FDA-filed SPL labeling · retrieved through openFDA

Remifentanil

Remifentanil is a fast-acting opioid pain reliever used intravenously during and immediately after surgery, including as part of general anesthesia and monitored anesthesia care.

Brand name Ultiva
Drug classes Full Opioid Agonists
Rx Schedule CII Form 1 Route Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 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 5 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 →

At a glance
Linked label effectiveDec 8, 2025
Clinical labels in scope 5
AvailabilityRx
Earliest approval/marketing year 1996
FDA-listed product records 49
Boxed warningYes
How we combine label and product data →
Remifentanil at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Remifentanil is a powerful, ultra-short-acting opioid used exclusively in monitored clinical settings to manage pain during and immediately after surgery. It works within seconds and clears within minutes, giving anesthesia teams precise, real-time control over pain relief. Because it can cause serious breathing problems and has real risks of misuse, it is always given by trained specialists with continuous monitoring — never outside a supervised medical environment.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

Remifentanil carries a serious FDA boxed warning — the highest-level safety alert. First, as an opioid, it carries risks of addiction, misuse, and abuse, which can lead to overdose and death. Second, it can cause life-threatening or fatal slowing of breathing, especially when treatment is first started or if the dose is increased — proper dosing by trained providers is essential. Third, using remifentanil together with benzodiazepines (such as diazepam or lorazepam), other sedatives, or alcohol can cause profound sedation, respiratory failure, coma, and death. These combinations should only be used when absolutely necessary, and patients must be watched closely for signs of breathing problems and excessive sedation.

Read the full warning on DailyMed →

📖 Remifentanil: Patient Information Guide

A plain-language walkthrough of Remifentanil — 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

Remifentanil is an intravenous opioid analgesic used exclusively in surgical and monitored clinical settings. Both Remifentanil Hydrochloride for injection and Ultiva are approved for the following uses:

  • Pain relief (analgesia) during the induction and maintenance of general anesthesia for inpatient and outpatient surgical procedures
  • Continued pain control into the immediate postoperative period in adult patients, when used under direct supervision of an anesthesia provider in a post-anesthesia care unit (PACU) or intensive care setting
  • As an analgesic component of monitored anesthesia care in adult patients
  • Maintenance of general anesthesia in pediatric patients from birth to 12 years (established for Remifentanil Hydrochloride for injection in controlled clinical studies; not studied in pediatric patients for postoperative analgesia or monitored anesthesia care)
⚙️How it works

Remifentanil is a mu-opioid agonist — it binds to and activates mu-opioid receptors in the brain and spinal cord, which are the body's main pain-modulating receptors. This binding blocks the transmission of pain signals, producing fast, powerful analgesia. Its effects are dose-dependent and similar to other opioids in this class.

What makes remifentanil unique is how quickly the body breaks it down. Rather than being metabolized by the liver, it is hydrolyzed (broken apart) almost immediately by esterase enzymes found throughout the blood and tissues. This produces an essentially inactive byproduct, and the drug's effects fade within 5 to 10 minutes of stopping the infusion — regardless of how long it has been running. Its opioid effects can be reversed by naloxone if needed.

💊How it's taken

Remifentanil is given only by intravenous infusion in a hospital, surgical center, or monitored clinical environment — it is never taken by mouth. It must be diluted before use and delivered through an infusion pump by anesthesia-trained personnel who adjust the rate continuously based on the patient's response and the level of surgical stimulation.

  • Dosing is individualized — the rate is titrated up or down every few minutes depending on how the patient is doing
  • Older adults (over 65) typically require a lower starting dose because they are more sensitive to the drug's effects
  • Because remifentanil wears off within minutes of stopping, a separate pain medication must be established before the infusion ends to prevent abrupt return of pain
  • Your anesthesia team manages all dosing decisions — always follow their guidance
🤒Side effects — in detail

The most common side effects seen in clinical studies with remifentanil include:

  • Low blood pressure (hypotension)
  • Slow heart rate (bradycardia)
  • Slowed or suppressed breathing (respiratory depression)
  • Muscle stiffness or rigidity, including chest wall stiffness
  • Nausea
  • Vomiting
  • Itching (pruritus)
  • Flushing and sweating

Breathing problems and low blood pressure are the most serious concerns and are actively monitored and managed by the anesthesia team throughout your procedure. Seek emergency care immediately if, after the procedure, breathing becomes very slow, you feel faint, or muscles become very stiff.

