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Details

Stereochemistry ABSOLUTE
Molecular Formula C21H30O2
Molecular Weight 314.4625
Optical Activity ( - )
Defined Stereocenters 2 / 2
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of CANNABIDIOL

SMILES

CCCCCc1cc(c([C@]2([H])C=C(C)CC[C@@]2([H])C(=C)C)c(c1)O)O

InChI

InChIKey=QHMBSVQNZZTUGM-ZWKOTPCHSA-N
InChI=1S/C21H30O2/c1-5-6-7-8-16-12-19(22)21(20(23)13-16)18-11-15(4)9-10-17(18)14(2)3/h11-13,17-18,22-23H,2,5-10H2,1,3-4H3/t17-,18+/m0/s1

HIDE SMILES / InChI
Molecular Formula C21H30O2
Molecular Weight 314.4625
Charge 0
Count
Stereochemistry ABSOLUTE
Additional Stereochemistry No
Defined Stereocenters 2 / 2
E/Z Centers 0
Optical Activity UNSPECIFIED

Description
Curator's Comment:: Description was created based on several sources, including https://www.ncbi.nlm.nih.gov/pubmed/24854329 | https://www.gwpharm.com/products-pipeline

Cannabidiol is the major nonpsychoactive ingredient in cannabis. Cannabidiol demonstrates a range of effects that may be therapeutically useful, including anti-seizure, antioxidant, neuroprotective, anti-inflammatory, analgesic, anti-tumor, anti-psychotic, and anti-anxiety properties. Exact mechanism of action of cannabidiol is not known, but may include effects on the orphan G-protein-coupled receptor GPR55; the transient receptor potential of vanilloid type-1 channel; the 5-HT1a receptor; and the α3 glycine receptors. GW Pharmaceuticals successfully developed the world’s first prescription medicine derived from the cannabis plant, Sativex® (buccal spray containing delta-9-tetrahydrocannabinol and cannabidiol) now approved in over 29 countries outside of the United States for the treatment of spasticity due to Multiple Sclerosis. GW Pharmaceuticals is developing Epidiolex® (a liquid formulation of pure plant-derived cannabidiol) for certain rare and severe early-onset, drug-resistant epilepsy syndromes.

CNS Activity

Originator

Adams, R. et al.
1
Sources: Adams R, Hunt M, Clark JH. Structure of cannabidiol, a product isolated from the marihuana extract of Minnesota wild hemp. J Am Chem Soc. 1940;62:196-200. | Mechoulam R, Shvo Y. Hashish. 1. Structure of Cannabidiol. Tetrahedron. 1963;19(12):2073-8
Curator's Comment:: Although cannabidiol was isolated from marijuana extract in 1940 by Adams et al., for almost 25 years no further work has been reported, except for a few early works about its isolation. Only in 1963 its exact chemical structure was elucidated by Mechoulam and Shvo. https://www.ncbi.nlm.nih.gov/pubmed/18833429

Approval Year

2018
97
Targets

Targets

Primary TargetPharmacologyConditionPotency
Agonist
2451
Agonist
2451
 3.2 µM [EC50]
Partial Agonist
259
 11.0 nM [Ki]
Antagonist
2575
 445.0 nM [IC50]
Binding Agent
989
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Palliative
Approved
7968
SATIVEX

Approved Use

Sativex is used in multiple sclerosis (MS) to improve symptoms related to muscle stiffness. This is also called “spasticity”. Spasticity means there is an increase in ‘muscle tone’ which makes the muscles feel more stiff or rigid. This means it is more difficult than normal to move the muscle. Sativex is used when other medicines have not helped your muscle stiffness.
Primary
Approved
7968
SATIVEX

Approved Use

SATIVEX® buccal spray is indicated 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.
Primary
Phase III
650
EPIDIOLEX

