Nalbuphine Injection
Nalbuphine Injection is an opioid pain reliever used to manage severe pain, as a supplement to anesthesia, and for pain relief during labor and delivery.
🧬 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 13 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 →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Nalbuphine Hydrochloride Injection carries three serious FDA boxed warnings — the highest-level safety alert.
Addiction and misuse: Like all opioids, this medicine can be misused or become addictive, even at prescribed doses. This can lead to overdose and death. Your prescriber should assess your risk before and during treatment.
Life-threatening breathing problems: This drug can slow or stop your breathing, especially when you first start it or after a dose increase. This can be fatal if not caught immediately. Watch closely for very slow, shallow, or stopped breathing — especially in the first few days of treatment.
Dangerous combinations with sedatives or alcohol: Taking nalbuphine with benzodiazepines (e.g., Valium, Xanax), alcohol, or other drugs that slow the brain can cause profound sedation, coma, stopped breathing, and death. This combination should only be used when there is absolutely no other option, under close medical supervision.
📖 Nalbuphine Injection: Patient Information Guide
A plain-language walkthrough of Nalbuphine Injection — 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▾
Nalbuphine Injection is an opioid analgesic (pain reliever) supported for the following uses:
- Management of severe pain when non-opioid treatments have not worked or cannot be tolerated
- Supplement to balanced anesthesia during surgery — administered intravenously by trained anesthesia professionals
- Preoperative analgesia (pain relief before surgery)
- Postoperative analgesia (pain relief after surgery)
- Obstetrical analgesia — pain relief during labor and delivery (use only when the benefit clearly outweighs risks to the infant)
⚙️How it works▾
Nalbuphine is a mixed opioid agonist-antagonist — meaning it both activates and blocks different opioid receptors. It activates kappa opioid receptors to produce pain relief, while blocking mu opioid receptors. Because it blocks mu receptors, it can partially reverse or reduce the breathing-suppressing effects of full mu opioids like morphine or fentanyl when given at the same time. However, it may also trigger opioid withdrawal in people who are physically dependent on full opioids.
Its pain-relieving strength is roughly equivalent to morphine up to a certain dose. Beyond that dose threshold, the risk of breathing depression does not increase further from nalbuphine alone — a property called a ceiling effect — but this ceiling does not apply when other sedating drugs are also being used.
💊How it's taken▾
Nalbuphine Hydrochloride Injection is given by a healthcare professional as an injection into a vein (intravenously), into a muscle (intramuscularly), or under the skin (subcutaneously). It is not available as an oral medication. For pain management, it may be given every 3 to 6 hours as needed, with the dose tailored to each patient's level of pain, health status, and other medications.
- Intravenous use for anesthesia requires specialized training and monitoring equipment
- The lowest effective dose should always be used for the shortest time needed
- If you have been using this medication regularly, do not stop suddenly — your prescriber will taper the dose gradually to avoid withdrawal
🤒Side effects — in detail▾
The most common side effect of Nalbuphine Hydrochloride Injection is drowsiness or sedation, which affects a significant portion of patients. Other frequently reported side effects include:
- Sweating or clammy skin
- Nausea or vomiting
- Dizziness or vertigo
- Dry mouth
- Headache
- Itching, flushing, or skin reactions at the injection site
- Nervousness, restlessness, or mood changes
- Constipation
Serious reactions that require immediate medical attention include life-threatening breathing problems, severe allergic reactions (including anaphylaxis — a sudden, whole-body allergic emergency), seizures, and serotonin syndrome (a dangerous drug reaction causing agitation, rapid heart rate, and high fever).
⚠️Warnings & precautions▾
- Respiratory depression (dangerous slowing of breathing): This is the most serious risk. It can be fatal, especially when starting treatment or after a dose increase. Risk is highest in the first 24 to 72 hours. Patients with lung disease, older adults, and debilitated patients are especially vulnerable.
- Addiction, abuse, and misuse: Nalbuphine is an opioid and carries real risk of addiction — even at recommended doses. Patients with a personal or family history of substance use disorder face higher risk.
