Epidiolex Side Effects

Generic name: cannabidiol

Medically reviewed by Philip Thornton, DipPharm. Last updated on Dec 30, 2024.

Note: This document provides detailed information about Epidiolex.

Applies to cannabidiol: oral solution Side Effects associated with cannabidiol. Some dosage forms listed on this page may not apply specifically to the brand name Epidiolex.

Applies to cannabidiol: oral solution.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not suddenly stop using this medicine without first checking with your doctor. Your doctor will need to slowly decrease your dose before you stop it completely. Stopping the medicine suddenly may cause your seizures to return or to occur more often.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may make you or your child drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with cannabidiol (the active ingredient contained in Epidiolex) may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

Cannabidiol may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Also tell your doctor if you or your child have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause serious allergic reactions, including angioedema. These can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals after using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Epidiolex

Along with its needed effects, cannabidiol 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:

Other side effects of Epidiolex

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:

For healthcare professionals

Applies to cannabidiol: oral liquid.

General adverse events

The more commonly reported adverse reactions have included somnolence, decreased appetite, diarrhea, transaminase elevations, rash, and insomnia.^[Ref]

Hepatic

• Very common (10% or more): Elevated hepatic transaminases (up to 25%)

In clinical trials, 13% (10 and 20 mg/kg/day) and 12% (25 mg/kg/day) 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. In clinical trials with doses of 10 and 20 mg/kg/day, ALT elevations greater than 3 x ULN occurred in 30% of patients taking both concomitant valproate and clobazam; 21% taking concomitant valproate; 4% concomitant clobazam and 3% taking neither valproate or clobazam. With doses of 25 mg/kg/day, ALT elevations of 3 x ULN occurred in 20% of patients taking both concomitant valproate and clobazam; 25% taking concomitant valproate; 0% concomitant clobazam and 6% taking neither valproate or clobazam.

Transaminase elevations were generally dose related. ALT elevations greater than 3 x ULN occurred in 17% of patients taking 10 or 20 mg/kg/day and 12% taking 20 or 25 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^[Ref]

Nervous system

• Very common (10% or more): Somnolence (up to 25%)
• Common (1% to 10%): Sedation, lethargy, gait disturbance^[Ref]

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%).^[Ref]

Hypersensitivity

• Frequency not reported: Hypersensitivity reaction (pruritus, erythema, angioedema)^[Ref]

Metabolic

• Very common (10% or more): Decreased appetite (up to 22%)
• Common (1% to 10%): Decreased weight^[Ref]

Hematologic

• Very common (10% or more): Laboratory-defined anemia (up to 38%)
• Common (1% to 10%): Anemia, decreased platelet count, increased eosinophil count^[Ref]

In clinical trials among patients with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS), mean decreases in hemoglobin (0.42 g/dL) and hematocrit of (1.5%) occurred in patients receiving this drug (compared with -0.03 g/dL and -0.4%, respectively in placebo). Among patients treated for tuberous sclerosis complex (TSC), a mean decrease in hemoglobin of 0.37 g/dL (compared to 0.07 g/dL in placebo) and drop in hematocrit of 1.2% (compared to 0.2% for placebo). A new laboratory-defined anemia defined as a normal hemoglobin at baseline and a reported value less than the lower limit of normal at a subsequent time occurred in 30% of patients in the LGS and DS trials (placebo=13%) and 38% of patients in the TSC trials (placebo=15%).^[Ref]

Immunologic

• Very common (10% or more): Viral infection (up to 11%), other infection (up to 21%)
• Common (1% to 10%): Fungal infection^[Ref]

Respiratory

• Common (1% to 10%): Pneumonia, hypoxia, respiratory failure, rhinorrhea^[Ref]

Other

• Very common (10% or more): Pyrexia (up to 19%), fatigue, malaise, and asthenia (up to 12%)
• Common (1% to 10%): Ear infection^[Ref]

Renal

• Frequency not reported: Increases in creatinine^[Ref]

Increased serum creatinine has been observed with use of this drug in healthy adults, in patients with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex. The mechanism has not been determined. 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, Dravet syndrome, or tuberous sclerosis complex.^[Ref]

Dermatologic

• Very common (10% or more): Rash (up to 13%)^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 31%), vomiting (up to 17%)
• Common (1% to 10%): Drooling, salivary hypersecretion, gastroenteritis, abdominal pain, nausea^[Ref]

Genitourinary

• Common (1% to 10%): Urinary tract infection

See also:

Frequently asked questions

• Does Epidiolex contain marijuana?
• What type of drug is Epidiolex?

Further information

Epidiolex side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer