FDA-filed SPL labeling · retrieved through openFDA

Butorphanol Nasal Spray

Butorphanol nasal spray is an opioid pain reliever used to manage severe pain when non-opioid treatments have not worked or are not expected to work.

Brand names Stadol NSDolorex SolutionButorphicTorbugesicTorphadine +1 more
Drug classes ⓘ Competitive Opioid Antagonists
Rx Schedule CIV Form 1 Route Nasal
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 3 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveNov 20, 2025
Clinical labels in scope ⓘ3
AvailabilityRx
Earliest approval/marketing year ⓘ1978
FDA-listed product records ⓘ8
Boxed warningYes
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 29, 2026
⭐ Butorphanol Nasal Spray at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Butorphanol Tartrate Nasal Spray is a powerful opioid reserved for severe pain that has not responded to other treatments. It comes with serious risks — including addiction, life-threatening respiratory depression, and dangerous interactions with sedatives and alcohol — so it must be used at the lowest effective dose for the shortest time necessary. Always keep a naloxone overdose reversal kit on hand and store this medication securely away from children.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

This medication carries serious, potentially fatal risks that are required by the FDA to be highlighted. Butorphanol Tartrate Nasal Spray can cause addiction, misuse, and overdose, including death. It can cause life-threatening slowing or stopping of breathing — this risk is highest when first starting the drug or after a dose increase. Even one accidental dose — especially in a child — can be fatal. Using this spray with benzodiazepines (like Valium or Xanax), alcohol, or other sedatives can cause coma or death. If you are pregnant and use opioids for a long period, your newborn may experience a serious, life-threatening withdrawal syndrome after birth. Certain medications that affect how the liver processes butorphanol can cause its levels to rise dangerously in the blood — always tell every provider about every medication you take.

Read the full warning on DailyMed →

📖 Butorphanol Nasal Spray: Patient Information Guide

A plain-language walkthrough of Butorphanol Nasal Spray — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Butorphanol Tartrate Nasal Spray is an opioid analgesic (pain reliever) approved for a specific, limited use:

  • Management of severe pain that requires an opioid and for which non-opioid alternatives have not worked, are not tolerated, or are not expected to provide adequate relief
  • It should only be continued long-term if pain remains severe enough to require an opioid and other options are still inadequate
  • Butorphanol Tartrate Nasal Spray is not recommended for use during labor, as it has not been studied in that setting
  • Butorphanol Tartrate Nasal Spray is not recommended for induction or maintenance of anesthesia
⚙️How it works▾

Butorphanol is a mixed opioid agonist — it partially activates the mu (μ) opioid receptor and fully activates the kappa (κ) opioid receptor. These receptors are found throughout the brain and spinal cord and play a key role in how the body perceives pain. By activating them, butorphanol reduces the sensation of pain. Its pain-relieving action starts within about 15 minutes of nasal administration and peaks within 1 to 2 hours, lasting roughly 4 to 5 hours.

Because butorphanol acts on both receptor types — rather than just one — its effects differ somewhat from standard opioids. Activating the kappa receptor in particular can cause some users to experience unusual psychological effects, such as a floating feeling or mild perceptual changes.

💊How it's taken▾

Butorphanol Tartrate Nasal Spray is sprayed into the nostril(s) as directed by your prescriber, generally on an as-needed basis for pain. Dosing is usually every 3 to 4 hours, though your prescriber will adjust this based on how you respond. Older adults and people with liver or kidney problems typically start with a lower, less frequent dose.

  • Always use the lowest dose that controls your pain
  • Do not take an extra dose sooner than your prescriber recommends
  • Never stop this medication abruptly — your prescriber will help you taper slowly to avoid withdrawal
  • Take no specific milligram dose without guidance from your prescriber or pharmacist
🤒Side effects — in detail▾

The most common side effects of Butorphanol Tartrate Nasal Spray include:

  • Drowsiness or somnolence (very common)
  • Dizziness
  • Nausea and/or vomiting
  • Nasal congestion, irritation, or runny nose
  • Headache
  • Insomnia (with longer-term use)
  • Sweating
  • Dry mouth or constipation

Seek emergency help immediately if you experience slow or very shallow breathing, extreme confusion, loss of consciousness, or signs of a serious allergic reaction (swelling, hives, difficulty breathing) — these require urgent medical attention.