Approved Use

Unknown
Primary
Phase III
650
EPIDIOLEX

Approved Use

Unknown
Primary
Phase III
650
EPIDIOLEX

Approved Use

Unknown
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
330.3 ng/mL
OTHER GOV
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000ClinPharmR.pdf
750 mg 2 times / day multiple, oral
dose: 750 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
CANNABIDIOL plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
541.2 ng/mL
OTHER GOV
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000ClinPharmR.pdf
1500 mg 2 times / day multiple, oral
dose: 1500 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
CANNABIDIOL plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
292.4 ng/mL
OTHER GOV
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000ClinPharmR.pdf
1500 mg single, oral
dose: 1500 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
CANNABIDIOL plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
327 ng/mL
OTHER GOV
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000ClinPharmR.pdf
1500 mg single, oral
dose: 1500 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
CANNABIDIOL plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
782 ng/mL
OTHER GOV
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000ClinPharmR.pdf
6000 mg single, oral
dose: 6000 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
CANNABIDIOL plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
1588 ng/mL
OTHER GOV
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000ClinPharmR.pdf
1500 mg single, oral
dose: 1500 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
CANNABIDIOL plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FED
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
1745 ng × h/mL
OTHER GOV
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000ClinPharmR.pdf
750 mg 2 times / day multiple, oral
dose: 750 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
CANNABIDIOL plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
3236 ng × h/mL
OTHER GOV
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000ClinPharmR.pdf
1500 mg 2 times / day multiple, oral
dose: 1500 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
CANNABIDIOL plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
1618 ng × h/mL
OTHER GOV
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000ClinPharmR.pdf
1500 mg single, oral
dose: 1500 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
CANNABIDIOL plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
2198 ng × h/mL
OTHER GOV
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000ClinPharmR.pdf
1500 mg single, oral
dose: 1500 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
CANNABIDIOL plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
3900 ng × h/mL
OTHER GOV
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000ClinPharmR.pdf
6000 mg single, oral
dose: 6000 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
CANNABIDIOL plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
8670 ng × h/mL
OTHER GOV
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000ClinPharmR.pdf
1500 mg single, oral
dose: 1500 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
CANNABIDIOL plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FED
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
56.41 h
OTHER GOV
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000ClinPharmR.pdf
750 mg 2 times / day multiple, oral
dose: 750 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
CANNABIDIOL plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
60.54 h
OTHER GOV
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000ClinPharmR.pdf
1500 mg 2 times / day multiple, oral
dose: 1500 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
CANNABIDIOL plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
14.43 h
OTHER GOV
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000ClinPharmR.pdf
1500 mg single, oral
dose: 1500 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
CANNABIDIOL plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
15.42 h
OTHER GOV
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000ClinPharmR.pdf
6000 mg single, oral
dose: 6000 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
CANNABIDIOL plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
6%
OTHER GOV
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000ClinPharmR.pdf
1500 mg single, oral
dose: 1500 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
CANNABIDIOL plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
6%
OTHER GOV
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000ClinPharmR.pdf
6000 mg single, oral
dose: 6000 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
CANNABIDIOL plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
Doses

Doses

DosePopulationAdverse events​
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Disc. AE: Transaminases increased...
Other AEs: Transaminases increased, Decreased appetite...
AEs leading to
discontinuation/dose reduction:
Transaminases increased (1.3%)
Other AEs:
Transaminases increased (8%)
Decreased appetite (16%)
Diarrhea (9%)
Weight decreased (3%)
Abdominal discomfort (3%)
Somnolence (23%)
Sedation (3%)
Lethargy (4%)
Fatigue (11%)
Malaise (11%)
Asthenia (11%)
Irritability (9%)
Agitation (9%)
Insomnia (11%)
Sleep disorder (11%)
Poor quality sleep (11%)
Aggression (3%)
Anger (3%)
Drooling (1%)
Salivary hypersecretion (1%)
Gait disturbance (3%)
Infection viral (7%)
Pneumonia (8%)
Fungal infection (1%)
Infection NOS (25%)
Rash (7%)
Hypoxia (3%)
Respiratory failure (3%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Disc. AE: Transaminases increased...
Other AEs: Transaminases increased, Decreased appetite...
AEs leading to
discontinuation/dose reduction:
Transaminases increased (5.9%)
Other AEs:
Transaminases increased (16%)
Decreased appetite (22%)
Diarrhea (20%)
Weight decreased (5%)
Abdominal discomfort (3%)
Somnolence (25%)
Sedation (6%)
Lethargy (8%)
Fatigue (12%)
Malaise (12%)
Asthenia (12%)
Irritability (5%)
Agitation (5%)
Aggression (5%)
Anger (5%)
Drooling (4%)
Salivary hypersecretion (4%)
Gait disturbance (2%)
Infection viral (11%)
Pneumonia (5%)
Fungal infection (3%)
Infection NOS (21%)
Rash (13%)
Hypoxia (3%)
Gastroenteritis (4%)
Insomnia (5%)
Sleep disorder (5%)
Poor quality sleep (5%)
Respiratory failure (3%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
50 mg/kg/day 1 times / day multiple, oral
Dose: 50 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg/kg/day, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/26724101
healthy, adult
n = 5
Health Status: healthy
Age Group: adult
Population Size: 5
Sources:
https://pubmed.ncbi.nlm.nih.gov/26724101
Sources:
https://pubmed.ncbi.nlm.nih.gov/26724101
AEs

