Two medicines, side by side
Butorphanol vs nalbuphine
Butorphanol and nalbuphine are both labeled for pain. Drugs@FDA records approvals of butorphanol since 1978 and of nalbuphine since 1979. Pharmacies paid $15.46 per mL (Butorphanol 10 mg/mL spray) and $4.32 per mL (Nalbuphine 10 mg/mL ampul) (NADAC, October 7, 2026). How each works, in its label's words: Butorphanol, “Mechanism of Action Butorphanol is a partial opioid agonist at the mu opioid receptor and a full agonist at the kappa opioid receptor.”; Nalbuphine, “Mechanism of Action Nalbuphine is an agonist at kappa opioid receptors and an antagonist at mu opioid receptors.”
Check it at the source: the butorphanol FDA label on DailyMed (effective January 2, 2026); the nalbuphine FDA label on DailyMed (effective December 31, 2025).
Highlights of the butorphanol record
Butorphanol (Stadol) · label of January 2, 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 ].
Used for
From the label: indicationsButorphanol 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. […]
On the market
- Earliest approval on file
- August 22, 1978
- Generic labelers
- 4 labelers
- Pharmacy cost
- $15.46 per mL
Supply and safety
- Shortage
- No current entry
- Recalls
- 1
Highlights of the nalbuphine record
Nalbuphine (Nubain) · label of December 31, 2025
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF NALBUPHINE HYDROCHLORIDE INJECTION Addiction, Abuse, and Misuse Because the use of Nalbuphine Hydrochloride 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 ].
Used for
From the label: indicationsNalbuphine Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Nalbuphine Hydrochloride Injection can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery. […]
On the market
- Earliest approval on file
- May 15, 1979
- Generic labelers
- 6 labelers
- Pharmacy cost
- $4.32 per mL
Supply and safety
- Shortage
- No current entry
- Recalls
- 1
Source: FDA drug labels via openFDA (Butorphanol label of January 2, 2026, Nalbuphine label of December 31, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do butorphanol and nalbuphine differ on the record?
How each works, in its label's words: Butorphanol, “Mechanism of Action Butorphanol is a partial opioid agonist at the mu opioid receptor and a full agonist at the kappa opioid receptor.”; Nalbuphine, “Mechanism of Action Nalbuphine is an agonist at kappa opioid receptors and an antagonist at mu opioid receptors.”
Both are in FDA's class opioid agonist/antagonists.
Half-life, in each label's words: Butorphanol, “The elimination half-life of hydroxybutorphanol is about 18 hours and, as a consequence, considerable accumulation …”; Nalbuphine, “The plasma half-life of nalbuphine is 5 hours, and in clinical studies the duration of analgesic activity has been …”
Both labels carry a boxed warning; the records quote them.
Generics: butorphanol since 1997; nalbuphine since 1986 (Drugs@FDA).
DEA schedule: butorphanol CIV; nalbuphine none.
| Butorphanol | Nalbuphine | |
|---|---|---|
| Labeled for | Pain | Pain |
| Pharmacologic class | Opioid Agonist/Antagonist | Opioid Agonist/Antagonist |
| How it works (label) | Mechanism of Action Butorphanol is a partial opioid agonist at the mu opioid receptor and a full agonist at the kappa opioid receptor. The principal therapeutic action of butorphanol is analgesia. | Mechanism of Action Nalbuphine is an agonist at kappa opioid receptors and an antagonist at mu opioid receptors. |
| Half-life (label) | The elimination half-life of hydroxybutorphanol is about 18 hours and, as a consequence, considerable accumulation (~5-fold) occurs when butorphanol is dosed to steady state. | The plasma half-life of nalbuphine is 5 hours, and in clinical studies the duration of analgesic activity has been reported to range from 3 to 6 hours. |
| Earliest approval on file (Drugs@FDA) | August 22, 1978 | May 15, 1979 |
| First generic approved | January 22, 1997 | July 2, 1986 |
| Generic labelers (NDC) | 4 labelers | 6 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $15.46 per mL (Butorphanol 10 mg/mL spray) | $4.32 per mL (Nalbuphine 10 mg/mL ampul) |
| 12-month price change | +2% | n/a |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 1 | 1 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 326 | 225 |
| DEA schedule | CIV | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What do the labels say about using others of their kind?
Butorphanol label, drug interactionsDrug Interactions Benzodiazepines and Other Central Nervous System (CNS) Depressants Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants such as alcohol, sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), and other opioids, can increase the risk of respiratory depression …
Nalbuphine label, drug interactionsTherefore, due to additive pharmacologic effects, the concomitant use of other opioid analgesics, benzodiazepines or other CNS depressants such as alcohol, non-benzodiazepine 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 …
Source: FDA drug labels via openFDA
What next?
- Alternatives to butorphanol
- every medicine labeled for the same conditions