Serious side effects of Epidiolex are rare. It is important to be aware of possible reactions and what to do if they happen. Only a very small number of people have died from them.
- Read the package insert for a complete list of all reactions to Epidiolex.
- Call your provider's office right away if any of these problems occur.
Allergic or hypersensitivity reactions: Tell your provider if you develop any redness, itching, rash, or swelling after starting Epidiolex. These may need treatment or the drug may be stopped.
- Epidiolex should not be given to anyone with a prior reaction or sensitivity to cannabidiol or any of the other ingredients in the product. Sesame seed oil is present in Epidiolex.
Liver problems: Increases in liver function can be seen on blood tests in some people taking Epidiolex, especially people who may also be taking valproate (also called valproic acid or sodium valproate). It has also been seen in people taking clobazam with Epidiolex.
- Increases in the liver function tests were usually seen in the first two months of starting the drug. The changes can be seen months later however, especially if a person also takes valproate.
- In 1 out of 3 people the blood tests returned to normal without any changes in medicine. In other people, the problems went away when Epidiolex was stopped or the dose of valproate or Epidiolex was lowered.
Monitoring for liver function: Blood tests for liver function should be done before starting Epidiolex and after taking it for 1, 3 and 6 months. Talk to your health care provider about when to have these done.
Some symptoms of liver problems may include:
- Black or pale color of bowel movements
- Loss of appetite
- Nausea, upset stomach, vomiting
- Stomach pain
- Yellow eyes or skin
- Dark urine
Tell your health care provider right away if you notice any of these problems. Do not stop taking Epidiolex or any seizure medicine without your doctor's advice.
Somnolence and Sedation: Some people taking Epidiolex may be unusually tired, sleepy or sedated. In controlled trials, these symptoms were seen in 1 out of 3 people taking the drug compared to 1 out of 10 people taking a placebo (inactive pill).
- Sleepiness and sedation happened more often in people also taking clobazam (Onfi).
- The symptoms were seen early when the medicine was started and tended to improve over time.
- Other medicines that cause sedation or sleepiness or using alcohol could make this worse in people taking Epidiolex.
- Talk to your health care provider if sleepiness happens and if you are taking clobazam (Onfi) or other substances that cause sleepiness.
Suicidal thoughts and behavior: In 2008, the Food and Drug Administration (FDA) reviewed data from drug studies that showed a possible relationship between many seizure medicines and suicidal thoughts and behavior. Together, these thoughts and behavior are called suicidality. According to the FDA’s Alert, among the patients with epilepsy in these drug studies, more had symptoms of suicidality than people taking a placebo or inactive substance - 3.5 of 1,000 people taking a seizure medicine had suicidality compared to 1 of 1,000 people taking a placebo.
- Taking seizure medicines may increase the risk of having suicidal thoughts or actions.
- Do not make any changes to the medicines without first talking to your prescribing health care provider.
- Pay close attention to any day-to-day changes in mood, behavior and actions. These changes can happen very quickly so it is important to be mindful of any sudden differences.
- Be aware of common warning signs that might be a signal for risk of suicide. Some of these are:
- Talking or thinking about wanting to hurt yourself or end your life
- Withdrawing from friends and family
- Becoming depressed or having your depression get worse
- Becoming preoccupied with death and dying
- Giving away prized possessions
- Contact your health care provider before stopping any seizure medicine. This could possibly lead to worsening of seizure and mood.
Withdrawal of seizure medicines: Epidiolex, just like any seizure medicine, should be withdrawn slowly when it is being stopped. Stopping Epidiolex or any seizure medicine suddenly can lead to more seizures and life-threatening status epilepticus.
- If Epidiolex needs to be stopped quicker due to another problem, follow your doctor's advice on how to make changes.