AEs

AESignificanceDosePopulation
Drooling 1%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Fungal infection 1%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Salivary hypersecretion 1%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Transaminases increased 1.3%
Disc. AE
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Asthenia 11%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Fatigue 11%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Insomnia 11%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Malaise 11%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Poor quality sleep 11%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Sleep disorder 11%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Decreased appetite 16%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Somnolence 23%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Infection NOS 25%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Abdominal discomfort 3%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Aggression 3%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Anger 3%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Gait disturbance 3%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Hypoxia 3%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Respiratory failure 3%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Sedation 3%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Weight decreased 3%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Lethargy 4%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Infection viral 7%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Rash 7%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Pneumonia 8%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Transaminases increased 8%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Agitation 9%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Diarrhea 9%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Irritability 9%
10 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 75
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 75
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Infection viral 11%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Asthenia 12%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Fatigue 12%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Malaise 12%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Rash 13%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Transaminases increased 16%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Gait disturbance 2%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Diarrhea 20%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Infection NOS 21%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Decreased appetite 22%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Somnolence 25%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Abdominal discomfort 3%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Fungal infection 3%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Hypoxia 3%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Respiratory failure 3%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Drooling 4%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Gastroenteritis 4%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Salivary hypersecretion 4%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Aggression 5%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Agitation 5%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Anger 5%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Insomnia 5%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Irritability 5%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Pneumonia 5%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Poor quality sleep 5%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Sleep disorder 5%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Weight decreased 5%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Transaminases increased 5.9%
Disc. AE
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Sedation 6%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Lethargy 8%
20 mg/kg/day 1 times / day multiple, oral
Recommended
Dose: 20 mg/kg/day, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg/kg/day, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
unhealthy, 14 years (range: 2 - 48 years)
n = 238
Health Status: unhealthy
Condition: seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
Age Group: 14 years (range: 2 - 48 years)
Sex: M+F
Population Size: 238
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG
substrate
1469

