Prescription medication · Opioid Agonist-Antagonist
nalbuphine
Also sold as Nubain. Nalbuphine injection is used to manage severe pain that requires a strong opioid medicine.
Data updated 2026-05-15
- 218
- FDA reportsRarely reported
- 19
- InteractionsSeveral interactions
- Rx
- Availability
What the data shows
nalbuphine (Nubain) is a prescription Opioid Agonist-Antagonist, among the least-reported drugs the FDA tracks (218 FDA reports), with 19 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.
nalbuphine (Nubain) is a prescription Opioid Agonist-Antagonist. Nalbuphine injection is used to manage severe pain that requires a strong opioid medicine.
Nalbuphine injection is a strong pain medicine. It is used when other pain treatments don't work well enough.
Verify with FDA → · CMS NADAC pricing →
What it does
Nalbuphine injection is used to manage severe pain that requires a strong opioid medicine.
Common side effects
Feeling sleepy, Sweaty or clammy skin, Nausea
Key warnings
Nalbuphine can cause serious breathing problems that can be life-threatening, especially when you first start taking it or after a dose increase.
The sections below are summarized in plain English from nalbuphine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Nalbuphine works by attaching to opioid receptors in the brain and spinal cord. These receptors help to block pain signals. Nalbuphine both activates and blocks opioid receptors.
Side Effects (from patient reports)
Based on 218 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for nalbuphine, by number of reports
- Drug Hypersensitivity
Drug Hypersensitivity
36 reports
- Foetal Exposure During Pregnancy 10
Foetal Exposure During Pregnancy
10 reports
- Neonatal Asphyxia 10
Neonatal Asphyxia
10 reports
- Neonatal Epileptic Seizure 10
Neonatal Epileptic Seizure
10 reports
- Pain 7
Pain
7 reports
- Pancreatitis Acute 7
Pancreatitis Acute
7 reports
- Acute Hepatic Failure 6
Acute Hepatic Failure
6 reports
- Encephalopathy 6
Encephalopathy
6 reports
- Product Package Associated Injury 6
Product Package Associated Injury
6 reports
- Pruritus 6
Pruritus
6 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 nalbuphine 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 nalbuphine sits
nalbuphine 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 nalbuphine; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 218 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2007–2025.
Total Reports
218
Reports Mentioning Death
10
4.6% of reports — not proof of cause
Hospitalization Reports
77
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG HYPERSENSITIVITY | 36 |
| 4 | FOETAL EXPOSURE DURING PREGNANCY | 10 |
| 5 | NEONATAL ASPHYXIA | 10 |
| 6 | NEONATAL EPILEPTIC SEIZURE | 10 |
| 7 | PAIN | 7 |
| 8 | PANCREATITIS ACUTE | 7 |
| 9 | ACUTE HEPATIC FAILURE | 6 |
| 10 | ENCEPHALOPATHY | 6 |
| 11 | PRODUCT PACKAGE ASSOCIATED INJURY | 6 |
| 13 | PRURITUS | 6 |
| 14 | PYREXIA | 6 |
| 15 | DRUG INTERACTION | 5 |
| 16 | FATIGUE | 5 |
| 17 | HEADACHE | 5 |
| 18 | HYPERTENSION | 5 |
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
Nalbuphine can cause serious breathing problems that can be life-threatening, especially when you first start taking it or after a dose increase. Taking nalbuphine with benzodiazepines (like anxiety or sleep medicines) or other drugs that can make you sleepy, including alcohol, can cause very serious sleepiness, breathing problems, coma, and death.
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: Combining these medications can lead to a dangerous increase in breathing problems and muscle weakness.
Serotonergic Drugs The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and...
Mechanism: Both drugs increase the levels of a brain chemical called serotonin. Taking them together can lead to a dangerous buildup of this chemical in your system.
Serotonergic Drugs The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and...
Mechanism: These medications both affect the serotonin system in your brain. Using them together increases the risk of having too much serotonin in your body at once.
Serotonergic Drugs The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and...
Mechanism: Combining these drugs can cause serotonin levels to rise too high because both medications influence the same pathways in your nervous system.
Serotonergic Drugs The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and...
Mechanism: Both drugs can increase serotonin levels in the brain. Taking them together might lead to a serious condition called serotonin syndrome.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I drive after taking nalbuphine?
Can I drink alcohol while taking nalbuphine?
What should I do if I have trouble breathing after taking nalbuphine?
Can I take other pain medicines with nalbuphine?
Is nalbuphine addictive?
What should I tell my doctor before taking nalbuphine?
Can nalbuphine cause constipation?
How long does nalbuphine stay in my system?
Can I stop taking nalbuphine suddenly?
What are the symptoms of an allergic reaction to nalbuphine?
What are the common side effects of nalbuphine?
Does nalbuphine interact with other medications?
What drug class is nalbuphine?
What pregnancy or breastfeeding source fields are listed for nalbuphine?
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Other drugs grouped near nalbuphine - same-class peers and common alternatives.
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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for nalbuphine: 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: 218.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 4.59%.
- vibegron Δ 0.03 pts · 6,501 reports · Beta-3 Agonist (Overactive Bladder) 4.55%death share
- methyldopa Δ 0.04 pts · 4,692 reports · Central Alpha-2 Agonist 4.62%death share
- testosterone Δ 0.07 pts · 40,954 reports · Androgen Hormone 4.52%death share
- fluocinonide Δ 0.08 pts · 5,460 reports · Topical Corticosteroid 4.67%death share
Medication Guides
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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 nalbuphine
The FDA label for nalbuphine (sold under brand names such as Nubain) classifies it as a prescription-only medication in the Opioid Agonist-Antagonist class. Nalbuphine injection is used to manage severe pain that requires a strong opioid medicine. Official labeling lists 6 commonly reported side effects, including Feeling sleepy, Sweaty or clammy skin, Nausea.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 218 voluntary reports. The database also lists 19 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.
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).
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: December 10, 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