{ "query": "cannabidiol", "ingredient": "cannabidiol", "slug": "cannabidiol", "rxcui": "2045371", "brands": [ "Epidiolex" ], "names": [ "cannabidiol" ], "classes": [], "alternatives": [], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 1 }, "boxed_warning": "", "indications_and_usage": "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 )", "contraindications": "is contraindicated in patients with a history of hypersensitivity to cannabidiol or any of the ingredients in the product [see Description ( 11 ) and Warnings and Precautions ( 5.4 )]. Hypersensitivity to cannabidiol or any of the ingredients in EPIDIOLEX ( 4 )", "warnings_and_cautions": "\u2022 Hepatic Injury: EPIDIOLEX can cause transaminase elevations. Concomitant use of valproate and higher doses of EPIDIOLEX increase the risk of transaminase elevations. See Full Prescribing Information for serum transaminase and bilirubin monitoring recommendations. ( 5.1 ) \u2022 Somnolence and Sedation: Monitor for somnolence and sedation and advise patients not to drive or operate machinery until they have gained sufficient experience on EPIDIOLEX. ( 5.2 ) \u2022 Suicidal Behavior and Ideation: Monitor patients for suicidal behavior and thoughts. ( 5.3 ) \u2022 Hypersensitivity Reactions: Advise patients to seek immediate medical care. Discontinue and do not restart EPIDIOLEX if hypersensitivity occurs. ( 5.4 ) \u2022 Withdrawal of Antiepileptic Drugs: EPIDIOLEX should be gradually withdrawn to minimize the risk of increased seizure frequency and status epilepticus. ( 5.5 ) 5.1 Hepatic Injury EPIDIOLEX can cause dose-related elevations of liver transaminases (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST]). In controlled studies for LGS and DS (10 and 20 mg/kg/day dosages) and TSC (25 mg/kg/day), the incidence of ALT elevations above 3 times the upper limit of normal (ULN) wa...", "warnings": "", "adverse_reactions": "The following important adverse reactions are described elsewhere in labeling: \u2022 Hepatic Injury [see Warnings and Precautions ( 5.1 )] \u2022 Somnolence and Sedation [see Warnings and Precautions ( 5.2 )] \u2022 Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.3 )] \u2022 Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] \u2022 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under wid...", "drug_abuse_and_dependence": "9.1 Controlled Substance EPIDIOLEX is not a controlled substance. 9.2 Abuse Animal abuse-related studies show that cannabidiol does not produce cannabinoid-like behavioral responses, including generalization to delta-9-tetrahydrocannabinol (THC) in a drug discrimination study. Cannabidiol also does not produce animal self-administration, suggesting it does not produce rewarding effects. In a human abuse potential study, acute administration of cannabidiol to non-dependent adult recreational drug users at therapeutic and supratherapeutic doses of 750, 1500, and 4500 mg in the fasted state (equivalent respectively to 10, 20, and 60 mg/kg in a 75 kg adult) produced responses on positive subjective measures such as Drug Liking and Take Drug Again that were within the acceptable placebo range. In contrast, 10 and 30 mg of dronabinol (synthetic THC) and 2 mg alprazolam produced large increases on positive subjective measures compared to placebo that were statistically significantly greater than those produced by cannabidiol. In other Phase 1 clinical studies conducted with cannabidiol, there were no reports of abuse-related adverse events. 9.3 Dependence In a human physical dependence st...", "controlled_substance": "9.1 Controlled Substance EPIDIOLEX is not a controlled substance.", "recent_major_changes": "", "information_for_patients": "Advise the caregiver or patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Administration Information Advise patients who are prescribed EPIDIOLEX to use the adapter and oral dosing syringes provided [see Dosage and Administration ( 2.4 ) and Instructions for Use ] . Provide instructions regarding which syringe to use and how to administer the specified dose, since EPIDIOLEX is supplied with 1 mL and 5 mL oral dispensing syringes. Instruct patients to discard any unused EPIDIOLEX oral solution after 12 weeks of first opening the bottle [see Dosage and Administration ( 2.4 )]. Hepatic Injury Inform patients about the potential for elevations of liver enzymes. Discuss with the patient the importance of measuring hepatic laboratory values and having them evaluated by the healthcare provider before treatment with EPIDIOLEX and periodically during treatment [see Warnings and Precautions ( 5.1 )] . Advise patients of the clinical signs or symptoms suggestive of hepatic dysfunction (e.g., unexplained nausea, vomiting, right upper quadrant abdominal pain, fatigue, anorexia, or jaundice and/or dark urine) and to contact a healthcare provider pro...", "spl_medguide": "MEDICATION GUIDE EPIDIOLEX \u00ae (EH-peh-DYE-oh-lex) (cannabidiol) oral solution Read this Medication Guide before you start taking EPIDIOLEX and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. 