pharmacopeia
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/api/v1/drug/rocuronium

Mechanism of action

Sourced from openFDA

Rocuronium bromide is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. It acts by competing for cholinergic receptors at the motor end-plate.

Indications

Sourced from openFDA
  • Rocuronium bromide injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Rocuronium bromide injection is a nondepolarizing neuromuscular blocking agent indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

Contraindications

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  • Rocuronium bromide is contraindicated in patients known to have hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents [see Warnings and Precautions ( 5.2 )]. Hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents.contraindicated

Dosage & administration

Sourced from openFDA

To be administered only by experienced clinicians or adequately trained individuals supervised by an experienced clinician familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents. ( 2.1 ) Individualize the dose for each patient. ( 2.1 ) Peripheral nerve stimulator recommended for determination of drug response and need for additional doses, and to evaluate recovery. ( 2.1 ) Store rocuronium bromide injection with cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product. ( 2.1 ) Tracheal intubation : Recommended initial dose is 0.6 mg/kg. ( 2.2 ) Rapid sequence intubation : 0.6 to 1.2 mg/kg. ( 2.3 ) Maintenance doses : Guided by response to prior dose, not administered until recovery is evident. ( 2.4 ) Continuous infusion : Initial rate of 10 to 12 mcg/kg/min. Start only after early evidence of spontaneous recovery from an intubating dose. ( 2.5 ) 2.1 Important Dosing and Administration Information Rocuronium bromide injection is for intravenous use only. This drug should only be administered by experienced clinicians or trained individuals supervised by an experienced clinician familiar with the use, actions, characteristics and complications of neuromuscular blocking agents. Doses of rocuronium bromide injection should be individualized and a peripheral nerve stimulator should be used to monitor drug effect, need for additional doses, adequacy of spontaneous recovery or antagonism, and to decrease the complications of overdosage if additional doses are administered.

Warnings & precautions

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Appropriate Administration and Monitoring : Use only if facilities for intubation, mechanical ventilation, oxygen therapy, and an antagonist are immediately available. ( 5.1 ) Anaphylaxis : Severe anaphylaxis has been reported. Consider cross-reactivity among neuromuscular blocking agents. ( 5.2 ) Risk of Death due to Medication Errors : Accidental administration can cause death. ( 5.3 ) Need for Adequate Anesthesia : Must be accompanied by adequate anesthesia or sedation. ( 5.4 ) Residual Paralysis : Consider using a reversal agent in cases where residual paralysis is more likely to occur. ( 5.5 ) 5.1 Appropriate Administration and Monitoring Rocuronium bromide should be administered in carefully adjusted dosages by or under the supervision of experienced clinicians who are familiar with the drug's actions and the possible complications of its use. The drug should not be administered unless facilities for intubation, mechanical ventilation, oxygen therapy, and an antagonist are immediately available. It is recommended that clinicians administering neuromuscular blocking agents such as rocuronium bromide employ a peripheral nerve stimulator to monitor drug effect, need for additional doses, adequacy of spontaneous recovery or antagonism, and to decrease the complications of overdosage if additional doses are administered. 5.2 Anaphylaxis Severe anaphylactic reactions to neuromuscular blocking agents, including rocuronium bromide, have been reported. These reactions have, in some cases (including cases with rocuronium bromide) been life threatening and fatal.

Adverse reactions

Sourced from openFDA

In clinical trials, the most common adverse reactions (2%) are transient hypotension and hypertension. The following adverse reactions are described, or described in greater detail, in other sections: Anaphylaxis [see Warnings and Precautions ( 5.2 )] Residual paralysis [see Warnings and Precautions ( 5.5 )] Myopathy [see Warnings and Precautions ( 5.6 )] Increased pulmonary vascular resistance [see Warnings and Precautions ( 5.12 )] Most common adverse reactions (2%) are transient hypotension and hypertension. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical studies in the U.S. (n=1137) and Europe (n=1394) totaled 2531 patients. The patients exposed in the U.S. clinical studies provide the basis for calculation of adverse reaction rates.

