Butalbital
Acetaminophen / Butalbital, Acetaminophen / Butalbital / Caffeine, Acetaminophen / Butalbital / Caffeine / Codeine, Allzital, Aspirin / Butalbital / Caffeine, Aspirin / Butalbital / Caffeine / Codeine, Axotal, Butapap, Fioricet, Lanorinal (butalbital) is a small molecule pharmaceutical. Butalbital was first approved as Butalbital, aspirin and caffeine on 1983-08-23. It is used to treat headache in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Combinations
Butalbital acetaminophen, Butalbital, acetaminophen caffeine, Butalbital, acetaminophen, caffeine codeine, Butalbital, aspirin caffeine, Butalbital, aspirin, caffeine, codeine, Fioricet, Lanorinal (discontinued: Anoquan, Axotal, Bancap, Bucet, Butalbital acetaminophen, Butalbital, acetaminophen caffeine, Butalbital, acetaminophen, caffeine codeine, Butalbital, aspirin caffeine, Butalbital, aspirin, caffeine, codeine, Esgic, Femcet, Fiorinal, Fiorinal w/codeine, Lanorinal, Phrenilin, Phrenilin with caffeine codeine, Tencon, Triad)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Aspirin
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Butalbital
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Caffeine
Aspirin
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Butalbital
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Caffeine
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Codeine phosphate
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| acetaminophen, butalbital and caffeine | ANDA | 2011-02-09 |
| allzital butalbital and acetaminophen | ANDA | 2024-10-10 |
| ascomp with codeine | ANDA | 2024-07-01 |
| bupap | ANDA | 2020-04-30 |
| butalbital acetaminophen and caffeine | ANDA | 2015-05-15 |
| butalbital and acetaminophen | ANDA | 2024-11-11 |
| butalbital, acetaminophen and caffeine | ANDA | 2024-10-16 |
| butalbital, acetaminophen, and caffeine | ANDA | 2024-11-12 |
| butalbital, acetaminophen, caffeine | ANDA | 2024-10-01 |
| butalbital, acetaminophen, caffeine and codeine phosphate | ANDA | 2024-04-05 |
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Indications
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Agency Specific
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HCPCS
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Clinical
Clinical Trials
2 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | — | 1 | 1 | — | — | 1 |
| Pseudotumor cerebri | D011559 | EFO_1001132 | G93.2 | — | 1 | 1 | — | — | 1 |
| Intracranial hypertension | D019586 | EFO_1000992 | — | — | 1 | 1 | — | — | 1 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | — | 1 | — | — | 1 |
Indications Phases 2
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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 | Butalbital |
| INN | butalbital |
| Description | Butalbital is a member of the class of barbiturates that is barbituric acid in which the hydrogens at position 5 are substituted by an allyl group and an isobutyl group. Frequently combined with other medicines, such as aspirin, paracetamol and codeine, it is used for treatment of pain and headache. It has a role as a sedative and an analgesic. It is functionally related to a barbituric acid. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C=CCC1(CC(C)C)C(=O)NC(=O)NC1=O |
Identifiers
| PDB | — |
| CAS-ID | 77-26-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL454 |
| ChEBI ID | 102524 |
| PubChem CID | 2481 |
| DrugBank | DB00241 |
| UNII ID | KHS0AZ4JVK (ChemIDplus, GSRS) |
Target
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Variants
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Financial
Revenue by drug
$
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Estimated US medical usage
Butalbital
+
Acetaminophen
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 588 documents
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Safety
Black-box Warning
Black-box warning for: Allzital butalbital and acetaminophen, Ascomp with codeine, Butalbital and acetaminophen, Butalbital, acetaminophen and caffeine, Butalbital, acetaminophen, and caffeine, Butalbital, acetaminophen, caffeine, Butalbital, acetaminophen, caffeine and codeine phosphate, Butalbital, acetaminophen, caffeine, and codeine phosphate, Butalbital, aspirin, caffeine and codeine phosphate, Fioricet, Fioricet with codeine
Adverse Events
Top Adverse Reactions
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3,709 adverse events reported
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