Atracurium besylate

What Atracurium besylate is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Atracurium besylate injection is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

— FDA label: Atracurium Besylate, Meitheal Pharmaceuticals Inc., effective December 4, 2024. Read the full label on DailyMed →

Label quoted: the one for the most common form (injection, solution, intravenous), Atracurium Besylate, Meitheal Pharmaceuticals Inc.; it covers 2 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 4 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 4 FDA labels for this medicine have a boxed warning.

Atracurium besylate side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

Observed in Controlled Clinical Studies Atracurium was well tolerated and produced few adverse reactions during extensive clinical trials. Most adverse reactions were suggestive of histamine release. In studies including 875 patients, atracurium was discontinued in only one patient (who required treatment for bronchial secretions) and six other patients required treatment for adverse reactions attributable to atracurium (wheezing in one, hypotension in five).

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Of the five patients who required treatment for hypotension, three had a history of significant cardiovascular disease. The overall incidence rate for clinically important adverse reactions, therefore, was 7/875 or 0.8%. Table 1 includes all adverse reactions reported attributable to atracurium during clinical trials with 875 patients. Table 1: Percent of Patients Reporting Adverse Reactions * Includes the recommended initial dosage range for most patients. Adverse Reaction Initial Atracurium Dose (mg/kg) 0.00-0.30 (n = 485) 0.31-0.50* (n = 366) ≥0.60 (n = 24) Total (n = 875) Skin Flush 1.0% 8.7% 29.2% 5.0% Erythema 0.6% 0.5% 0% 0.6% Itching 0.4% 0% 0% 0.2% Wheezing/Bronchial Secretions 0.2% 0.3% 0% 0.2% Hives 0.2% 0% 0% 0.1% Most adverse reactions were of little clinical significance unless they were associated with significant hemodynamic changes. Table 2 summarizes the incidences of substantial vital sign changes noted during atracurium clinical trials with 530 patients, without cardiovascular disease, in whom these parameters were assessed. Table 2: Percent of Patients Showing >30% Vital Sign Changes Following Administration of Atracurium * Includes the recommended initial dosage range for most patients. Vital Sign Change Initial Atracurium Dose (mg/kg) 0.00-0.30 (n = 365) 0.31-0.50* (n = 144) ≥0.60 (n = 21) Total (n = 530) Mean Arterial Pressure Increase 1.9% 2.8% 0% 2.1% Decrease 1.1% 2.1% 14.3% 1.9% Heart Rate Increase 1.6% 2.8% 4.8% 2.1% Decrease 0.8% 0% 0% 0.6% Observed in Clinical Practice Based on initial clinical practice experience in approximately 3 million patients who received atracurium in the U.S. and in the United Kingdom, spontaneously reported adverse reactions were uncommon (approximately 0.01% to 0.02%). The following adverse reactions are among the most frequently reported, but there are insufficient data to support an estimate of their incidence: General: Allergic reactions (anaphylactic or anaphylactoid responses) which, in rare instances, were severe (e.g., cardiac arrest) Musculoskeletal: Inadequate block, prolonged block Cardiovascular: Hypotension, vasodilatation (flushing), tachycardia, bradycardia Respiratory: Dyspnea, bronchospasm, laryngospasm Integumentary: Rash, urticaria, reaction at injection site There have been rare spontaneous reports of seizures in ICU patients following long-term infusion of atracurium to support mechanical ventilation. There are insufficient data to define the contribution, if any, of atracurium and/or its metabolite laudanosine (see PRECAUTIONS, Long-Term Use in Intensive Care Unit (ICU)). There have been post-marketing reports of severe allergic reactions (anaphylactic and anaphylactoid reactions) associated with use of neuromuscular blocking agents, including atracurium besylate.

— FDA label: Atracurium Besylate, Meitheal Pharmaceuticals Inc., effective December 4, 2024. This is part of the section. Read the full label on DailyMed →

Atracurium besylate drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

Drugs which may enhance the neuromuscular blocking action of atracurium include: enflurane; isoflurane; halothane; certain antibiotics, especially the aminoglycosides and polymyxins; lithium; magnesium salts; procainamide; and quinidine. If other muscle relaxants are used during the same procedure, the possibility of a synergistic or antagonist effect should be considered.