- Dangerous combinations: Mixing with benzodiazepines, alcohol, antipsychotics, sedatives, or other opioids can cause coma, stopped breathing, and death.
- Withdrawal: Do not stop abruptly after regular use. Gradual dose reduction under medical guidance is required to avoid withdrawal symptoms.
- Use in pregnancy and labor: Nalbuphine crosses the placenta rapidly. It can cause serious slowing of the baby's heart rate, breathing problems at birth, and in rare cases, permanent neurological harm. Use only when benefit clearly outweighs risk, with fetal monitoring in place.
- Opioid-induced hyperalgesia: Rarely, opioids can paradoxically increase pain sensitivity. If pain worsens after a dose increase, contact your prescriber.
- Seizure risk: Nalbuphine may increase seizure frequency in patients with seizure disorders.
🔀What it interacts with▾
Nalbuphine Hydrochloride Injection can interact with several types of medications and substances — some interactions are life-threatening:
- Benzodiazepines and sedatives (e.g., diazepam, lorazepam, sleep aids) — dramatically increases risk of fatal breathing suppression and coma
- Alcohol — deepens sedation and raises risk of dangerous breathing problems; avoid completely
- Other opioid pain medicines — additive breathing suppression; nalbuphine may also block their pain-relieving effect or trigger withdrawal
- MAO inhibitors (e.g., phenelzine, tranylcypromine, linezolid) — can cause severe opioid toxicity or serotonin syndrome; avoid within 14 days of each other
- Antidepressants (SSRIs, SNRIs, tricyclics, triptans, trazodone, mirtazapine) — increased risk of serotonin syndrome
- Muscle relaxants (e.g., cyclobenzaprine, metaxalone) — can worsen respiratory depression
- Anticholinergic drugs — increased risk of severe constipation and urinary retention
- Diuretics (water pills) — nalbuphine may reduce their effectiveness
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▾
- Tell your doctor if you have significant breathing problems, COPD, asthma, or low oxygen levels — risk of life-threatening breathing suppression is higher
- Tell your doctor if you have a history of seizures — nalbuphine may worsen seizure control
- Tell your doctor if you have a personal or family history of addiction or substance use disorder — opioid risk is higher
- Tell your doctor if you have increased pressure in the brain, a brain tumor, or recent head injury — nalbuphine can raise intracranial pressure further
- Do not use if you have a known or suspected gastrointestinal blockage (including paralytic ileus) — this is a contraindication
- Do not use if you have a known allergy to nalbuphine or any ingredient in the injection
- If pregnant: discuss risks carefully; use during labor can cause serious heart rate and breathing problems in the newborn
- Older adults and frail or underweight patients need closer monitoring due to higher risk of breathing complications
- Tell your doctor if you are currently taking or recently stopped taking MAO inhibitors
🚑If you take too much▾
An overdose of Nalbuphine Hydrochloride Injection can cause dangerously slow or stopped breathing, extreme drowsiness, limpness, pinpoint pupils, cold clammy skin, low blood pressure, and in severe cases, coma or death. If overdose is suspected, call 911 immediately. The overdose antidote naloxone can reverse nalbuphine's breathing suppression and should be administered by medical personnel; repeated doses may be needed since nalbuphine's effects can outlast the antidote.
📡Pharmacodynamics — effects in the body▾
Nalbuphine Hydrochloride Injection is a potent pain reliever with analgesic strength roughly equal to morphine at comparable doses. It slows breathing by acting directly on brain stem centers that control respiration, but appears to have a ceiling effect — meaning that above a certain dose, additional nalbuphine alone does not cause progressively worse breathing suppression (though this protection disappears when other sedating drugs are present). It also slows movement through the digestive tract, causing constipation, and can reduce bile and pancreatic secretions. When given alongside full opioids like morphine or fentanyl, it can partially reverse their breathing-suppressing effects.
