THE EPIDIOLEX DIFFERENCE:
Why FDA approval for CBD matters

EPIDIOLEX is the only FDA-approved prescription CBD medicine, which among many things, means that it has a safety and efficacy profile that has been thoroughly evaluated in clinical trials. It also means that this plant-based, never synthetic, highly purified form of CBD is manufactured to meet the high standards of the FDA’s current Good Manufacturing Practices and the World Health Organization’s Good Agricultural Practices.

EPIDIOLEX® (cannabidiol) bottle

What makes EPIDIOLEX different?

Highly Purified CBD

The active ingredient in EPIDIOLEX is nearly 100% pure CBD, which means EPIDIOLEX will not make you feel “high”

Contaminant free

Strict regulations make sure EPIDIOLEX contains no toxic heavy metals, no pesticides, and no contaminants

Accurately labeled

Each bottle is guaranteed to be consistent from dose to dose, and to contain the exact amount and concentration of CBD listed on the label. This is important because EPIDIOLEX uses personalized dosing based on weight

Made without sugar or carbohydrates

EPIDIOLEX is compatible with different epilepsy diets, including the keto diet

Naturally grown

The active ingredient in EPIDIOLEX is not synthetic. It is a highly purified form of CBD medicine that is greenhouse-grown from non-GMO plants

Rigorously tested safety

The safety profile of FDA-approved EPIDIOLEX has been studied for over 3 years. More than 40,000 families made the choice to start on EPIDIOLEX

Non–FDA approved CBD products may be inaccurately labeled

There have been studies of non–FDA approved CBD products that have shown wildly inaccurate labeling. This is because they aren’t regulated in the same way as EPIDIOLEX.

In one study published in the Journal of the American Medical Association (JAMA), of the non–FDA approved CBD products tested:

had less CBD than claimed
on the label

contained more CBD than
claimed on the label

included detectable levels of
tetrahydrocannabinol (THC) that
could cause intoxication ,
especially among children

Experience the EPIDIOLEX difference

How EPIDIOLEX® (cannabidiol) is grown & manufactured video

How EPIDIOLEX is grown & manufactured

What’s the EPIDIOLEX difference? It starts with how it’s grown and manufactured. The active ingredient in EPIDIOLEX is plant-based and not synthetic. From our (green)house to yours, there’s a lot of detail that goes into making every bottle

How EPIDIOLEX® (cannabidiol) is tested and FDA approved video

How EPIDIOLEX is tested & FDA approved

EPIDIOLEX is FDA approved so you know what to expect. In addition to a safety and efficacy profile that has been thoroughly evaluated in clinical trials, EPIDIOLEX is also guaranteed to have accurate labeling that provides consistency from bottle to bottle

How EPIDIOLEX® (cannabidiol) is prescribed and delivered video

How EPIDIOLEX is prescribed & delivered

Unlike non–FDA approved CBD products, you can only get EPIDIOLEX through a doctor’s prescription, which gives you access to medical guidance, potential insurance coverage, and continued support and resources

Understanding CBD

Now that you know more about EPIDIOLEX and the difference FDA approval makes, download this helpful resource for an in-depth exploration of cannabidiol, the active ingredient in EPIDIOLEX.

Use this resource to help answer any additional questions you may have about adding EPIDIOLEX to your treatment plan.

CBD 101 Brochure

Important Safety Information

What is the Most Important Information I Should Know About EPIDIOLEX (cannabidiol)?
Do not take if you are allergic to cannabidiol or any of the ingredients in EPIDIOLEX. EPIDIOLEX may cause liver problems. Your doctor may order blood tests to check your liver before you start taking EPIDIOLEX and during treatment. In some cases, EPIDIOLEX treatment may need to be stopped. Call your doctor right away if…

What is EPIDIOLEX (cannabidiol)?
EPIDIOLEX is a prescription medicine that is used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex … in patients 1 year of age and older. It is not known if EPIDIOLEX is safe and effective in children under 1 year of age.

Important Safety & Indications Important Safety Information & Indications

What is the Most Important Information I Should Know About EPIDIOLEX (cannabidiol)?

Do not take if you are allergic to cannabidiol or any of the ingredients in EPIDIOLEX.

EPIDIOLEX may cause liver problems. Your doctor may order blood tests to check your liver before you start taking EPIDIOLEX and during treatment. In some cases, EPIDIOLEX treatment may need to be stopped. Call your doctor right away if you start to have any of these signs and symptoms of liver problems during treatment with EPIDIOLEX :

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

EPIDIOLEX may cause you to feel sleepy, which may get better over time. Other medicines (e.g., clobazam) or alcohol may increase sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how EPIDIOLEX affects you.

Like other antiepileptic drugs, EPIDIOLEX may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any signs of depression or anxiety, thoughts about suicide or self-harm, feelings of agitation or restlessness, aggression, irritability, or other unusual changes in behavior or mood, especially if they are new, worse, or worry you.

Take EPIDIOLEX exactly as your healthcare provider tells you. Do not stop taking EPIDIOLEX without first talking to your healthcare provider. Stopping a seizure medicine suddenly can cause serious problems.

What Else Should I Know When Taking EPIDIOLEX?

The most common side effects of EPIDIOLEX include increase in liver enzymes, sleepiness, decreased appetite, diarrhea, fever, vomiting, feeling very tired and weak, rash, sleep problems, and infections.

EPIDIOLEX may affect the way other medicines work, and other medicines may affect how EPIDIOLEX works. Do not start or stop other medicines without talking to your healthcare provider. Tell healthcare providers about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and cannabis-based products.

What Additional Information Applies to Women?

If you are pregnant or plan to become pregnant, EPIDIOLEX may harm your unborn baby. You and your healthcare provider will have to decide if you should take EPIDIOLEX while you are pregnant.

If you become pregnant while taking EPIDIOLEX, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry (by calling 1-888-233-2334). The purpose of this registry is to collect information about the safety of antiepileptic medicines during pregnancy.

Because many medicines like EPIDIOLEX are passed into breast milk, talk to your healthcare provider about the best way to feed your baby while taking EPIDIOLEX.

What is EPIDIOLEX (cannabidiol)?

EPIDIOLEX is a prescription medicine that is used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients 1 year of age and older.

It is not known if EPIDIOLEX is safe and effective in children under 1 year of age.

Please refer to the EPIDIOLEX Medication Guide and Instructions for Use for additional important information.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also contact Jazz Pharmaceuticals at 1-800-520-5568.