⚠️Warnings & precautions▾
  • Respiratory depression: Butorphanol can slow breathing to a life-threatening degree, especially when you first start it or after a dose increase. This risk is highest in combination with alcohol, sedatives, or benzodiazepines.
  • Addiction and misuse: As a Schedule IV controlled substance, butorphanol carries a real risk of addiction even when taken as prescribed. This risk is higher in people with a personal or family history of substance use disorder.
  • Accidental exposure: Even one dose can be fatal to a child. Store this medication securely and out of reach at all times.
  • Opioid-induced hyperalgesia: In some cases, opioids can paradoxically make pain worse over time. If your pain increases after a dose increase, tell your prescriber.
  • Neonatal opioid withdrawal syndrome: Long-term use during pregnancy can cause life-threatening withdrawal in newborns. Always discuss this with your OB provider.
  • Hormonal effects: Extended use of opioids can affect hormone levels, potentially causing low libido, erectile dysfunction, or irregular periods.
🔀What it interacts with▾

Butorphanol Tartrate Nasal Spray can interact with many common medications and substances. The most important ones include:

  • Benzodiazepines and sedatives (e.g., diazepam, alprazolam, zolpidem): Combining these can cause life-threatening breathing problems, coma, or death
  • Alcohol: Greatly increases sedation and respiratory depression — avoid completely
  • Other opioids: Additive risk of overdose and severe respiratory depression
  • Serotonergic drugs (SSRIs, SNRIs, tricyclic antidepressants, MAO inhibitors, triptans, tramadol): Risk of serotonin syndrome — a dangerous reaction involving agitation, high fever, and rapid heart rate
  • CYP3A4 inhibitors (e.g., erythromycin, ketoconazole, ritonavir): Raise butorphanol blood levels, increasing overdose risk
  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): Lower butorphanol levels — stopping them suddenly can cause a dangerous spike
  • Sumatriptan nasal spray: Using it in the same nostril shortly before butorphanol may reduce how much butorphanol is absorbed and slow pain relief
  • Nasal decongestants (e.g., oxymetazoline): Do not reduce the total amount absorbed but can slow the onset of pain relief

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Do not use if you have significant breathing problems or respiratory depression that is not being monitored
  • Do not use if you have severe, unmonitored asthma
  • Do not use if you have a bowel blockage (including paralytic ileus)
  • Do not use if you are allergic to butorphanol tartrate, benzethonium chloride, or any ingredient in the formulation
  • Tell your doctor if you have liver or kidney disease — your dose may need to be reduced
  • Older adults should use with extra caution: the drug clears more slowly and effects may be stronger
  • Tell your doctor if you are pregnant or planning to become pregnant — extended use can cause serious newborn withdrawal
  • Tell your doctor if you are breastfeeding — butorphanol passes into breast milk
  • Keep out of reach of children — accidental exposure to even one dose can be fatal
  • Tell your doctor about all other medications, especially sedatives, antidepressants, antifungals, antibiotics, and anti-seizure drugs
  • Share your full history of substance use or mental health conditions with your prescriber before starting
🚑If you take too much▾

An overdose of Butorphanol Tartrate Nasal Spray can cause dangerously slow or stopped breathing, extreme drowsiness leading to unconsciousness, limpness of the muscles, pinpoint pupils, low blood pressure, and in severe cases, death. If you suspect an overdose, call 911 immediately and administer naloxone if it is available — note that larger doses of naloxone than usual may be needed because butorphanol is a mixed opioid agonist-antagonist. Even after a reversal agent is given, the patient must be closely monitored because butorphanol's effects may outlast the reversal agent.

📡Pharmacodynamics — effects in the body▾

After nasal administration, butorphanol begins relieving pain within about 15 minutes, with peak effect occurring 1 to 2 hours later. The pain-relieving effect lasts roughly 4 to 5 hours. Butorphanol slows breathing by directly acting on the brain's respiratory control centers — a risk that increases with higher doses and longer use. It can also cause nausea, sedation, constipation, and at higher doses, unpleasant perceptual effects due to its action at the kappa opioid receptor.

