{
 "query": "oxcarbazepine",
 "ingredient": "oxcarbazepine",
 "slug": "oxcarbazepine",
 "rxcui": "32624",
 "brands": [
  "Trileptal",
  "Oxtellar"
 ],
 "names": [
  "oxcarbazepine"
 ],
 "classes": [
  {
   "id": "N03AF",
   "name": "Carboxamide derivatives"
  }
 ],
 "alternatives": [
  "carbamazepine",
  "eslicarbazepine",
  "rufinamide"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 70
  },
  "boxed_warning": "",
  "indications_and_usage": "is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. TRILEPTAL is indicated for: Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures Pediatrics: - Monotherapy in the treatment of partial-onset seizures in children 4-16 years - Adjunctive therapy in the treatment of partial-onset seizures in children 2-16 years ( 1 )",
  "contraindications": "is contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate [ see Warnings and Precautions (5.2, 5.3) ]. Known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate ( 4 , 5.2 )",
  "warnings_and_cautions": "Hyponatremia: Monitor serum sodium levels ( 5.1 ) Cross Hypersensitivity Reaction to Carbamazepine: Discontinue immediately if hypersensitivity occurs ( 5.3 ) Serious Dermatological Reactions: If occurs, consider discontinuation ( 5.4 ) Suicidal Behavior and Ideation: Monitor for suicidal thoughts/behavior ( 5.5 ) Withdrawal of AEDs: Withdraw TRILEPTAL gradually ( 5.6 ) Cognitive/Neuropsychiatric Adverse Reactions: May cause cognitive dysfunction, somnolence, and coordination abnormalities. Use caution when operating machinery ( 5.7 ) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity: Monitor and discontinue if another cause cannot be established ( 5.8 ) Hematologic Events: Consider discontinuing ( 5.9 ) Seizure Control During Pregnancy: Active metabolite may decrease ( 5.10 ) Risk of Seizure Aggravation: Discontinue if occurs ( 5.11 ) 5.1 Hyponatremia Clinically significant hyponatremia (sodium < 125 mmol/L) can develop during TRILEPTAL use. In the 14 controlled epilepsy studies, 2.5% of TRILEPTAL-treated patients (38/1524) had a sodium of less than 125 mmol/L at some point during treatment, compared to no such patients assigned placebo or ...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are described below and elsewhere in the labeling: Hyponatremia [see Warnings and Precautions (5.1)] Anaphylactic Reactions and Angioedema [see Warnings and Precautions (5.2)] Cross Hypersensitivity Reaction to Carbamazepine [see Warnings and Precautions (5.3)] Serious Dermatological Reactions [see Warnings and Precautions (5.4)] Suicidal Behavior and Ideation [see Warnings and Precautions (5. 5 )] Cognitive/Neuropsychiatric Adverse Reactions [see Warnings and Precautions (5. 7 )] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity [see Warnings and Precautions (5. 8 )] Hematologic Events [see Warnings and Precautions (5. 9 )] The most common (\u2265 10% more than placebo for adjunctive or low dose for monotherapy) adverse reactions in adults and pediatrics were: dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, headache, nystagmus, tremor, and abnormal gait ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are ...",
  "drug_abuse_and_dependence": "9.2 Abuse The abuse potential of TRILEPTAL has not been evaluated in human studies. 9.3 Dependence Intragastric injections of oxcarbazepine to 4 cynomolgus monkeys demonstrated no signs of physical dependence as measured by the desire to self-administer oxcarbazepine by lever pressing activity.",
  "controlled_substance": "",
  "recent_major_changes": "Dosage and Administration ( 2.8 ) 9/2025",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Administration Information Counsel patients that TRILEPTAL may be taken with or without food. For TRILEPTAL oral suspension, advise patients to shake the bottle well and prepare the dose immediately afterwards using the oral dosing syringe supplied. Inform patients that TRILEPTAL oral suspension can be mixed in a small glass of water just prior to administration or, alternatively, may be swallowed directly from the syringe. Instruct patients to discard any unused TRILEPTAL oral suspension after 7 weeks of first opening the bottle [ se e Dosage and Administration (2.8 ) and How Supplied/Storage and Handling (16) ] . Hyponatremia Advise patients that TRILEPTAL may reduce the serum sodium concentrations especially if they are taking other medications that can lower sodium. Instruct patients to report symptoms of low sodium like nausea, tiredness, lack of energy, confusion, and more frequent or more severe seizures [ see Warnings and Precautions (5.1) ]. Anaphylactic Reactions and Angioedema Anaphylactic reactions and angioedema may occur during treatment with TRILEPTAL. Advise pat...