Cannabidiol

Brand Names: Epidiolex

Cannabidiol (KAN a bi DYE ol) has been approved by the FDA to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients 1 year of age and older.

Your epilepsy treatment should always be discussed with your healthcare provider before use. Based on their judgment and knowledge, a drug may be prescribed for other epilepsy types not included in the indications. For more information, please see the prescribing information.

How can you take cannabidiol? (Available formulations)

Cannabidiol is available as an oral solution. Food may affect cannabidiol levels, so you should take cannabidiol at the same time (concerning meals) every day. For example, if you take cannabidiol before breakfast, you should always take it before breakfast.

Who should not take cannabidiol?

If you are allergic to cannabidiol or any of the inactive ingredients, then you should not take it.

Other considerations may influence whether you should take cannabidiol. Tell your healthcare provider if you:

  • have or have had depression, mood problems, or suicidal thoughts or behavior.
  • have liver disease.
  • have abused or been dependent on prescription medicines, street drugs, or alcohol.
  • are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed.

What is important to know about taking cannabidiol?

Do not stop taking cannabidiol suddenly unless directed to do so by your healthcare provider.

As with all antiseizure medications, cannabidiol should be withdrawn gradually to minimize the risk of causing or worsening seizures or status epilepticus. You should not stop using cannabidiol suddenly unless your healthcare provider tells you to stop the medicine because of a serious side effect.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking cannabidiol with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider. Especially tell your healthcare provider if you take: any cannabis-based products.

Do not drive, operate heavy machinery, or do other dangerous activities until you know how cannabidiol affects you

Cannabidiol may cause you to feel sleepy, which may get better over time. Using certain medicines with cannabidiol such as clobazam or alcohol may increase sleepiness.

Tell your healthcare provider if you are planning to have a cannabis drug screen because cannabidiol may affect your test results. Tell the person giving the drug test that you are taking cannabidiol may affect cannabis drug screening results.

Women or those who are/plan to become pregnant

Use in Pregnancy

At this time, there is not enough evidence regarding developmental risks associated with the use of cannabidiol in pregnant people. In animal studies, there were instances of developmental issues at clinically relevant doses. However, having a seizure during pregnancy could harm both the pregnant individual and the baby. Tell your healthcare provider right away if you become pregnant. Do not start or stop taking seizure medication during pregnancy without your healthcare provider’s advice.

If you become pregnant while taking cannabidiol, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiseizure medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334.

Use during breastfeeding

There is no evidence to determine if cannabidiol is present in breast milk. It is unknown if there are effects on the breastfed infant, or if cannabidiol impacts milk production. Talk to your healthcare provider about the risks. Your healthcare provider will consider the developmental and health benefits of breastfeeding along with your need for cannabidiol and the potential effect on the infant from cannabidiol or from your epilepsy.

What are the side effects of cannabidiol?

Cannabidiol is approved by the FDA because it is safe and effective for the majority of people who take it. However, there are risks associated with all medicines. Some side effects caused by cannabidiol can be very serious, and even life-threatening. It is important to be informed about these serious reactions and to be aware of their symptoms.

Common side effects

The most common side effects that were reported in studies of cannabidiol are: sleepiness, decreased appetite, diarrhea, increase in liver enzymes, feeling very tired and weak, fever, vomiting, and infections.

Rare, but serious side effects

Suicidal thoughts or behaviors

Studies have found that people who take antiseizure medications including cannabidiol may have suicidal thoughts or behaviors, which occur in approximately 1 in 500 patients. If you experience any thoughts or impulses to hurt yourself, you should contact your healthcare provider immediately.

Hepatocellular injury

Cannabidiol may cause liver problems (hepatocellular injury). Your healthcare provider may order blood tests to check your liver before you start taking cannabidiol and during treatment. In some cases, cannabidiol treatment may need to be stopped. If you take valproic acid, it can increase your risk. Call your healthcare provider right away if you develop any of these signs and symptoms of liver problems during treatment with cannabidiol:

  • loss of appetite, nausea, vomiting
  • fever, feeling unwell, unusual tiredness
  • yellowing of the skin or the whites of the eyes (jaundice)
  • itching
  • unusual darkening of the urine
  • right upper stomach area pain or discomfort

Hypersensitivity reactions

Cannabidiol has caused hypersensitivity reactions. You should seek immediate medical care. Tell your healthcare provider if this happens as they may have you stop taking cannabidiol.