inhibitor
1171

inducer
657
inhibitor
1318
inhibitor
1359

OverviewOther

Other InhibitorOther SubstrateOther Inducer
OATP1B3
613

CYP2C19
1215

CYP1A2
1268

CYP2B6
679

CYP2C8
761

UGT1A9
102

UGT2B7
130

P-gp
1087

OAT1
547

OAT3
570

OCT2
582

MATE1
290

MATE2
258

OATP1B1
698

BSEP
363

OCT1
473

BCRP
574
CYP2C19
830

UGT1A7
197

UGT1A9
327

UGT2B7
329

P-gp
1222

OATP1B1
353

OATP1B3
303

BCRP
461
CYP1A2
618

CYP2B6
486
Drug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
BCRP
639
 no
7-COOH-CBD
1
BCRP
639
 no
7-OH-CBD
1
BSEP
364
 no
BSEP
364
 no
7-COOH-CBD
1
BSEP
364
 no
7-OH-CBD
1
MATE1
291
 no
MATE1
291
 no
7-COOH-CBD
1
MATE1
291
 no
7-OH-CBD
1
MATE2
258
 no
MATE2
258
 no
7-COOH-CBD
1
MATE2
258
 no
7-OH-CBD
1
OAT1
551
 no
OAT1
551
 no
7-COOH-CBD
1
OAT1
551
 no
7-OH-CBD
1
OAT3
572
 no
OAT3
572
 no
7-COOH-CBD
1
OAT3
572
 no
7-OH-CBD
1
OATP1B1
713
 no
OATP1B1
713
 no
7-COOH-CBD
1
OATP1B1
713
 no
7-OH-CBD
1
OATP1B3
622
 no
OATP1B3
622
 no
7-COOH-CBD
1
OATP1B3
622
 no
7-OH-CBD
1
OCT1
488
 no
OCT1
488
 no
7-COOH-CBD
1
OCT1
488
 no
7-OH-CBD
1
OCT2
583
 no
OCT2
583
 no
7-COOH-CBD
1
OCT2
583
 no
7-OH-CBD
1
P-gp
1253
 no
P-gp
1253
 no
7-OH-CBD
1
CYP1A2
1406
 yes
CYP1A2
1406
 yes
CYP2B6
845
 yes
CYP2B6
845
 yes
CYP2C19
1277
 yes
CYP2C8
810
 yes
CYP2C9
1362
 yes
CYP3A4
1461
 yes
CYP3A4
1461
 yes
UGT1A9
107
 yes
UGT2B7
138
 yes
Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
BCRP
461
 no
BCRP
461
 no
7-COOH-CBD
1
OATP1B1
353
 no
OATP1B1
353
 no
7-COOH-CBD
1
OATP1B3
303
 no
OATP1B3
303
 no
7-COOH-CBD
1
P-gp
1222
 no
UGT1A7
197
 yes
UGT1A9
327
 yes
UGT2B7
329
 yes
CYP2C19
830
 yes
likely
Comment: Co-administration with moderate or strong inhibitors of CYP3A4 or CYP2C19 is predicted to increase CBD plasma concentrations which may increase the risk CBD toxicities.
Page: 7.0
CYP3A4
1469
 yes
likely
Comment: Co-administration with moderate or strong inhibitors of CYP3A4 or CYP2C19 is predicted to increase CBD plasma concentrations which may increase the risk CBD toxicities.
Page: 7.0
Tox targets

Tox targets

TargetModalityActivityMetaboliteClinical evidence
hERG
1391
Sourcing

Sourcing

Vendor/AggregatorIDURL
ChEBI
CHEBI:69478
https://www.ebi.ac.uk/chebi/searchId.do?chebiId=CHEBI:69478
ChemicalBook
CB7673434
https://www.chemicalbook.com/ChemicalProductProperty_EN_CB7673434
ZINC
ZINC000004097406
http://zinc15.docking.org/substances/ZINC000004097406
eMolecules
536311
https://www.emolecules.com/cgi-bin/more?vid=536311
PubMed