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 9/2025 MEDICATION GUIDE TRILEPTAL (try-L\u0114P-t\u0103l) (oxcarbazepine) film-coated tablets, for oral use and oral suspension What is the most important information I should know about TRILEPTAL? Do not stop taking TRILEPTAL without first talking to your healthcare provider. Stopping TRILEPTAL suddenly can cause serious problems. TRILEPTAL can cause serious side effects, including: 1. TRILEPTAL may cause the level of sodium in your blood to be low . Symptoms of low blood sodium include: \u2022 nausea \u2022 confusion \u2022 tiredness (lack of energy) \u2022 more frequent or more severe seizures \u2022 headache Similar symptoms that are not related to low sodium may occur from taking TRILEPTAL. You should tell your healthcare provider if you have any of these side effects and if they bother you or they do not go away. Some other medicines can also cause low sodium in your blood. Be sure to tell your healthcare provider about all the other medicines that you are taking. Your healthcare provider may do blood tests to check your sodium levels during your treatment with TRILEPTAL. 2. TRILEPTAL may also cause allergic reactions or ...",
  "clinical_studies": "The effectiveness of TRILEPTAL as adjunctive and monotherapy for partial-onset seizures in adults, and as adjunctive therapy in children aged 2 to 16 years was established in seven multicenter, randomized, controlled trials. The effectiveness of TRILEPTAL as monotherapy for partial-onset seizures in children aged 4 to 16 years was determined from data obtained in the studies described, as well as by pharmacokinetic/pharmacodynamic considerations. Figure 1 Kaplan-Meier Estimates of Exit Rate by Treatment Group. Figure 2 Kaplan-Meier Estimates of First Seizure Event Rate by Treatment Group. Figure 3 Kaplan-Meier Estimates of Exit Rate by Treatment Group. Figure 4 Kaplan-Meier Estimates of Exit Rate by Treatment Group. 14.1 TRILEPTAL Monotherapy Trials Four randomized, controlled, double-blind, multicenter trials, conducted in a predominately adult population, demonstrated the efficacy of TRILEPTAL as monotherapy. Two trials compared TRILEPTAL to placebo and 2 trials used a randomized withdrawal design to compare a high dose (2400 mg) with a low dose (300 mg) of TRILEPTAL, after substituting TRILEPTAL 2400 mg/day for 1 or more AEDs. All doses were administered on a twice a day schedul...",
  "brand_name": "Trileptal",
  "manufacturer": "Novartis Pharmaceuticals Corporation",
  "application_number": "NDA021014",
  "pharm_class_epc": [
   "Anti-epileptic Agent [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20251216",
  "set_id": "4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 23535,
  "serious": 17084,
  "death": 1380,
  "hospitalization": 6993,
  "primary_suspect": 23431,
  "top_reactions": [
   [
    "Seizure",
    2992
   ],
   [
    "Drug Ineffective",
    2548
   ],
   [
    "Off Label Use",
    1708
   ],
   [
    "Fatigue",
    1264
   ],
   [
    "Somnolence",
    1107
   ],
   [
    "Dizziness",
    1055
   ],
   [
    "Headache",
    1046
   ],
   [
    "Fall",
    893
   ],
   [
    "Nausea",
    883
   ],
   [
    "Hyponatraemia",
    852
   ],
   [
    "Epilepsy",
    773
   ],
   [
    "Vomiting",
    759
   ],
   [
    "Anxiety",
    745
   ],
   [
    "Rash",
    723
   ],
   [
    "Pain",
    709
   ]
  ],
  "by_year": {
   "2019": 2148,
   "2020": 2452,
   "2021": 2016,
   "2022": 1665,
   "2023": 1777,
   "2024": 1763,
   "2025": 1725,
   "2026": 911
  },
  "by_year_primary": {
   "2019": 2145,
   "2020": 2451,
   "2021": 2013,
   "2022": 1650,
   "2023": 1761,
   "2024": 1732,
   "2025": 1706,
   "2026": 895
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20221201",
   "reason": "Presence of foreign substance",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20140129",
   "reason": "Failed Tablet Specifications: Broken Tablets Present.",
   "firm": "Caraco Pharmaceutical Laboratories Ltd.",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 40,
  "nda": 3,
  "anda": 32,
  "first_approval": "20000114",
  "rems": false,
  "rems_last": "20120119",
  "labeling_supplements": 43,
  "labeling_recent": 6,
  "sponsors": [
   "ACTAVIS LABS FL INC",
   "ADAPTIS",
   "AJANTA PHARMA LTD",
   "ALKEM LABS LTD",
   "AMNEAL PHARMS",
   "ANI PHARMS",
   "ANNORA PHARMA",
   "APOTEX"
  ],
  "unapproved": false,