🔬Pharmacokinetics — how your body processes it▾

When sprayed into the nose, about 60–70% of the dose is absorbed into the bloodstream, with peak blood levels reached within 30 to 60 minutes. Butorphanol is about 80% bound to proteins in the blood and is extensively processed (metabolized) by the liver — primarily into a compound called hydroxybutorphanol. The drug and its byproducts are mainly cleared through the urine. The half-life (the time it takes for half the drug to leave the body) is roughly 4.7 hours in younger adults and longer — about 6.6 hours — in older adults, which is why lower doses and longer intervals between doses are recommended in that group. Using a nasal decongestant at the same time does not reduce the total amount absorbed, but does slow down how quickly the drug reaches peak levels.

📦How to store it▾

Store at 20°C to 25°C (68°F to 77°F) . Store butorphanol tartrate nasal spray securely and dispose of properly .

📄 Written from Butorphanol Nasal Spray’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Butorphanol Nasal Spray — the kind of thing our pharmacy team would talk through with you at the counter.

What kind of pain is butorphanol nasal spray actually for? ▾
It's meant for severe pain — the kind that genuinely needs an opioid to control and hasn't responded to other options like non-opioid pain relievers. It's not a first-line choice. Your prescriber should only recommend it when alternatives haven't worked or aren't expected to work for you.
How quickly will I feel it working after I use the spray? ▾
Most people start to notice pain relief within about 15 minutes of using butorphanol nasal spray. The strongest effect usually kicks in within 1 to 2 hours. Effects generally last around 4 to 5 hours, though that can vary from person to person.
Can I drink alcohol or take a sleep aid while using this? ▾
No — this is one of the most important safety points. Combining butorphanol with alcohol, benzodiazepines (like Xanax or Valium), sleeping pills, or other sedatives can cause your breathing to slow dangerously or stop completely. This combination has caused deaths. Be very upfront with every provider and pharmacist about every substance you use.
Is it safe to use if I'm pregnant or breastfeeding? ▾
If you use this medication regularly during pregnancy, your newborn can go through opioid withdrawal after birth — and that can be life-threatening for a baby if it isn't recognized and treated right away. Butorphanol also passes into breast milk. Talk honestly with your OB provider before using this medication so you have a proper plan in place.
What side effects should I call my doctor about versus just wait out? ▾
Drowsiness, dizziness, and mild nausea are common and usually manageable. But call 911 right away if breathing becomes slow or very shallow, or if someone can't be woken up — those are emergency signs of overdose. Also contact your doctor if you notice worsening pain after a dose increase, severe confusion, hallucinations, or signs of a serious allergic reaction like hives or swelling.
Can I just stop taking it when I feel better? ▾
If you've been using it regularly for a while, stopping suddenly can cause withdrawal symptoms — things like restlessness, muscle aches, chills, nausea, or anxiety. It's important to work with your prescriber to gradually reduce the dose over time rather than stopping all at once. They'll create a tapering plan that's right for your situation.
Is Butorphanol Nasal Spray available over the counter? ▾
Butorphanol Nasal Spray is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
Is Butorphanol Nasal Spray a controlled substance? ▾
Yes — Butorphanol Nasal Spray is a federally controlled substance (Schedule IV) in the United States, so how it is prescribed, refilled and dispensed is regulated by the DEA.
When was Butorphanol Nasal Spray first available? ▾
Butorphanol Nasal Spray has been available in the United States since at least 1978, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Butorphanol Nasal Spray? ▾
Butorphanol Nasal Spray is supplied by 4 manufacturers listed in the FDA NDC Directory, including Apotex Corp., Bryant Ranch Prepack, Hikma Pharmaceuticals USA Inc..

