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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Carbamazepine, Carbatrol, Epitol, Equetro, Tegretol, Teril (discontinued: Carbamazepine, Carnexiv, Tegretol, Teril)
Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Carbamazepine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TEGRETOL | Novartis | N-016608 RX | 1982-01-01 | 1 products, RLD, RS |
| TEGRETOL | Novartis | N-018927 RX | 1987-12-18 | 1 products, RLD, RS |
| TEGRETOL-XR | Novartis | N-020234 RX | 1996-03-25 | 3 products, RLD, RS |
| CARBATROL | Takeda | N-020712 RX | 1997-09-30 | 3 products, RLD |
| EQUETRO | Validus Pharmaceuticals | N-021710 RX | 2004-12-10 | 3 products, RLD, RS |
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| carbamazepin carbamazepine | ANDA | 2023-10-19 |
| carbamazepine | ANDA | 2026-03-20 |
| carbamazepine er | ANDA | 2026-03-17 |
| carbatrol | New Drug Application | 2025-06-27 |
| carbatrol extended-release | 2007-03-30 | |
| epitol | ANDA | 2024-01-31 |
| equetro | New Drug Application | 2025-08-19 |
| hand sanitizer | OTC monograph not final | 2021-11-30 |
| tegretol | New Drug Application | 2025-12-16 |
| tegretol tegretol - xr | 2006-05-11 |
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216 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Epilepsy | D004827 | EFO_0000474 | G40.9 | — | — | 2 | 2 | — | 4 |
| Seizures | D012640 | — | G40.4 | — | — | 1 | 2 | — | 3 |
| Partial epilepsies | D004828 | EFO_0004263 | — | — | — | 1 | 2 | — | 3 |
| Neuralgia | D009437 | EFO_0009430 | — | — | — | — | 1 | — | 1 |
| Metabolic clearance rate | D008657 | — | — | — | — | — | 1 | — | 1 |
| Conduct disorder | D019955 | EFO_0004216 | F91 | — | — | — | 1 | — | 1 |
| Aggression | D000374 | EFO_0003015 | — | — | — | — | 1 | — | 1 |
| Impulsive behavior | D007175 | — | — | — | — | — | 1 | — | 1 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sclerosis | D012598 | — | — | — | 1 | 1 | — | — | 2 |
| Tuberous sclerosis | D014402 | — | Q85.1 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 1 | — | — | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | 1 | — | — | — | 1 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 1 | — | — | — | 1 |
| Alpha 1-antitrypsin deficiency | D019896 | — | E88.01 | — | 1 | — | — | — | 1 |
Indications Phases 1
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Carbamazepine |
| INN | carbamazepine |
| 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 class | tricyclic compounds |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | NC(=O)N1c2ccccc2C=Cc2ccccc21 |
Identifiers
| PDB | — |
| CAS-ID | 298-46-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL108 |
| ChEBI ID | 3387 |
| PubChem CID | 2554 |
| DrugBank | DB00564 |
| UNII ID | 33CM23913M (ChemIDplus, GSRS) |
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Carbatrol – Shire
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Estimated US medical usage
Carbamazepine
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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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49,387 adverse events reported
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