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The prior administration of succinylcholine does not enhance the duration, but quickens the onset and may increase the depth, of neuromuscular block induced by atracurium besylate. Atracurium should not be administered until a patient has recovered from succinylcholine-induced neuromuscular block.

— FDA label: Atracurium Besylate, Meitheal Pharmaceuticals Inc., effective December 4, 2024. Read the full label on DailyMed →

Atracurium besylate dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

To avoid distress to the patient, atracurium should not be administered before unconsciousness has been induced. Atracurium should not be mixed in the same syringe, or administered simultaneously through the same needle, with alkaline solutions (e.g., barbiturate solutions). Atracurium besylate should be administered intravenously. DO NOT GIVE ATRACURIUM BESYLATE BY INTRAMUSCULAR ADMINISTRATION.

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Intramuscular administration of atracurium besylate may result in tissue irritation and there are no clinical data to support this route of administration. As with other neuromuscular blocking agents, the use of a peripheral nerve stimulator will permit the most advantageous use of atracurium besylate, minimizing the possibility of overdosage or underdosage, and assist in the evaluation of recovery. Bolus Doses for Intubation and Maintenance of Neuromuscular Block Adults An atracurium besylate dose of 0.4 to 0.5 mg/kg (1.7 to 2.2 times the ED 95), given as an intravenous bolus injection, is the recommended initial dose for most patients. With this dose, good or excellent conditions for nonemergency intubation can be expected in 2 to 2.5 minutes in most patients, with maximum neuromuscular block achieved approximately 3 to 5 minutes after injection. Clinically required neuromuscular block generally lasts 20 to 35 minutes under balanced anesthesia. Under balanced anesthesia, recovery to 25% of control is achieved approximately 35 to 45 minutes after injection, and recovery is usually 95% complete approximately 60 minutes after injection. Atracurium is potentiated by isoflurane or enflurane anesthesia. The same initial atracurium besylate dose of 0.4 to 0.5 mg/kg may be used for intubation prior to administration of these inhalation agents; however, if atracurium is first administered under steady-state of isoflurane or enflurane, the initial atracurium besylate dose should be reduced by approximately one-third, i.e., to 0.25 to 0.35 mg/kg, to adjust for the potentiating effects of these anesthetic agents. With halothane, which has only a marginal (approximately 20%) potentiating effect on atracurium, smaller dosage reductions may be considered. Atracurium besylate doses of 0.08 to 0.10 mg/kg are recommended for maintenance of neuromuscular block during prolonged surgical procedures. The first maintenance dose will generally be required 20 to 45 minutes after the initial atracurium besylate injection, but the need for maintenance doses should be determined by clinical criteria. Because atracurium lacks cumulative effects, maintenance doses may be administered at relatively regular intervals for each patient, ranging approximately from 15 to 25 minutes under balanced anesthesia, slightly longer under isoflurane or enflurane. Higher atracurium doses (up to 0.2 mg/kg) permit maintenance dosing at longer intervals. Pediatric Patients No atracurium dosage adjustments are required for pediatric patients two years of age or older. An atracurium besylate dose of 0.3 to 0.4 mg/kg is recommended as the initial dose for infants (1 month to 2 years of age) under halothane anesthesia.

— FDA label: Atracurium Besylate, Meitheal Pharmaceuticals Inc., effective December 4, 2024. This is part of the section. Read the full label on DailyMed →

Atracurium besylate in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Teratogenic Effects: Pregnancy Category C Atracurium besylate has been shown to be potentially teratogenic in rabbits when given in doses up to approximately one-half the human dose. There are no adequate and well-controlled studies in pregnant women. Atracurium should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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Atracurium besylate was administered subcutaneously on days 6 through 18 of gestation to non-ventilated Dutch rabbits. Treatment groups were given either 0.15 mg/kg once daily or 0.10 mg/kg twice daily. Lethal respiratory distress occurred in two 0.15 mg/kg animals and in one 0.10 mg/kg animal, with transient respiratory distress or other evidence of neuromuscular block occurring in 10 of 19 and in 4 of 20 of the 0.15 mg/kg and 0.10 mg/kg animals, respectively. There was an increased incidence of certain spontaneously occurring visceral and skeletal anomalies or variations in one or both treated groups when compared to non-treated controls. The percentage of male fetuses was lower (41% vs. 51%) and the post-implantation losses were increased (15% vs. 8%) in the group given 0.15 mg/kg once daily when compared to the controls; the mean numbers of implants (6.5 vs. 4.4) and normal live fetuses (5.4 vs. 3.8) were greater in this group when compared to the control group.

