EPIDIOLEX® (cannabidiol) is the first in a new class of AEDs for seizures associated with LGS or Dravet syndrome in patients 2 years and older1

Important Considerations

Adverse Reactions

Most Common Adverse Reactions (≥10% and Greater Than Placebo) in All Three Phase 3 Clinical Trials (Patients Reporting, %)*2

 Placebo
(n=227)
EPIDIOLEX
10 mg/kg/day
(n=75)
EPIDIOLEX
20 mg/kg/day
(n=238)
Hepatic Disorders 
Transaminases
elevated
3816
Gastrointestinal
Disorders
 
Decreased appetite51622
Diarrhea9920
Nervous System
Disorders
 
Somnolence82325
Fatigue, malaise,
asthenia
41112
Insomnia, sleep
disorder, poor
quality sleep
4115
Infections 
Infection, all314140
Other 
Rash3713
Hepatic Disorders
Transaminases elevated3
Transaminases elevated8
Transaminases elevated16
Gastrointestinal Disorders
Decreased appetite5
Decreased appetite16
Decreased appetite22
Diarrhea9
Diarrhea9
Diarrhea20
Nervous System Disorders
Somnolence8
Somnolence23
Somnolence25
Fatigue, malaise, asthenia4
Fatigue, malaise, asthenia11
Fatigue, malaise, asthenia12
Insomnia, sleep disorder, poor quality sleep4
Insomnia, sleep disorder, poor quality sleep11
Insomnia, sleep disorder, poor quality sleep5
Infections
Infection, all31
Infection, all41
Infection, all40
Other
Rash3
Rash7
Rash13

Adverse reactions during the 14-week treatment period of the Phase 3 controlled trials.

  • Hematologic abnormalities, decreased weight, and increased creatinine levels were also observed2
  • In controlled studies, the rate of discontinuation for any adverse event was 1% for patients treated with placebo, 3% with EPIDIOLEX 10 mg/kg/day and 12% with EPIDIOLEX 20 mg/kg/day2
  • The most frequent causes of discontinuation were transaminase elevation, somnolence, sedation, and lethargy2
  • The adverse event profile was consistent across both indications, in both children and adults2
850 patients with LGS and Dravet syndrome have been treated with EPIDIOLEX in controlled and uncontrolled trials (N=689) and an expanded access program and other compassionate use programs (N=161)2

482 patients treated for more than
1 year
 

50 patients treated for more than
2 years