  "first_approval_fmt": "01/14/2000"
 },
 "trials": {
  "total": 73,
  "completed": 51,
  "terminated": 9,
  "with_results": 19,
  "industry": 38,
  "phase3": 13,
  "results_share": 0.37254901960784315,
  "terminated_share": 0.1232876712328767
 },
 "pubmed": {
  "rct": 84,
  "meta": 26,
  "recent_rct": 5,
  "cochrane": [
   {
    "pmid": "32129501",
    "title": "Oxcarbazepine add-on for drug-resistant focal epilepsy",
    "year": "2020"
   },
   {
    "pmid": "30350354",
    "title": "Oxcarbazepine versus phenytoin monotherapy for epilepsy: an individual participant data review",
    "year": "2018"
   },
   {
    "pmid": "29199767",
    "title": "Oxcarbazepine for neuropathic pain",
    "year": "2017"
   },
   {
    "pmid": "27845825",
    "title": "WITHDRAWN: Oxcarbazepine add-on for drug-resistant partial epilepsy",
    "year": "2016"
   },
   {
    "pmid": "23728645",
    "title": "Oxcarbazepine versus phenytoin monotherapy for epilepsy",
    "year": "2013"
   },
   {
    "pmid": "23543558",
    "title": "Oxcarbazepine for neuropathic pain",
    "year": "2013"
   },
   {
    "pmid": "22161387",
    "title": "Oxcarbazepine for acute affective episodes in bipolar disorder",
    "year": "2011"
   },
   {
    "pmid": "19821367",
    "title": "Oxcarbazepine versus carbamazepine monotherapy for partial onset seizures",
    "year": "2009"
   },
   {
    "pmid": "18254071",
    "title": "Oxcarbazepine in the maintenance treatment of bipolar disorder",
    "year": "2008"
   },
   {
    "pmid": "16625587",
    "title": "Oxcarbazepine versus phenytoin monotherapy for epilepsy",
    "year": "2006"
   },
   {
    "pmid": "10908522",
    "title": "Oxcarbazepine add-on for drug-resistant partial epilepsy",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "oxcarbazepine",
   "Trileptal",
   "Oxtellar"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1288863,
  "beneficiaries": 207523,
  "spend": 118089543.01,
  "by_brand": [
   {
    "brand": "Oxcarbazepine",
    "claims": 1257078,
    "per_claim": 53.811489383,
    "is_generic": true
   },
   {
    "brand": "Oxtellar XR",
    "claims": 18806,
    "per_claim": 1513.4420754,
    "is_generic": false
   },
   {
    "brand": "Trileptal",
    "claims": 10640,
    "per_claim": 1825.5732857,
    "is_generic": false
   },
   {
    "brand": "Oxcarbazepine ER",
    "claims": 2339,
    "per_claim": 1093.8059555,
    "is_generic": false
   }
  ],
  "per_claim": 91.6230375222192
 },
 "mdl": [],
 "dsc": [],
 "settlements": [
  {
   "year": 2010,
   "company": "Novartis",
   "amount_usd": 423000000.0,
   "amount_text": "$423 million",
   "violations": "Off-label promotion, kickbacks",
   "products": "Trileptal",
   "laws": "False Claims Act, FDCA",
   "urls": [
    "http://www.novartis.com/newsroom/media-releases/en/2010/1448151.shtml"
   ],
   "matched": "trileptal"
  }
 ],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 4333,
  "fills": 1288863,
  "per_million": 3361.877872202088,
  "ratio": 1.214134661562559,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 93,
   "letter": "A",
   "why": [
    "3,362 FDA reports naming it as the suspect drug per million Medicare fills, 1.2x the median drug on this site (-2)",
    "Death share in reports is near or below the FAERS average (0.6x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 57,
   "letter": "D",
   "why": [
    "84 randomized trials and 26 systematic reviews/meta-analyses indexed in PubMed",
    "11 independent Cochrane review(s) exist",
    "Only 37% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 86,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 32 generic makers (-1)",
    "6 label changes approved since 2021: the safety story is still moving (-8)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 85,
   "letter": "B",
   "why": [
    "Maker paid $423 million in 2010 to settle federal allegations naming this drug (Off-label promotion, kickbacks) (-15)",
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (32 applications)",
    "3 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 82,
 "grade": "B",
 "questions": [
  "The maker paid $423 million in 2010 to settle federal allegations about how this drug was marketed. Is my use one of the uses that was promoted improperly?",
  "The most-reported problems in FDA's adverse event data are seizure, fatigue. 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?",
  "Why this one over carbamazepine, eslicarbazepine, rufinamide? What would make you pick one of those instead?",
  "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.)"
 ]
}