— FDA label: Atracurium Besylate, Meitheal Pharmaceuticals Inc., effective December 4, 2024. Read the full label on DailyMed →

Atracurium besylate and breastfeeding

Quoted from the nursing mothers / lactation part of the FDA-approved label.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when atracurium besylate is administered to a nursing woman.

— FDA label: Atracurium Besylate, Meitheal Pharmaceuticals Inc., effective December 4, 2024. Read the full label on DailyMed →

When Atracurium besylate should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

Atracurium besylate is contraindicated in patients known to have a hypersensitivity to it. Use of atracurium besylate from multiple dose vials containing benzyl alcohol as a preservative is contraindicated in patients with a known hypersensitivity to benzyl alcohol.

— FDA label: Atracurium Besylate, Meitheal Pharmaceuticals Inc., effective December 4, 2024. Read the full label on DailyMed →

Atracurium besylate overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

There has been limited experience with overdosage of atracurium besylate. The possibility of iatrogenic overdosage can be minimized by carefully monitoring muscle twitch response to peripheral nerve stimulation. Excessive doses of atracurium can be expected to produce enhanced pharmacological effects. Overdosage may increase the risk of histamine release and cardiovascular effects, especially hypotension.

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If cardiovascular support is necessary, this should include proper positioning, fluid administration, and the use of vasopressor agents if necessary. The patient's airway should be assured, with manual or mechanical ventilation maintained as necessary. A longer duration of neuromuscular block may result from overdosage and a peripheral nerve stimulator should be used to monitor recovery. Recovery may be facilitated by administration of an anticholinesterase reversing agent such as neostigmine, edrophonium, or pyridostigmine, in conjunction with an anticholinergic agent such as atropine or glycopyrrolate. The appropriate package inserts should be consulted for prescribing information. Three pediatric patients (3 weeks, 4 and 5 months of age) unintentionally received doses of 0.8 mg/kg to 1 mg/kg of atracurium besylate. The time to 25% recovery (50 to 55 minutes) following these doses, which were 5 to 6 times the ED 95 dose, was moderately longer than the corresponding time observed following doses 2 to 2.5 times the atracurium ED 95 dose in infants (22 to 36 minutes). Cardiovascular changes were minimal. Nonetheless the possibility of cardiovascular changes must be considered in the case of overdose. An adult patient (17 years of age) unintentionally received an initial dose of 1.3 mg/kg of atracurium besylate. The time from injection to 25% recovery (83 minutes) was approximately twice that observed following maximum recommended doses in adults (35 to 45 minutes). The patient experienced moderate hemodynamic changes (13% increase in mean arterial pressure and 27% increase in heart rate) which persisted for 40 minutes and did not require treatment. The intravenous LD 50 s determined in non-ventilated male and female albino mice and male Wistar rats were 1.9, 2.01 and 1.31 mg/kg, respectively. Deaths occurred within 2 minutes and were caused by respiratory paralysis. The subcutaneous LD 50 determined in non-ventilated male Wistar rats was 282.8 mg/kg. Tremors, ptosis, loss of reflexes and respiratory failure preceded death which occurred 45 to 120 minutes after injection.

— FDA label: Atracurium Besylate, Meitheal Pharmaceuticals Inc., effective December 4, 2024. Read the full label on DailyMed →

Forms and how it is given

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Meitheal Pharmaceuticals Inc.2 products
• Hospira, Inc.2 products
• AuroMedics Pharma LLC2 products

FDA approval history

• ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (6)

• ANDA091488Meitheal · February 17, 2012
• ANDA091489Meitheal · February 17, 2012
• ANDA090761Hospira Inc · October 18, 2012
• ANDA090782Hospira Inc · October 18, 2012
• ANDA206010Eugia Pharma · April 8, 2015
• ANDA206011Eugia Pharma · April 8, 2015

Shortage status

The FDA drug shortage list does not show these products.

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Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

Next steps

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• Meitheal Pharmaceuticals Inc.Maker or distributor
• Hospira, Inc.Maker or distributor
• AuroMedics Pharma LLCMaker or distributor
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Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Atracurium Besylate, Meitheal Pharmaceuticals Inc., effective December 4, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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