FDA-filed SPL labeling · retrieved through openFDA

Rocuronium

Rocuronium is a fast-acting intravenous muscle relaxant used during general anesthesia to help with breathing tube placement and to keep muscles relaxed during surgery or mechanical ventilation.

Brand name Rocuronium Bromide
Drug class Nondepolarizing Neuromuscular Blocker
Rx 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 47 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 effectiveOct 24, 2025
Clinical labels in scope 47
AvailabilityRx
Earliest approval/marketing year 1994
FDA-listed product records 133
Boxed warningNone found in compared labels
How we combine label and product data →
Rocuronium at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Rocuronium bromide injection is a powerful, short-acting muscle relaxant used exclusively in hospital settings to help with breathing tube placement and to keep muscles relaxed during surgery or mechanical ventilation. It must always be paired with proper anesthesia and used only by trained clinicians with full resuscitation equipment available. Doses are tailored to each individual patient's weight, age, and medical condition.

📖 Rocuronium: Patient Information Guide

A plain-language walkthrough of Rocuronium — 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

Rocuronium bromide injection is a neuromuscular blocking agent (muscle relaxant) used exclusively in clinical settings as part of general anesthesia.

  • Facilitates routine tracheal intubation (planned breathing tube placement) in adults and pediatric patients
  • Facilitates rapid sequence intubation (emergency breathing tube placement) in eligible adult patients — not recommended for rapid sequence intubation in pediatric patients
  • Provides skeletal muscle relaxation during surgery
  • Provides skeletal muscle relaxation during mechanical ventilation
  • Not recommended for rapid sequence induction in patients undergoing Cesarean section
⚙️How it works

Rocuronium is a nondepolarizing neuromuscular blocking agent. It works by competing with acetylcholine — the body's natural nerve-to-muscle messenger — at the motor end-plate (the junction between a nerve and a muscle). By blocking acetylcholine from binding, rocuronium temporarily prevents the muscle from receiving the signal to contract, causing controlled, reversible paralysis. The effect can be reversed with acetylcholinesterase inhibitors such as neostigmine or edrophonium, which restore normal signaling.

Rocuronium has no effect on consciousness, pain threshold, or awareness. It must always be given alongside adequate anesthesia or sedation so the patient remains unaware and comfortable during the procedure.

💊How it's taken

Rocuronium bromide injection is given only as an intravenous (IV) injection or infusion — directly into a vein — in a hospital or clinical setting. It is never taken at home. The dose is tailored to each patient based on body weight, age, clinical condition, and the type of anesthesia used.

  • A peripheral nerve stimulator is used throughout to monitor muscle response and guide additional doses
  • Maintenance doses are only given after signs of recovery from the previous dose are observed
  • When used as a continuous infusion, the infusion rate is adjusted based on how the patient responds — dosing requirements typically decrease over time with prolonged use
  • Patients with liver disease or certain other conditions may need dose adjustments due to prolonged drug effects
🤒Side effects — in detail

The most commonly reported side effects of rocuronium bromide injection are temporary changes in blood pressure.

  • Temporary low blood pressure (hypotension)
  • Temporary high blood pressure (hypertension)
  • Fast heart rate (tachycardia)
  • Irregular heartbeat (arrhythmia)
  • Nausea or vomiting
  • Skin rash, itching, or injection site swelling
  • Wheezing or bronchospasm (airway tightening)

Serious reactions — including life-threatening anaphylaxis (severe allergic reaction), prolonged muscle weakness, malignant hyperthermia (dangerous overheating reaction), and muscle damage with long-term ICU use — have been reported and require immediate medical attention.

