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.
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
- Drug Hypersensitivity
Drug Hypersensitivity
48 reports
- Nausea
Nausea
25 reports
- Headache 16
Headache
16 reports
- Pain 16
Pain
16 reports
- Pruritus 16
Pruritus
16 reports
- Vomiting 15
Vomiting
15 reports
- Anxiety 14
Anxiety
14 reports
- Dyspnoea 14
Dyspnoea
14 reports
- Migraine 13
Migraine
13 reports
- Product Quality Issue 13
Product Quality Issue
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) 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.
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.
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for butorphanol?
Related Medications in Opioid Agonist-Antagonist
Other drugs grouped near butorphanol - same-class peers and common alternatives.
abatacept
Orencia
Orencia is a medicine that helps to reduce inflammation.
Compare with butorphanol →
acetaminophen
Tylenol
Acetaminophen (Tylenol) is a medicine that can relieve pain and reduce fever.
Compare with butorphanol →
acetaminophen/hydrocodone
Vicodin, Norco
This medicine contains acetaminophen and hydrocodone.
Compare with butorphanol →
acetaminophen/oxycodone
Percocet
Percocet is a strong pain medicine.
Compare with butorphanol →
adalimumab
Humira
Idacio is a medicine that blocks a protein called TNF.
Compare with butorphanol →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for butorphanol: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 318.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 2.20%.
- eluxadoline Δ 0.01 pts · 2,870 reports · Mu-Opioid Receptor Agonist (IBS-D) 2.20%death share
- progesterone Δ 0.06 pts · 21,004 reports · Progestogen Hormone 2.27%death share
- canagliflozin Δ 0.09 pts · 29,554 reports · SGLT2 Inhibitor 2.29%death share
- liothyronine Δ 0.12 pts · 8,408 reports · Thyroid Hormone (T3) 2.32%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: April 17, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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