Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following important adverse reactions are described elsewhere in labeling: • Hepatic Injury [see Warnings and Precautions ( 5.1 )] • Somnolence and Sedation [see Warnings and Precautions ( 5.2 )] • Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.3 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] • Withdrawal of Antiepileptic Drugs [see Warnings and Precautions ( 5.5 )] The most common adverse reactions (10% or more for EPIDIOLEX and greater than placebo) in patients with Lennox-Gastaut syndrome or Dravet syndrome are: somnolence;
decreased appetite;
transaminase elevations;
fatigue, malaise, and asthenia;
insomnia, sleep disorder, and poor quality sleep;
and infections.
( 6.1 ) The most common adverse reactions (10% or more for EPIDIOLEX and greater than placebo) in patients with tuberous sclerosis complex are: diarrhea;
transaminase elevations;
decreased appetite;
somnolence;
5 WARNINGS AND PRECAUTIONS • Hepatic Injury: EPIDIOLEX can cause transaminase elevations.
Concomitant use of valproate and higher doses of EPIDIOLEX increase the risk of transaminase elevations.
See Full Prescribing Information for serum transaminase and bilirubin monitoring recommendations.
( 5.1 ) • Somnolence and Sedation: Monitor for somnolence and sedation and advise patients not to drive or operate machinery until they have gained sufficient experience on EPIDIOLEX.
( 5.2 ) • Suicidal Behavior and Ideation: Monitor patients for suicidal behavior and thoughts.
Like all medications, Epidiolex can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: