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Overview: Epidiolex is used to treat seizures associated with certain conditions. Common side effects include sleepiness, loss of appetite, diarrhea, and vomiting. Epidiolex can make you sleepy and affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how Epidiolex affects you.

Uses

What is Epidiolex used for?

Epidiolex (cannabidiol) is commonly used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex.

Epidiolex may also be used for other conditions as determined by your healthcare provider.

How does Epidiolex work (mechanism of action)?

Seizures happen when too many nerve signals are sent between brain cells too quickly. Epidiolex is thought to work by slowing down overactive signals and making seizures less likely.

How is Epidiolex supplied (dosage forms)?

Brands and other names

  • Epidiolex

Dosage forms and strengths

  • 100 mg/mL oral solution

How should I store Epidiolex?

Epidiolex should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store upright in a cool, dry place. Do not freeze. Throw away any unused medicine 12 weeks after opening the bottle.

Side Effects

What are the most common side effects of Epidiolex?

The most common side effects of Epidiolex are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Liver damage (see below)
  • Sleepiness
  • Loss of appetite
  • Diarrhea
  • Vomiting
  • General feeling of being unwell, tired, or not having your usual energy
  • Rash
  • Fever
  • Trouble sleeping
  • Infections

There may be other side effects of Epidiolex that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Epidiolex?

While less common, the most serious side effects of Epidiolex are described below, along with what to do if they happen.

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Epidiolex. Keep all appointments to have your blood checked. Call your healthcare provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Decreased Alertness or Coordination. Epidiolex can make you sleepy and affect your alertness and coordination. Do not drive or do other activities that require alertness or coordination until you know how Epidiolex affects you.

Suicidal Thoughts and Actions. Epidiolex may cause suicidal thoughts or actions in a small number of people. If you are about to harm yourself, call 911 or call or text 988, the Suicide & Crisis Lifeline. Call your healthcare provider right away if you have any of the following symptoms.

  • New or increased thoughts of suicide or death
  • Suicide attempt
  • New or increased feelings of anxiety, depression, or other unusual changes in mood or behavior

Mood or Behavior Changes. Epidiolex may rarely cause mood or behavior changes. Call your healthcare provider right away if you or a caregiver notice any of the following symptoms.

  • Agitation or restlessness
  • Panic attacks
  • Trouble sleeping
  • Irritability (new or getting worse)
  • Aggressive behavior, anger, or violence
  • Dangerous and impulsive behavior (gambling, sex, shopping, eating)
  • Excessive happiness
  • Talking more or faster than usual

Severe Allergic Reactions. Epidiolex may cause allergic reactions, which can be serious. Stop taking Epidiolex and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Warnings & Precautions

Who should not use Epidiolex?

Allergies to Ingredients. People who are allergic to any of the following should not take Epidiolex.

  • Epidiolex
  • Cannabidiol
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Epidiolex.

What should I know about Epidiolex before using it?

Do not take Epidiolex unless it has been prescribed to you by a healthcare provider. Take it as prescribed.

Epidiolex should be taken consistently with or without food. This helps keep the amount of medicine in your body consistent.

Read and follow the “Instructions for Use” that come with your medicine. Only use the provided syringe to measure your dose. A household spoon is not an accurate measuring device and may cause you to take the wrong dose. 

Do not share Epidiolex with other people, even if they have the same condition as you. It may harm them.

Keep Epidiolex out of the reach of children.

While Epidiolex helps make seizures less likely, it does not cure them. Do not stop taking Epidiolex without talking to your healthcare provider. Stopping Epidiolex suddenly may cause an increase in seizure activity, which can be serious.

While you are taking Epidiolex, a drug test (urine or blood) for cannabis, marijuana, or THC may come back positive. Talk to your healthcare provider if you have concerns

What should I tell my healthcare provider before using Epidiolex?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Epidiolex is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

  • Liver problems
  • Mental health problems, including depression, mood problems, or thoughts of suicide
  • Substance use disorder
  • Alcohol use disorder

Other Medicines and Supplements. Epidiolex may interact with other medicines and supplements. Before taking Epidiolex, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how Epidiolex could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you if you should take Epidiolex while you are pregnant or trying to get pregnant. If you become pregnant while taking Epidiolex, you can sign up for the North American Antiepileptic Drug Pregnancy Registry by calling 888-233-2334 or at www.aedpregnancyregistry.org. This registry collects safety information about the use of antiepileptic medicines during pregnancy.

Breastfeeding. It is not known if Epidiolex passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take Epidiolex while breastfeeding.

How can I get more information about Epidiolex?

For more information about Epidiolex, you can visit the manufacturer’s website at www.epidiolex.com or call them at 800-520-5568.

Interactions

Does Epidiolex interact with foods or drinks?

Epidiolex can increase levels of caffeine, a mild stimulant commonly found in coffee, tea, and sodas, causing it to have more effect. Ask your healthcare provider if it is safe to drink caffeine while taking this medicine.

It is unknown if drinking alcohol will affect Epidiolex. The risk of dizziness and drowsiness may be increased if you drink alcohol while taking Epidiolex. Alcohol and Epidiolex can both cause liver damage. Your risk of liver damage may be increased if you drink alcohol while taking Epidiolex. It is best to limit the amount of alcohol you drink.

Does Epidiolex interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Epidiolex.

  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • Theophylline (Theo-24, Elixophyllin), which is a medicine for asthma or certain other breathing problems
  • Tizanidine (Zanaflex), which is a muscle relaxant
  • A medicine for HIV or AIDS
  • Bupropion, which is a medicine commonly used for depression and to help stop smoking
  • Gemfibrozil (Lopid) or fenofibrate (Tricor), which is a medicine for high cholesterol
  • Any medicine for seizures, such as clobazam, carbamazepine, phenytoin, or phenobarbital
  • Morphine, which is a medicine used for certain types of pain
  • A benzodiazepine, such as diazepam (Valium and others), or lorazepam (Ativan and others), which is a medicine used for anxiety, muscle spasms, or seizures
  • An immunosuppressant, such as everolimus, sirolimus, or tacrolimus
  • Digoxin (Lanoxin), which is a medicine used to treat irregular heartbeat and some types of heart failure
  • Valproic acid, divalproex sodium, and valproate sodium (Depakote and others), which is a medicine used for seizures and other conditions
  • Any other medicine that causes dizziness and sleepiness, such as prescription pain medicines, sleep medicines, or medicines for anxiety

Many other medicines may alter the blood levels of Epidiolex, and vice versa. Tell your healthcare provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Epidiolex. Always check with your healthcare provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Epidiolex?

If you or someone else has used too much Epidiolex, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Epidiolex?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.

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