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The following safety information outlines important considerations and potential risks associated with the use of Epidiolex (cannabidiol). Review these warnings carefully and consult your healthcare provider if you have any questions or concerns.

• Liver Damage: Epidiolex may cause liver damage, especially if used with valproate (e.g., valproic acid, divalproex) or clobazam. Individuals with pre-existing liver issues or those on high doses of Epidiolex are also at increased risk. Symptoms such as dark urine, fatigue, stomach pain, nausea, vomiting, or yellowing of the skin or eyes should be reported to your healthcare provider immediately. Regular liver function tests are recommended.

• Drowsiness and Sleepiness: This medication can impair your ability to concentrate and react. The risk increases with alcohol consumption or when combined with other drowsiness-inducing substances like benzodiazepines and opioids. Avoid driving or engaging in activities that require full alertness until you understand how the medication affects you. Drowsiness often diminishes with ongoing treatment.

• Suicidal Thoughts or Actions: As with other antiepileptic medications, Epidiolex may elevate the risk of suicidal thoughts or behavior. Monitor for signs of depression or unusual mood changes, and inform your healthcare provider of any concerns. If suicidal thoughts occur, seek immediate medical assistance.

• Severe Allergic Reactions: Although uncommon, allergic reactions such as hives, swelling, red skin, or breathing difficulties may occur. Seek emergency medical care if these symptoms develop.

• Withdrawal Symptoms: Abruptly stopping Epidiolex can lead to withdrawal effects, including increased seizure frequency and duration. To minimize this risk, collaborate with your healthcare provider to gradually reduce the dosage if discontinuation is necessary.

Always follow your healthcare provider's guidance and attend all scheduled medical appointments to ensure safe and effective use of Epidiolex.

When taking this medication, you may experience some common side effects such as drowsiness, tiredness, trouble sleeping, poor appetite, and diarrhea. These are generally mild and should not cause concern unless they persist or worsen, in which case contacting a healthcare provider is advisable. Some users also report an increase in liver enzymes or rashes, but these effects are not prevalent.

More severe side effects, though rare, need immediate medical attention. These include symptoms of liver damage like persistent nausea, vomiting, loss of appetite, stomach pain, yellowing of the skin or eyes, and dark urine. Be vigilant for signs of infection such as a persistent sore throat, fever, chills, or cough. Mental health changes, such as depression or suicidal thoughts, are also serious and require prompt consultation with a healthcare professional.

In very rare cases, there may be an allergic reaction characterized by rash, swelling, severe dizziness, or trouble breathing. Immediate medical help is crucial if these symptoms arise. If you experience unexpected side effects or any other concerning symptoms, it is important to consult a healthcare provider promptly.

This medication can impact the way your body processes other drugs, potentially altering their effectiveness. Notably, it may affect medications like fezolinetant and mavacamten. It's important to inform your doctor or pharmacist if you're using other substances that cause drowsiness. These include opioid pain or cough medications (like codeine or hydrocodone), alcohol, marijuana, sleep or anxiety treatments (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and antihistamines (such as cetirizine, diphenhydramine).

Be vigilant with over-the-counter products for allergies or colds, as they might contain ingredients that can cause drowsiness. Consult your pharmacist to ensure these products are safe for you to use. Additionally, this medication might influence certain laboratory test results, including cannabis drug screenings, so it's crucial to inform all healthcare professionals and lab staff that you are taking this medication.