedical marijuana in neurology
Benbadis, S. R., Sanchez‐Ramos, J., Bozorg, A. M., Giarratano, M., Kalidas, K., Katzin, L. W., Robertson, D. S., Vu, T., Smith, A., & Zesiewicz, T. A. (2014) · Expert Review of Neurotherapeutics · doi:10.1586/14737175.2014.985209 · Cited by 40
“A review of 25 studies on the safety and efficacy of CBD reported that administration did not induce side effects across a wide range of dosages, including acute and chronic dose regimens, using various modes of administration [97].”
BackgroundAnorexia and the Cancer Patient
Johannes, C. M., & Musser, M. L. (2019) · Veterinary Clinics of North America Small Animal Practice · doi:10.1016/j.cvsm.2019.04.008 · Cited by 41
Schlienz, N. J., Scalsky, R. J., Martin, E. L., Jackson, H., Munson, J., Strickland, J. C., Bonn‐Miller, M. O., Loflin, M., & Vandrey, R. G. (2020) · Cannabis and Cannabinoid Research · doi:10.1089/can.2019.0096 · Cited by 40
Hosseini, A., McLachlan, A. J., & Lickliter, J. D. (2020) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.14617 · Cited by 44
Fear extinction learning and anandamide: an fMRI study in healthy humans
Spohrs, J., Martin, U., Grön, G., Prost, M., Plener, P. L., Fegert, J. M., Bîndilă, L., & Abler, B. (2021) · Translational Psychiatry · doi:10.1038/s41398-020-01177-7 · Cited by 43
“Bergamaschi et al.75 demonstrated that cannabidiol (CBD) reduced anxiety when given to subjects with an untreated social anxiety disorder before a public speech.”
BackgroundBarak, T., Eden, S., Steinberg, D., Feldman, M., Sionov, R. V., & Shalish, M. (2022) · International Journal of Molecular Sciences · doi:10.3390/ijms232415878 · Cited by 39
“Due to that, CBD was found beneficial in treatment of various diseases including cancer, inflammatory, neurodegenerative, autoimmune and cardiovascular diseases [1,5,7,12].”
BackgroundCannabidiol and the Canonical WNT/β-Catenin Pathway in Glaucoma
Vallée, A., Lecarpentier, Y., & Vallée, J.-N. (2021) · International Journal of Molecular Sciences · doi:10.3390/ijms22073798 · Cited by 40
“CBD, one of the main compounds of Cannabis sativa, has recently presented numerous interesting actions in many neuropsychiatric disorders [157].”
BackgroundPalmitoylethanolamide: A Potential Alternative to Cannabidiol
Clayton, P., Subah, S., Venkatesh, R., Hill, M., & Bogoda, N. O. (2021) · Journal of Dietary Supplements · doi:10.1080/19390211.2021.2005733 · Cited by 42
Schönhofen, P., de Medeiros, L. M., Bristot, I. J., Lopes, F. M., Bastiani, M. A. D., Kapczinski, F. P., Crippa, J. A. S., Castro, M. A. A., Parsons, R. B., & Klamt, F. (2014) · Molecular Neurobiology · doi:10.1007/s12035-014-8843-1 · Cited by 39
González‐García, C., Moreno‐Torres, I., García-Hernández, R., Campos-Ruíz, L., Rodríguez‐Esparragoza, L., Coronado, M. J., Grande, A. G., García‐Merino, A., & Sánchez, A. (2017) · Experimental Neurology · doi:10.1016/j.expneurol.2017.08.017 · Cited by 40
Introduction to spasticity and related mouse models
Wieters, F., Lucas, C. W., Gruhn, M., Büschges, A., Fink, G. R., & Aswendt, M. (2020) · Experimental Neurology · doi:10.1016/j.expneurol.2020.113491 · Cited by 37
Alviz-Amador, A., Contreras‐Puentes, N., & Mercado‐Camargo, J. (2021) · Computational Biology and Chemistry · doi:10.1016/j.compbiolchem.2021.107590 · Cited by 39
Tagne, A. M., Marino, F., Legnaro, M., Luini, A., Pacchetti, B., & Cosentino, M. (2019) · International Journal of Molecular Sciences · doi:10.3390/ijms20081833 · Cited by 37
Beyond the high: Mapping patterns of use and motives for use of cannabis as medicine
Kvamme, S. L., Pedersen, M. M., Alagem-Iversen, S., & Thylstrup, B. (2021) · Nordic Studies on Alcohol and Drugs · doi:10.1177/1455072520985967 · Cited by 38
“…cognitive, and behavioural effects (Colizzi & Bhattacharyya, 2017; Rømer Thomsen et al., 2017), and that CBD may have a superior safety profile (Bergamaschi et al., 2011; Iffland & Grotenhermen, 2017) and limited abuse potential (Schoedel et al., 2018) compared to THC. Nonetheless,…”
BackgroundWagoner, K. G., Lazard, A. J., Romero-Sandoval, E. A., & Reboussin, B. A. (2021) · Cannabis and Cannabinoid Research · doi:10.1089/can.2020.0166 · Cited by 39
“10 CBD’s anti-inflammatory and antioxidant properties, as well as its tolerability profile, 11 make it a potential candidate for a range of medical uses beyond epilepsy, spurring new research to determine its effectiveness in treating a variety of conditions.”
High-Dose Cannabidiol Induced Hypotension after Global Hypoxia-Ischemia in Piglets
Garberg, H. T., Solberg, R., Barlinn, J., Martínez-Orgado, J. A., Løberg, E. M., & Saugstad, O. D. (2017) · Neonatology · doi:10.1159/000471786 · Cited by 36
Cannabinoids alter endothelial function in the Zucker rat model of type 2 diabetes
Stanley, C. P., Wheal, A. J., Randall, M. D., & O’Sullivan, S. E. (2013) · European Journal of Pharmacology · doi:10.1016/j.ejphar.2013.10.002 · Cited by 35
Shayesteh, M. R. H., Haghi‐Aminjan, H., Mousavi, M. J., Momtaz, S., & Abdollahi, M. R. (2019) · Current Pharmaceutical Design · doi:10.2174/2210327909666190710103103 · Cited by 35
Perkins, D., Butler, J., Ong, K., Nguyen, T., Cox, S. W., Francis, B., McIntosh, M. P., & Lilley, B. (2020) · European Journal of Drug Metabolism and Pharmacokinetics · doi:10.1007/s13318-020-00624-6 · Cited by 38
“In other studies, the most frequently reported TEAEs for cannabidiol were tiredness/somnolence, diarrhoea, nausea, headache, pyrexia, decreased appetite, vomiting and anaemia [1, 6, 15, 18, 25].”
BackgroundMethodRizzo, M. D., Henriquez, J. E., Blevins, L. K., Bach, A. P., Crawford, R. B., & Kaminski, N. E. (2020) · Journal of Neuroimmune Pharmacology · doi:10.1007/s11481-020-09918-7 · Cited by 35
Psychosocial and pharmacological interventions for the treatment of cannabis use disorder
Sabioni, P., & Le Foll, B. (2018) · F1000Research · doi:10.12688/f1000research.11191.1 · Cited by 37
“Unlike THC, CBD does not produce psycho-tropic effects and this is probably because of its low affinity for CB1 receptors 55–57 .”
Background
Metadata
- 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)
- 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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