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: \u2022 loss of appetite, nausea, vomiting \u2022 fever, feeling unwell, unusual tiredness \u2022 yellowing of the skin or the whites of the eyes (jaundice) \u2022 itching \u2022 unusual darkening of the urine \u2022 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 sleepines...", "clinical_studies": "6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In controlled and uncontrolled trials in patients with LGS and DS, 689 patients were treated with EPIDIOLEX, including 533 patients treated for more than 6 months, and 391 patients treated for more than 1 year. In controlled and uncontrolled trials in patients with TSC, 223 patients were treated with EPIDIOLEX, including 151 patients treated for more than 6 months, 88 patients treated for more than 1 year, and 15 patients treated for more than 2 years. In an expanded access program and other compassionate use programs, 271 patients with DS, LGS, or TSC were treated with EPIDIOLEX, including 237 patients treated for more than 6 months, 204 patients treated for more than 1 year, and 140 patients treated for more than 2 years. Patients with LGS or DS In placebo-controlled trials of patients with LGS or DS (includes Studies 1, 2, 3, and a Phase 2 controlled study in DS), 323 patients received EPI...", "brand_name": "Epidiolex", "manufacturer": "Jazz Pharmaceuticals, Inc.", "application_number": "NDA210365", "pharm_class_epc": [], "route": [ "ORAL" ], "effective_time": "20260529", "set_id": "8bf27097-4870-43fb-94f0-f3d0871d1eec", "has_boxed_warning": false, "controlled": false, "mentions_rems": false }, "faers": { "total": 23579, "serious": 13943, "death": 1884, "hospitalization": 7136, "primary_suspect": 23466, "top_reactions": [ [ "Seizure", 6049 ], [ "Hospitalisation", 2450 ], [ "Off Label Use", 2417 ], [ "Product Use In Unapproved Indication", 1808 ], [ "Diarrhoea", 1759 ], [ "Drug Ineffective", 1417 ], [ "Death", 1331 ], [ "Somnolence", 1309 ], [ "Fatigue", 1229 ], [ "Product Dose Omission Issue", 1163 ], [ "Weight Decreased", 871 ], [ "Weight Increased", 830 ], [ "Vomiting", 748 ], [ "Decreased Appetite", 730 ], [ "Nausea", 676 ] ], "by_year": { "2019": 3505, "2020": 3616, "2021": 4487, "2022": 3787, "2023": 2467, "2024": 2044, "2025": 2193, "2026": 975 }, "by_year_primary": { "2019": 3505, "2020": 3614, "2021": 4474, "2022": 3761, "2023": 2448, "2024": 2015, "2025": 2179, "2026": 967 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [], "recall_total": 0, "drugsfda": { "applications": 1, "nda": 1, "anda": 0, "first_approval": "20180625", "rems": false, "rems_last": "", "labeling_supplements": 11, "labeling_recent": 8, "sponsors": [ "JAZZ PHARMS RES" ], "unapproved": false, "first_approval_fmt": "06/25/2018" }, "trials": { "total": 540, "completed": 244, "terminated": 77, "with_results": 126, "industry": 189, "phase3": 101, "results_share": 0.5163934426229508, "terminated_share": 0.1425925925925926 }, "pubmed": { "rct": 247, "meta": 88, "recent_rct": 173, "cochrane": [] }, "payments": { "year": "2024", "usd": 1683276.87, "records": 9846, "by_name": [ [ "Epidiolex", 1683276.87 ] ], "names_checked": [ "cannabidiol", "Epidiolex" ], "source": "bulk-index" }, "partd": null, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": "", "name": "", "matched": null, "stewardship": [] }, "exposure": null, "scores": { "safety": { "score": 95, "letter": "A", "why": [ "Death share in reports is near or below the FAERS average (0.9x)", "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)" ], "weight": 0.35 }, "evidence": { "score": 75, "letter": "B", "why": [ "247 randomized trials and 88 systematic reviews/meta-analyses indexed in PubMed", "No Cochrane review found (-5)" ], "weight": 0.25 }, "regulatory": { "score": 92, "letter": "A", "why": [ "No recalls on record since 2016", "8 label changes approved since 2021: the safety story is still moving (-8)" ], "weight": 0.15 }, "conflict": { "score": 70, "letter": "C", "why": [ "Pharma paid doctors $1,683,277 tied to this drug last year (-30)", "Not named in any pending federal MDL" ], "weight": 0.15 }, "options": { "score": 40, "letter": "F", "why": [ "No generic version approved: brand-only pricing (-30)", "No same-class alternatives found: little leverage to switch (-30)" ], "weight": 0.1 } }, "total": 80, "grade": "B", "questions": [ "The most-reported problems in FDA's adverse event data are seizure, hospitalisation, product use in unapproved indication. How would we recognize and handle those?", "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?", "There is no generic. Is there an older generic in the same class that works as well for my situation?", "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?", "What result are we expecting, by when, and what is the plan if it does not happen?", "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)" ] }