Use in specific populations

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Labor and Delivery : Not recommended for rapid sequence induction in patients undergoing Cesarean section. ( 8.2 ) Pediatric Use : Onset time and duration will vary with dose, age, and anesthetic technique. Not recommended for rapid sequence intubation in pediatric patients. ( 8.4 ) 8.1 Pregnancy Developmental toxicology studies have been performed with rocuronium bromide in pregnant, conscious, nonventilated rabbits and rats. Inhibition of neuromuscular function was the endpoint for high-dose selection. The maximum tolerated dose served as the high dose and was administered intravenously 3 times a day to rats (0.3 mg/kg, 15% to 30% of human intubation dose of 0.6 to 1.2 mg/kg based on the body surface unit of mg/m 2 ) from Day 6 to 17 and to rabbits (0.02 mg/kg, 25% human dose) from Day 6 to 18 of pregnancy. High-dose treatment caused acute symptoms of respiratory dysfunction due to the pharmacological activity of the drug. Teratogenicity was not observed in these animal species. The incidence of late embryonic death was increased at the high dose in rats, most likely due to oxygen deficiency. Therefore, this finding probably has no relevance for humans because immediate mechanical ventilation of the intubated patient will effectively prevent embryo-fetal hypoxia. However, there are no adequate and well-controlled studies in pregnant women.

Pharmacokinetics

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Metabolism
Adult and Geriatric Patients In an effort to maximize the information gathered in the in vivo pharmacokinetic studies, the data from the studies was used to develop population estimates of the parameters for the subpopulations represented (e.g., geriatric, pediatric, renal and hepatic impairment). These population-based estimates and a measure of the estimate variability are contained in the following section.

Overdosage

Sourced from openFDA

Overdosage with neuromuscular blocking agents may result in neuromuscular block beyond the time needed for surgery and anesthesia. The primary treatment is maintenance of a patent airway, controlled ventilation, and adequate sedation until recovery of normal neuromuscular function is assured. Once evidence of recovery from neuromuscular block is observed, further recovery may be facilitated by administration of an anticholinesterase agent in conjunction with an appropriate anticholinergic agent. Reversal of Neuromuscular Blockade: Anticholinesterase agents should not be administered prior to the demonstration of some spontaneous recovery from neuromuscular blockade. The use of a nerve stimulator to document recovery is recommended. Patients should be evaluated for adequate clinical evidence of neuromuscular recovery, e.g., 5-second head lift, adequate phonation, ventilation, and upper airway patency. Ventilation must be supported while patients exhibit any signs of muscle weakness. Recovery may be delayed in the presence of debilitation, carcinomatosis, and concomitant use of certain drugs which enhance neuromuscular blockade or separately cause respiratory depression.

Approval history

Sourced from openFDA
  • Nov 26, 2008ANDAANDA078519Hospira
  • Nov 26, 2008ANDAANDA079199Mylan Institutional
  • Dec 5, 2008ANDAANDA079195Sandoz
  • Dec 29, 2008ANDAANDA078651Fresenius Kabi Usa
  • Aug 27, 2012ANDAANDA091115Tamarang
  • Feb 28, 2017ANDAANDA204679West Ward Pharm Corp
  • Jun 9, 2025NDANDA217472Fresenius Kabi Usa
  • Oct 24, 2025NDANDA219108B Braun Medical

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Rocuronium Bromide, Injection, 100 mg/10 mL (NDC 66794-229-41)Active
    Sponsor: Piramal Critical Care Inc. · Reason: Demand increase for the drug
    Updated
  • Rocuronium Bromide, Injection, 50 mg/5 mL (NDC 66794-228-41)Active
    Sponsor: Piramal Critical Care Inc. · Reason: Demand increase for the drug
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
11,093 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Anaphylactic Reaction1,22411%
  2. 2Hypotension1,0889.8%
  3. 3Drug Ineffective1,0679.6%
  4. 4Anaphylactic Shock9568.6%
  5. 5Cardiac Arrest6495.9%
  6. 6Drug Interaction4584.1%
  7. 7Tachycardia4083.7%
  8. 8Off Label Use4023.6%
  9. 9Bradycardia3913.5%
  10. 10Bronchospasm3593.2%
  11. 11Rash2742.5%
  12. 12Urticaria2722.5%
  13. 13Respiratory Failure2542.3%
  14. 14Hypoxia2522.3%
  15. 15Oxygen Saturation Decreased2492.2%

Literature

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Recent PubMed references pinned to Rocuronium as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 765 ClinicalTrials.gov registrations naming Rocuronium as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Rocuronium work?
Rocuronium bromide is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. It acts by competing for cholinergic receptors at the motor end-plate.
What is Rocuronium used for?
According to FDA labeling, Rocuronium carries indications including: Rocuronium bromide injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Rocuronium bromide injection is a nondepolarizing neuromuscular blocking agent indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Rocuronium?
Rocuronium is classified as Nondepolarizing Neuromuscular Blocker, Neuromuscular Nondepolarizing Blockade.
What are the contraindications for Rocuronium?
Rocuronium labeling lists contraindications including: Rocuronium bromide is contraindicated in patients known to have hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents [see Warnings and Precautions ( 5.2 )]. Hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents.. Always consult the full prescribing information and a clinician.
Note. Data for rocuronium is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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