{ "query": "carbamazepine", "ingredient": "carbamazepine", "slug": "carbamazepine", "rxcui": "2002", "brands": [ "Tegretol", "Carbatrol", "Equetro", "Epitol" ], "names": [ "carbamazepine" ], "classes": [ { "id": "N03AF", "name": "Carboxamide derivatives" } ], "alternatives": [ "eslicarbazepine", "oxcarbazepine", "rufinamide" ], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 64 }, "boxed_warning": "WARNINGS SERIOUS DERMATOLOGIC REACTIONS AND HLA-B*1502 ALLELE SERIOUS AND SOMETIMES FATAL DERMATOLOGIC REACTIONS, INCLUDING TOXIC EPIDERMAL NECROLYSIS (TEN) AND STEVENS-JOHNSON SYNDROME (SJS), HAVE BEEN REPORTED DURING TREATMENT WITH CARBAMAZEPINE. THESE REACTIONS ARE ESTIMATED TO OCCUR IN 1 TO 6 PER 10,000 NEW USERS IN COUNTRIES WITH MAINLY CAUCASIAN POPULATIONS, BUT THE RISK IN SOME ASIAN COUNTRIES IS ESTIMATED TO BE ABOUT 10 TIMES HIGHER. STUDIES IN PATIENTS OF CHINESE ANCESTRY HAVE FOUND A STRONG ASSOCIATION BETWEEN THE RISK OF DEVELOPING SJS/TEN AND THE PRESENCE OF HLA-B*1502, AN INHERITED ALLELIC VARIANT OF THE HLA-B GENE. HLA-B*1502 IS FOUND ALMOST EXCLUSIVELY IN PATIENTS WITH ANCESTRY ACROSS BROAD AREAS OF ASIA. PATIENTS WITH ANCESTRY IN GENETICALLY AT-RISK POPULATIONS SHOULD BE SCREENED FOR THE PRESENCE OF HLA-B*1502 PRIOR TO INITIATING TREATMENT WITH CARBAMAZEPINE. PATIENTS TESTING POSITIVE FOR THE ALLELE SHOULD NOT BE TREATED WITH CARBAMAZEPINE UNLESS THE BENEFIT CLEARLY OUTWEIGHS THE RISK (SEE AND ). WARNINGS PRECAUTIONS, LABORATORY TESTS APLASTIC ANEMIA AND AGRANULOCYTOSIS APLASTIC ANEMIA AND AGRANULOCYTOSIS HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF CARBAMAZEPI...", "indications_and_usage": "INDICATIONS AND USAGE Epilepsy Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1. Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. 2. Generalized tonic-clonic seizures (grand mal). 3. Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see ). PRECAUTIONS, General Trigeminal Neuralgia Carbamazepine is indicated in the treatment of the pain associated with true trigeminal neuralgia. Beneficial results have also been reported in glossopharyngeal neuralgia. This drug is not a simple analgesic and should not be used for the relief of trivial aches or pains.", "contraindications": "CONTRAINDICATIONS Carbamazepine should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline, nortriptyline, etc. Likewise, on theoretical grounds its use with monoamine oxidase (MAO) inhibitors is not recommended. Before administration of carbamazepine, MAO inhibitors should be discontinued for a minimum of 14 days, or longer if the clinical situation permits. Coadministration of carbamazepine and nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. Coadministration of carbamazepine with nefazodone is contraindicated.", "warnings_and_cautions": "", "warnings": "WARNINGS Serious Dermatologic Reactions Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have been reported with carbamazepine treatment. The risk of these events is estimated to be about 1 to 6 per 10,000 new users in countries with mainly Caucasian populations. However, the risk in some Asian countries is estimated to be about 10 times higher. Carbamazepine should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered. SJS/TEN and HLA-B*1502 Allele Retrospective case-control studies have found that in patients of Chinese ancestry there is a strong association between the risk of developing SJS/TEN with carbamazepine treatment and the presence of an inherited variant of the HLA-B gene, HLA-B*1502. The occurrence of higher rates of these reactions in countries with higher frequencies of this allele suggests that the risk may be increased in allele-positive individuals of any ethnicity. Across Asian populations, notable variation exists in the prev...", "adverse_reactions": "ADVERSE REACTIONS If adverse reactions are of such severity that the drug must be discontinued, the physician must be aware that abrupt discontinuation of any anticonvulsant drug in a responsive epileptic patient may lead to seizures or even status epilepticus with its life-threatening hazards. The most severe adverse reactions have been observed in the hemopoietic system and skin (see ), the liver, and the cardiovascular system. BOXED WARNING The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. To minimize the possibility of such reactions, therapy should be initiated at the lowest dosage recommended. The following additional adverse reactions have been reported: Aplastic anemia, agranulocytosis, pancytopenia, bone marrow depression, thrombocytopenia, leukopenia, leukocytosis, eosinophilia, acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda. Hemopoietic System: Toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) (see ), Acute