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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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Commercial
Clinical
Drug
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Variants
Financial
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Safety
Events Timeline
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FDA approval date
EMA approval date
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Study first post 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
Carbamazepine, Carbatrol, Epitol, Equetro, Tegretol, Teril (discontinued: Carbamazepine, Carnexiv, Tegretol, 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
carbamazepineANDA2025-10-03
carbamazepine erANDA2024-11-13
carbatrolNew Drug Application2025-06-27
carbatrol extended-release2007-03-30
epitolANDA2024-01-31
equetroNew Drug Application2025-08-19
hand sanitizerOTC monograph not final2021-11-30
tegretolNew Drug Application2025-01-21
tegretol tegretol - xr2006-05-11
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Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
substance withdrawal syndromeEFO_0005800D013375—
restless legs syndromeEFO_0004270D012148G25.81
trigeminal neuralgiaEFO_1001219D014277G50.0
complex partial epilepsyEFO_1000877D017029—
tonic-clonic epilepsyEFO_0007262D004830—
schizophreniaEFO_0000692D012559F20
psychotic disorders—D011618F20.81
bipolar disorderEFO_0000289D001714F30.9
post-traumatic stress disordersEFO_0001358D013313F43.1
mood disordersEFO_0004247D019964F30-F39
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
206 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bipolar disorderD001714EFO_0000289F30.9——22—4
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
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
8325
Protein name
frizzled-8
Protein synonyms
frizzled 8, seven transmembrane spanning receptor, frizzled family receptor 8, frizzled homolog 8
Uniprot ID
Q9H461
Mouse ortholog
Fzd8 (14370)
frizzled-8 (Q61091)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Carbatrol – Shire
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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 40,678 documents
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Safety
Black-box Warning
Black-box warning for: Carbamazepin carbamazepine, Carbamazepine, Carbamazepine er, Carbatrol, Carbatrol extended-release, Epitol, Equetro, Tegretol, Tegretol tegretol - xr
Adverse Events
Top Adverse Reactions
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48,937 adverse events reported
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