⚠️Warnings & precautions
  • Life-threatening breathing suppression: Remifentanil can slow or stop breathing — this is the top risk. It must be given only by professionals trained in airway management, with oxygen and resuscitation equipment on hand.
  • Combining with other sedatives or alcohol is dangerous: Using remifentanil alongside benzodiazepines, sleep aids, antipsychotics, other opioids, or alcohol can cause profound sedation, respiratory failure, coma, and death. Patients should avoid alcohol for at least 24 hours after surgery.
  • Addiction and misuse: As a Schedule II controlled opioid, remifentanil carries risk of addiction, abuse, and diversion.
  • Muscle rigidity: Remifentanil can cause the chest wall or other muscles to become very stiff, which can make breathing difficult and requires immediate management by the care team.
  • Rapid offset — pain returns quickly: Because the drug wears off within minutes, the care team must have post-procedure pain control in place before stopping the infusion.
  • Serotonin syndrome: Combining remifentanil with certain antidepressants or other serotonergic drugs can trigger a potentially life-threatening reaction with agitation, rapid heart rate, high fever, and muscle twitching.
  • Opioid-induced hyperalgesia: In some cases, remifentanil can paradoxically increase pain sensitivity — if pain seems worse rather than better, inform the care team.
🔀What it interacts with

Remifentanil can interact seriously with several drug classes and substances. Tell your care team about everything you take before your procedure:

  • Benzodiazepines and other sedatives/CNS depressants (e.g., diazepam, lorazepam, sleep aids, muscle relaxants, antipsychotics) — additive sedation and breathing suppression; can be fatal
  • Alcohol — increases sedation and breathing risk; avoid for at least 24 hours after surgery
  • Other opioids — compound respiratory depression risk
  • MAO inhibitors (MAOIs) (e.g., phenelzine, selegiline, linezolid, IV methylene blue) — serious or fatal reactions possible; remifentanil should not be used within 14 days of an MAOI
  • Serotonergic drugs (SSRIs, SNRIs, tricyclic antidepressants, triptans, tramadol, mirtazapine, trazodone, cyclobenzaprine) — risk of serotonin syndrome
  • Mixed opioid agonist/antagonist drugs (butorphanol, nalbuphine, buprenorphine, pentazocine) — may blunt pain relief or trigger withdrawal symptoms

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
  • Allergy to remifentanil: Do not use if you have had a serious allergic reaction (such as anaphylaxis) to remifentanil — this is a contraindication
  • Remifentanil cannot be given into the spine (epidural or intrathecal): The formulation contains glycine, which makes this route unsafe
  • Pregnancy: Remifentanil may cause harm to the fetus; it is not recommended during or immediately before labor when other pain options exist. Newborns of mothers given opioids near delivery must be monitored for breathing problems
  • Breastfeeding: It is not known if remifentanil passes into breast milk, but because related drugs do, nursing infants should be monitored for excess sleepiness and breathing difficulty; withdrawal can occur if breastfeeding is stopped abruptly
  • Older adults (65+): More sensitive to remifentanil's effects; starting doses are reduced by 50% and titrated slowly
  • Lung disease or reduced breathing capacity: Patients with COPD, cor pulmonale, hypoxia, or reduced respiratory reserve are at significantly higher risk of breathing complications
  • Seizure disorders: Remifentanil may worsen seizure control — close monitoring is required
  • Biliary tract disease or acute pancreatitis: Opioids can worsen these conditions; monitor for worsening symptoms
  • Morbidly obese patients: Special care is required due to changes in cardiovascular and respiratory function
  • Kidney or liver impairment: Remifentanil's clearance is not affected by liver or kidney disease, but its inactive metabolite is excreted by the kidneys — monitor renal function, especially in elderly patients
🚑If you take too much

Too much remifentanil can cause very slow or stopped breathing, extreme drowsiness progressing to unconsciousness, muscle limpness, pinpoint pupils, low blood pressure, slow heart rate, and in severe cases, death. The care team manages overdose by stopping the infusion, securing the airway, supporting breathing, and administering an opioid reversal agent such as naloxone if needed. Because remifentanil clears the body so quickly on its own, stopping the infusion is often the first and most important step.

📡Pharmacodynamics — effects in the body

Remifentanil's pain-relieving effects start and peak within about 1 to 2 minutes of administration and fade just as quickly — blood concentrations drop by 50% within 3 to 6 minutes of stopping, and most effects are gone within 5 to 10 minutes. Its cardiovascular effects include lowering of blood pressure and heart rate, which are dose-dependent. It can also slow movement through the gut (potentially causing constipation), cause pinpoint pupils, and suppress the brain's drive to breathe — all typical opioid effects that the care team watches and manages throughout your procedure.

