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Drug ReportsCarbamazepine
Carbamazepine
Carbamazepine, Carbatrol, Epitol, Equetro, Tegretol, Teril (carbamazepine) is a small molecule pharmaceutical. Carbamazepine was first approved as Tegretol on 1982-01-01. It is used to treat bipolar disorder, complex partial epilepsy, mood disorders, post-traumatic stress disorders, and psychotic disorders amongst others in the USA. It is known to target frizzled-8.
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Novartis Pharmaceuticals
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Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
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6M
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2Y
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FDA approval date
EMA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
stomatognathic diseasesD009057
nervous system diseasesD009422
chemically-induced disordersD064419
mental disordersD001523
Trade Name
FDA
EMA
Carbatrol, Equetro, Tegretol (generic drugs available since 1986-09-17, discontinued: Carnexiv, Teril)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Carbamazepine
Tradename
Company
Number
Date
Products
TEGRETOLNovartisN-016608 RX1982-01-01
1 products, RLD, RS
TEGRETOLNovartisN-018927 RX1987-12-18
1 products, RLD, RS
TEGRETOL-XRNovartisN-020234 RX1996-03-25
3 products, RLD, RS
CARBATROLTakedaN-020712 RX1997-09-30
3 products, RLD
EQUETROValidus PharmaceuticalsN-021710 RX2004-12-10
3 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
carbamazepin carbamazepineANDA2023-10-19
carbamazepineANDA2024-02-02
carbamazepine erANDA2024-01-03
carbatrolNew Drug Application2023-04-17
carbatrol extended-release2007-03-30
carnexivNew Drug Application2024-01-09
epitolANDA2022-03-22
equetroNew Drug Application2022-10-13
hand sanitizerOTC monograph not final2021-11-30
tegretolNew Drug Application2023-09-13
Show 2 more
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Carbamazepine, Carnexiv, Lundbeck Pharms Llc
115293572040-01-31DP
94935822033-02-27DP
76357732029-03-13DP
84100772029-03-13DP
97508222029-03-13DP
96297972028-11-10U-2004, U-2005, U-2006
97704072028-11-10DP
Carbamazepine, Equetro, Validus Pharms
69772532024-05-19U-693
ATC Codes
N: Nervous system drugs
— N03: Antiepileptics
— N03A: Antiepileptics
— N03AF: Carboxamide derivatives, antiepileptics
— N03AF01: Carbamazepine
HCPCS
No data
Clinical
Clinical Trials
149 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EpilepsyD004827EFO_0000474G40.942981133
Healthy volunteers/patients———15——1117
Bipolar disorderD001714EFO_0000289F30.911310216
SeizuresD012640HP_0002069G40.4——4149
Partial epilepsiesD004828EFO_0004263———13—4
Trigeminal neuralgiaD014277EFO_1001219G50.0—11124
Cocaine-related disordersD019970—F14—3—1—4
Rolandic epilepsyD019305—————3—3
Substance-related disordersD019966EFO_0003890F13—2—1—3
NeuralgiaD009437EFO_0009430————112
Show 9 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SchizophreniaD012559EFO_0000692F201—1——2
Tuberous sclerosisD014402HP_0009720Q85.1——1——1
DementiaD003704EFO_0003862F03——1——1
Psychophysiologic disordersD011602—F45.9——1——1
DepressionD003863—F33.9——1——1
Anxiety disordersD001008EFO_0006788F41.1——1——1
StrokeD020521EFO_0000712I63.9——1——1
Tonic-clonic epilepsyD004830EFO_0007262———1——1
Generalized epilepsyD004829————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Central nervous system neoplasmsD016543——12———2
Liver cirrhosisD008103EFO_0001422K74.0—1———1
Alpha 1-antitrypsin deficiencyD019896—E88.01—1———1
Reflex epilepsyD020195EFO_1001146——1———1
Infantile spasmsD013036HP_0011097G40.82—1———1
Hiv infectionsD015658EFO_0000764B20—1———1
VomitingD014839HP_0002013R11.1—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GlioblastomaD005909EFO_0000515—4————4
GliosarcomaD018316——4————4
AstrocytomaD001254EFO_0000271—3————3
Covid-19D000086382—U07.12————2
GliomaD005910EFO_0000520—1————1
OligodendrogliomaD009837EFO_0000631—1————1
InfectionsD007239EFO_0000544—1————1
Hepatitis bD006509——1————1
Hot flashesD019584——1————1
Parkinson diseaseD010300EFO_0002508G201————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Metabolic bone diseasesD001851HP_0000938—————11
OsteoporosisD010024HP_0000939M81.0————11
PainD010146EFO_0003843R52————11
Mood disordersD019964EFO_0004247F30-F39————11
Drug hypersensitivity syndromeD063926EFO_1002004D72.12————11
Congenital abnormalitiesD000013EFO_0003915Q89.9————11
Autistic disorderD001321HP_0000717F84.0————11
Cognition disordersD003072——————11
Postherpetic neuralgiaD051474——————11
Multiple sclerosisD009103EFO_0003885G35————11
Show 6 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCarbamazepine
INNcarbamazepine
Description
Carbamazepine is a dibenzoazepine that is 5H-dibenzo[b,f]azepine carrying a carbamoyl substituent at the azepine nitrogen, used as an anticonvulsant. It has a role as an anticonvulsant, an EC 3.5.1.98 (histone deacetylase) inhibitor, a mitogen, a glutamate transporter activator, an antimanic drug, an analgesic, a non-narcotic analgesic, an environmental contaminant, a xenobiotic, a drug allergen and a sodium channel blocker. It is a dibenzoazepine and a member of ureas.
Classification
Small molecule
Drug classtricyclic compounds
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
NC(=O)N1c2ccccc2C=Cc2ccccc21
Identifiers
PDB—
CAS-ID298-46-4
RxCUI—
ChEMBL IDCHEMBL108
ChEBI ID3387
PubChem CID2554
DrugBankDB00564
UNII ID33CM23913M (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
FZD8
FZD8
Organism
Homo sapiens
Gene name
FZD8
Gene synonyms
NCBI Gene ID
Protein name
frizzled-8
Protein synonyms
frizzled 8, seven transmembrane spanning receptor, frizzled family receptor 8, frizzled homolog 8
Uniprot ID
Mouse ortholog
Fzd8 (14370)
frizzled-8 (Q61091)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Carbatrol – Shire
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Tabular view
Estimated US medical usage
Carbamazepine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 35,318 documents
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Safety
Black-box Warning
Black-box warning for: Carbamazepin carbamazepine, Carbamazepine, Carbamazepine er, Carbatrol, Carbatrol extended-release, Carnexiv, Epitol, Equetro, Tegretol, Tegretol tegretol - xr
Adverse Events
Top Adverse Reactions
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39,099 adverse events reported
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