Epidiolex
Strength not reported
ORAL · SOLUTION
12 identifiers · DailyMed structured labels · Drugs@FDA application data · FDA drug labels (openFDA) · FDA Orange BookLoading medicine record…
This is a locally preserved regulatory record. Source labeling does not by itself prove efficacy for a condition.
Regulatory product record. The connected regulator reports this product as approved, authorised or currently marketed.
Product data
Medicine name group
Records share the same exact normalized name. Different identifiers, strengths, countries, presentations and statuses remain separate.
Strength not reported
ORAL · SOLUTION
12 identifiers · DailyMed structured labels · Drugs@FDA application data · FDA drug labels (openFDA) · FDA Orange BookCANNABIDIOL · 100 MG / ML
Oral · Solution
3 identifiers · Health Canada Drug Product DatabaseLinked local records
Substance links use source-reported active ingredients. Condition links come from registered study context and are not efficacy claims.
Regulatory record
Patent and exclusivity fields are preserved from the regulator. They are not a legal opinion and are separate from clinical development.
Approval / market date · Not reported
Approval / market date · 2018-09-28
| Patent | Source-reported expiry | Use code |
|---|---|---|
| 10092525 | 2035-06-17 | U-2427 |
| 10111840 | 2035-06-17 | U-2442 |
| 10137095 | 2035-06-17 | U-2454 |
| 10603288 | 2035-06-17 | U-2783 |
| 10709671 | 2035-06-17 | U-2862 |
| 10709673 | 2035-06-17 | - |
| 10709674 | 2035-06-17 | U-2780 |
| 10849860 | 2035-06-17 | U-2454 |
| 10966939 | 2035-06-17 | U-2781 |
| 11154516 | 2035-06-17 | U-3236 |
| 11311498 | 2035-06-17 | U-3376 |
| 11357741 | 2035-06-17 | U-2862 |
| 11446258 | 2035-06-17 | U-3071 |
| 11633369 | 2035-06-17 | U-2781 |
| 11701330 | 2035-06-17 | U-2781 |
| 11766411 | 2035-06-17 | U-2781 |
| 11963937 | 2035-06-17 | U-2781 |
| 12064399 | 2035-06-17 | U-3989 |
| 9949937 | 2035-06-17 | U-2421 |
| 9956183 | 2035-06-17 | U-2423 |
| 9956184 |
Source-reported use
1 INDICATIONS AND USAGE EPIDIOLEX 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 ( 1 )
Medicine identity matching
RxNorm normalizes identity; FAERS supplies non-causal post-market signals.
Matched from: Epidiolex
Official RxNorm recordMatched from: Epidiolex
Official RxNorm recordMatched from: Epidiolex
Official RxNorm recordMatched from: Epidiolex
Official RxNorm recordMatched from: Epidiolex
Official RxNorm recordMatched from: Epidiolex
Official RxNorm recordMatched from: Epidiolex
Safety signals
FAERS/AEMS reports are post-market signals. Counts do not establish causality or incidence and may contain duplicates or reporting bias.
Sources and provenance
8bf27097-4870-43fb-94f0-f3d0871d1eec · version 35
Retrieved 22/08/2026, 21:20:19Verify at sourceNDA210365:001 · version d6a5fe5ae6834d4ffa421948a56cd423f489d4c5b0c2849ca3e240439e70d3a0
Retrieved 25/08/2026, 09:57:07Verify at source8bf27097-4870-43fb-94f0-f3d0871d1eec · version 35
Retrieved 31/07/2026, 13:05:37Verify at sourceNDA210365:001 · version 2026-08-19
Retrieved 20/08/2026, 10:33:18Verify at source| 2035-06-17 |
| U-2424 |
| 9956185 | 2035-06-17 | U-2425 |
| 9956186 | 2035-06-17 | U-2426 |
| 10918608 | 2035-10-13 | U-3073 |
| 11065209 | 2035-10-13 | U-3071 |
| 11096905 | 2035-10-13 | U-2781 |
| 11400055 | 2035-10-13 | U-3071 |
| 11207292 | 2039-04-26 | U-3236 |
| 11865102 | 2039-04-26 | U-3277 |
| 11160795 | 2041-03-01 | U-3233 |
| 11406623 | 2041-03-01 | U-3233 |
| 12102619 | 2041-03-01 | U-3233 |
| 12661365 | 2042-09-24 | U-4575 |
Clinical development
Phases and statuses are source-reported study stages matched by governed token phrases. They do not prove medicine identity, approval or efficacy.
