Possible side effects

EPIDIOLEX may cause liver problems. Your doctor may order blood tests to check your liver before and during EPIDIOLEX 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

Your doctor may order blood tests to monitor for other EPIDIOLEX side effects. 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 of these symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• attempt to commit suicide
• new or worse depression
• new or worse anxiety
• feeling agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood

How can I watch for early symptoms of suicidal thoughts and actions?

• Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings
• Keep all follow-up visits with your healthcare provider as scheduled

Do not stop taking EPIDIOLEX without first talking to your healthcare provider. Stopping an antiseizure medicine such as EPIDIOLEX suddenly can cause you to have seizures more often or seizures that do not stop (status epilepticus).

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

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

• The most common side effects include increase in liver enzymes, sleepiness, decreased appetite, diarrhea, fever, vomiting, feeling very tired and weak, rash, sleep problems, and infections
• Across studies in Lennox-Gastaut syndrome (LGS), Dravet syndrome, and tuberous sclerosis complex (TSC), EPIDIOLEX was found to have a consistent safety profile in both children and adults
• In the LGS and Dravet syndrome studies, the rate of discontinuation (patients who stopped taking the medicine) for any side effect was 1% for patients taking placebo and 3% for patients taking EPIDIOLEX 10 mg/kg/day. For patients taking EPIDIOLEX 20 mg/kg/day, the rate of discontinuation for any side effect was 12%
• In the TSC study, the rate of discontinuation for any side effect was 3% for patients taking placebo and 11% for patients taking EPIDIOLEX 25 mg/kg/day
• The most frequent causes of discontinuation were increase in liver enzymes and sleepiness in the LGS and Dravet syndrome studies, and rash in the TSC study
• EPIDIOLEX can cause weight loss
• Your doctor may also order blood tests to look out for other side effects
• These are not all of the possible EPIDIOLEX side effects. For more information, ask your healthcare provider or pharmacist

EPIDIOLEX may interact with some antiseizure medicines or other medicines you are taking. Do not start or stop other medicines without talking to your doctor. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and cannabis-based products.