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Butalbital
Anoquan, Axotal, Bancap, Bucet, Butapap, Esgic, Femcet, Fioricet, Fiorinal, Lanorinal, Medigesic, Phrenilin, Sedapap, Tencon, Triad, Triaprin (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 conditionsD013568
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
Tradename
Company
Number
Date
Products
FIORICET W/ CODEINEAllerganN-020232 RX1992-07-30
1 products, RLD, RS
Aspirin
+
Butalbital
+
Caffeine
Tradename
Company
Number
Date
Products
FIORINALAllerganN-017534 DISCN1986-04-16
2 products, RLD
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Aspirin
+
Butalbital
+
Caffeine
+
Codeine phosphate
Tradename
Company
Number
Date
Products
FIORINAL W/CODEINEAllerganN-019429 DISCN1990-10-26
1 products, RLD
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
allzital butalbital and acetaminophenANDA2021-10-18
butalbital, acetaminophen, caffeineANDA2023-06-08
esgicANDA2022-11-09
fioricetANDA2021-01-01
tenconANDA2020-02-18
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
headacheHP_0002315D006261R51
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
11 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AnesthesiaD000758———1—1
Kidney neoplasmsD007680EFO_0003865C64———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GastroenteritisD005759EFO_1001463K52.9——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471C61—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD0022892————2
Prostatic hyperplasiaD011470EFO_0000284N401————1
SchizophreniaD012559EFO_0000692F201————1
Lung neoplasmsD008175C34.901————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBUTALBITAL
INNbutalbital
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-ID77-26-9
RxCUI19860
ChEMBL IDCHEMBL454
ChEBI ID102524
PubChem CID2481
DrugBankDB00241
UNII IDKHS0AZ4JVK (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 651 documents
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Safety
Black-box Warning
Black-box warning for: Allzital butalbital and acetaminophen, Butalbital, acetaminophen, caffeine, Fioricet
Adverse Events
Top Adverse Reactions
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24 adverse events reported
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