PubMed

TitleDatePubMed
Medicinal cannabis: is delta9-tetrahydrocannabinol necessary for all its effects?
2003 Dec
Cannabidiol-transdermal delivery and anti-inflammatory effect in a murine model.
2003 Dec 12
Gamma-irradiation enhances apoptosis induced by cannabidiol, a non-psychotropic cannabinoid, in cultured HL-60 myeloblastic leukemia cells.
2003 Oct
Neuroprotective effect of cannabidiol, a non-psychoactive component from Cannabis sativa, on beta-amyloid-induced toxicity in PC12 cells.
2004 Apr
Atypical cannabinoid stimulates endothelial cell migration via a Gi/Go-coupled receptor distinct from CB1, CB2 or EDG-1.
2004 Apr 5
Do cannabis-based medicinal extracts have general or specific effects on symptoms in multiple sclerosis? A double-blind, randomized, placebo-controlled study on 160 patients.
2004 Aug
An open-label pilot study of cannabis-based extracts for bladder dysfunction in advanced multiple sclerosis.
2004 Aug
Efficacy, safety and tolerability of an orally administered cannabis extract in the treatment of spasticity in patients with multiple sclerosis: a randomized, double-blind, placebo-controlled, crossover study.
2004 Aug
Pain reduction and lack of psychotropic effects with ajulemic acid: comment on the article by Sumariwalla et al.
2004 Dec
Differential effects of THC- or CBD-rich cannabis extracts on working memory in rats.
2004 Dec
Efficacy of two cannabis based medicinal extracts for relief of central neuropathic pain from brachial plexus avulsion: results of a randomised controlled trial.
2004 Dec
(+)-Cannabidiol analogues which bind cannabinoid receptors but exert peripheral activity only.
2004 Dec 15
Effects of coadministration of cannabinoids and morphine on nociceptive behaviour, brain monoamines and HPA axis activity in a rat model of persistent pain.
2004 Feb
Medicinal cannabis extracts for the treatment of multiple sclerosis.
2004 Jul
A comparative analysis of the potential of cannabinoids and ondansetron to suppress cisplatin-induced emesis in the Suncus murinus (house musk shrew).
2004 Jul
Synthesis and antitumor activity of quinonoid derivatives of cannabinoids.
2004 Jul 15
Effect of Delta-9-tetrahydrocannabinol and cannabidiol on nocturnal sleep and early-morning behavior in young adults.
2004 Jun
Human skin permeation of Delta8-tetrahydrocannabinol, cannabidiol and cannabinol.
2004 Mar
A novel synthetic, nonpsychoactive cannabinoid acid (HU-320) with antiinflammatory properties in murine collagen-induced arthritis.
2004 Mar
Oral anti-inflammatory activity of cannabidiol, a non-psychoactive constituent of cannabis, in acute carrageenan-induced inflammation in the rat paw.
2004 Mar
Antitumor effects of cannabidiol, a nonpsychoactive cannabinoid, on human glioma cell lines.
2004 Mar
6"-Azidohex-2"-yne-cannabidiol: a potential neutral, competitive cannabinoid CB1 receptor antagonist.
2004 Mar 8
Initial experiences with medicinal extracts of cannabis for chronic pain: results from 34 'N of 1' studies.
2004 May
Cannabidiol lacks the vanilloid VR1-mediated vasorespiratory effects of capsaicin and anandamide in anaesthetised rats.
2004 May 3
Determination of cannabinoids in cannabis products using liquid chromatography-ion trap mass spectrometry.
2004 Nov 26
NMR assignments of the major cannabinoids and cannabiflavonoids isolated from flowers of Cannabis sativa.
2004 Nov-Dec
Cannabidiol prevents infarction via the non-CB1 cannabinoid receptor mechanism.
2004 Oct 25
Cannabinoids in hair: strategy to prove marijuana/hashish consumption.
2004 Oct 29
Cannabis (marijuana) contamination of United States and foreign paper currency.
2004 Sep
Vanilloid TRPV1 receptor mediates the antihyperalgesic effect of the nonpsychoactive cannabinoid, cannabidiol, in a rat model of acute inflammation.
2004 Sep
Effect of low doses of delta9-tetrahydrocannabinol and cannabidiol on the extinction of cocaine-induced and amphetamine-induced conditioned place preference learning in rats.
2004 Sep
Cannabidiol inhibits human glioma cell migration through a cannabinoid receptor-independent mechanism.
2005 Apr
Cannabidiol inhibits the hyperlocomotion induced by psychotomimetic drugs in mice.
2005 Apr 11
Comparison of cannabidiol, antioxidants, and diuretics in reversing binge ethanol-induced neurotoxicity.
2005 Aug
Gene ancestry of the cannabinoid receptor family.
2005 Dec
The nonpsychoactive component of marijuana cannabidiol modulates chemotaxis and IL-10 and IL-12 production of murine macrophages both in vivo and in vitro.
2005 Feb
Marijuana extracts possess the effects like the endocrine disrupting chemicals.
2005 Jan 31
A rapid and simple procedure for the determination of cannabinoids in hemp food products by gas chromatography-mass spectrometry.
2005 Jan 4
Flavonoid glycosides and cannabinoids from the pollen of Cannabis sativa L.
2005 Jan-Feb
The use of cannabinoids in multiple sclerosis.
2005 Jul
Evidence that (-)-7-hydroxy-4'-dimethylheptyl-cannabidiol activates a non-CB(1), non-CB(2), non-TRPV1 target in the mouse vas deferens.
2005 Jun
Peripheral, but not central effects of cannabidiol derivatives: mediation by CB(1) and unidentified receptors.
2005 Jun
CB1 cannabinoid receptor-mediated modulation of food intake in mice.
2005 Jun
Cannabinoids provide neuroprotection against 6-hydroxydopamine toxicity in vivo and in vitro: relevance to Parkinson's disease.
2005 Jun-Jul
Effect of cannabis use in human brain activity.
2005 Mar
Enantiomeric cannabidiol derivatives: synthesis and binding to cannabinoid receptors.
2005 Mar 21
Cannabinoids in bipolar affective disorder: a review and discussion of their therapeutic potential.
2005 May
Cannabidiol prevents cerebral infarction via a serotonergic 5-hydroxytryptamine1A receptor-dependent mechanism.
2005 May
Neurophysiological and subjective profile of marijuana with varying concentrations of cannabinoids.
2005 Sep
Cannabidiol reverses MK-801-induced disruption of prepulse inhibition in mice.
2006 Apr
Patents