💬 Answers drafted from Butorphanol Nasal Spray’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Butorphanol Nasal Spray comes

Butorphanol Nasal Spray is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Nasal spray

In the nose
How this form is used
What it may be used for
  • Butorphanol Tartrate Nasal Spray is used to manage severe pain when opioid treatment is needed and other options have not worked or are not tolerated
  • Butorphanol Tartrate Nasal Spray is not recommended for use during labor or as part of anesthesia induction
Important instructions
  • Butorphanol Tartrate Nasal Spray is sprayed into one or both nostrils as directed by your prescriber — follow their exact instructions on how many sprays and how often
  • Butorphanol Tartrate Nasal Spray has a pain-relieving effect that starts within about 15 minutes and peaks within 1 to 2 hours after use
  • If a nasal decongestant spray is used around the same time as Butorphanol Tartrate Nasal Spray, expect a slower onset of pain relief
  • Do not stop using Butorphanol Tartrate Nasal Spray suddenly — work with your prescriber to gradually reduce the dose if you need to discontinue
Available strengths 1 strength
8 FDA-listed product records ⓘ

📊 Butorphanol Nasal Spray across the U.S. market

How Butorphanol Nasal Spray appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
4
Manufacturers
1
Brand names
8
FDA-listed product records ⓘ
1978
First marketed ⓘ
Apotex Corp.38%
Bryant Ranch Prepack25%
Hikma Pharmaceuticals USA Inc.25%
West-Ward Pharmaceuticals Corp.13%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Butorphanol Nasal Spray is used

A general measure of how commonly Butorphanol Nasal Spray is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Butorphanol Nasal Spray is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

1,967
Medicaid prescriptions filled (Q1–Q4 2025)
$106,428 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Butorphanol Nasal Spray prescribed? Of the 1,597 medications we measure, Butorphanol Nasal Spray ranks #1,193 by Medicaid prescriptions — more than 25% of them.

Where Butorphanol Nasal Spray ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Butorphanol Nasal Spray product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

butorphanol tartrate 1 MG/ACTUAT Metered Dose Nasal Spray

1,967 Medicaid prescriptions (Q1–Q4 2025) 100% of Butorphanol Nasal Spray prescriptions shown $106,428 gross reimbursement (before rebates) ≈ $54 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 886634

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Butorphanol Nasal Spray, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 4 listed Butorphanol Nasal Spray NDCs with Medicaid activity.

🔍 Compare Butorphanol Nasal Spray products

A representative set of FDA-listed product records for Butorphanol Nasal Spray — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Nasal spray
10 mg/mL Nasal Apotex Corp. × 3 listings ANDA View NDC →
10 mg/mL Nasal Bryant Ranch Prepack × 2 listings ANDA View NDC →
10 mg/mL Nasal Hikma Pharmaceuticals USA Inc. × 2 listings ANDA View NDC →
10 mg/mL Nasal West-Ward Pharmaceuticals Corp. ANDA View NDC →

Showing 8 of 8 products — FDA National Drug Code Directory. See every product, package size and price: browse all 8 Butorphanol Nasal Spray NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Butorphanol Nasal Spray RxCUI 1841 3 dose forms · 6 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 371174 No current FDA listing
    Clinical drug / strength (SCD) tartrate 2 MG/ML RxCUI 886622 10 MG/ML RxCUI 1302739
  2. Dose form (SCDF) Metered Dose Nasal Spray RxCUI 2201634 In current FDA listings
    Clinical drug / strength (SCD) tartrate 1 MG/ACTUAT RxCUI 886634

Look up RxCUI 1841 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Stadol NS Dolorex Solution Butorphic Torbugesic Torphadine Vetorphic

🏭 Manufacturers & labelers

Apotex Corp. 3 Bryant Ranch Prepack 2 Hikma Pharmaceuticals USA Inc. 2 West-Ward Pharmaceuticals Corp. 1

RxNorm drug class

Butorphanol Nasal Spray belongs to the Opioid Agonist/Antagonist class.

Pharmacologic class Opioid Agonist/Antagonist
Drug family (ATC) Morphinan derivatives
How it works Partial Opioid Agonists, Competitive Opioid Antagonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Nov 20, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Butorphanol Nasal Spray.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Butorphanol Nasal Spray after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
3
NDC products indexed
8
Distinct labelers/manufacturers represented
4
Linked representative label ⓘ
West-Ward Pharmaceuticals Corp.
Linked label effective
Nov 20, 2025
Composite sections available
22
Linked SPL Set ID
5a50d22e-acbe-4b15-9ed6-70713378408a
Linked SPL Document ID
57de4cd2-a163-4ac7-9e86-a04355a00d78
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 3 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. West-Ward Pharmaceuticals Corp. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.