🔬Pharmacokinetics — how your body processes it

After an IV dose, remifentanil distributes rapidly through the blood and well-perfused tissues and reaches the brain within about 1 minute. It is broken down almost entirely (over 95%) by esterase enzymes in the blood and tissues — not by the liver — into an essentially inactive metabolite that is then cleared by the kidneys. The effective half-life (how long it takes the body to reduce drug levels by half) is only about 3 to 10 minutes, and this does not lengthen even after hours of continuous infusion. Clearance is reduced by about 25% in people over 65, though drug levels still fall just as quickly after the infusion stops. Kidney or liver disease does not meaningfully affect how the body handles remifentanil itself.

📦How to store it

stored at 2° to 25°C (36° to 77°F).

📄 Written from Remifentanil’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 →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Remifentanil — the kind of thing our pharmacy team would talk through with you at the counter.

Why am I getting remifentanil instead of a regular pain medicine?
Remifentanil is a specialized opioid used only in surgery and closely monitored settings. It works within seconds and wears off within minutes, which gives your anesthesia team precise, real-time control over your pain during the procedure. That kind of instant on-and-off effect isn't something oral or longer-acting pain medicines can provide in an operating room. Once your procedure is done, your team will switch you to a different pain medicine before stopping the remifentanil, so you're not left without relief.
Will I be awake or remember anything during surgery if I'm given this?
Remifentanil controls pain but cannot put you to sleep on its own, so it is always used together with other anesthetics that do cause unconsciousness. Your team combines it with medicines like propofol or inhaled anesthetic gases to keep you fully under during surgery. There have been rare reports of intraoperative awareness (becoming aware during surgery) in certain settings, which is one reason your anesthesia team carefully monitors and adjusts everything throughout your procedure.
What side effects should I watch for after surgery?
The most important things to watch for after your procedure are breathing that feels very slow or difficult, extreme drowsiness that you can't shake, or muscle stiffness. These can be signs that your body is still responding to the medication and need immediate attention from your care team. Nausea, vomiting, low blood pressure, and itching are also common but usually manageable. Because remifentanil clears so quickly, most effects wear off fast — but pain can return abruptly once it's stopped, which is why your team will have a plan ready for post-procedure pain control.
Is it safe to drink alcohol after my procedure if I was given this medicine?
No — you should avoid alcohol for at least 24 hours after surgery. Combining alcohol with opioid medicines, even after the procedure is over, increases the risk of dangerous sedation and breathing problems. Your care team may also give you other medications around the time of surgery (like sedatives or anti-nausea drugs) that can interact with alcohol the same way. When in doubt, check with your anesthesia team or surgeon before having any alcoholic drinks.
I'm pregnant — is this safe for my baby?
Remifentanil crosses the placenta, so your baby can be exposed to it. If you receive it near the time of delivery, your newborn will be closely monitored for breathing problems and excess sleepiness, and staff will have a reversal medicine (naloxone) available. Remifentanil is generally not recommended for use during or right before labor when other pain options are available. If you're pregnant and need surgery, your anesthesia team will weigh the risks carefully and choose the safest approach for both you and your baby.
I take an antidepressant — could that be a problem?
It depends on which one, and it's really important to tell your care team. Certain antidepressants — including SSRIs (like sertraline or fluoxetine), SNRIs (like venlafaxine), tricyclic antidepressants, and especially MAO inhibitors — can interact with remifentanil and raise the risk of a dangerous condition called serotonin syndrome, which causes agitation, rapid heart rate, fever, and muscle problems. MAO inhibitors in particular are a serious concern, and remifentanil should not be used within 14 days of taking one. Always bring a full list of your medications to your pre-surgery appointment.
Is Remifentanil available over the counter?
Remifentanil is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
Is Remifentanil a controlled substance?
Yes — Remifentanil is a federally controlled substance (Schedule II) in the United States, so how it is prescribed, refilled and dispensed is regulated by the DEA.
When was Remifentanil first available?
Remifentanil has been available in the United States since at least 1996, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Remifentanil?
Remifentanil is supplied by 10 manufacturers listed in the FDA NDC Directory, including Mylan Institutional LLC, Hikma Pharmaceuticals USA Inc., Fresenius Kabi USA, LLC.

