Is Cannabidiol approved by the US FDA?

Drugs@FDA lists 1 application product line for Cannabidiol, including EPIDIOLEX (Prescription).

Is Cannabidiol authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Cannabidiol: Epidyolex.

Are there safety signals or safety updates for Cannabidiol?

EMA PRAC: 3 entries; US FDA: 1 entry (latest 2026-06-05).

Active substance

Cannabidiol

US FDA 1
EMA 1
Health Canada 1
NHS prices 1
Safety 4

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
EPIDIOLEX	100MG/ML	solution · oral	JAZZ PHARMS RES	Prescription	25 Jun 2018

EMA European Union — centrally authorised medicines

Epidyolex Jazz Pharmaceuticals Ireland Limited · Authorised · authorised 19 Sep 2019 · ATC N03AX

Therapeutic indication (EMA)

Epidyolex is indicated for use as adjunctive therapy of seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome (DS), in conjunction with clobazam, for patients 2 years of age and older.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
EPIDIOLEX	02543079	100 MG / ML	SOLUTION · ORAL	JAZZ PHARMACEUTICALS RESEARCH UK LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
NHS Drug Tariff	Cannabidiol 100mg/ml oral solution sugar free	£850.29	100 ml	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 5 Jun 2026 EPIDIOLEX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 10 Mar 2022 PRAC signal: Drug interaction with cannabidiol leading to calcineurin inhibitors and mTOR inhibitors serum levels increased and toxicity
Action for MAH: update of the product information: Yes
EMA PRAC 10 Jun 2021 PRAC signal: Drug interaction with cannabidiol leading to calcineurin inhibitors and mTOR inhibitors serum levels increased and toxicity
Action for MAH: update of the product information: No
EMA PRAC 29 Oct 2020 PRAC signal: Drug interaction with cannabidiol leading to calcineurin inhibitors and mTOR inhibitors plasma concentrations increase and toxicity
Action for MAH: update of the product information: Yes

All safety entries for cannabidiol →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.