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Drug ReportsButorphanol
Butorphanol
Butorphanol (butorphanol) is a small molecule pharmaceutical. Butorphanol was first approved as Stadol preservative free on 1982-01-01. It is used to treat pain in the USA. The pharmaceutical is active against mu-type opioid receptor and kappa-type opioid receptor.
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YTD
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2Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
signs and symptoms pathological conditionsD013568
psychological phenomenaD011579
musculoskeletal and neural physiological phenomenaD055687
Trade Name
FDA
EMA
Butorphanol (discontinued: Butorphanol, Stadol)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Butorphanol tartrate
Tradename
Company
Number
Date
Products
STADOL PRESERVATIVE FREEBristol Myers SquibbN-017857 DISCN1982-01-01
2 products, RLD
STADOLBristol Myers SquibbN-017857 DISCN1982-01-01
1 products, RLD
STADOLBristol Myers SquibbN-019890 DISCN1991-12-12
1 products
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Labels
FDA
EMA
Brand Name
Status
Last Update
butorphanol tartrateANDA2025-01-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
painEFO_0003843D010146R52
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
N: Nervous system drugs
— N02: Analgesics
— N02A: Opioid analgesics
— N02AF: Morphinan derivatives, opiod analgesics
— N02AF01: Butorphanol
HCPCS
Code
Description
J0595
Injection, butorphanol tartrate, 1 mg
S0012
Butorphanol tartrate, nasal spray, 25 mg
Clinical
Clinical Trials
21 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Postoperative painD010149—G89.18———4—4
AnalgesiaD000698—————224
PainD010146EFO_0003843R52———112
Visceral painD059265—————112
Obstetrical analgesiaD016362—————1—1
Breast feedingD001942—————1—1
AgnosiaD000377EFO_0007136F88———1—1
CurettageD003475—————1—1
ColonoscopyD003113—————1—1
MastectomyD008408—————1—1
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Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Anxiety disordersD001008EFO_0006788F41.1—2———2
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AnesthesiaD000758——————11
HyperalgesiaD006930——————11
Endometrial neoplasmsD016889EFO_0004230—————11
LeiomyomaD007889—D25————11
Uterine cervical neoplasmsD002583——————11
AdenomyosisD062788EFO_1001757N80.0————11
MyofibromaD047708——————11
Labor painD048949——————11
Emergence deliriumD000071257——————11
Psychomotor agitationD011595——————11
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameButorphanol
INNbutorphanol
Description
Butorphanol is levorphanol in which a hydrogen at position 14 of the morphinan skeleton is substituted by hydroxy and one of the hydrogens of the N-methyl group is substituted by cyclopropyl. A semi-synthetic opioid agonist-antagonist analgesic, it is used as its (S,S)-tartaric acid salt for relief or moderate to severe pain. It has a role as an opioid analgesic, a mu-opioid receptor agonist, a kappa-opioid receptor agonist and an antitussive.
Classification
Small molecule
Drug classnarcotic antagonists/agonists (morphinan derivatives)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Oc1ccc2c(c1)[C@@]13CCCC[C@@]1(O)[C@@H](C2)N(CC1CCC1)CC3
Identifiers
PDB—
CAS-ID42408-82-2
RxCUI—
ChEMBL IDCHEMBL33986
ChEBI ID3242
PubChem CID5361092
DrugBankDB00611
UNII IDQV897JC36D (ChemIDplus, GSRS)
Target
Agency Approved
OPRM1
OPRM1
OPRK1
OPRK1
Organism
Homo sapiens
Gene name
OPRM1
Gene synonyms
MOR1
NCBI Gene ID
Protein name
mu-type opioid receptor
Protein synonyms
hMOP, MOP, Mu opiate receptor, Mu opioid receptor, mu opioid receptor hMOR-1a
Uniprot ID
Mouse ortholog
Oprm1 (18390)
mu-type opioid receptor (Q9R1M0)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Butorphanol
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 8,633 documents
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Safety
Black-box Warning
Black-box warning for: Butorphanol tartrate
Adverse Events
Top Adverse Reactions
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2,001 adverse events reported
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