FDA-filed SPL labeling · retrieved through openFDA

Cannabidiol

Cannabidiol is a prescription anti-seizure medicine used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex.

Brand name Epidiolex
Drug class ⓘ Cytochrome P450 2c8 Inhibitors
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveMay 29, 2026
AvailabilityRx
Earliest approval/marketing year ⓘ2018
FDA-listed product records ⓘ12
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 25, 2026
⭐ Cannabidiol at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Epidiolex (cannabidiol oral solution) is the only FDA-approved cannabidiol product for seizures linked to Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex in patients 1 year and older. Liver monitoring is essential throughout treatment, and the medicine should never be stopped suddenly. Work closely with your prescriber on dosing, especially if you also take valproate or clobazam.

📖 Cannabidiol: Patient Information Guide

A plain-language walkthrough of Cannabidiol — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Cannabidiol, available as Epidiolex oral solution, is an FDA-approved prescription anti-seizure treatment for several rare epilepsy conditions.

  • Lennox-Gastaut syndrome (LGS): Epidiolex is approved to reduce seizures in patients 1 year of age and older with this severe form of epilepsy that usually begins in childhood.
  • Dravet syndrome (DS): Epidiolex is approved to reduce seizures in patients 1 year of age and older with this genetic epilepsy that causes frequent, prolonged seizure episodes.
  • Tuberous sclerosis complex (TSC): Epidiolex is approved to reduce seizures in patients 1 year of age and older with this genetic condition that causes noncancerous growths in the brain and other organs, often leading to seizures.
⚙️How it works▾

Exactly how Epidiolex prevents seizures in people is not fully understood. Importantly, it does not work by binding to cannabinoid receptors — the pathway typically associated with cannabis. Researchers believe the anti-seizure effect comes through a different mechanism that is still being studied. The medicine is broken down in the liver into active compounds that may also contribute to its anti-seizure effects, though their exact role in humans remains unclear.

💊How it's taken▾

Epidiolex oral solution is taken by mouth twice a day. The dose is adjusted gradually over time based on how well it is working and how well it is tolerated — your prescriber will guide this titration. Food matters: taking Epidiolex consistently with or without food each day helps keep blood levels steady, since fatty meals can significantly increase absorption.

  • Use only the calibrated syringes provided — not a household teaspoon or tablespoon
  • If needed, Epidiolex can be given through silicone feeding tubes
  • Never stop suddenly — taper the dose under your doctor's guidance to avoid a sudden increase in seizures
  • Discard any remaining liquid 12 weeks after opening the bottle
🤒Side effects — in detail▾

The most common side effects of Epidiolex include:

  • Drowsiness, sedation, or lethargy (especially early in treatment and with higher doses)
  • Decreased appetite and weight loss
  • Diarrhea
  • Elevated liver enzymes (seen on blood tests)
  • Fatigue or general weakness
  • Rash
  • Sleep difficulties
  • Vomiting (particularly in people with tuberous sclerosis complex)

Drowsiness is more pronounced when Epidiolex is taken with clobazam or other sedating medicines. Contact your doctor promptly if you notice signs of liver problems — such as yellowing of the skin or eyes, dark urine, or right-sided stomach pain — or if mood changes or suicidal thoughts emerge.

⚠️Warnings & precautions▾
  • Liver injury: Epidiolex can cause dose-related rises in liver enzymes, a sign of liver stress. The risk is highest with higher doses and when taken alongside valproate or clobazam. Liver blood tests are required before starting and at regular intervals during treatment. Watch for nausea, right-sided stomach pain, fatigue, yellowing of the skin or eyes, or dark urine.
  • Suicidal thoughts and behavior: Like all anti-seizure drugs, Epidiolex carries a small increased risk of suicidal thinking or behavior. Monitor for new depression, mood changes, or any self-harm thoughts, especially in the first weeks of treatment.
  • Drowsiness and sedation: Epidiolex can significantly impair alertness, especially early in treatment and when combined with other sedating medicines or alcohol. Do not drive or operate machinery until you know how it affects you.
  • Hypersensitivity reactions: Epidiolex can cause allergic reactions including rash, itching, and swelling. Stop the medicine and seek emergency care if these occur. The product contains sesame seed oil — alert your doctor if you have sesame allergies.
  • Withdrawal risk: Stopping Epidiolex suddenly can trigger more frequent seizures or status epilepticus (prolonged seizure). Always taper the dose gradually under medical supervision.
🔀What it interacts with▾

Epidiolex interacts with several medications — always give your pharmacist and doctor a complete list of everything you take.

