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Epidiolex

Last reviewed on RxList: 9/14/2020
Epidiolex Side Effects Center

What Is Epidiolex?

Epidiolex (cannabidiol) oral solution, CX is a plant-derived cannabidiol (CBD) antiepileptic drug (AED) indicated for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.

What Are Side Effects of Epidiolex?

Common side effects of Epidiolex include:

Dosage for Epidiolex

The recommended starting dosage of Epidiolexis 2.5 mg/kg taken twice daily (5 mg/kg/day). After one week, the dosage can be increased to a maintenance dosage of 5 mg/kg twice daily (10 mg/kg/day).

What Drugs, Substances, or Supplements Interact with Epidiolex?

Epidiolex may interact with inhibitors or inducers of CYP3A4 or CYP2C19, theophylline, caffeine, bupropion, efavirenz, diflunisal, propofol, fenofibrate, gemfibrozil, lamotrigine, morphine, lorazepam, and phenytoin. Tell your doctor all medications and supplements you use.

Epidiolex During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Epidiolex; it may harm a fetus. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as Epidiolex, during pregnancy. Women who are taking Epidiolex during pregnancy are encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. It is unknown if Epidiolex passes into breast mik. Consult your doctor before breastfeeding. Withdrawal symptoms such as increased seizure frequency and status epilepticus may occur if you suddenly stop taking Epidiolex.

Additional Information

Our Epidiolex (cannabidiol) Oral Solution, CX Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Epidiolex Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have symptoms of liver problems, such as:

  • nausea, vomiting, loss of appetite;
  • tiredness, not feeling well;
  • right-sided upper stomach pain;
  • itching;
  • dark urine; or
  • jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • drowsiness;
  • changes in appetite or weight;
  • feeling weak or tired;
  • infections (fever, flu symptoms, cough, swelling, redness, itching);
  • diarrhea;
  • sleep problems (insomnia);
  • rash; or
  • abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Epidiolex (Cannabidiol Oral Solution)

QUESTION

If you have had a seizure, it means you have epilepsy. See Answer
Epidiolex Professional Information

SIDE EFFECTS

The following important adverse reactions are described elsewhere in labeling:

  • Hepatocellular Injury [see WARNINGS AND PRECAUTIONS]
  • Somnolence and Sedation [see WARNINGS AND PRECAUTIONS]
  • Suicidal Behavior and Ideation [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Withdrawal of Antiepileptic Drugs [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In controlled and uncontrolled trials in patients with LGS and DS, 689 patients were treated with EPIDIOLEX, including 533 patients treated for more than 6 months, 391 patients treated for more than 1 year. In controlled and uncontrolled trials in patients with TSC, 223 patients were treated with EPIDIOLEX, including 151 patients treated for more than 6 months, 88 patients treated for more than 1 year, and 15 patients treated for more than 2 years.

In an expanded access program and other compassionate use programs, 271 patients with DS, LGS, or TSC were treated with EPIDIOLEX, including 237 patients treated for more than 6 months, 204 patients treated for more than 1 year, and 140 patients treated for more than 2 years.

Patients With LGS Or DS

In placebo-controlled trials of patients with LGS or DS (includes Studies 1, 2, 3, and a Phase 2 controlled study in DS), 323 patients received EPIDIOLEX [see Clinical Studies]. Adverse reactions are presented below; the duration of treatment in these trials was up to 14 weeks. Approximately 46% of patients were female, 83% were Caucasian, and the mean age was 14 years (range 2 to 48 years). All patients were taking other AEDs.

In controlled trials in LGS or DS, the rate of discontinuation as a result of any adverse reaction was 2.7% for patients taking EPIDIOLEX 10 mg/kg/day, 11.8% for patients taking EPIDIOLEX 20 mg/kg/day, and 1.3% for patients on placebo. The most frequent cause of discontinuations was transaminase elevation. Discontinuation for transaminase elevation occurred at an incidence of 1.3% in patients taking EPIDIOLEX 10 mg/kg/day, 5.9% in patients taking EPIDIOLEX 20 mg/kg/day, and 0.4% in patients on placebo. Somnolence, sedation, and lethargy led to discontinuation in 3% of patients taking EPIDIOLEX 20 mg/kg/day compared to 0% of patients taking EPIDIOLEX 10 mg/kg/day or on placebo.

The most common adverse reactions that occurred in EPIDIOLEX-treated patients with LGS or DS (incidence at least 10% and greater than placebo) were somnolence; decreased appetite; diarrhea; transaminase elevations; fatigue, malaise, and asthenia; rash; insomnia, sleep disorder, and poor quality sleep; and infections.

Table 3 lists the adverse reactions that were reported in at least 3% of EPIDIOLEX-treated patients, and at a rate greater than those on placebo, in the placebo-controlled trials in LGS and DS.

