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Epidiolex

Last reviewed on RxList: 6/3/2019
Epidiolex Side Effects Center

Last reviewed on RxList 6/3/2019

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. Common side effects of Epidiolex include:

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). 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. 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.

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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Epilepsy: Symptoms, Causes and Treatment See Slideshow
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)

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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, and 391 patients treated for more than 1 year. In an expanded access program and other compassionate use programs, 161 patients with DS and LGS were treated with EPIDIOLEX, including 109 patients treated for more than 6 months, 91 patients treated for more than 1 year, and 50 patients treated for more than 2 years.

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. 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, 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 (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 ≥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

Adverse Reactions EPIDIOLEX Placebo
10 mg/kg/day 20 mg/kg/day  
N=75 % N=238 % N=227 %
Hepatic Disorders
  Transaminases elevated 8 16 3
Gastrointestinal Disorders
  Decreased appetite 16 22 5
  Diarrhea 9 20 9
  Weight decreased 3 5 1
  Gastroenteritis 0 4 1
  Abdominal pain, discomfort 3 3 1
Nervous System Disorders
  Somnolence 23 25 8
  Sedation 3 6 1
  Lethargy 4 8 2
  Fatigue, malaise, asthenia 11 12 4
  Insomnia, sleep disorder, poor quality sleep 11 5 4
  Irritability, agitation 9 5 2
  Aggression, anger 3 5 <1
  Drooling, salivary hypersecretion 1 4 <1
  Gait disturbance 3 2 <1
Infections
  Infection, all 41 40 31
    Infection, viral 7 11 6
    Pneumonia 8 5 1
    Infection, fungal 1 3 0
    Infection, other 25 21 24
Other
  Rash 7 13 3
  Hypoxia, respiratory failure 3 3 1

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

Decreased Weight

EPIDIOLEX can cause weight loss. In the controlled trials of patients with LGS or DS, based on measured weights, 16% of EPIDIOLEX-treated patients had a decrease in weight of ≥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 some cases, the decreased weight was reported as an adverse event (see Table 3).

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 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. There was no effect on red blood cell indices. Thirty percent (30%) of EPIDIOLEX-treated patients 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 on placebo.

Increases In Creatinine

EPIDIOLEX can cause elevations in serum creatinine. The mechanism has not been determined. In controlled studies in healthy adults and in patients with LGS and DS, 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 and DS.

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

QUESTION

If you have had a seizure, it means you have epilepsy. See Answer
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© 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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