DRUG · Epidiolex 100 mg/mL Oral Solution
Dravet Syndrome (DS) · Lennox-Gastaut Syndrome (LGS)DRUG · Cannabidiol
Early Life Adversity · Trauma · StressDRUG · CardiolRx
Recurrent PericarditisDRUG · CBD
Multiple SclerosisDRUG · Cannabidiol (CBD)
Osteoarthritis, Knee · Osteoarthritis of the KneeDRUG · Trichomylin® capsule (5 mg delta-9-tetrahydrocannabinol: 5 mg cannabidiol: 5 mg cannabichromene)
Cancer PainDRUG · ZYN002 - transdermal gel
Fragile X Syndrome · Fragile X Syndrome (FXS)DRUG · Cannabidiol Oral Solution
Lennox-Gastaut SyndromeDRUG · Epidiolex 100 mg/mL Oral Solution
Electrical Status Epilepticus of Slow-Wave SleepDRUG · Cannabidiol
Lennox Gastaut Syndrome · Dravet Syndrome · Tuberous Sclerosis ComplexDRUG · Cannabidiol (CBD) only
PTSD · Post Traumatic Stress Disorder · Suicide · Cannabis UseOTHER · Non cannabidiol group control
Well-Being, Psychological · Quality of Life · Sexual Behavior · Sexual Pain DisorderDIETARY_SUPPLEMENT · Cannabidiol suppository intervention 2
Well-Being, Psychological · Quality of Life · Sexual Behavior · Sexual Pain DisorderDIETARY_SUPPLEMENT · Cannabidiol suppository intervention 3
Well-Being, Psychological · Quality of Life · Sexual Behavior · Sexual Pain DisorderDIETARY_SUPPLEMENT · Cannabidiol suppository intervention 1
Well-Being, Psychological · Quality of Life · Sexual Behavior · Sexual Pain DisorderDRUG · Epidiolex
Maternal Complications · Pregnancy Complication · Birth Outcomes, Adverse · PregnancyDRUG · Cannabidiol
Advanced Breast Cancer · Anxiety · CBDDRUG · Cannabidiol (CBD)
Alcohol Use Disorder (AUD) · Withdrawal From Addictive Substance; Detoxification · CravingDRUG · Placebo Cannabidiol
Cannabis · Abuse Liability · Experimental Pain in Healthy Human ParticipantsDRUG · Cannabidiol, Medium Dose
Cannabis · Abuse Liability · Experimental Pain in Healthy Human ParticipantsDRUG · Cannabidiol, Higher Dose
Cannabis · Abuse Liability · Experimental Pain in Healthy Human ParticipantsDRUG · Cannabidiol
Phobia, SocialDRUG · Epidiolex
CBD · Stress · Nicotine Dependence · Tobacco SmokingDRUG · Cannabidiol
Metastatic Castration Resistant Prostate Cancer (mCRPC)DRUG · Cannabidiol
Post Traumatic Stress Disorder · Cannabis Use · Suicide · Veterans · MarijuanaOTHER · Cannabidiol (CBD)
Chronic Pruritus · Eczema · Nummular Eczema · Atopic Dermatitis · Prurigo NodularisDRUG · Cannabidiol
Obsessive-Compulsive Disorder · Trichotillomania (Hair-Pulling Disorder) · Tourette Syndrome · Hoarding DisorderDRUG · Cannabidiol
EndometriosisDRUG · Cannabidiol (CBD)
Multiple Sclerosis · Sleep · PainDRUG · BRC-001
Anatomic Stage 0 Breast Cancer AJCC v8 · Anatomic Stage I Breast Cancer AJCC v8 · Anatomic Stage II Breast Cancer AJCC v8 · Anatomic Stage IIIA Breast Cancer AJCC v8 · Breast Adenocarcinoma · Breast Ductal Carcinoma In Situ · Estrogen Receptor-Positive Breast Carcinoma · Progesterone Receptor-Positive Breast CarcinomaDRUG · Hemp Derived Cannabidiol Extract
Anxiety · Generalized Anxiety Disorder · Sleep ProblemsDRUG · Cannabidiol Administered as Nantheia ATL5
PTSDDRUG · Cannabidiol (CBD) Capsule 75mg
InsomniaDRUG · Cannabidiol (CBD) oral solution
Refractory Epilepsy in Children · Refractory Epilepsy · EpilepsyDRUG · Epidiolex
Sanfilippo Syndrome · Mucopolysaccharidosis IIIDRUG · Cannabidiol (CBD) 400mg
Opioid Use DisorderDRUG · Cannabidiol (CBD) 200mg
Opioid Use DisorderDRUG · CardiolRx
Acute MyocarditisDIETARY_SUPPLEMENT · Full-spectrum Cannabidiol (CBD) oil
Parkinson's Disease (PD)DRUG · Cannabidiol
Alcohol Use DisorderDRUG · Epidiolex
SeizuresDRUG · Cannabidiol
Mild Cognitive ImpairmentDRUG · Cannabidiol oral oil
Alcohol Use DisorderDRUG · Cannabidiol - fsCBD
Cannabis Use DisorderDRUG · Cannabidiol - bsCBD
Cannabis Use DisorderDRUG · Cannabidiol