  • Valproate: Significantly raises the risk of liver enzyme elevations when used with Epidiolex — more frequent liver monitoring is needed
  • Clobazam: Epidiolex raises levels of clobazam's active metabolite, increasing the risk of sedation and liver enzyme elevations; a clobazam dose reduction may be needed
  • Stiripentol: Epidiolex raises stiripentol blood levels; watch for stiripentol-related side effects
  • Everolimus (and other P-gp substrates like sirolimus, tacrolimus, digoxin taken by mouth): Epidiolex can more than double everolimus levels — close monitoring and dose adjustment required
  • Strong CYP3A4 or CYP2C19 inducers (e.g., rifampin): These can lower Epidiolex blood levels, potentially reducing seizure control
  • CYP2C19 substrates (e.g., clopidogrel): Epidiolex can raise levels of these drugs, or for prodrugs like clopidogrel, reduce their active metabolite and effectiveness
  • Alcohol: Significantly increases Epidiolex absorption and adds to sedation — avoid
  • Other CNS depressants (sedatives, sleep aids, opioids): Combining with Epidiolex increases drowsiness risk

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Liver disease: Dose adjustments are required for moderate or severe liver impairment; mild liver impairment does not require adjustment
  • Liver tests: Blood tests for liver enzymes and bilirubin must be done before starting Epidiolex and monitored regularly throughout treatment
  • Sesame allergy: Epidiolex contains sesame seed oil — tell your doctor if you have a sesame allergy
  • Prior allergic reaction to cannabidiol or Epidiolex ingredients: The medicine is contraindicated — do not take it
  • Pregnancy: Animal studies showed developmental harm at doses similar to or higher than human therapeutic doses; the risk in humans is unknown. Enroll in the EPIDIOLEX Pregnancy Surveillance Program if you become pregnant while taking it
  • Breastfeeding: It is unknown whether cannabidiol passes into human breast milk; discuss with your doctor before breastfeeding
  • Children under 1 year: Safety and effectiveness have not been established in infants under 1 year of age
  • Older adults (over 55): Clinical trials had limited data in this age group; use with extra caution given the higher likelihood of liver, kidney, or heart issues and other medications
📡Pharmacodynamics — effects in the body▾

Epidiolex can affect the heart's electrical rhythm in a dose-dependent way — specifically, it may cause mild QTc prolongation (a slight delay in the heart's electrical reset between beats). At recommended doses taken with a fatty meal, this effect stays below a clinically significant threshold. However, factors like food intake, alcohol, and certain co-medications such as clobazam can increase Epidiolex exposure and may amplify this effect.

Epidiolex also raises creatinine levels in the blood, which can look like reduced kidney function on standard lab tests. However, a dedicated study showed that Epidiolex does not actually reduce the kidney's filtering ability (measured glomerular filtration rate) — the creatinine rise is a known lab effect, not true kidney damage.

🔬Pharmacokinetics — how your body processes it▾

After swallowing Epidiolex, cannabidiol reaches peak blood levels in about 2.5 to 5 hours. Food — especially a high-fat meal — dramatically increases how much is absorbed (up to 5-fold higher peak levels compared to fasting), so consistent dosing habits around meals matter. Cannabidiol is extensively broken down in the liver by CYP2C19 and CYP3A4 enzymes into active metabolites, and it stays in the body for a long time — the half-life (time for blood levels to fall by half) is roughly 56 to 61 hours with regular dosing. The medicine leaves the body primarily through the stool, with only a small amount cleared by the kidneys. People with moderate or severe liver disease absorb significantly more of the drug and require lower doses.

📦How to store it▾

Store EPIDIOLEX in an upright position at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C to 30°C (59°F to 86°F) . Do not freeze.

