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Epidiolex

Generic Name: cannabidiol (KAN a bi DYE ol)
Brand Names: Epidiolex
Epidiolex (cannabidiol) is used to treat Lennox-Gastaut syndrome and Dravet syndrome. Includes Epidiolex side effects, interactions and indications.
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Drug Information:
Epidiolex (cannabidiol) is a prescription medicine used to treat seizures in people with Lennox-Gastaut syndrome or Dravet syndrome. Epidiolex is for use in adults and children who are at least 2 years old. Epidiolex is controlled in Schedule V of the Controlled Substances Act. Keep this medicine in a safe place to prevent misuse and abuse. You should not use Epidiolex if you are allergic to cannabidiol or sesame seed oil. Cannabidiol can harm your liver. Your liver function may need to be checked before and during treatment. Learn more

Epidiolex Side Effects

Epidiolex Side Effects

Note: This document contains side effect information about cannabidiol. Some of the dosage forms listed on this page may not apply to the brand name Epidiolex.

For the Consumer

Applies to cannabidiol: oral solution

Along with its needed effects, cannabidiol (the active ingredient contained in Epidiolex) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking cannabidiol:

More common

  • Agitation
  • chills
  • cough
  • fever
  • hoarseness
  • irritability
  • lower back or side pain
  • painful or difficult urination
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Less common

  • Aggression
  • anger
  • blue lips, fingernails, or skin
  • confusion
  • diarrhea
  • difficult or troubled breathing
  • dizziness
  • fast heartbeat
  • irregular, fast or slow, or shallow breathing
  • loss of appetite
  • nausea
  • stomach pain

Some side effects of cannabidiol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Decreased appetite
  • lack or loss of strength
  • rash
  • trouble sleeping

Less common

  • Change in walking and balance
  • clumsiness or unsteadiness
  • decreased weight
  • drooling
  • increased saliva

For Healthcare Professionals

Applies to cannabidiol: oral liquid

General

The more commonly reported adverse reactions have included somnolence, decreased appetite, diarrhea, transaminase elevations, rash, and insomnia

Hepatic

Very common (10% or more): Elevated hepatic transaminases (up to 16%)

In clinical trials, 13% of drug-treated patients experienced hepatic transaminase elevations of greater than 3 times the upper limit of normal (3 x ULN) compared to 1% in placebo patients. Less than 1% had elevations greater than 20 x ULN. Most ALT elevations occurred in patients concomitantly taking valproate and/or clobazam (30% taking both concomitant valproate and clobazam; 21% taking concomitant valproate; 4% concomitant clobazam). Just 3% of transaminase elevations occurred in patients taking neither valproate or clobazam.

Transaminase elevations were dose related. ALT elevations greater than 3 x ULN occurred in 17% of patients taking 20 mg/kg/day compared to 1% in patients taking 10 mg/kg/day.

Patients with baseline transaminase elevations above the ULN had higher rates of treatment emergent ALT elevations. For patients taking 20 mg/kg/day, ALT elevations to greater than 3 x ULN occurred in 30% of patients who had baseline ALT elevations compared to 12% in patients whose ALT levels were within the normal range at baseline.

Psychiatric

Common (1% to 10%): Insomnia, sleep disorder, poor quality sleep, irritability, agitation, aggression, anger

Nervous system

Very common (10% or more): Somnolence (up to 25%)

Common (1% to 10%): Sedation, lethargy, gait disturbance

Somnolence and sedation (including lethargy) occurred in 32% of patients compared with 11% of those on placebo. Occurrences were higher among patients on higher doses (34% vs 27% for doses of 20 mg/kg/day and 10 mg/kg/day, respectively). Occurrences were even higher in patients on concomitant clobazam (46% vs 16%).

Hypersensitivity

Frequency not reported: Hypersensitivity reaction (pruritus, erythema, angioedema)

Metabolic

Common (1% to 10%): Decreased weight

Hematologic

Very common (10% or more): Laboratory-defined anemia (30%)

Mean decreases in hemoglobin (-0.42 g/dL) and hematocrit of (-1.5%) occurred in patients receiving this drug. Thirty percent of patients developed a new laboratory-defined anemia during the clinical trial defined as a normal hemoglobin at baseline and a reported value less than the lower limit of normal at a subsequent time. This is compared to 13% percent of placebo patients.

Immunologic

Very common (10% or more): Viral infection (up to 11%), other infection (up to 21%)

Common (1% to 10%): Fungal infection

Respiratory

Common (1% to 10%): Pneumonia, hypoxia, respiratory failure

Other

Very common (10% or more): Fatigue, malaise, and asthenia (up to 12%)

Renal

Frequency not reported: Increases in creatinine

This drug increased serum creatinine in healthy adults and in patients with Lennox-Gastaut syndrome or Dravet Syndrome. An increase of about 10% has been observed within 2 weeks of initiating therapy. In healthy adults, this increase was reversible. Reversibility was not assessed in patients with Lennox-Gastaut syndrome or Dravet Syndrome. The mechanism for this increase is unknown.

Dermatologic

Very common (10% or more): Rash (up to 13%)

Gastrointestinal

Very common (10% or more): Decreased appetite (up to 22%), diarrhea (up to 20%)

Common (1% to 10%): Drooling, salivary hypersecretion, gastroenteritis, abdominal pain

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Epidiolex