⚠️Warnings & precautions
  • Risk of accidental administration: Rocuronium causes full paralysis and can cause death if given to the wrong patient or in an uncontrolled setting. Hospital staff must confirm the correct product before every use.
  • Anaphylaxis (severe allergic reaction): Life-threatening and fatal reactions have occurred. People with prior reactions to any muscle relaxant are at higher risk due to cross-reactivity.
  • No effect on consciousness or pain: Rocuronium must always be accompanied by adequate anesthesia or sedation — patients are fully paralyzed but aware without it.
  • Residual paralysis: Some muscle weakness may linger after the procedure. Older adults are especially at risk. Patients should not be extubated (taken off the breathing tube) until full recovery is confirmed.
  • Long-term ICU use: Prolonged use may lead to tolerance, extended paralysis, and muscle damage (myopathy) — especially when used with corticosteroids. Use should be as brief as possible.
  • Malignant hyperthermia: Though rocuronium itself has not been shown to trigger this dangerous reaction, it is always used with other anesthetic agents that can. Clinicians must be prepared to recognize and treat it.
  • Pulmonary vascular resistance: May be increased with rocuronium use — use with caution in patients with pulmonary hypertension or valvular heart disease.
  • QT interval prolongation: In pediatric patients, use with general anesthetics may prolong the QTc interval (a measure of heart electrical activity).
🔀What it interacts with

Several medications can alter how rocuronium works — either making it stronger and longer-lasting, or reducing its effectiveness.

  • Inhalation anesthetics (enflurane, isoflurane): Significantly extend the duration of rocuronium's muscle-relaxing effect and reduce the amount of drug needed
  • Certain antibiotics (aminoglycosides, vancomycin, tetracyclines, polymyxins, bacitracin, colistin): May prolong neuromuscular blockade
  • Anticonvulsants (carbamazepine, phenytoin): May reduce rocuronium's effectiveness, requiring higher or more frequent doses
  • Magnesium salts: Used for pre-eclampsia or eclampsia — can enhance and prolong muscle relaxation
  • Lithium: May increase duration of neuromuscular block
  • Local anesthetics: May prolong muscle blockade
  • Procainamide: May increase the duration of neuromuscular block
  • Quinidine: May cause paralysis to return unexpectedly during the recovery phase
  • Succinylcholine: Rocuronium should not be given until the patient has fully recovered from succinylcholine
  • Other nondepolarizing muscle relaxants: Interactions have been observed when these drugs are used in succession

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
  • Known allergy or anaphylactic reaction to rocuronium or any other muscle relaxant — this is a contraindication (a reason not to use the drug)
  • Liver disease (hepatic impairment) — the drug may last significantly longer and dose adjustments are needed
  • Kidney disease (renal impairment) — duration can be more unpredictable; usual dosing guidance still applies but individual variation is greater
  • Myasthenia gravis or Eaton-Lambert syndrome — even small doses can cause profound, prolonged paralysis
  • Pulmonary hypertension or valvular heart disease — rocuronium may raise pressure in the lung blood vessels
  • Burns, muscle wasting (disuse atrophy), nerve injury, or direct muscle trauma — these conditions can cause resistance to rocuronium, requiring higher doses
  • Cerebral palsy or long-term anticonvulsant use — may also lead to resistance
  • Pregnancy — rocuronium crosses the placenta; it is not recommended for rapid-sequence induction in Cesarean section patients
  • Breastfeeding — it is unknown whether rocuronium passes into breast milk; discuss with your care team
  • Older adults (65+) — onset may be slower, duration may be longer, and risk of residual muscle weakness after surgery is higher
  • Pediatric patients — not recommended for rapid sequence intubation; onset and duration vary with age and anesthetic technique
🚑If you take too much

Too much rocuronium can result in muscle paralysis that lasts well beyond what is needed, including paralysis of the breathing muscles. The primary treatment in this situation is maintaining an open airway and supporting breathing with mechanical ventilation until muscle function naturally returns.

Once some recovery of muscle function is observed, reversal agents (anticholinesterase medications, given alongside an anticholinergic drug) can be used to speed recovery. Recovery may take longer in patients who are debilitated, have certain cancers, or are taking other drugs that affect neuromuscular function.

📡Pharmacodynamics — effects in the body

Rocuronium produces a rapid to intermediate onset of neuromuscular blockade (muscle paralysis) depending on the dose given. At the standard intubating dose, muscle paralysis typically begins within about one minute, allowing breathing tube placement within roughly 1.5 to 2 minutes in most adults. The duration of the muscle-relaxing effect varies with dose — lower doses may last around 20–30 minutes in adults, while higher doses can extend the effect considerably longer.

Older adults tend to have a slower onset and longer duration of effect compared to younger adults. In patients with liver disease, the duration of effect can be approximately 1.5 times longer than in patients with normal liver function. The muscle block can be reversed with appropriate reversal medications once the procedure is complete.

