Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Cannabidiol
Drug ID BADD_D02468
Description Cannabidiol, or CBD, is one of at least 85 active cannabinoids identified within the Cannabis plant. It is a major phytocannabinoid, accounting for up to 40% of the Cannabis plant's extract, that binds to a wide variety of physiological targets of the endocannabinoid system within the body. Although the exact medical implications are currently being investigated, CBD has shown promise as a therapeutic and pharmaceutical drug target. In particular, CBD has shown promise as an analgesic, anticonvulsant, muscle relaxant, anxiolytic, antipsychotic and has shown neuroprotective, anti-inflammatory, and antioxidant activity, among other currently investigated uses [A32477, A32469]. CBD's exact place within medical practice is still currently hotly debated, however as the body of evidence grows and legislation changes to reflect its wide-spread use, public and medical opinion have changed significantly with regards to its usefulness in a number of medical conditions ranging from anxiety to epilepsy.
Indications and Usage When used in combination with delta-9-tetrahydrocannabinol as the product Sativex, cannabidiol was given a standard marketing authorization (ie. a Notice of Compliance (NOC)) by Health Canada for the following indications: 1) as adjunctive treatment for symptomatic relief of spasticity in adult patients with multiple sclerosis (MS) who have not responded adequately to other therapy and who demonstrate meaningful improvement during an initial trial of therapy [L886]; Due to the need for confirmatory studies to verify the clinical benefit coupled with the promising nature of the clinical evidence, Sativex was also given a Notice of Compliance with Conditions (NOC/c) by Health Canada for the following indications: 1) as adjunctive treatment for the symptomatic relief of neuropathic pain in adult patients with multiple sclerosis; 2) as adjunctive analgesic treatment in adult patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain [L886].
Marketing Status approved; investigational
ATC Code N03AX24
DrugBank ID DB09061
KEGG ID D10915
MeSH ID D002185
PubChem ID 644019
TTD Drug ID D0O1UZ
NDC Product Code 68108-0881; 73548-2155; 51634-2155; 48251-0300; 73435-015; 70127-100; 82876-001; 82876-283; 57821-006
UNII 19GBJ60SN5
Synonyms Cannabidiol | 1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)- | Epidiolex
Chemical Information
Molecular Formula C21H30O2
CAS Registry Number 13956-29-1
SMILES CCCCCC1=CC(=C(C(=C1)O)C2C=C(CCC2C(=C)C)C)O
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Urine odour abnormal20.02.01.0200.000423%Not Available
Appetite disorder19.09.01.002; 14.03.01.0040.000635%Not Available
Brain neoplasm17.20.01.003; 16.30.01.0030.000125%Not Available
Eye movement disorder17.02.05.025; 06.05.02.0080.000423%Not Available
Feeding disorder19.09.01.003; 14.03.02.0030.000610%Not Available
Partial seizures17.12.03.0100.000822%Not Available
Abnormal behaviour19.01.01.0010.005953%Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.022141%
Psychiatric symptom19.01.02.0010.000125%Not Available
Increased upper airway secretion22.12.03.0070.000423%Not Available
Bowel movement irregularity07.02.03.0030.000909%Not Available
Hypophagia07.01.06.010; 19.09.01.004; 14.03.01.0060.001183%Not Available
Sudden unexplained death in epilepsy17.12.03.019; 08.04.01.0120.000249%Not Available
Skin haemorrhage24.07.01.103; 23.06.07.0010.000423%Not Available
Head titubation17.01.06.0060.000697%Not Available
Adverse reaction08.06.01.0180.000635%Not Available
Slow speech17.02.08.016; 19.19.02.0040.000423%Not Available
Glassy eyes08.01.03.055; 06.08.03.0210.000423%Not Available
Faeces soft07.01.03.0080.001332%Not Available
Feeding intolerance18.04.11.003; 14.02.01.0060.000125%Not Available
Frustration tolerance decreased19.04.02.0160.000423%Not Available
Atonic seizures17.12.03.0200.002802%Not Available
Epileptic aura17.12.03.0240.000274%Not Available
Head banging19.11.03.0070.000847%Not Available
Impulsive behaviour19.18.01.0010.000423%Not Available
Poverty of speech19.19.02.007; 17.02.08.0200.000847%Not Available
Laziness19.04.04.0050.000423%Not Available
Neurodegenerative disorder17.02.10.0240.000125%Not Available
Regressive behaviour19.01.01.0040.000423%Not Available
Seizure cluster17.12.03.0290.003574%Not Available
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