🔬Pharmacokinetics — how your body processes it▾
When given intravenously, Nalbuphine Hydrochloride Injection begins working within 2 to 3 minutes. When given intramuscularly or subcutaneously, it takes effect in under 15 minutes. Pain relief typically lasts 3 to 6 hours. The drug has a plasma half-life (the time for blood levels to fall by half) of about 5 hours, meaning it stays active in the body for several hours after each dose. Nalbuphine is most likely broken down by the liver, though its precise metabolic pathway has not been fully defined.
📦How to store it▾
Store at 20℃ to 25°C (68℉ to 77°F). Protect from excessive light. Store in carton until contents have been used.
📄 Written from Nalbuphine Injection’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 →
Supplements & herbs that interact with Nalbuphine Injection
100 supplements and herbal products have documented interactions with Nalbuphine Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 7
- Moderate · 78
- Minor · 15
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Nalbuphine Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What is nalbuphine injection actually used for? ▾
Will nalbuphine make me feel very drowsy or out of it? ▾
Is there anything I absolutely cannot take with nalbuphine? ▾
I'm pregnant — is it safe for me to receive nalbuphine during labor? ▾
Can I become dependent on or addicted to nalbuphine? ▾
What should I do if I think I or someone else has had too much nalbuphine? ▾
Is Nalbuphine Injection available over the counter? ▾
When was Nalbuphine Injection first available? ▾
Who makes Nalbuphine Injection? ▾
💬 Answers drafted from Nalbuphine Injection’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 Nalbuphine Injection comes
Nalbuphine Injection 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.
Injection
How this form is used
- Nalbuphine Hydrochloride Injection is used to manage severe pain when other pain treatments are inadequate
- Nalbuphine Hydrochloride Injection is used as a supplement to general balanced anesthesia during surgery
- Nalbuphine Hydrochloride Injection is used for pain relief before and after operations (preoperative and postoperative analgesia)
- Nalbuphine Hydrochloride Injection is used for pain management during labor and delivery
- Nalbuphine Hydrochloride Injection is given by a healthcare professional via intravenous, intramuscular, or subcutaneous injection — not taken by mouth
- Nalbuphine Hydrochloride Injection given intravenously works within 2 to 3 minutes; given intramuscularly or subcutaneously, it takes effect in under 15 minutes
- Nalbuphine Hydrochloride Injection should be used at the lowest effective dose for the shortest time needed; dosing is individualized by the prescriber
- Nalbuphine Hydrochloride Injection should not be stopped abruptly if used regularly — doses must be tapered gradually under medical supervision
📊 Nalbuphine Injection across the U.S. market
How Nalbuphine Injection 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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Nalbuphine Injection is used
A general measure of how commonly Nalbuphine Injection 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 Nalbuphine Injection 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.
How commonly is Nalbuphine Injection prescribed? Of the 1,596 medications we measure, Nalbuphine Injection ranks #1,236 by Medicaid prescriptions — more than 23% of them.
Utilization by Nalbuphine Injection 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.
1 ML nalbuphine hydrochloride 10 MG/ML Injection Most dispensed
Summed across the 2 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1866543
nalbuphine hydrochloride 10 MG/ML Injectable Solution
Summed across the 1 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 904415
nalbuphine hydrochloride 20 MG/ML Injectable Solution
Summed across the 1 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 904440
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 Nalbuphine Injection, 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 4 of 27 listed Nalbuphine Injection NDCs with Medicaid activity.
