Generic name: cannabidiol
Dosage form: Oral solution (100 mg/mL)
Drug class: Miscellaneous anticonvulsants

Medically reviewed by Melisa Puckey, BPharm. Last updated on Jun 26, 2024.

What is Epidiolex?

Epidiolex (CBD) is used to help reduce seizures in people with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex. The active ingredient in Epidiolex is CBD (cannabidiol). Epidiolex is available as a strawberry-flavored oral liquid taken twice daily.

Epidiolex is not a controlled substance. It originally was a Schedule V controlled substance, but this was removed by the U.S. Drug Enforcement Administration (DEA) in April 2020.

Epidiolex is an FDA-approved prescription medicine for adults and children who are 1 year of age and older with seizures due to Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex.

Epidiolex side effects

Common Epidiolex side effects

Common Epidiolex side effects may include:

• drowsiness;
• changes in appetite or weight;
• feeling weak or tired;
• infections (fever, flu symptoms, cough, swelling, redness, itching);
• diarrhea;
• sleep problems (insomnia);
• rash; or
• abnormal liver function tests.

Serious Epidiolex side effects 

Get emergency medical help if you have signs of an allergic reaction to Epidiolex, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have symptoms of liver problems, such as:

• nausea, vomiting, loss of appetite;
• tiredness, not feeling well;
• right-sided upper stomach pain;
• itching;
• dark urine; or
• jaundice (yellowing of the skin or eyes).

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Warnings

You should not use Epidiolex if you are allergic to cannabidiol or sesame seed oil.

Cannabidiol can harm your liver. Your liver function may need to be checked before and during treatment.

Call your doctor at once if you have symptoms such as nausea, vomiting, loss of appetite, right-sided upper stomach pain, tiredness, itching, dark urine, or yellowing of the skin or eyes.

Avoid driving or hazardous activity until you know how Epidiolex will affect you.

Some people have thoughts about suicide while taking Epidiolex. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

As with most antiepileptic drugs, Epidiolex should not be stopped suddenly due to increased seizure frequency and status epilepticus; the dose can be slowly tapered following your healthcare provider's instructions. 

Before taking this medicine

Epidiolex is not approved for use by anyone younger than 1 year old.

To make sure Epidiolex is safe for you, tell your doctor if you have ever had:

• liver disease;
• drug or alcohol addiction;
• depression, a mood disorder; or
• suicidal thoughts or actions.

Some people have thoughts about suicide while taking Epidiolex. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Pregnancy

Talk to your healthcare provider if you are pregnant or plan to become pregnant. Tell your healthcare provider right away if you become pregnant while taking this medicine. You and your healthcare provider will decide if you should take this while you are pregnant. If you become pregnant while taking this medicine, talk to your healthcare provider about registering for both the Epidiolex Pregnancy Surveillance Program and the North American Antiepileptic Drug (NAAED) registry. The purpose of the surveillance program and exposure registry is to collect information about the safety of this medicine and other antiepileptic drugs during pregnancy. It is not known whether cannabidiol will harm an unborn baby.

Breastfeeding

It may not be safe to breastfeed while using Epidiolex. Ask your doctor about any risks.

How should I take Epidiolex?

Take Epidiolex exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Epidiolex is usually taken 2 times per day. Take the medicine at the same time each day.

You may take Epidiolex with or without food, but take it the same way each time.

Measure this medicine carefully. Use the adapter and oral dosing syringes provided. This medicine is supplied with 1 mL and 5 mL oral dispensing syringes, follow your healthcare providers on dose and which syringe to use.  Make sure the dosing syringe is completely dry before measuring your dose.

Epidiolex liquid may be given through a feeding tube that is not made of polyvinyl chloride (PVC).

Cannabidiol can harm your liver. Your liver function may need to be checked before and during treatment. You may need to stop taking Epidiolex based on the results.

Epidiolex can affect a drug-screening test and you may test positive for cannabis (marijuana). Tell the laboratory staff that you use cannabidiol.

Do not stop using Epidiolex suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor's instructions about tapering your dose.

Dosing information

Usual Adult Dose for Lennox-Gastaut Syndrome

Initial dose: 2.5 mg/kg orally twice a day
-After 1 week, may increase dose to 5 mg/kg orally twice a day
-For patients tolerating therapy and requiring further seizure reduction, may increase in 2.5 mg/kg twice a day increments as tolerated but no more frequently than every other day
Maintenance dose: 10 to 20 mg/kg/day
Maximum dose: 20 mg/kg/day
Comments:
-A dose of 20 mg/kg/day has demonstrated a greater reduction in seizure rates, but is associated with an increase in adverse reactions.
-Consistent dosing with respect to meals is recommended to reduce variability in cannabidiol plasma exposure.