Generalized Exanthematous Pustulosis (AGEP), pruritic and erythematous rashes, urticaria, photosensitivity rea...", "drug_abuse_and_dependence": "DRUG ABUSE AND DEPENDENCE No evidence of abuse potential has been associated with carbamazepine, nor is there evidence of psychological or physical dependence in humans.", "controlled_substance": "", "recent_major_changes": "", "information_for_patients": "Information for Patients Patients should be informed of the availability of a Medication Guide and they should be instructed to read the Medication Guide before taking carbamazepine. Patients should be made aware of the early toxic signs and symptoms of a potential hematologic problem, as well as dermatologic, hypersensitivity or hepatic reactions. These symptoms may include, but are not limited to, fever, sore throat, rash, ulcers in the mouth, easy bruising, lymphadenopathy and petechial or purpuric hemorrhage, and in the case of liver reactions, anorexia, nausea/vomiting, or jaundice. The patient should be advised that, because these signs and symptoms may signal a serious reaction, that they must report any occurrence immediately to a physician. In addition, the patient should be advised that these signs and symptoms should be reported even if mild or when occurring after extended use. Patients should be advised that serious skin reactions have been reported in association with carbamazepine. In the event a skin reaction should occur while taking carbamazepine, patients should consult with their physician immediately (see ). WARNINGS Patients, their caregivers, and families sho...", "spl_medguide": "MEDICATION GUIDE Carbamazepine (kar\" ba maz' e peen) Tablets USP, Carbamazepine (kar\" ba maz' e peen) Oral Suspension USP, Carbamazepine (kar\" ba maz' e peen) Tablets USP (Chewable), and Carbamazepine (kar\" ba maz' e peen) Extended-Release Tablets USP Read this Medication Guide before you start taking Carbamazepine Tablets USP, Carbamazepine Oral Suspension USP, Carbamazepine Tablets USP (Chewable), or Carbamazepine Extended-Release Tablets USP 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 carbamazepine? Do not stop taking carbamazepine without first talking to your healthcare provider. Stopping carbamazepine suddenly can cause serious problems. Carbamazepine can cause serious side effects, including: 1. Carbamazepine may cause rare but serious skin rashes that may lead to death. These serious skin reactions are more likely to happen when you begin taking carbamazepine within the first four months of treatment but may occur at later times. These reactions can happen in anyone, but are mo...", "clinical_studies": "", "brand_name": "Carbamazepine", "manufacturer": "Atlantic Biologicals Corps", "application_number": "ANDA076729", "pharm_class_epc": [ "Mood Stabilizer [EPC]" ], "route": [ "ORAL" ], "effective_time": "20250318", "set_id": "25939406-a836-43cd-9301-56808e9b31ec", "has_boxed_warning": true, "controlled": false, "mentions_rems": false }, "faers": { "total": 45172, "serious": 37810, "death": 3452, "hospitalization": 17121, "primary_suspect": 44664, "top_reactions": [ [ "Drug Ineffective", 4204 ], [ "Seizure", 3869 ], [ "Off Label Use", 2627 ], [ "Toxicity To Various Agents", 2408 ], [ "Drug Interaction", 2387 ], [ "Fall", 2345 ], [ "Dizziness", 1893 ], [ "Fatigue", 1818 ], [ "Nausea", 1791 ], [ "Pain", 1753 ], [ "Vomiting", 1668 ], [ "Somnolence", 1569 ], [ "Headache", 1529 ], [ "Rash", 1515 ], [ "Pyrexia", 1472 ] ], "by_year": { "2019": 4527, "2020": 3813, "2021": 3997, "2022": 3443, "2023": 2939, "2024": 2941, "2025": 2931, "2026": 1478 }, "by_year_primary": { "2019": 4515, "2020": 3804, "2021": 3944, "2022": 3362, "2023": 2859, "2024": 2829, "2025": 2837, "2026": 1418 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class II", "date": "20250915", "reason": "Failed Dissolution Specifications.", "firm": "Amerisource Health Services LLC", "status": "Ongoing" }, { "class": "Class II", "date": "20211202", "reason": "Failed Dissolution Specifications", "firm": "Torrent Pharma Inc.", "status": "Terminated" }, { "class": "Class II", "date": "20200511", "reason": "Failed Dissolution Specifications", "firm": "Torrent Pharma Inc.", "status": "Terminated" } ], "recall_total": 3, "drugsfda": { "applications": 52, "nda": 7, "anda": 42, "first_approval": "19680311", "rems": false, "rems_last": "20120127", "labeling_supplements": 122, "labeling_recent": 12, "sponsors": [ "ACTAVIS ELIZABETH", "AJANTA PHARMA LTD", "ALEMBIC", "ALKEM LABS LTD", "AMNEAL PHARMS", "ANBISON LAB", "ANI PHARMS", "APOTEX" ], "unapproved": false, "first_approval_fmt": "03/11/1968" }, "trials": { "total": 225, "completed": 166, "terminated": 17, "with_results": 48, "industry": 132, "phase3": 31, "results_share": 