💬 Answers drafted from Remifentanil’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 Remifentanil comes

Remifentanil 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

Into a vein
Brands Ultiva
How this form is used
What it may be used for
  • Remifentanil Hydrochloride is used intravenously to provide pain relief during induction and maintenance of general anesthesia for inpatient and outpatient procedures
  • Remifentanil Hydrochloride is approved to continue pain control into the immediate postoperative period in adults under direct anesthesia supervision in a post-anesthesia care unit or ICU
  • Ultiva is used intravenously as an analgesic component of monitored anesthesia care in adult patients
  • Ultiva is used intravenously to provide pain relief during induction and maintenance of general anesthesia for inpatient and outpatient procedures
Important instructions
  • Remifentanil Hydrochloride must always be diluted before use and given only through an infusion device by trained anesthesia personnel — never as a direct undiluted injection
  • Ultiva continuous infusions must be administered only by an infusion device; IV bolus doses of Ultiva should be used only during maintenance of general anesthesia
  • When Ultiva infusion is stopped, the IV tubing must be cleared immediately to prevent accidental later dosing, which can cause breathing problems or muscle rigidity
  • Because both Remifentanil Hydrochloride and Ultiva wear off very rapidly, alternative post-procedure pain relief must be established before the infusion is discontinued
Available strengths 3 strengths
43 FDA-listed product records

📊 Remifentanil across the U.S. market

How Remifentanil 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.

1
Dose forms
10
Manufacturers
2
Brand names
49
FDA-listed product records
1996
First marketed

Also listed with the FDA, not a patient dose form: Powder (6) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Mylan Institutional LLC47%
Hikma Pharmaceuticals USA Inc.18%
Fresenius Kabi USA, LLC16%
Navinta LLC6%
American Pacific Corporation2%
Arevipharma GmbH2%
Other makers8%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Remifentanil is used

A general measure of how commonly Remifentanil 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 Remifentanil 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.

842
Medicaid prescriptions filled (Q1–Q4 2025)
$45,797 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Remifentanil prescribed? Of the 1,596 medications we measure, Remifentanil ranks #1,311 by Medicaid prescriptions — more than 18% of them.

Where Remifentanil ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Remifentanil 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.

The 2 mg injection is the most-dispensed Remifentanil product — about 52% of these Medicaid prescriptions.

remifentanil 2 MG Injection Most dispensed

440 Medicaid prescriptions (Q1–Q4 2025) 52% of Remifentanil prescriptions shown $15,012 gross reimbursement (before rebates) ≈ $34 per prescription (gross)

Summed across the 3 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1729584

remifentanil 1 MG Injection

402 Medicaid prescriptions (Q1–Q4 2025) 48% of Remifentanil prescriptions shown $30,785 gross reimbursement (before rebates) ≈ $77 per prescription (gross)

Summed across the 3 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1729578

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 Remifentanil, 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 6 of 22 listed Remifentanil NDCs with Medicaid activity.

🔍 Compare Remifentanil products

A representative set of FDA-listed product records for Remifentanil — 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.)

Showing 49 of 49 products — FDA National Drug Code Directory. See every product, package size and price: browse all 49 Remifentanil NDCs →

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.

Ingredient (IN) Remifentanil RxCUI 73032 1 dose form · 3 strengths
  1. Dose form (SCDF) Injection RxCUI 1729577 In current FDA listings
    Clinical drug / strength (SCD) 1 MG RxCUI 1729578 2 MG RxCUI 1729584 5 MG RxCUI 1729710

Look up RxCUI 73032 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.

🏷️ Sold under these brand names

Ultiva

🏭 Manufacturers & labelers

Mylan Institutional LLC 23 Hikma Pharmaceuticals USA Inc. 9 Fresenius Kabi USA, LLC 8 Navinta LLC 3 American Pacific Corporation 1 Arevipharma GmbH 1 Cilag AG 1 Fine Chemicals Corporation (PTY) Ltd. 1 Navinta LLC, NJ, USA 1 Veranova, L.P. 1

RxNorm drug class

Remifentanil belongs to the Opioid Agonist class.

Pharmacologic class Opioid Agonist
Drug family (ATC) Opioid anesthetics
How it works Full Opioid Agonists

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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Dec 8, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Remifentanil.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Remifentanil after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
5
NDC products indexed
49
Distinct labelers/manufacturers represented
10
Linked representative label
Mylan Institutional LLC
Linked label effective
Dec 8, 2025
Composite sections available
24
Linked SPL Set ID
8b4c8696-e23e-4c51-a4d2-babab5bd945a
Linked SPL Document ID
594087a1-25f2-4f68-aea6-ad7df40559ab
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 5 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.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. 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. Mylan Institutional LLC 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.