Usual Adult Dose for Dravet Syndrome

Initial dose: 2.5 mg/kg orally twice a day
-After 1 week, may increase dose to 5 mg/kg orally twice a day
-For patients tolerating therapy and requiring further seizure reduction, may increase in 2.5 mg/kg twice a day increments as tolerated but no more frequently than every other day
Maintenance dose: 10 to 20 mg/kg/day
Maximum dose: 20 mg/kg/day
Comments:
-A dose of 20 mg/kg/day has demonstrated a greater reduction in seizure rates, but is associated with an increase in adverse reactions.
-Consistent dosing with respect to meals is recommended to reduce variability in cannabidiol plasma exposure.

Usual Adult Dose for Tuberous Sclerosis Complex

Initial dose: 2.5 mg/kg orally twice a day
-Increase dose in weekly increments of 2.5 mg twice a day (5 mg/kg/day) as tolerated to 12.5 mg/kg twice a day
-For patients requiring a more rapid titration, the dose may be increased no more frequently than every other day
Maintenance dose: 25 mg/kg/day
Maximum dose: 25 mg/kg/day
Comments:
-The effectiveness of doses lower than 25 mg/kg/day has not been studied.
-Consistent dosing with respect to meals is recommended to reduce variability in cannabidiol plasma exposure.

Usual Pediatric Dose for Lennox-Gastaut Syndrome (1 year or older)

Initial dose: 2.5 mg/kg orally twice a day
-After 1 week, may increase dose to 5 mg/kg orally twice a day
-For patients tolerating therapy and requiring further seizure reduction, may increase in 2.5 mg/kg twice a day increments as tolerated but no more frequently than every other day
Maintenance dose: 10 to 20 mg/kg/day
Maximum dose: 20 mg/kg/day
Comments:
-A dose of 20 mg/kg/day has demonstrated a greater reduction in seizure rates, but is associated with an increase in adverse reactions.
-Consistent dosing with respect to meals is recommended to reduce variability in cannabidiol plasma exposure.

Usual Pediatric Dose for Dravet Syndrome (1 year or older)

Initial dose: 2.5 mg/kg orally twice a day
-After 1 week, may increase dose to 5 mg/kg orally twice a day
-For patients tolerating therapy and requiring further seizure reduction, may increase in 2.5 mg/kg twice a day increments as tolerated but no more frequently than every other day
Maintenance dose: 10 to 20 mg/kg/day
Maximum dose: 20 mg/kg/day

Comments:
-A dose of 20 mg/kg/day has demonstrated a greater reduction in seizure rates, but is associated with an increase in adverse reactions.
-Consistent dosing with respect to meals is recommended to reduce variability in cannabidiol plasma exposure.

Usual Pediatric Dose for Tuberous Sclerosis Complex (1 year or older)

Initial dose: 2.5 mg/kg orally twice a day
-Increase dose in weekly increments of 2.5 mg twice a day (5 mg/kg/day) as tolerata to 12.5 mg/kg twice a day
-For patients requiring a more rapid titration, the dose may be increased no more frequently than every other day
Maintenance dose: 25 mg/kg/day
Maximum dose: 25 mg/kg/day

Comments:
-The effectiveness of doses lower than 25 mg/kg/day has not been studied.
-Consistent dosing with respect to meals is recommended to reduce variability in cannabidiol plasma exposure.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What to avoid

Drinking alcohol with Epidiolex can increase drowsiness.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

What other drugs will affect Epidiolex?

Using Epidiolex with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your other medicines, especially:

• other seizure medications (especially clobazam or valproate); or
• cannabis-based products.

This list is not complete. Many other drugs can interact with cannabidiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using. Click the link below to check for interactions with this medicine.

Storage

• Store at room temperature between 68ºF to 77ºF (20ºC to 25ºC).  
• Always store bottle in an upright position.
• Do not freeze.
• Keep the child-resistant cap tightly closed.
• Use within 12 weeks of first opening the bottle. 
• Throw away any unused medicine after 12 weeks.
• Keep this and all medicines out of the reach of children. 

Epidiolex Ingredients 

Active ingredient: cannabidiol

Inactive ingredients: dehydrated alcohol, sesame seed oil, strawberry flavor, and sucralose.

Epidiolex is gluten-free, it does not contain wheat, barley, or rye. 

Company

Jazz Pharmaceuticals, Inc. Palo Alto, CA 94304 

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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