🔬Pharmacokinetics — how your body processes it

After IV administration, rocuronium is rapidly distributed throughout the body and is approximately 30% bound to plasma proteins. It is primarily eliminated by the liver, with the kidneys playing only a limited role in clearance. In healthy adults, the elimination half-life (the time for the body to clear half of the drug) is approximately 1.4 to 1.5 hours.

In patients with significant liver disease (cirrhosis), the volume of distribution is markedly increased, roughly doubling the elimination half-life to about 4 hours — meaning the drug's effects last considerably longer. Patients with kidney failure have a similar overall half-life to healthy adults, but with greater variability in how long the effects last. In pediatric patients, clearance is generally faster than in adults, and duration of effect varies with age and the type of anesthesia used.

📦How to store it

stored at 20°C to 25°C (68°F to 77°F); Excursion permitted between 15°C and 30°C (59°F and 86°F) . DO NOT FREEZE.

📄 Written from Rocuronium’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 Rocuronium — the kind of thing our pharmacy team would talk through with you at the counter.

Why am I being given rocuronium? What does it actually do?
Rocuronium is a muscle relaxant your anesthesia team uses to temporarily relax all your muscles — including the ones that control your airway — so they can safely place a breathing tube and keep you still during surgery or while you're on a ventilator. It's a routine and widely used part of anesthesia. It does not put you to sleep or affect your awareness, which is why it's always given together with anesthetic or sedative medications.
Will I be awake or feel anything while it's working?
No — rocuronium has no effect on consciousness or your ability to feel pain. It only relaxes your muscles. Your anesthesia team will always give you anesthesia or sedation alongside it to ensure you are completely unaware and comfortable throughout your procedure. You will not be able to move or speak while it's working, but you won't feel anything either.
How long will the muscle relaxation last, and when will I be able to move again?
That depends on the dose you received and your individual health factors. In most adults, the effects of a standard dose can last roughly 30 to 60 minutes, though this can be shorter or longer depending on your age, liver function, and other medications. Your care team monitors your muscle response throughout and can give a reversal medication to help restore muscle function more quickly at the end of your procedure. Older adults and people with liver disease may take longer to fully recover.
Are there any side effects I should know about?
The most common side effects are temporary changes in blood pressure — either a brief drop or rise — during the procedure. Your anesthesia team monitors this closely the entire time. Less commonly, some people experience a faster heart rate, nausea, or minor skin reactions at the injection site. A rare but serious risk is a severe allergic reaction (anaphylaxis); if you've ever had a reaction to a muscle relaxant before, be sure to tell your care team ahead of time.
I'm pregnant — is this safe for my baby?
Rocuronium does cross the placenta and reach the baby, so your care team will weigh the risks and benefits carefully. Available evidence from clinical use has not shown a clear increase in birth defects. However, rocuronium is specifically not recommended for emergency rapid-sequence intubation in Cesarean section patients, so your team will use an alternative approach in that situation. If you are pregnant or think you might be, always let your anesthesia team know before any procedure.
I take other medications — could they interfere with rocuronium?
Yes, several medications can affect how rocuronium works. Certain antibiotics, anti-seizure medications like phenytoin or carbamazepine, lithium, magnesium supplements, and some heart medications can either make rocuronium stronger and longer-lasting or reduce its effectiveness. It's very important to tell your anesthesia team about every medication you take — including over-the-counter drugs and supplements — so your dose can be adjusted safely.
Is Rocuronium available over the counter?
Rocuronium 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.
When was Rocuronium first available?
Rocuronium has been available in the United States since at least 1994, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Rocuronium?
Rocuronium is supplied by 43 manufacturers listed in the FDA NDC Directory, including Medical Purchasing Solutions, LLC, Fresenius Kabi USA, LLC, HF Acquisition Co LLC, DBA HealthFirst.