🔍 Compare Nalbuphine Injection products
A representative set of FDA-listed product records for Nalbuphine Injection — 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 |
|---|---|---|---|---|
| 💊Injection | ||||
| 10 mg/mL | Intramuscular; Intravenous; Subcutaneous | General Injectables & Vaccines, Inc | ANDA | View NDC → |
| 10 mg/mL | Intramuscular; Intravenous; Subcutaneous | General Injectables and Vaccines, Inc. | ANDA | View NDC → |
| 20 mg/mL | Intramuscular; Intravenous; Subcutaneous | General Injectables and Vaccines,Inc. | ANDA | Find on DailyMed ↗ |
| 10 mg/mL | Intramuscular, Intravenous, Subconjunctival | Henry Schein, Inc. | ANDA | View NDC → |
| 10 mg/mL | Intramuscular, Intravenous, Subcutaneous | Henry Schein, Inc. | ANDA | View NDC → |
| 10 mg/mL | Intramuscular; Intravenous; Subcutaneous | Henry Schein, Inc. × 4 listings | ANDA | View NDC → |
| 20 mg/mL | Intramuscular, Intravenous, Subcutaneous | Henry Schein, Inc. | ANDA | View NDC → |
| 20 mg/mL | Intramuscular; Intravenous; Subcutaneous | Henry Schein, Inc. × 2 listings | ANDA | View NDC → |
| 10 mg/mL | Intramuscular, Intravenous, Subcutaneous | HF Acquisition Co LLC, DBA HealthFirst | ANDA | View NDC → |
| 10 mg/mL | Intramuscular; Intravenous; Subcutaneous | HF Acquisition Co LLC, DBA HealthFirst | ANDA | View NDC → |
| 20 mg/mL | Intramuscular, Intravenous, Subcutaneous | HF Acquisition Co LLC, DBA HealthFirst | ANDA | View NDC → |
| 20 mg/mL | Intramuscular; Intravenous; Subcutaneous | HF Acquisition Co LLC, DBA HealthFirst | ANDA | View NDC → |
| 10 mg/mL | Intramuscular, Intravenous, Subcutaneous | Hospira, Inc. × 4 listings | ANDA | View NDC → |
| 10 mg/mL | Intramuscular; Intravenous; Subcutaneous | Hospira, Inc. × 6 listings | ANDA | View NDC → |
| 20 mg/mL | Intramuscular, Intravenous, Subcutaneous | Hospira, Inc. × 2 listings | ANDA | View NDC → |
| 20 mg/mL | Intramuscular; Intravenous; Subcutaneous | Hospira, Inc. × 4 listings | ANDA | View NDC → |
| 10 mg/mL | Intramuscular, Intravenous, Subcutaneous | Medical Purchasing Solutions, LLC × 2 listings | ANDA | View NDC → |
| 10 mg/mL | Intramuscular; Intravenous; Subcutaneous | Medical Purchasing Solutions, LLC | ANDA | View NDC → |
| 20 mg/mL | Intramuscular, Intravenous, Subcutaneous | Medical Purchasing Solutions, LLC | ANDA | View NDC → |
| 10 mg/mL | Intramuscular, Intravenous, Subcutaneous | ProPharma Distribution | ANDA | View NDC → |
| 10 mg/mL | Intramuscular, Intravenous, Subcutaneous | Somerset Therapeutics, LLC × 2 listings | ANDA | View NDC → |
| 20 mg/mL | Intramuscular, Intravenous, Subcutaneous | Somerset Therapeutics, LLC × 2 listings | ANDA | View NDC → |
Showing 41 of 41 products — FDA National Drug Code Directory. See every product, package size and price: browse all 41 Nalbuphine Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Nalbuphine Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Nalbuphine Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Nalbuphine Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
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.
RxCUI 7238 2 dose forms · 4 strengths
-
Dose form (SCDF) Injectable Solution RxCUI 372986In current FDA listingsClinical drug / strength (SCD) hydrochloride 10 MG/MLRxCUI 904415hydrochloride 20 MG/MLRxCUI 904440 -
Dose form (SCDF) Injection RxCUI 1866542In current FDA listingsClinical drug / strength (SCD) 1 ML nalbuphine hydrochloride 10 MG/MLRxCUI 18665431 ML nalbuphine hydrochloride 20 MG/MLRxCUI 1866551
Look up RxCUI 7238 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.
📦 Supply & shortage status
Whether Nalbuphine Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Nalbuphine Injection belongs to the Opioid Agonist/Antagonist class.
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.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 13 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. Hospira, Inc. 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.