Sleep · Alcohol MisuseDRUG · bsCBD Cannabidiol
Sleep · Anxiety · Depression · PainDRUG · fsCBD Cannabidiol
Sleep · Anxiety · Depression · PainDRUG · Epidiolex steady-state and tacrolimus single dose
CBD · Transplant Complication · Kidney Disease, ChronicDRUG · Epidiolex single dose
CBD · Transplant Complication · Kidney Disease, ChronicDIETARY_SUPPLEMENT · Cannabidiol (CBD)
OsteoarthitisOTHER · Placebo Epidiolex
Opioid Use DisorderDRUG · Epidiolex 100 mg/mL Oral Solution
Opioid Use DisorderDRUG · Cannabidiol (CBD)
Knee ArthritisDRUG · Cannabidiol in the form of hemp
InteractionDRUG · Cannabidiol
Persistent Post Traumatic HeadacheDRUG · Epidiolex 100 mg/mL Oral Solution
Lennox Gastaut Syndrome · Dravet Syndrome · Tuberous Sclerosis ComplexDRUG · Cannabidiol
Pain, ChronicDRUG · ZYN002 - Cannabidiol Transdermal Gel
Fragile X SyndromeDRUG · cannabidiol
Pain, Postoperative · Opioid Use · Knee OsteoarthritisDRUG · Cannabidiol
PTSDDRUG · Cannabidiol or placebo
Sleep QualityDRUG · Cannabidiol
Neurodevelopmental Disorders With Severe Self-injuriesDRUG · CBD
HIV · Cannabis · THC · Neuroinflammatory Disease · Neuroinflammatory Response · MicrobiomeDRUG · Broad Spectrum Cannabidiol (bsCBD) 400 mg
Cannabis Use DisorderDRUG · Broad Spectrum Cannabidiol (bsCBD) 400 mg
Cannabis Use DisorderDRUG · Broad Spectrum Cannabidiol (bsCBD) 200 mg
Cannabis Use DisorderDRUG · 600 mg cannabidiol (CBD)
HIV-1-infectionDRUG · Cannabidiol (CBD) oral solution
Diabetic Peripheral Neuropathic Pain (DPN) · Diabetic NeuropathiesDRUG · Cannabidiol Oral Product
Anxiety and FearDRUG · Cannabidiol Oral Solution [Epidiolex]
Tuberous Sclerosis Complex Associated Neuropsychiatric DiseaseDRUG · Cannabidiol (CBD) 600 mg
Opioid-use DisorderDRUG · Cannabidiol, pharmaceutically produced with < 5 ppm THC
COVID-19 · Cardiovascular Diseases · Cardiovascular Risk FactorDRUG · Epidiolex
Shoulder Osteoarthritis · Rotator Cuff InjuriesBEHAVIORAL · Cannabidiol (CBD)
CancerDRUG · Epidiolex oral solution
Knee Replacement Surgery · Osteoarthritis, KneeDRUG · 1200 mg Cannabidiol
Chronic Pain · Opioid Use DisorderDRUG · 800 mg Cannabidiol
Chronic Pain · Opioid Use DisorderDRUG · 400 mg Cannabidiol
Chronic Pain · Opioid Use DisorderDRUG · Cannabidiol (CBD) 800 mg
Tobacco Use Disorder · Tobacco Smoking · Tobacco DependenceDRUG · Broad-Spectrum Cannabidiol (CBD)
Alcohol Use DisorderDRUG · Full-Spectrum Cannabidiol (CBD)
Alcohol Use DisorderBIOLOGICAL · Group 1 cannabidiol (CBD) with silicone ointment
Forehead; WoundDRUG · Cannabidiol
Bipolar DisorderDRUG · Cannabidiol
Chronic PainDRUG · Cannabidiol
Rheumatoid ArthritisDRUG · Single-Compound Cannabidiol
AnxietyDRUG · Full-Spectrum Cannabidiol
AnxietyDRUG · Cannabidiol (CBD)
GlioblastomaDRUG · delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)
Cannabis IntoxicationDRUG · Cannabidiol Epidyolex 100 mg/ml
Drug Drug InteractionDRUG · ZYN002
22Q11.2 Deletion SyndromeDRUG · Placebo Matched to Moderate-Dose Cannabidiol
Generalized Anxiety Disorder (GAD) · Anxiety DisordersDRUG · Moderate-Dose Cannabidiol
Generalized Anxiety Disorder (GAD) · Anxiety DisordersDRUG · Placebo Matched to Low-Dose Cannabidiol
Generalized Anxiety Disorder (GAD) · Anxiety DisordersDRUG · Low-Dose Cannabidiol
Generalized Anxiety Disorder (GAD) · Anxiety DisordersDRUG · Cannabidiol
Hereditary Epidermolysis BullosaDRUG · CBD
Supra-sacral Spinal Cord Injury · Spinal Cord Injury · Urinary IncontinenceDRUG · Cannabidiol (CBD) Topical Gel
Older Adults (60 - 85 Years Old) · OA KneeDRUG · Cannabidiol (CBD)
Clinical High Risk for Psychosis (CHR) · Clinical High Risk for Psychosis · Clinical High Risk for Developing PsychosisMatched from: Epidiolex
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