Epidiolex

E275978

Epidiolex is a prescription cannabidiol-based medication used to treat certain rare and severe forms of epilepsy.

All labels observed (1)

Label Occurrences
Epidiolex canonical 1

How this entity was disambiguated

Statements (48)

Predicate Object
instanceOf antiepileptic drug
cannabidiol-based medication
pharmaceutical drug
ageGroupIndication adult patients
pediatric patients
approvedBy European Medicines Agency
Food and Drug Administration
surface form: U.S. Food and Drug Administration
ATCCode N03AX24
blackBoxWarning risk of suicidal thoughts and behavior similar to other antiepileptic drugs
canCause liver injury
commonAdverseEffect decreased appetite
diarrhea
elevated liver enzymes
fatigue
somnolence
contains plant-derived cannabidiol
controlledSubstanceStatusInUnitedStates not controlled under the Controlled Substances Act
developedBy GW Pharmaceuticals
doesNotContain tetrahydrocannabinol
dosageForm oral solution
drugInteractionWith CYP2C19 substrates
CYP3A4 substrates
clobazam
valproate
EMAAuthorizationYear 2019
FDAApprovalYear 2018
halfLife approximately 56 to 61 hours
hasActiveIngredient cannabidiol
indicatedFor Dravet syndrome
Lennox-Gastaut syndrome
tuberous sclerosis complex-associated seizures
isFirst FDA-approved drug derived from cannabis
legalStatusInEuropeanUnion prescription-only medicine
legalStatusInUnitedStates prescription-only medicine
marketedBy Jazz Pharmaceuticals
mechanismOfAction modulation of endocannabinoid system
metabolism hepatic
metabolizedBy CYP2C19
CYP3A4
pregnancyCategory data limited; use only if potential benefit justifies potential risk
proteinBinding high
requiresMonitoring liver function tests
routeOfAdministration oral
scheduleStatusHistoryInUnitedStates previously Schedule V controlled substance
therapeuticArea epileptology
neurology
usedFor treatment of rare forms of epilepsy
treatment of seizures

How these facts were elicited

Referenced by (1)

Full triples — surface form annotated when it differs from this entity's canonical label.

CBD approvedDrugForm Epidiolex