Patents

JP2008501770A
1

Sample Use Guides

In Vivo Use Guide
SATIVEX® is provided as a buccal spray in a 5.5 ml vial, with each 100 microlitre spray providing 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). In patients with multiple sclerosis, the median daily dosage of SATIVEX® in the extension phase of the 4-week clinical trial was 5 sprays per day. The majority of patients required 12 sprays or less; dosage should be adjusted as needed and tolerated. There is limited experience with doses higher than 12 sprays per day. Some patients may require and may tolerate a higher number of sprays. In patients with pain in cancer, the median daily dosage of SATIVEX® was 8 actuations (sprays).
Route of Administration: Topical
In Vitro Use Guide
in vitro pre-treatment of Human Gingival Mesenchymal Stem Cells with 5 uM Cannabidiol (CBD) can influence their expression profile
Substance Class Chemical
Created
by admin
on Fri Jun 25 21:23:38 UTC 2021
Edited
by admin
on Fri Jun 25 21:23:38 UTC 2021
Record UNII
19GBJ60SN5
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
CANNABIDIOL
INCI   INN   MART.   MI   USAN   WHO-DD  
USAN   INN   INCI  
Official Name English
CANNABIDIOL [USAN]
Common Name English
CANNABIDIOL [USP-RS]
Common Name English
.DELTA.1(2)-TRANS-CANNABIDIOL
Common Name English
(-)-CANNABIDIOL
Common Name English
EPIDIOLEX
Brand Name English
CANNABIDIOL [MART.]
Common Name English
2-((1R,6R)-3-METHYL-6-(PROP-1-EN-2-YL)CYCLOHEX-2-EN-1-YL)-5-PENTYLBENZENE-1,3-DIOL
Systematic Name English
2-((1R,6R)-3-METHYL-6-(1-METHYLETHENYL)CYCLOHEX-2-ENYL)-5-PENTYLBENZENE-1,3-DIOL
Systematic Name English
CANNABIDIOL [INCI]
Common Name English
BTX-1503
Code English
(-)-CBD
Common Name English
GWP-42003
Code English
CANNABIDIOL [MI]
Common Name English
CBD
Common Name English
BTX-1204
Code English
CANNABIDIOL [ORANGE BOOK]
Common Name English
1,3-BENZENEDIOL, 2-((1R,6R)-3-METHYL-6-(1-METHYLETHENYL)-2-CYCLOHEXEN-1-YL)-5-PENTYL-
Systematic Name English
CANNABIDIOL SOLUTION [USP-RS]
Common Name English
GWP-42003-P
Code English
CANNABIDIOL [INN]
Common Name English
CANNABIDIOL [WHO-DD]
Common Name English
GWP42003
Code English
(-)-TRANS-CANNABIDIOL
Common Name English
GWP42003-P
Code English
Classification Tree Code System Code
EU-Orphan Drug EU/3/17/1959
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 471815
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
NCI_THESAURUS C274
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
NCI_THESAURUS C1742
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 444814
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 409313
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 609617
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
DSLD 3397 (Number of products:162)
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 617417
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 521416
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
WHO-ATC N03AX24
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 452614
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 620417
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 696519
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 734820
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 806620
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 545316
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 482315
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 656618
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 736020
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 538916
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
WHO-ATC N02BG10
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 486115
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 610117
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 488315
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 510716
