Prescription medicine
Butorphanol First approved as Stadol
Butorphanol (Stadol) is a prescription medicine with an FDA approval on record since 1978. FDA's NDC Directory lists it from 4 generic labelers, and pharmacies paid $15.46 per mL (Butorphanol 10 mg/mL spray) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the butorphanol FDA label on DailyMed (effective January 2, 2026, Hospira, Inc.); the NDA 17857 record on Drugs@FDA; every butorphanol label on DailyMed.
Highlights of the record
FDA label of January 2, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BUTORPHANOL TARTRATE INJECTION.
Addiction, Abuse, and Misuse Because the use of Butorphanol Tartrate Injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see WARNINGS ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Butorphanol Tartrate Injection, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Butorphanol Tartrate Injection are essential [see WARNINGS ]. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of Butorphanol Tartrate Injection and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see WARNINGS , PRECAUTIONS ; Drug Interactions ]. […]
Used for
From the label: indications and usageButorphanol Tartrate Injection is indicated - as a preoperative or pre-anesthetic medication - as a supplement to balanced anesthesia - for the relief of pain during labor, and - for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Forms and strengths
- 1 mg/ml
- 2 mg/ml
- 10 mg/ml
Injection (solution); spray; spray (metered).
On the market
- Earliest approval on file
- August 22, 1978 Stadol, Apothecon; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 14 first January 22, 1997; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 4 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $15.46 per mL Butorphanol 10 mg/mL spray
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2021 0 Class I among all firms' recalls; latest March 15, 2021
- FAERS reports
- 326 through July 30, 2026
What is butorphanol used for?
From the label: indications and usageButorphanol Tartrate Injection is indicated - as a preoperative or pre-anesthetic medication - as a supplement to balanced anesthesia - for the relief of pain during labor, and - for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. […]
Conditions named in the indications of butorphanol's FDA labels, with every medicine labeled for each:
From other butorphanol labelsPain: INDICATIONS AND USAGE Butorphanol Tartrate Injection is indicated - as a preoperative or pre-anesthetic medication - as a supplement to balanced anesthesia - for the relief of pain during labor, and - for the management of pain severe …
FDA pharmacologic class: Opioid Agonist/Antagonist.
Source: FDA drug label (Butorphanol Tartrate), Hospira, Inc., effective January 2, 2026 (SPL set 9822ca3f-aee2-46e5-8a96-495400e65d10), via openFDA; the full label on DailyMed
Is there a generic for butorphanol (Stadol)?
The FDA approved the first generic butorphanol on January 22, 1997. 14 generic applications are approved; 6 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists butorphanol from 4 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1978 earliest approval on file
- 1997 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for butorphanol (Stadol)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $15.46 per mL (Butorphanol 10 mg/mL spray), up 2% from $15.21 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Butorphanol 10 mg/mL spray (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Butorphanol 10 mg/mL spray | Generic | $15.46 per mL | n/a | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has butorphanol been recalled?
The FDA's Enforcement Report lists 1 recall naming butorphanol since 2021: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the butorphanol label say about other medicines?
The butorphanol label names 13 other medicines in its interaction, contraindication or warning sections. The labels of 26 other medicines name butorphanol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cyclobenzaprine | drug interactions | … serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (eg., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin … |
| Erythromycin | drug interactions | Cytochrome P450 (CYP 450) Interactions It is not known if the effects of Butorphanol Tartrate Injection are altered by concomitant medications that affect hepatic metabolism of drugs (CYP 450 inhibitors or inducers) (e.g., erythromycin, theophylline, etc.), but physicians should be alert to the possibility that a … |
| Gabapentin | drug interactions | … alcohol, sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), and other opioids, can increase the risk of respiratory depression, profound sedation, coma, and death. |
| Linezolid | drug interactions | … monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome [see PRECAUTIONS; |
| Metaxalone | drug interactions | … neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (eg., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome … |
| Methylene blue | drug interactions | … inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome [see PRECAUTIONS; |
| Mirtazapine | drug interactions | … (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (eg., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as … |
| Nalmefene | warnings | Management of respiratory depression may include close observation, supportive measures, and use of opioid overdose reversal agents (e.g., naloxone, nalmefene), depending on the patient's clinical status [see OVERDOSAGE ]. |
| Naloxone | drug interactions | If concomitant use is warranted, consider prescribing naloxone for the emergency treatment of opioid overdose. |
| Pregabalin | drug interactions | … anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), and other opioids, can increase the risk of respiratory depression, profound sedation, coma, and death. |
| Theophylline | drug interactions | Cytochrome P450 (CYP 450) Interactions It is not known if the effects of Butorphanol Tartrate Injection are altered by concomitant medications that affect hepatic metabolism of drugs (CYP 450 inhibitors or inducers) (e.g., erythromycin, theophylline, etc.), but physicians should be alert to the possibility that a … |
| Tramadol | drug interactions | … receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (eg., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous … |
| Trazodone | drug interactions | … triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (eg., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid … |
Other labels that name butorphanol
Source: FDA drug label (Butorphanol Tartrate), Hospira, Inc., effective January 2, 2026 (SPL set 9822ca3f-aee2-46e5-8a96-495400e65d10), via openFDA; the full label on DailyMed
What do FAERS reports show for butorphanol?
The FDA Adverse Event Reporting System holds 326 reports that list butorphanol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 9 are coded as a death and 50 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
How does butorphanol compare with medicines for the same use?
1 side-by-side page set butorphanol beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to butorphanol
- medicines labeled for the same conditions
- Other opioid agonist/antagonists
- the pharmacologic class, with prices and generics
- Butorphanol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other