0.2891566265060241, "terminated_share": 0.07555555555555556 }, "pubmed": { "rct": 354, "meta": 74, "recent_rct": 8, "cochrane": [ { "pmid": "31318037", "title": "Carbamazepine versus phenytoin monotherapy for epilepsy: an individual participant data review", "year": "2019" }, { "pmid": "31233229", "title": "Topiramate versus carbamazepine monotherapy for epilepsy: an individual participant data review", "year": "2019" }, { "pmid": "30353945", "title": "Carbamazepine versus phenobarbitone monotherapy for epilepsy: an individual participant data review", "year": "2018" }, { "pmid": "29952431", "title": "Lamotrigine versus carbamazepine monotherapy for epilepsy: an individual participant data review", "year": "2018" }, { "pmid": "28240353", "title": "Carbamazepine versus phenytoin monotherapy for epilepsy: an individual participant data review", "year": "2017" }, { "pmid": "27976799", "title": "Carbamazepine versus phenobarbitone monotherapy for epilepsy: an individual participant data review", "year": "2016" }, { "pmid": "27933615", "title": "Immediate-release versus controlled-release carbamazepine in the treatment of epilepsy", "year": "2016" }, { "pmid": "27922722", "title": "Topiramate versus carbamazepine monotherapy for epilepsy: an individual participant data review", "year": "2016" }, { "pmid": "27841445", "title": "Lamotrigine versus carbamazepine monotherapy for epilepsy: an individual participant data review", "year": "2016" }, { "pmid": "26580100", "title": "Vigabatrin versus carbamazepine monotherapy for epilepsy", "year": "2015" }, { "pmid": "26275105", "title": "Carbamazepine versus phenytoin monotherapy for epilepsy: an individual participant data review", "year": "2015" }, { "pmid": "26204241", "title": "Carbamazepine versus phenobarbitone monotherapy for epilepsy: an individual participant data review", "year": "2015" } ] }, "payments": { "year": "2024", "usd": 12256.67, "records": 207, "by_name": [ [ "Equetro", 12256.67 ] ], "names_checked": [ "carbamazepine", "Tegretol", "Carbatrol", "Equetro", "Epitol" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 1339939, "beneficiaries": 229289, "spend": 128082406.35000001, "by_brand": [ { "brand": "Carbamazepine", "claims": 771346, "per_claim": 51.712266726, "is_generic": true }, { "brand": "Carbamazepine ER", "claims": 503816, "per_claim": 112.51662186, "is_generic": false }, { "brand": "Tegretol XR", "claims": 28016, "per_claim": 556.08626678, "is_generic": false }, { "brand": "Tegretol", "claims": 21732, "per_claim": 532.90993604, "is_generic": false }, { "brand": "Carbatrol", "claims": 11532, "per_claim": 281.53438085, "is_generic": false }, { "brand": "Equetro", "claims": 2532, "per_claim": 413.50859005, "is_generic": false }, { "brand": "Epitol", "claims": 965, "per_claim": 54.416673575, "is_generic": false } ], "per_claim": 95.58823674062775 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": true, "status": "AddedToEml", "name": "carbamazepine", "matched": "carbamazepine", "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 7084, "fills": 1339939, "per_million": 5286.807832296843, "ratio": 1.9093188040193518, "median": 2768.949753790441 }, "scores": { "safety": { "score": 59, "letter": "D", "why": [ "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)", "5,287 FDA reports naming it as the suspect drug per million Medicare fills, 1.9x the median drug on this site (-6)", "Death share in reports is near or below the FAERS average (0.8x)", "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)" ], "weight": 0.35 }, "evidence": { "score": 62, "letter": "D", "why": [ "354 randomized trials and 74 systematic reviews/meta-analyses indexed in PubMed", "On the WHO Model List of Essential Medicines (shown for context; no score effect)", "12 independent Cochrane review(s) exist", "Only 29% of completed registered trials posted results (-15)", "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)" ], "weight": 0.25 }, "regulatory": { "score": 88, "letter": "A", "why": [ "Recalls since 2016: 0 Class I, 3 Class II, 0 Class III across 42 generic makers (-4)", "12 label changes approved since 2021: the safety story is still moving (-8)" ], "weight": 0.15 }, "conflict": { "score": 100, "letter": "A", "why": [ "Pharma paid doctors $12,257 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 (42 applications)", "3 same-class alternatives exist" ], "weight": 0.1 } }, "total": 74, "grade": "C", "questions": [ "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?", "The most-reported problems in FDA's adverse event data are seizure, toxicity to various agents. 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 eslicarbazepine, oxcarbazepine, 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.)" ] }