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 628818
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 549616
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 498215
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 668918
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 734620
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 438214
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 439414
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 421213
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
FDA ORPHAN DRUG 450814
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
NCI_THESAURUS C105578
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
Code System Code Type Description
RXCUI
2045371
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
PRIMARY
ChEMBL
CHEMBL190461
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
PRIMARY
USP_CATALOG
1089149
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
PRIMARY USP-RS
LACTMED
Cannabidiol
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
PRIMARY
EVMPD
SUB26600
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
PRIMARY
NCI_THESAURUS
C118452
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
PRIMARY
WIKIPEDIA
CANNABIDIOL
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
PRIMARY
INN
10423
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
PRIMARY
DRUG BANK
DB09061
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
PRIMARY
USP_CATALOG
1089161
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
PRIMARY USP-RS
DRUG CENTRAL
5288
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
PRIMARY
FDA UNII
19GBJ60SN5
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
PRIMARY
CAS
13956-29-1
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
PRIMARY
PUBCHEM
644019
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
PRIMARY
MESH
D002185
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
PRIMARY
MERCK INDEX
M3020
Created by admin on Fri Jun 25 21:23:38 UTC 2021 , Edited by admin on Fri Jun 25 21:23:38 UTC 2021
PRIMARY Merck Index
Related Record Type Details
CANNABINOID RECEPTOR 1
TARGET->INVERSE AGONIST
URIDINE DIPHOSPHATE GLUCURONOSYLTRANSFERASE 1A7
METABOLIC ENZYME -> SUBSTRATE
CANNABIS SATIVA SUBSP. INDICA TOP
PARENT -> ACTIVE CONSTITUENT ALWAYS PRESENT
Cannabidiol Class | Anxiolytic Antipsychotic | Analgesic | Anti-inflammatory | Antioxydant | Antispasmodic
G-PROTEIN COUPLED RECEPTOR 55
TARGET -> INHIBITOR
5-HYDROXYTRYPTAMINE RECEPTOR 1A
TARGET -> ACTIVATOR
URIDINE DIPHOSPHATE GLUCURONOSYLTRANSFERASE 1A9
METABOLIC ENZYME -> SUBSTRATE
URIDINE DIPHOSPHATE GLUCURONOSYLTRANSFERASE 2B7
METABOLIC ENZYME -> SUBSTRATE
CYTOCHROME P450 3A4
METABOLIC ENZYME -> SUBSTRATE
PLASMA PROTEIN FRACTION (HUMAN)
BINDER->LIGAND
CYTOCHROME P450 2C19
METABOLIC ENZYME -> SUBSTRATE
CANNABINOID RECEPTOR 2
TARGET->INVERSE AGONIST
Related Record Type Details
Structure of 2''-HYDROXYCANNABIDIOL
METABOLITE -> PARENT
MINOR
Structure of 6ALPHA-HYDROXYCANNABIDIOL
METABOLITE -> PARENT
MAJOR
Structure of 5''-HYDROXYCANNABIDIOL
METABOLITE -> PARENT
MINOR
Structure of 3''-HYDROXYCANNABIDIOL
METABOLITE -> PARENT
MINOR
Structure of CANNABIDIOL DIMETHYL ETHER
METABOLITE -> PARENT
Structure of 1''-HYDROXYCANNABIDIOL
METABOLITE -> PARENT
MINOR
Structure of 7-HYDROXYCANNABIDIOL
METABOLITE ACTIVE -> PARENT
The major circulating metabolites include 7-hydroxy-cannabidiol (7-OH-CBD), which was approximately 38% of the parent based on AUC of cannabidiol.
MAJOR
Structure of 4''-HYDROXYCANNABIDIOL
METABOLITE -> PARENT
MINOR
Structure of 6.BETA.-HYDROXYCANNABIDIOL
METABOLITE -> PARENT
MAJOR
Related Record Type Details
Structure of CANNABIDIOL
ACTIVE MOIETY
Name Property Type Amount Referenced Substance Defining Parameters References
Tmax PHARMACOKINETIC
Volume of Distribution PHARMACOKINETIC
Biological Half-life PHARMACOKINETIC TWICE-DAILY DOSING FOR 7 DAYS

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