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
Fioricet (generic drugs available since 1984-11-09, discontinued: Anoquan, Axotal, Bancap, Bucet, Butapap, Esgic, Femcet, Fiorinal, Lanorinal, Medigesic, Phrenilin, Sedapap, Tencon, Triad, Triaprin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Acetaminophen
+
Butalbital
+
Caffeine
+
Codeine phosphate
Aspirin
+
Butalbital
+
Caffeine
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| acetaminophen, butalbital and caffeine | ANDA | 2011-02-09 |
| allzital butalbital and acetaminophen | ANDA | 2023-10-11 |
| ascomp with codeine | ANDA | 2022-01-25 |
| bupap | ANDA | 2020-04-30 |
| butalbital acetaminophen and caffeine | ANDA | 2015-05-15 |
| butalbital and acetaminophen | ANDA | 2024-01-09 |
| butalbital, acetaminophen and caffeine | ANDA | 2024-01-31 |
| butalbital, acetaminophen, and caffeine | ANDA | 2024-02-14 |
| butalbital, acetaminophen, caffeine | ANDA | 2024-01-22 |
| butalbital, acetaminophen, caffeine and codeine phosphate | ANDA | 2024-01-03 |
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| headache | HP_0002315 | D006261 | R51 |
Agency Specific
FDA
EMA
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Patent Expiration
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ATC Codes
No data
HCPCS
No data
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 |
|---|---|---|---|---|---|---|---|---|---|
| Pseudotumor cerebri | D011559 | EFO_1001132 | G93.2 | — | 1 | 1 | — | — | 1 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
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
No data
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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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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 568 documents
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Safety
Black-box Warning
Black-box warning for: Allzital butalbital and acetaminophen, Ascomp with codeine, 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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2,892 adverse events reported
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