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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Commercial
Therapeutic Areas
Trade Name
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Butorphanol (discontinued: Butorphanol, Stadol)
Drug Products
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Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Butorphanol tartrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| STADOL PRESERVATIVE FREE | Bristol Myers Squibb | N-017857 DISCN | 1982-01-01 | 2 products, RLD |
| STADOL | Bristol Myers Squibb | N-017857 DISCN | 1982-01-01 | 1 products, RLD |
| STADOL | Bristol Myers Squibb | N-019890 DISCN | 1991-12-12 | 1 products, RLD |
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EMA
Brand Name | Status | Last Update |
|---|---|---|
| butorphanol tartrate | ANDA | 2025-08-28 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| pain | EFO_0003843 | D010146 | R52 |
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Clinical
Clinical Trials
22 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 pain | D010149 | — | G89.18 | — | — | — | 4 | 1 | 5 |
| Agnosia | D000377 | EFO_0007136 | F88 | — | — | — | 4 | 1 | 5 |
| Analgesia | D000698 | — | — | — | — | — | 2 | 2 | 4 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | 1 | 1 | 2 |
| Visceral pain | D059265 | — | — | — | — | — | 1 | 1 | 2 |
| Obstetrical analgesia | D016362 | — | — | — | — | — | 1 | — | 1 |
| Breast feeding | D001942 | — | — | — | — | — | 1 | — | 1 |
| Curettage | D003475 | — | — | — | — | — | 1 | — | 1 |
| Colonoscopy | D003113 | — | — | — | — | — | 1 | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | — | 1 | — | 1 |
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Indications Phases 3
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | 2 | — | — | — | 2 |
Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anesthesia | D000758 | — | — | — | — | — | — | 1 | 1 |
| Hyperalgesia | D006930 | — | — | — | — | — | — | 1 | 1 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | — | — | — | — | 1 | 1 |
| Leiomyoma | D007889 | — | D25 | — | — | — | — | 1 | 1 |
| Uterine cervical neoplasms | D002583 | — | — | — | — | — | — | 1 | 1 |
| Adenomyosis | D062788 | EFO_1001757 | N80.0 | — | — | — | — | 1 | 1 |
| Myofibroma | D047708 | — | — | — | — | — | — | 1 | 1 |
| Labor pain | D048949 | — | — | — | — | — | — | 1 | 1 |
| Emergence delirium | D000071257 | — | — | — | — | — | — | 1 | 1 |
| Psychomotor agitation | D011595 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Butorphanol |
| INN | butorphanol |
| 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 class | narcotic antagonists/agonists (morphinan derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Oc1ccc2c(c1)[C@@]13CCCC[C@@]1(O)[C@@H](C2)N(CC1CCC1)CC3 |
Identifiers
| PDB | — |
| CAS-ID | 42408-82-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL33986 |
| ChEBI ID | 3242 |
| PubChem CID | 5361092 |
| DrugBank | DB00611 |
| UNII ID | QV897JC36D (ChemIDplus, GSRS) |
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Butorphanol
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Safety
Black-box Warning
Black-box warning for: Butorphanol tartrate
Adverse Events
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607 adverse events reported
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