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.
How to Take It
Nalbuphine injection is given by a healthcare provider. It can be injected under the skin, into a muscle, or into a vein. The usual dose for adults is 10 mg, which can be repeated every 3 to 6 hours as needed. Your doctor will adjust the dose based on your pain and how you respond to the medicine.
This is a plain-language summary of nalbuphine's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Using nalbuphine during pregnancy may cause breathing problems in the newborn. Talk to your doctor if you are pregnant or plan to become pregnant. It is not known if nalbuphine passes into breast milk. Talk to your doctor about the risks and benefits of breastfeeding.
This is a plain-language summary of nalbuphine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
Since nalbuphine is given by a healthcare provider, you are not likely to miss a dose. If you are concerned, talk to your doctor.
This is a plain-language summary of nalbuphine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store nalbuphine at room temperature (68°F to 77°F) and protect it from light. Keep it in its original container until you are ready to use it.
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
- Allergic reaction to the medicine
Allergic reaction to the medicine
36 reports
- Baby exposed to the medicine during pregnancy 10
Baby exposed to the medicine during pregnancy
10 reports
- Newborn has trouble breathing 10
Newborn has trouble breathing
10 reports
- Newborn has a seizure 10
Newborn has a seizure
10 reports
- Pain 7
Pain
7 reports
- Sudden inflammation of the pancreas 7
Sudden inflammation of the pancreas
7 reports
- Sudden liver failure 6
Sudden liver failure
6 reports
- Brain disorder 6
Brain disorder
6 reports
- Injury related to the product packaging 6
Injury related to the product packaging
6 reports
- Itching 6
Itching
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) 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.
What to do: Do not take these drugs together as it can be unsafe.
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.
What to do: Your doctor should monitor you for signs of serotonin syndrome, such as agitation, fast heartbeat, or muscle twitching.
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.
What to do: Tell your doctor immediately if you experience symptoms like shivering, sweating, or confusion while taking these drugs.
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.
What to do: Your healthcare provider should watch you closely for any serious side effects related to high serotonin levels while you are on both medications.
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.
What to do: Your doctor should monitor you closely for symptoms like confusion or a fast heartbeat. They may need to adjust your treatment if these drugs are used together.
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 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?
Is nalbuphine safe during pregnancy?
Related Medications in Opioid Agonist-Antagonist
Other drugs grouped near nalbuphine - same-class peers and common alternatives.
abatacept
Orencia
Orencia is a medicine that helps to reduce inflammation.
Compare with nalbuphine →
acetaminophen
Tylenol
Acetaminophen (Tylenol) is a medicine that can relieve pain and reduce fever.
Compare with nalbuphine →
acetaminophen/hydrocodone
Vicodin, Norco
This medicine contains acetaminophen and hydrocodone.
Compare with nalbuphine →
acetaminophen/oxycodone
Percocet
Percocet is a strong pain medicine.
Compare with nalbuphine →
adalimumab
Humira
Idacio is a medicine that blocks a protein called TNF.
Compare with nalbuphine →
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
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Save on nalbuphine
Compare prices and find discounts at pharmacies near you. Free coupons can save up to 80% on prescriptions.
Disclosure: This link may earn us a commission at no extra cost to you. See our terms.
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 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).
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: December 10, 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