Prescription medicine
Cannabidiol Brand names: Epidiolex
Cannabidiol (Epidiolex) is a prescription medicine with an FDA approval on record since 2018. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the cannabidiol FDA label on DailyMed (effective May 29, 2026, Jazz Pharmaceuticals, Inc.); the NDA 210365 record on Drugs@FDA; every cannabidiol label on DailyMed.
Highlights of the record
FDA label of May 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageEPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older.
Forms and strengths
- 100 mg/ml
Solution.
On the market
- Earliest approval on file
- June 25, 2018 Epidiolex, Jazz Pharms Res; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- September 24, 2042 Epidiolex oral solution; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2020 0 Class I among all firms' recalls; 3 more by firms not listed as its makers
- FAERS reports
- 23,265 through July 30, 2026
What is cannabidiol used for?
From the label: indications and usageEPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older. EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients 1 year of age and older
Source: FDA drug label (Epidiolex), Jazz Pharmaceuticals, Inc., effective May 29, 2026 (SPL set 8bf27097-4870-43fb-94f0-f3d0871d1eec), via openFDA; the full label on DailyMed
What does the patient leaflet for cannabidiol say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about EPIDIOLEX?EPIDIOLEX can cause serious side effects, including: 1. EPIDIOLEX may cause liver problems. Your healthcare provider may order blood tests to check your liver before you start taking EPIDIOLEX and during treatment. In some cases, EPIDIOLEX treatment may need to be stopped. Call your healthcare provider right away if you develop any of these signs and symptoms of liver problems during treatment with EPIDIOLEX: • loss of appetite, nausea, vomiting • fever, feeling unwell, unusual tiredness • yellowing of the skin or the whites of the eyes (jaundice) • itching • unusual darkening of the urine • right upper stomach area pain or discomfort 2. EPIDIOLEX may cause you to feel sleepy, which may get better over time. Using certain medicines with EPIDIOLEX such as clobazam or alcohol may increase sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how EPIDIOLEX affects you. 3. Like other antiepileptic drugs, EPIDIOLEX may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • attempt to commit suicide • new or worse depression • new or worse anxiety • feeling agitated or restless • panic attacks • trouble sleeping (insomnia) • new or worse irritability • acting aggressive, being angry, or violent • acting on dangerous impulses • an extreme increase in activity and talking (mania) • other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions? • Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. […]
From the patient leaflet: What should I avoid while taking EPIDIOLEX?Do not drive, operate heavy machinery, or do other dangerous activities until you know how EPIDIOLEX affects you. EPIDIOLEX may cause you to feel sleepy.
From the patient leaflet: How should I store EPIDIOLEX?Store EPIDIOLEX at room temperature between 68ºF to 77ºF (20ºC to 25ºC). • Always store EPIDIOLEX in an upright position. • Do not freeze. • Keep the child-resistant cap tightly closed. • Use EPIDIOLEX within 12 weeks of first opening the bottle. Throw away (dispose of) any unused medicine after 12 weeks. Keep EPIDIOLEX and all medicines out of the reach of children. General Information about the safe and effective use of EPIDIOLEX. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use EPIDIOLEX for a condition for which it was not prescribed. Do not give EPIDIOLEX to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about EPIDIOLEX that is written for health professionals.
Source: FDA drug label (Epidiolex), Jazz Pharmaceuticals, Inc., effective May 29, 2026 (SPL set 8bf27097-4870-43fb-94f0-f3d0871d1eec), via openFDA; the full label on DailyMed
Is there a generic for cannabidiol (Epidiolex)?
No generic cannabidiol is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 33 patents for Epidiolex oral solution: the compound patent runs to April 26, 2039, and the last listed entry to September 24, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2042 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has cannabidiol been recalled?
The FDA's Enforcement Report lists 3 recalls naming cannabidiol since 2020: 0 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of cannabidiol and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 11, 2020 | Class II | BIOTA Biosciences LLC not a listed maker | Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the cannabidiol label say about other medicines?
The cannabidiol label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name cannabidiol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Clobazam | drug interactions | Concomitant use of EPIDIOLEX with clobazam increases plasma concentrations of N‑desmethylclobazam, the active metabolite of clobazam [see Clinical Pharmacology ( 12.3 )], which may increase the risk of clobazam-related adverse reactions [see Adverse Reactions ( 6.1 ) and Warnings and Precautions ( 5.1 , 5.2 )]. |
| Clopidogrel | drug interactions | For CYP2C19 substrates (e.g., clopidogrel) where efficacy is mainly due to their active metabolite (s), concomitant use of EPIDIOLEX may decrease plasma concentration of the active metabolite (s) and may therefore decrease efficacy. |
| Digoxin | drug interactions | Increases in exposure of other orally administered P‑gp substrates (e.g., sirolimus, tacrolimus, digoxin) may be observed when concomitantly used with EPIDIOLEX. |
| Everolimus | drug interactions | A lower starting dose of orally administered everolimus is recommended. |
| Rifampin | drug interactions | Drugs on EPIDIOLEX Strong CYP3A4 or CYP2C19 Inducers Concomitant use with a strong CYP3A4 and CYP2C19 inducer (rifampin 600 mg once daily) decreased cannabidiol and 7-hydroxy-cannabidiol (7-OH-CBD) plasma concentrations by approximately 32% and 63%. |
| Sirolimus | drug interactions | Increases in exposure of other orally administered P‑gp substrates (e.g., sirolimus, tacrolimus, digoxin) may be observed when concomitantly used with EPIDIOLEX. |
| Stiripentol | drug interactions | Stiripentol Concomitant use of EPIDIOLEX with stiripentol increases plasma exposures of stiripentol [see Clinical Pharmacology ( 12.3 )]. |
| Tacrolimus | drug interactions | Increases in exposure of other orally administered P‑gp substrates (e.g., sirolimus, tacrolimus, digoxin) may be observed when concomitantly used with EPIDIOLEX. |
| Theophylline | drug interactions | Increases in exposure of certain CYP1A2 substrates (e.g., theophylline, tizanidine) may be observed when concomitantly used with EPIDIOLEX. |
| Tizanidine | drug interactions | Increases in exposure of certain CYP1A2 substrates (e.g., theophylline, tizanidine) may be observed when concomitantly used with EPIDIOLEX. |
Other labels that name cannabidiol
Source: FDA drug label (Epidiolex), 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 for cannabidiol?
The FDA Adverse Event Reporting System holds 23,265 reports that list cannabidiol among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Cannabidiol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other