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cannabidiol

Epidyolex · ATC code N03AX

Key facts
Active substance
cannabidiol
Drug class
Anticonvulsant agent
ATC code
N03AX
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Epidyolex 100 mg/ml oral solution
Marketing authorisation holder
Jazz Pharmaceuticals Ireland Limited
Information as of
2026-10-27

Key facts

Cannabidiol is an antiepileptic medicine (Epidyolex oral solution). It is used as adjunctive therapy for seizures associated with Lennox-Gastaut syndrome, Dravet syndrome and tuberous sclerosis complex.

What it is used for

  • Adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS), with clobazam, in patients 2 years and older
  • Adjunctive therapy of seizures associated with tuberous sclerosis complex (TSC), in patients 2 years and older

Dosing

  • Initiated and supervised by physicians experienced in treating epilepsy
  • LGS and DS: start 2.5 mg/kg twice daily for one week, then maintenance 5 mg/kg twice daily; maximum 10 mg/kg twice daily (20 mg/kg/day)
  • TSC: same start; weekly increments of 2.5 mg/kg twice daily up to a maximum of 12.5 mg/kg twice daily (25 mg/kg/day)
  • Increases above 10 mg/kg/day only after weighing benefit and risk and with the full monitoring schedule
  • With concomitant antiepileptic drugs, dose adjustment of cannabidiol or the other medicine may be needed

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Transaminase elevations greater than 3 times the upper limit of normal (ULN) together with bilirubin greater than 2 times the ULN

Important warnings

  • Dose-related elevations of liver transaminases (ALT/AST), typically in the first two months, particularly with concomitant valproate
  • Clobazam also increases the incidence of transaminase elevations; adjustment of valproate or clobazam should be considered
  • Patients with baseline transaminases above the ULN have higher rates of elevations
  • Further warnings (e.g. somnolence, suicidal ideation) are in the full text

Side effects

  • Most common: somnolence (23%), decreased appetite (21%), diarrhoea (20%), pyrexia (16%), vomiting (12%), fatigue (10%)
  • Also very common: decreased haemoglobin and haematocrit
  • Common: pneumonia, urinary tract infection, irritability, aggression, lethargy, seizure, increased AST/ALT

Interactions

  • Strong CYP3A4/2C19 inducers (rifampicin, carbamazepine, enzalutamide, mitotane, St John's wort) lower cannabidiol and active-metabolite levels; dose adjustment may be necessary
  • Caution with inhibitors of UGT1A7, UGT1A9 and UGT2B7
  • Valproate and clobazam increase the risk of transaminase elevations

Pregnancy and breastfeeding

  • Pregnancy: limited data; should not be used unless the potential benefit to the mother clearly outweighs the risk to the foetus
  • Breast-feeding: no clinical data on presence in human milk; toxicological changes seen in lactating animals

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • EpidyolexJazz Pharmaceuticals Ireland Limited · EMEA/H/C/004675

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Epidyolex
Liechtenstein
Epidyolex
Norway
Epidyolex

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

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Sources

  1. European Medicines Agency. Epidyolex – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/epidyolex-epar-product-information_en.pdf
  2. Wikidata (CC0): ATC N03AX.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.