📄 Written from Cannabidiol’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

234

Supplements & herbs that interact with Cannabidiol

234 supplements and herbal products have documented interactions with Cannabidiol in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 10
  • Moderate · 184
  • Minor · 40
Every supplement checked against Cannabidiol — ranked by severity The full interaction hub: 10 major · 184 moderate · 40 minor · every one linked to its full report. Check Cannabidiol against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Cannabidiol — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Epidiolex, and how is it different from regular CBD products you can buy online? ▾
Epidiolex is a prescription-only, pharmaceutical-grade cannabidiol oral solution that has been rigorously tested and FDA-approved specifically to treat seizures in Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex. Over-the-counter CBD products are not FDA-approved medications and have not been tested for safety, purity, or effectiveness in the same way. They are not interchangeable with Epidiolex.
Does Epidiolex make you feel 'high' like marijuana? ▾
No. Epidiolex works through a different pathway than the one responsible for the 'high' associated with cannabis — it does not appear to act on cannabinoid receptors. That said, it can cause drowsiness and sedation, especially early in treatment or at higher doses, so you should be cautious about driving or operating machinery until you know how it affects you.
Should I take Epidiolex with food or on an empty stomach? ▾
Either way can work, but consistency is what really matters. Food — especially a fatty meal — significantly increases how much cannabidiol your body absorbs, which could affect how well it works or increase side effects. Pick a routine (always with a meal, or always without) and stick to it every day. And definitely avoid taking it with alcohol, which can also raise your cannabidiol levels and add to drowsiness.
Why does my doctor want to do blood tests while I'm on Epidiolex? ▾
Epidiolex can cause the liver to release enzymes into the blood — an early sign of liver stress. Your doctor will check these enzyme levels before you start, then at one, three, and six months, and periodically after that. It's an important safety step, not a cause for alarm. If you notice yellowing of your skin or eyes, dark urine, right-sided stomach pain, or unusual fatigue between tests, call your doctor right away rather than waiting for your next appointment.
Can I stop taking Epidiolex if I feel like it's not working or I don't like the side effects? ▾
Please don't stop it suddenly without talking to your doctor first. Stopping any anti-seizure medicine abruptly can cause your seizures to come back worse or even trigger a prolonged seizure called status epilepticus, which is a medical emergency. Your doctor can help you taper the dose safely or switch to something else if needed.
Is it safe to take Epidiolex during pregnancy? ▾
The honest answer is that we don't have solid human data yet. Animal studies did show potential developmental harm at doses similar to human therapeutic levels, so there is reason for caution. If you're pregnant or planning to become pregnant, talk openly with your doctor — stopping seizure medication also carries real risks during pregnancy. If you do take Epidiolex while pregnant, you can enroll in the EPIDIOLEX Pregnancy Surveillance Program (1-855-272-7158) to help researchers gather safety data.
Is Cannabidiol available over the counter? ▾
Cannabidiol is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Cannabidiol first available? ▾
Cannabidiol has been available in the United States since at least 2018, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Cannabidiol? ▾
Cannabidiol is supplied by 10 manufacturers listed in the FDA NDC Directory, including Agno Pharma Jiangsu, Jazz Pharmaceuticals, Inc., Biophore India Pharmaceuticals Pvt. Ltd.

💬 Answers drafted from Cannabidiol’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Cannabidiol comes

Cannabidiol is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Oral solution

By mouth
Brands Epidiolex
How this form is used
What it may be used for
  • Epidiolex is used to treat seizures associated with Lennox-Gastaut syndrome in patients 1 year of age and older
  • Epidiolex is used to treat seizures associated with Dravet syndrome in patients 1 year of age and older
  • Epidiolex is used to treat seizures associated with tuberous sclerosis complex in patients 1 year of age and older
Important instructions
  • Epidiolex is taken by mouth twice daily using only the calibrated oral syringes provided — not a household spoon
  • Epidiolex should be taken consistently with respect to meals each day to reduce variability in how much is absorbed
  • Epidiolex can be given through silicone feeding tubes (such as nasogastric or gastrostomy tubes) when oral intake is not possible — do not use PVC or polyurethane tubes
  • Discard any unused Epidiolex 12 weeks after first opening the bottle
Available strengths 2 strengths
4 FDA-listed product records ⓘ

