Prescription medication · Opioid Agonist-Antagonist
butorphanol
Also sold as Stadol. This medicine treats severe pain that requires an opioid pain reliever.
Data updated 2026-05-15
- 318
- FDA reportsRarely reported
- 11
- InteractionsSeveral interactions
- $12.56
- Generic price (NADAC)
What the data shows
butorphanol (Stadol) is a prescription Opioid Agonist-Antagonist, among the least-reported drugs the FDA tracks (318 FDA reports), with 11 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
butorphanol (Stadol) is a prescription Opioid Agonist-Antagonist. This medicine treats severe pain that requires an opioid pain reliever.
Butorphanol nasal spray is a strong pain medicine. It is used when other pain medicines are not strong enough or cannot be tolerated.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$12.56/unit
Generic Available
Yes (4 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine treats severe pain that requires an opioid pain reliever.
Common side effects
Sleepiness, Dizziness, Nausea
Key warnings
This medicine has serious warnings.
The sections below are summarized in plain English from butorphanol's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Butorphanol is an opioid agonist-antagonist. It works by changing how your brain and nervous system respond to pain. It attaches to certain receptors in the brain to reduce pain signals.
How to Take It
Only a healthcare provider who knows about opioid medicines should prescribe this nasal spray. Use the lowest dose that works for the shortest time needed. For each spray, prime the pump by pressing firmly and releasing several times. If you don't use it for 48 hours, you will need to prime it again.
This is a plain-language summary of butorphanol's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
If you need to use this medicine for a long time during pregnancy, it can cause withdrawal symptoms in your newborn. Make sure a newborn specialist is available when you deliver your baby.
This is a plain-language summary of butorphanol's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
This is a plain-language summary of butorphanol's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at room temperature between 68°F to 77°F and keep it in a safe place.
Side Effects (from patient reports)
Based on 318 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for butorphanol, by number of reports
- Allergic reaction to the drug
Allergic reaction to the drug
48 reports
- Feeling sick to your stomach
Feeling sick to your stomach
25 reports
- Head pain 16
Head pain
16 reports
- Discomfort 16
Discomfort
16 reports
- Itching 16
Itching
16 reports
- Throwing up 15
Throwing up
15 reports
- Feeling worried or nervous 14
Feeling worried or nervous
14 reports
- Difficulty breathing 14
Difficulty breathing
14 reports
- Severe headache 13
Severe headache
13 reports
- Problem with the medicine's quality 13
Problem with the medicine's quality
13 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for butorphanol each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where butorphanol sits
butorphanol has more FDA adverse-event reports than 2% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is butorphanol; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 318 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2002–2025.
Total Reports
318
Reports Mentioning Death
7
2.2% of reports — not proof of cause
Hospitalization Reports
48
Top Indication
Migraine
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG HYPERSENSITIVITY | 48 |
| 4 | NAUSEA | 25 |
| 5 | HEADACHE | 16 |
| 6 | PAIN | 16 |
| 7 | PRURITUS | 16 |
| 8 | VOMITING | 15 |
| 9 | ANXIETY | 14 |
| 10 | DYSPNOEA | 14 |
| 11 | MIGRAINE | 13 |
| 12 | PRODUCT QUALITY ISSUE | 13 |
| 13 | DIZZINESS | 12 |
| 14 | PRODUCT PACKAGING QUANTITY ISSUE | 11 |
| 15 | DEPRESSION | 10 |
| 16 | FATIGUE | 9 |
| 17 | MALAISE | 9 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
This medicine has serious warnings. It can cause addiction, abuse, and misuse, which can lead to overdose and death. It can also cause life-threatening breathing problems, especially when you first start using it or after a dose increase. Accidental use, even one dose, can cause a fatal overdose, especially in children. Using this medicine with benzodiazepines or other drugs that can make you sleepy, including alcohol, can cause serious problems, including coma and death. If you use this medicine for a long time during pregnancy, it can cause withdrawal symptoms in the newborn that could be life-threatening if not treated.
Known Drug Interactions
Intervention: Avoid concomitant use Examples: Butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants Clinical Impact: Oxycodone may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
Mechanism: These drugs both slow down your breathing and can make your muscles very weak when taken together.
What to do: You should avoid using these two medications at the same time.
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics The concomitant use of opioids with other opioid analgesics, such as butorphanol, nalbuphine, pentazocine, may reduce the analgesic effect of PERCOCET and/or precipitate withdrawal symptoms.
Mechanism: Butorphanol can block the pain-relieving effects of oxycodone and may cause sudden withdrawal symptoms. This happens because the two drugs compete for the same spots in your body's nervous system.
What to do: Avoid using these two types of pain medications together to ensure your pain is managed and to prevent withdrawal.
Examples: butorphanol, nalbuphine, pentazocine Muscle Relaxants Clinical Impact: Buprenorphine may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
Mechanism: These medicines can work together to slow your breathing and make your muscles very weak. This increases the risk of serious breathing problems.
What to do: Your doctor should monitor you for slow breathing and may need to adjust your treatment plan.
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics The concomitant use of opioids with other opioid analgesics, such as butorphanol, nalbuphine, pentazocine, may reduce the analgesic effect of acetaminophen and codeine phosphate tablets and/or precipitate withdrawal symptoms.
Mechanism: Butorphanol can block the pain-relieving effects of codeine and may cause sudden, uncomfortable withdrawal symptoms.
What to do: Avoid using these two medicines at the same time to ensure your pain is managed safely.
Examples: Butorphanol, nalbuphine, pentazocine, buprenorphine.
Mechanism: Butorphanol can block the pain-relieving effects of fentanyl or cause sudden withdrawal symptoms because it works differently on the same brain receptors.
What to do: Avoid using these two medicines together. Your doctor may need to adjust your pain management plan.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can this medicine cause addiction?
What should I do if I accidentally spray this in my child's face?
Can I drink alcohol while using this medicine?
How many sprays are in one bottle?
What should I do if I have trouble breathing?
Can I drive while taking this medicine?
What is naloxone?
What should I tell my doctor before taking this medicine?
How often can I use this nasal spray?
What if this medicine stops working?
What are the common side effects of butorphanol?
Does butorphanol interact with other medications?
What drug class is butorphanol?
Is butorphanol safe during pregnancy?
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What the FDA Data Shows for butorphanol
The FDA label for butorphanol (sold under brand names such as Stadol) classifies it as a prescription-only medication in the Opioid Agonist-Antagonist class. This medicine treats severe pain that requires an opioid pain reliever. Official labeling lists 6 commonly reported side effects, including Sleepiness, Dizziness, Nausea.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 318 voluntary reports. The database also lists 11 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $12.56.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: April 17, 2024
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages