Cannabidiol is a prescription medicine indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older. MedsAcross supplies Cannabidiol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older. EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients 1 year of age and older
Source: US FDA prescribing information
The precise mechanisms by which EPIDIOLEX exerts its anticonvulsant effect in humans are unknown. Cannabidiol does not appear to exert its anticonvulsant effects through interaction with cannabinoid receptors.
Source: US FDA prescribing information
• Obtain serum transaminases (ALT and AST) and total bilirubin levels in all patients prior to starting treatment. • See Full Prescribing Information for titration. Seizures Associated with Lennox-Gastaut Syndrome or Dravet Syndrome • The recommended starting dosage is 2.5 mg/kg by mouth twice daily (5 mg/kg/day). After one week, the dosage can be increased to a maintenance dosage of 5 mg/kg twice daily (10 mg/kg/day). • Based on individual clinical response and tolerability, EPIDIOLEX can be increased up to a maximum recommended maintenance dosage of 10 mg/kg twice daily (20 mg/kg/day). Seizures Associated with Tuberous Sclerosis Complex • The recommended starting dosage is 2.5 mg/kg by mouth twice daily (5 mg/kg/day). Increase the dose weekly by 2.5 mg/kg twice daily (5 mg/kg/day), as tolerated, to a recommended maintenance dosage of 12.5 mg/kg twice daily (25 mg/kg/day).
Source: US FDA prescribing information
EPIDIOLEX is contraindicated in patients with a history of hypersensitivity to cannabidiol or any of the ingredients in the product. Hypersensitivity to cannabidiol or any of the ingredients in EPIDIOLEX
Source: US FDA prescribing information
• Hepatic Injury: EPIDIOLEX can cause transaminase elevations. Concomitant use of valproate and higher doses of EPIDIOLEX increase the risk of transaminase elevations. See Full Prescribing Information for serum transaminase and bilirubin monitoring recommendations. • Somnolence and Sedation: Monitor for somnolence and sedation and advise patients not to drive or operate machinery until they have gained sufficient experience on EPIDIOLEX. • Suicidal Behavior and Ideation: Monitor patients for suicidal behavior and thoughts. • Hypersensitivity Reactions: Advise patients to seek immediate medical care. Discontinue and do not restart EPIDIOLEX if hypersensitivity occurs. • Withdrawal of Antiepileptic Drugs: EPIDIOLEX should be gradually withdrawn to minimize the risk of increased seizure frequency and status epilepticus.
Source: US FDA prescribing information
The following important adverse reactions are described elsewhere in labeling: • Hepatic Injury • Somnolence and Sedation • Suicidal Behavior and Ideation • Hypersensitivity Reactions • Withdrawal of Antiepileptic Drugs The most common adverse reactions (10% or more for EPIDIOLEX and greater than placebo) in patients with Lennox-Gastaut syndrome or Dravet syndrome are: somnolence, decreased appetite, diarrhea, transaminase elevations, fatigue, malaise, and asthenia, rash, insomnia, sleep disorder, and poor quality sleep, and infections. The most common adverse reactions (10% or more for EPIDIOLEX and greater than placebo) in patients with tuberous sclerosis complex are: diarrhea, transaminase elevations, decreased appetite, somnolence, pyrexia, and vomiting.
Source: US FDA prescribing information
• Strong inducer of CYP3A4 or CYP2C19: Consider dose increase of EPIDIOLEX. • Consider a dose reduction of substrates of CYP1A2, CYP2C8, UGT1A9, and orally administered P-gp substrates. • A lower starting dose of orally administered everolimus is recommended. • Consider dose modification of CYP2B6 or CYP2C19 substrates.
Source: US FDA prescribing information
Store EPIDIOLEX in an upright position at 20°C to 25°C (68°F to 77°F), excursions are permitted between 15°C to 30°C (59°F to 86°F). Do not freeze.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Cannabidiol, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Epidiolex 100 mg/mL oral solutionOral | Jazz Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Cannabidiol and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Cannabidiol, including Epidiolex.
Yes. The US FDA first approved Cannabidiol on 25 June 2018, according to Drugs@FDA.
Yes. Cannabidiol has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Cannabidiol is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Cannabidiol is classified under ATC code N03AX24 (Cannabidiol).
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