What the label lists and what reports show
Cannabidiol side effects
Cannabidiol's FDA label: “The most common adverse reactions (10% or more for EPIDIOLEX and greater than placebo) in patients with Lennox-Gastaut syndrome or Dravet syndrome are: somnolence; decreased appetite; diarrhea; transaminase elevations; fatigue, malaise, and asthenia; rash; …” FAERS holds 23,265 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (1,731 reports).
- No generic listed
Check it at the source: the cannabidiol FDA label on DailyMed (effective May 29, 2026, Jazz Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of EPIDIOLEX?EPIDIOLEX can cause serious side effects, including: • See “What is the most important information I should know about EPIDIOLEX?” The most common side effects of EPIDIOLEX include: • sleepiness • decreased appetite • diarrhea • increase in liver enzymes • feeling very tired and weak • rash • sleep problems • fever • vomiting • infections These are not all of the possible side effects of EPIDIOLEX. For more information ask your healthcare provider or pharmacist. Tell your healthcare provider about any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also contact Jazz Pharmaceuticals at 1-800-520-5568.
Source: FDA drug label, Jazz Pharmaceuticals, Inc., effective May 29, 2026 (SPL set 8bf27097-4870-43fb-94f0-f3d0871d1eec), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (10% or more for EPIDIOLEX and greater than placebo) in patients with Lennox-Gastaut syndrome or Dravet syndrome are: somnolence; decreased appetite; diarrhea; transaminase elevations; fatigue, malaise, and asthenia; rash; insomnia, sleep disorder, and poor quality sleep; and infections.
Table 3: Adverse Reactions in Patients Treated with EPIDIOLEX in Controlled Trials of LGS and DS (Studies 1, 2, and 3)
| Reaction | Adverse Reactions N=75 % | EPIDIOLEX N=238 % | Placebo N=227 % |
|---|---|---|---|
| Transaminases elevated | 8 | 16 | 3 |
| Decreased appetite | 16 | 22 | 5 |
| Diarrhea | 9 | 20 | 9 |
| Weight decreased | 3 | 5 | 1 |
| Gastroenteritis | 0 | 4 | 1 |
| Abdominal pain, discomfort | 3 | 3 | 1 |
| Somnolence | 23 | 25 | 8 |
| Fatigue, malaise, asthenia | 11 | 12 | 4 |
| Lethargy | 4 | 8 | 2 |
| Sedation | 3 | 6 | 1 |
| Irritability, agitation | 9 | 5 | 2 |
| Aggression, anger | 3 | 5 | <1 |
| Insomnia, sleep disorder, poor quality sleep | 11 | 5 | 4 |
| Drooling, salivary hypersecretion | 1 | 4 | <1 |
| Gait disturbance | 3 | 2 | <1 |
| Infection, all | 41 | 40 | 31 |
| Infection, other | 25 | 21 | 24 |
| Infection, viral | 7 | 11 | 6 |
| Pneumonia | 8 | 5 | 1 |
| Infection, fungal | 1 | 3 | 0 |
| Rash | 7 | 13 | 3 |
| Hypoxia, respiratory failure | 3 | 3 | 1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following important adverse reactions are described elsewhere in labeling: • Hepatic Injury [see Warnings and Precautions ( 5.1 )] • Somnolence and Sedation [see Warnings and Precautions ( 5.2 )] • Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.3 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] • Withdrawal of Antiepileptic Drugs [see Warnings and Precautions ( 5.5 )] The most common adverse reactions (10% or more for EPIDIOLEX and greater than placebo) in patients with Lennox-Gastaut syndrome or Dravet syndrome are: somnolence; decreased appetite; diarrhea; transaminase elevations; fatigue, malaise, and asthenia; rash; insomnia, sleep disorder, and poor quality sleep; and infections. ( 6.1 ) The most common adverse reactions (10% or more for EPIDIOLEX and greater than placebo) in patients with tuberous sclerosis complex are: diarrhea; transaminase elevations; decreased appetite; somnolence; pyrexia; and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Jazz Pharmaceuticals, Inc. at 1-800-520-5568 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Jazz Pharmaceuticals, Inc., effective May 29, 2026 (SPL set 8bf27097-4870-43fb-94f0-f3d0871d1eec), via openFDA; the full label on DailyMed
What do FAERS reports show?
23,265 reports list cannabidiol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,868 are coded as a death and 7,074 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 16 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Cannabidiol: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions