U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

Details

Stereochemistry ABSOLUTE
Molecular Formula C21H30O2
Molecular Weight 314.4617
Optical Activity UNSPECIFIED
Defined Stereocenters 2 / 2
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of CANNABIDIOL

SMILES

CCCCCC1=CC(O)=C([C@@H]2C=C(C)CC[C@H]2C(C)=C)C(O)=C1

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 314.4617
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
436
Targets

Targets

Primary TargetPharmacologyConditionPotency
Agonist
2678
Agonist
2678
 3.2 µM [EC50]
Partial Agonist
290
 11.0 nM [Ki]
Antagonist
2778
 445.0 nM [IC50]
Binding Agent
1064
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Palliative
Approved
8429
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
8429
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
656
EPIDIOLEX

Approved Use

Unknown
Primary
Phase III
656
EPIDIOLEX

Approved Use

Unknown
Primary
Phase III
656
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
1737

inhibitor
1587

inducer
781
inhibitor
1767
inhibitor
1612

OverviewOther

Other InhibitorOther SubstrateOther Inducer
OATP1B3
706

CYP2C19
1478

CYP1A2
1524

CYP2B6
810

CYP2C8
911

UGT1A9
116

UGT2B7
146

P-gp
1461

OAT1
599

OAT3
642

OCT2
647

MATE1
306

MATE2
263

OATP1B1
788

BSEP
402

OCT1
512

BCRP
699
CYP2C19
991

UGT1A7
236

UGT1A9
380

UGT2B7
389

P-gp
1537

OATP1B1
406

OATP1B3
350

BCRP
561
CYP1A2
701

CYP2B6
547
Drug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
BCRP
773
 no
7-COOH-CBD
1
BCRP
773
 no
7-OH-CBD
1
BSEP
403
 no
BSEP
403
 no
7-COOH-CBD
1
BSEP
403
 no
7-OH-CBD
1
MATE1
308
 no
MATE1
308
 no
7-COOH-CBD
1
MATE1
308
 no
7-OH-CBD
1
MATE2
263
 no
MATE2
263
 no
7-COOH-CBD
1
MATE2
263
 no
7-OH-CBD
1
OAT1
603
 no
OAT1
603
 no
7-COOH-CBD
1
OAT1
603
 no
7-OH-CBD
1
OAT3
644
 no
OAT3
644
 no
7-COOH-CBD
1
OAT3
644
 no
7-OH-CBD
1
OATP1B1
803
 no
OATP1B1
803
 no
7-COOH-CBD
1
OATP1B1
803
 no
7-OH-CBD
1
OATP1B3
715
 no
OATP1B3
715
 no
7-COOH-CBD
1
OATP1B3
715
 no
7-OH-CBD
1
OCT1
543
 no
OCT1
543
 no
7-COOH-CBD
1
OCT1
543
 no
7-OH-CBD
1
OCT2
648
 no
OCT2
648
 no
7-COOH-CBD
1
OCT2
648
 no
7-OH-CBD
1
P-gp
1650
 no
P-gp
1650
 no
7-OH-CBD
1
CYP1A2
1692
 yes
CYP1A2
1692
 yes
CYP2B6
1001
 yes
CYP2B6
1001
 yes
CYP2C19
1553
 yes
CYP2C8
965
 yes
CYP2C9
1819
 yes
CYP3A4
1925
 yes
CYP3A4
1925
 yes
UGT1A9
121
 yes
UGT2B7
157
 yes
Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
BCRP
561
 no
BCRP
561
 no
7-COOH-CBD
1
OATP1B1
406
 no
OATP1B1
406
 no
7-COOH-CBD
1
OATP1B3
350
 no
OATP1B3
350
 no
7-COOH-CBD
1
P-gp
1537
 no
UGT1A7
236
 yes
UGT1A9
380
 yes
UGT2B7
389
 yes
CYP2C19
991
 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
1737
 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
1647
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
Synthesis and pharmacological evaluation in mice of halogenated cannabidiol derivatives.
1999 Nov
Characterization of palmitoylethanolamide transport in mouse Neuro-2a neuroblastoma and rat RBL-2H3 basophilic leukaemia cells: comparison with anandamide.
2001 Apr
Cannabinoid-induced alterations in brain disposition of drugs of abuse.
2001 Jun 1
Cannabinoid CB(1) receptor agonists produce cerebellar dysfunction in mice.
2001 May
Molecular targets for cannabidiol and its synthetic analogues: effect on vanilloid VR1 receptors and on the cellular uptake and enzymatic hydrolysis of anandamide.
2001 Oct
The cannabinoids: an overview. Therapeutic implications in vomiting and nausea after cancer chemotherapy, in appetite promotion, in multiple sclerosis and in neuroprotection.
2001 Summer
Novel 1',1'-chain substituted Delta(8)-tetrahydrocannabinols.
2002 Dec 16
Cannabidiol: an overview of some chemical and pharmacological aspects. Part I: chemical aspects.
2002 Dec 31
(-)-Cannabidiol antagonizes cannabinoid receptor agonists and noradrenaline in the mouse vas deferens.
2002 Dec 5
Resorcinol derivatives: a novel template for the development of cannabinoid CB(1)/CB(2) and CB(2)-selective agonists.
2002 May
Fully automated determination of cannabinoids in hair samples using headspace solid-phase microextraction and gas chromatography-mass spectrometry.
2002 Nov-Dec
Therapeutic potential of cannabinoids in CNS disease.
2003
Vasodilator actions of abnormal-cannabidiol in rat isolated small mesenteric artery.
2003 Apr
Automated headspace solid-phase dynamic extraction for the determination of cannabinoids in hair samples.
2003 Apr 23
The CB1 cannabinoid receptor agonist, HU-210, reduces levodopa-induced rotations in 6-hydroxydopamine-lesioned rats.
2003 Aug
Medicinal cannabis: is delta9-tetrahydrocannabinol necessary for all its effects?
2003 Dec
A preliminary controlled study to determine whether whole-plant cannabis extracts can improve intractable neurogenic symptoms.
2003 Feb
Nonpsychotropic cannabinoid receptors regulate microglial cell migration.
2003 Feb 15
Safety, tolerability, and efficacy of orally administered cannabinoids in MS.
2003 Feb 25
The inheritance of chemical phenotype in Cannabis sativa L.
2003 Jan
[Weather-induced changes in cannabinoid content of hair].
2003 Jan-Feb
Gateways to clinical trials.
2003 Jun
Simultaneous detection of some drugs of abuse in saliva samples by SPME technique.
2003 Jun 24
Selective ligands and cellular effectors of a G protein-coupled endothelial cannabinoid receptor.
2003 Mar
Evidence for cannabinoid receptor-dependent and -independent mechanisms of action in leukocytes.
2003 Sep
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
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 cannabidiol (CBD) on regional cerebral blood flow.
2004 Feb
Determination of cannabinoids in hemp food products by use of headspace solid-phase microextraction and gas chromatography-mass spectrometry.
2004 Jan
Medicinal cannabis extracts for the treatment of multiple sclerosis.
2004 Jul
A novel synthetic, nonpsychoactive cannabinoid acid (HU-320) with antiinflammatory properties in murine collagen-induced arthritis.
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
Determination of cannabinoids in cannabis products using liquid chromatography-ion trap mass spectrometry.
2004 Nov 26
Vanilloid TRPV1 receptor mediates the antihyperalgesic effect of the nonpsychoactive cannabinoid, cannabidiol, in a rat model of acute inflammation.
2004 Sep
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
Peripheral, but not central effects of cannabidiol derivatives: mediation by CB(1) and unidentified receptors.
2005 Jun
Enantiomeric cannabidiol derivatives: synthesis and binding to cannabinoid receptors.
2005 Mar 21
Neurophysiological and subjective profile of marijuana with varying concentrations of cannabinoids.
2005 Sep
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 Sat Dec 16 16:30:49 GMT 2023
Edited
by admin
on Sat Dec 16 16:30:49 GMT 2023
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 [WHO-DD]
Common Name English
(-)-CANNABIDIOL
Common Name English
EPIDIOLEX
Brand Name English
CANNABIDIOL [MART.]
Common Name English
CARDIOLRX
Brand 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
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 Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 471815
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 510716
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
NCI_THESAURUS C274
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 914322
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
NCI_THESAURUS C1742
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 444814
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 409313
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 860921
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 609617
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
DSLD 3397 (Number of products:162)
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 617417
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 521416
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
WHO-ATC N03AX24
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 452614
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 620417
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 696519
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 734820
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 806620
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 545316
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 482315
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 656618
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 736020
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 439414
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 819221
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 538916
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
WHO-ATC N02BG10
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 763820
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 486115
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 610117
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 488315
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 421213
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 628818
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 549616
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 498215
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 438214
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 668918
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 734620
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 860821
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
FDA ORPHAN DRUG 450814
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
NCI_THESAURUS C105578
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
Code System Code Type Description
RXCUI
2045371
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
PRIMARY
RS_ITEM_NUM
1089149
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
PRIMARY
ChEMBL
CHEMBL190461
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
PRIMARY
LACTMED
Cannabidiol
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
PRIMARY
USAN
CD-48
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
PRIMARY
EVMPD
SUB26600
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
PRIMARY
NCI_THESAURUS
C118452
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
PRIMARY
WIKIPEDIA
CANNABIDIOL
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
PRIMARY
CHEBI
69478
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
PRIMARY
RS_ITEM_NUM
1089161
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
ALTERNATIVE
INN
10423
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
PRIMARY
DRUG BANK
DB09061
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
PRIMARY
DAILYMED
19GBJ60SN5
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
PRIMARY
DRUG CENTRAL
5288
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
PRIMARY
FDA UNII
19GBJ60SN5
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
PRIMARY
CAS
13956-29-1
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
PRIMARY
PUBCHEM
644019
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
PRIMARY
EPA CompTox
DTXSID00871959
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
PRIMARY
SMS_ID
100000091179
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
PRIMARY
MESH
D002185
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
PRIMARY
MERCK INDEX
m3020
Created by admin on Sat Dec 16 16:30:52 GMT 2023 , Edited by admin on Sat Dec 16 16:30:52 GMT 2023
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 2C9
METABOLIC ENZYME -> SUBSTRATE
CYTOCHROME P450 2C19
METABOLIC ENZYME -> INHIBITOR
Responsible for a drug interaction with clobazam. Mean increase in clozabam and N-desmethylclozabam levels was 60% and 500%, respectively, after 4 weeks of concomitant therapy.
CYTOCHROME P450 3A4
METABOLIC ENZYME -> SUBSTRATE
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 7-CARBOXYCANNABIDIOL
METABOLITE INACTIVE -> PARENT
The major circulating metabolites include 7-carboxy-cannabidiol (7-COOH-CBD), which was approximately 40-fold higher than the parent.
MAJOR
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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