📊 Cannabidiol across the U.S. market

How Cannabidiol appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
10
Manufacturers
1
Brand names
12
FDA-listed product records ⓘ
2018
First marketed ⓘ

Also listed with the FDA, not a patient dose form: Powder (8) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Agno Pharma Jiangsu17%
Jazz Pharmaceuticals, Inc.17%
Biophore India Pharmaceuticals Pvt. Ltd8%
Greenwich Biosciences, LLC8%
Indena SpA8%
MSN Life Sciences Private Limited8%
Other makers33%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Cannabidiol is used

A general measure of how commonly Cannabidiol is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Cannabidiol is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

148,283
Medicaid prescriptions filled (Q1–Q4 2025)
$556.2M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Cannabidiol prescribed? Of the 1,597 medications we measure, Cannabidiol ranks #437 by Medicaid prescriptions — more than 73% of them.

Where Cannabidiol ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Cannabidiol product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

cannabidiol 100 MG/ML Oral Solution

148,283 Medicaid prescriptions (Q1–Q4 2025) 100% of Cannabidiol prescriptions shown $556.2M gross reimbursement (before rebates) ≈ $3,751 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2058900

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Cannabidiol, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 4 listed Cannabidiol NDCs with Medicaid activity.

🔍 Compare Cannabidiol products

A representative set of FDA-listed product records for Cannabidiol — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Oral solution
100 mg/mL Oral Greenwich Biosciences, LLC NDA View NDC →
100 mg/mL Oral Jazz Pharmaceuticals, Inc. × 2 listings NDA View NDC →
1 kg/kg — Symrise AG BULK INGREDIENT View NDC →
💊Bulk drug substance
1 kg/kg — Agno Pharma Jiangsu × 2 listings BULK INGREDIENT View NDC →
10 kg/10 kg — Biophore India Pharmaceuticals Pvt. Ltd BULK INGREDIENT View NDC →
1 g/g — Indena SpA BULK INGREDIENT View NDC →
1 kg/kg — MSN Life Sciences Private Limited BULK INGREDIENT View NDC →
1 kg/kg — Purisys LLC BULK INGREDIENT View NDC →
1 kg/kg — Rolabo Outsourcing S.L. BULK INGREDIENT View NDC →
1 kg/kg — SCI PHarmtech, Inc. BULK INGREDIENT View NDC →

Showing 12 of 12 products — FDA National Drug Code Directory. See every product, package size and price: browse all 12 Cannabidiol NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Cannabidiol RxCUI 2045371 1 dose form · 1 strength
  1. Dose form (SCDF) Oral Solution RxCUI 2058899 In current FDA listings
    Clinical drug / strength (SCD) 100 MG/ML RxCUI 2058900

Look up RxCUI 2045371 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Epidiolex

🏭 Manufacturers & labelers

Agno Pharma Jiangsu 2 Jazz Pharmaceuticals, Inc. 2 Biophore India Pharmaceuticals Pvt. Ltd 1 Greenwich Biosciences, LLC 1 Indena SpA 1 MSN Life Sciences Private Limited 1 Purisys LLC 1 Rolabo Outsourcing S.L. 1 SCI PHarmtech, Inc. 1 Symrise AG 1

RxNorm drug class

Cannabidiol belongs to the Other antiepileptics class.

Drug family (ATC) Other antiepileptics
How it works Cytochrome P450 1A2 Inhibitors, Cytochrome P450 2B6 Inhibitors, Cytochrome P450 2C19 Inhibitors, Cytochrome P450 2C9 Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective May 29, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Cannabidiol.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Cannabidiol after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
12
Distinct labelers/manufacturers represented
10
Linked representative label ⓘ
Jazz Pharmaceuticals, Inc.
Linked label effective
May 29, 2026
Composite sections available
25
Linked SPL Set ID
8bf27097-4870-43fb-94f0-f3d0871d1eec
Linked SPL Document ID
1eb7ac65-8df5-4a4a-9156-802cfaa92b06
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Jazz Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.