💬 Answers drafted from Rocuronium’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 Rocuronium comes

Rocuronium 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 Rocuronium Bromide
How this form is used
What it may be used for
  • Used as part of general anesthesia to help place a breathing tube (tracheal intubation) — including emergency rapid-sequence intubation in eligible adult patients
  • Used to maintain skeletal muscle relaxation during surgery
  • Used to maintain muscle relaxation in patients on mechanical ventilation
  • Approved for use in adult, geriatric, and pediatric patients, with dosing individualized by age and weight
Important instructions
  • Given only by intravenous (IV) injection or infusion, under the direct supervision of an experienced clinician
  • Dose is individualized for each patient; a peripheral nerve stimulator is used to monitor drug effect and guide additional dosing
  • Maintenance doses are given only after evidence of recovery from the previous dose is observed
  • Should not be mixed with alkaline solutions (such as barbiturates) in the same syringe or IV line
Available strengths 3 strengths
121 FDA-listed product records

📊 Rocuronium across the U.S. market

How Rocuronium 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
43
Manufacturers
2
Brand names
133
FDA-listed product records
1994
First marketed

Also listed with the FDA, not a patient dose form: Powder (12) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Medical Purchasing Solutions, LLC10%
Fresenius Kabi USA, LLC8%
HF Acquisition Co LLC, DBA HealthFirst7%
Hospira, Inc.6%
Hikma Pharmaceuticals USA Inc.5%
Baxter Healthcare Corporation5%
Other makers60%

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

📈 How widely Rocuronium is used

A general measure of how commonly Rocuronium 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 Rocuronium 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.

38,861
Medicaid prescriptions filled (Q1–Q4 2025)
$3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Rocuronium prescribed? Of the 1,596 medications we measure, Rocuronium ranks #683 by Medicaid prescriptions — more than 57% of them.

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

Utilization by Rocuronium 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.

rocuronium bromide 10 MG/ML Injectable Solution

38,861 Medicaid prescriptions (Q1–Q4 2025) 100% of Rocuronium prescriptions shown $3M gross reimbursement (before rebates) ≈ $77 per prescription (gross)

Summed across the 34 of 131 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1234995

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 Rocuronium, 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 34 of 131 listed Rocuronium NDCs with Medicaid activity.

🔍 Compare Rocuronium products

A representative set of FDA-listed product records for Rocuronium — 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 133 of 133 products — FDA National Drug Code Directory. See every product, package size and price: browse all 133 Rocuronium 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) Rocuronium RxCUI 68139 3 dose forms · 4 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 375623 In current FDA listings
    Clinical drug / strength (SCD) bromide 10 MG/ML RxCUI 1234995

Look up RxCUI 68139 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

Rocuronium Bromide

🏭 Manufacturers & labelers

Medical Purchasing Solutions, LLC 13 Fresenius Kabi USA, LLC 10 HF Acquisition Co LLC, DBA HealthFirst 9 Hospira, Inc. 8 Hikma Pharmaceuticals USA Inc. 6 Baxter Healthcare Corporation 6 Civica, Inc. 6 Piramal Critical Care Inc 6 Almaject, Inc. 4 Gland Pharma Limited 4 Meitheal Pharmaceuticals Inc. 4 Eugia US LLC 4 Caplin Steriles Limited 4 Shandong New Time Pharmaceutical Co., Ltd. 4 Solco Healthcare US, LLC 4 ProPharma Distribution 3 B. Braun Medical Inc. 3 Mylan Institutional LLC 2 Phlow Corporation 2 Sagent Pharmaceuticals 2 Lupin Pharmaceuticals, Inc. 2 XGen Pharmaceuticals DJB, Inc. 2 HF Acquisition Co. LLC, DBA HealthFirst 2 Lifestar Pharma LLC 2

…and 16 more on the FDA NDC directory.

RxNorm drug class

Rocuronium belongs to the Nondepolarizing Neuromuscular Blocker class.

Pharmacologic class Nondepolarizing Neuromuscular Blocker
Drug family (ATC) Other quaternary ammonium compounds

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 Oct 24, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Rocuronium.
📈
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 Rocuronium after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
47
NDC products indexed
133
Distinct labelers/manufacturers represented
43
Linked representative label
Medical Purchasing Solutions, LLC.
Linked label effective
Oct 24, 2025
Composite sections available
21
Linked SPL Set ID
41efca22-7a40-91b1-e063-6294a90a8018
Linked SPL Document ID
41efca22-7a41-91b1-e063-6294a90a8018
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 47 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. Medical Purchasing Solutions, 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.