Table 3: Adverse Reactions in Patients Treated with EPIDIOLEX in Controlled Trials of LGS and DS (Studies 1, 2, and 3)

Adverse ReactionsEPIDIOLEXPlacebo
10 mg/kg/day20 mg/kg/day
N=75
%
N=238
%
N=227
%
Hepatic Disorders
  Transaminases elevated8163
Gastrointestinal Disorders
  Decreased appetite16225
  Diarrhea9209
  Weight decreased351
  Gastroenteritis041
  Abdominal pain, discomfort331
Nervous System Disorders
  Somnolence23258
  Fatigue, malaise, asthenia11124
  Lethargy482
  Sedation361
  Irritability, agitation952
  Aggression, anger35<1
  Insomnia, sleep disorder, poor quality sleep1154
  Drooling, salivary hypersecretion14<1
  Gait Disturbance32<1
Infections
  Infection, all414031
    Infection, other252124
    Infection, viral7116
    Pneumonia851
    Infection, fungal130
Other
  Rash7133
  Hypoxia, respiratory failure331

Adverse reactions were similar across LGS and DS in pediatric and adult patients.

Patients With TSC

In a placebo-controlled trial of patients with TSC (Study 4), 148 patients received EPIDIOLEX [see Clinical Studies]. Adverse reactions are presented below; the duration of treatment in this trial was up to 16 weeks. Approximately 42% of patients were female, 90% were Caucasian, and the mean age was 14 years (range 1 to 57 years). All patients but one (25 mg/kg/day group) were taking other AEDs.

In the controlled trial in TSC, the rate of discontinuation as a result of any adverse reaction was 11% for patients taking EPIDIOLEX 25 mg/kg/day and 3% for patients on placebo. The most frequent cause of discontinuation was rash (5%).

The most common adverse reactions that occurred in EPIDIOLEX-treated patients with TSC (incidence at least 10% at the recommended dosage and greater than placebo) were diarrhea; transaminase elevations; decreased appetite; somnolence; pyrexia; and vomiting.

Table 4: Adverse Reactions in Patients Treated with EPIDIOLEX in Controlled Trial of TSC (Study 4)

Adverse ReactionsEPIDIOLEXPlacebo
25 mg/kg/day
N = 75
%
N = 76
%
Hematological changes
  Anemia71
  Platelet count decreased51
  Eosinophil count increased50
Hepatic Disorders
  Transaminases elevated250
Gastrointestinal Disorders
  Diarrhea3125
  Decreased appetite2012
  Vomiting179
  Nausea93
  Gastroenteritis87
  Weight decreased70
Nervous System Disorders
  Somnolence139
  Gait disturbance95
  Fatigue, malaise, asthenia51
Infections
  Ear infection83
  Urinary tract infection50
  Pneumonia41
Other
  Pyrexia198
  Rash84
  Rhinorrhea40

Adverse reactions were similar in pediatric and adult patients with TSC.

Additional Adverse Reactions In Patients With LGS, DS, Or TSC

Decreased Weight

EPIDIOLEX can cause weight loss. In the controlled trials of patients with LGS or DS (10 and 20 mg/kg/day), based on measured weights, 16% of EPIDIOLEX-treated patients had a decrease in weight of at least 5% from their baseline weight, compared to 8% of patients on placebo. The decrease in weight appeared to be dose-related, with 18% of patients on EPIDIOLEX 20 mg/kg/day experiencing a decrease in weight ≥5%, compared to 9% in patients on EPIDIOLEX 10 mg/kg/day. In the controlled trial of patients with TSC (25 mg/kg/day), 31% of EPIDIOLEX-treatment patients had a decrease in weight of at least 5% from their baseline weight, compared to 8% of patients on placebo. In some cases, the decreased weight was reported as an adverse event (see Tables 3 and 4).

Hematologic Abnormalities

EPIDIOLEX can cause decreases in hemoglobin and hematocrit. In controlled trials of patients with LGS or DS, the mean decrease in hemoglobin from baseline to end of treatment was −0.42 g/dL in EPIDIOLEX-treated patients receiving 10 or 20 mg/kg/day and -0.03 g/dL in patients on placebo. A corresponding decrease in hematocrit was also observed, with a mean change of −1.5% in EPIDIOLEX-treated patients, and −0.4% in patients on placebo. In trial of patients with TSC, the mean decrease in hemoglobin from baseline to end treatment was -0.37 g/dL in EPIDIOLEX-treated patients receiving 25 mg/kg/day and 0.07 g/dL in patients on placebo. A corresponding decrease in hematocrit was also observed, with a mean change of -1.2% in EPIDIOLEX-treated patients, and -0.2% in patients on placebo.

There was no effect on red blood cell indices. Thirty percent (30%) of EPIDIOLEX-treated patients with LGS and DS and 38% of EPIDIOLEX-treated patients with TSC developed a new laboratory-defined anemia during the course of the study (defined as a normal hemoglobin concentration at baseline, with a reported value less than the lower limit of normal at a subsequent time point), versus 13% of patients with LGS and DS on placebo and 15% of patients with TSC on placebo.

Increases in Creatinine

EPIDIOLEX can cause elevations in serum creatinine. The mechanism has not yet been determined. In controlled studies in healthy adults and in patients with LGS, DS and TSC, an increase in serum creatinine of approximately 10% was observed within 2 weeks of starting EPIDIOLEX. The increase was reversible in healthy adults. Reversibility was not assessed in studies in LGS, DS or TSC.

Read the entire FDA prescribing information for Epidiolex (Cannabidiol Oral Solution)

SLIDESHOW

What Is Epilepsy? Symptoms, Causes, and Treatments See Slideshow
Related Resources for Epidiolex

© Epidiolex Patient Information is supplied by Cerner Multum, Inc. and Epidiolex Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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