Cisatracurium besylate

What Cisatracurium besylate is used for

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

Cisatracurium besylate injection is indicated: •as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age •to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU •to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older …

— FDA label: Cisatracurium Besylate, Camber Pharmaceuticals Inc., effective April 30, 2026. Read the full label on DailyMed →

Label quoted: the one for the most common form (injection, intravenous), Cisatracurium Besylate, Camber Pharmaceuticals Inc.; it covers 3 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 19 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 19 FDA labels for this medicine have a boxed warning.

Cisatracurium besylate side effects

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

The most common adverse reactions (0.1% to 0.4%) were bradycardia, hypotension, flushing, bronchospasm, and rash.

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(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Piramal Pharma Solutions Inc. at 1-626-206-0832 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adverse Reactions in Clinical Trials of Cisatracurium besylate in Surgical Patients The data presented below are based on studies involving 945 surgical patients who received Cisatracurium besylate in conjunction with other drugs in US and European clinical studies in a variety of procedures [see Clinical Studies (14.1)]. Table 3 displaysadverse reactions that occurred at a rate of less than 1%. Table 3. Adverse Reactions in Clinical Trials of Cisatracurium besylate in Surgical Patients Adverse Reaction Incidence Bradycardia 0.4% Hypotension 0.2% Flushing 0.2% Bronchospasm 0.2% Rash 0.1% Adverse Reactions in Clinical Trials of Cisatracurium besylate in Intensive Care Unit Patients The adverse reactions presented below were from studies involving 68 adult ICU patients who received Cisatracurium besylate in conjunction with other drugs in US and European clinical studies [see Clinical Studies (14.3)]. One patient experienced bronchospasm. In one of the two ICU studies, a randomized and double-blind study of ICU patients using TOF neuromuscular monitoring, there were two reports of prolonged recovery (range: 167 and 270 minutes) among 28 patients administered Cisatracurium besylate and 13 reports of prolonged recovery (range: 90 minutes to 33 hours) among 30 patients administered vecuronium. 6.2 Postmarketing Experience The following events have been identified during post-approval use of Cisatracurium besylate in conjunction with one or more anesthetic agents in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to Cisatracurium besylate: anaphylaxis, histamine release, prolonged neuromuscular block, muscle weakness, myopathy.

— FDA label: Cisatracurium Besylate, Camber Pharmaceuticals Inc., effective April 30, 2026. Read the full label on DailyMed →

Cisatracurium 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.

Succinylcholine: May decrease time to onset of maximum neuromuscular blockade (7.1) Inhalational anesthetics, antibiotics, local anesthetics, magnesium salts, procainamide, lithium, quinidine: May potentiate or prolong neuromuscular blockade action of Cisatracurium besylate. Use peripheral nerve stimulator and monitor clinical signs of neuromuscular blockade. (5.8, 7.1) Phenytoin and Carbamazepine: May shorten duration of neuromuscular blockade.

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Use peripheral nerve stimulator and monitor clinical signs of neuromuscular blockade. (5.9, 7.1) 7.1 Clinically Significant Drug Interactions Table 4 displays clinically significant drug interactions with Cisatracurium besylate. Table 4. Clinically Significant Drug Interactions with Cisatracurium besylate Drug or Drug Class Clinical Implications * Succinylcholine The use of succinylcholine prior to Cisatracurium besylate administration may decrease the time to onset of maximum neuromuscular blockade but has no effect on the duration of neuromuscular blockade. Inhalational Anesthetics Administration of inhalational anesthetics with nitrous oxide/oxygen for greater than 30 minutes to achieve 1.25 Minimum Alveolar Concentration (MAC) may prolong the duration of action of initial and maintenance doses of Cisatracurium besylate. This may potentiate the neuromuscular blockade. Antibiotics † Local anesthetics Magnesium salts Procainamide Lithium Quinidine May prolong the neuromuscular blockade action of Cisatracurium besylate Phenytoin, Carbamazepine May increase resistance to the neuromuscular blockade action of Cisatracurium besylate resulting in shorter durations of neuromuscular blockade and infusion rate requirements may be higher. * The use of peripheral nerve stimulator is strongly recommended to evaluate the level of neuromuscular blockade, to assess the need for additional doses of Cisatracurium besylate, and to determine whether adjustments need to be made to the dose with subsequent administration. † Examples: aminoglycosides, tetracyclines, bacitracin, polymyxins, lincomycin, clindamycin, colistin, sodium colistimethate 7.2 Drugs Without Clinically Significant Drug Interactions With Cisatracurium besylate In clinical studies, propofol had no effect on the duration of action or dosing requirements for Cisatracurium besylate. Cisatracurium besylate is not compatible with propofol for Y-site administration.

— FDA label: Cisatracurium Besylate, Camber Pharmaceuticals Inc., effective April 30, 2026. This is part of the section. Read the full label on DailyMed →

Cisatracurium 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.

Store Cisatracurium besylate injection with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product (2.1) Administer intravenously only by or under the supervision of experienced clinicians familiar with drug’s actions and possible complications (2.1) Use only if personnel and facilities for resuscitation and life support, and a Cisatracurium besylate injection, USP antagonist are immediately available (2.1) Use a peripheral …

— FDA label: Cisatracurium Besylate, Camber Pharmaceuticals Inc., effective April 30, 2026. This is part of the section. Read the full label on DailyMed →

Cisatracurium 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.

Risk Summary The 10 mL Cisatracurium besylate injection multiple-dose vials contain the preservative benzyl alcohol. Therefore, if Cistracurium besylate injection is needed during pregnancy, consider using a benzyl alcohol-free formulation (i.e., 5 mL and 20 mL Cisatracurium besylate injection single-dose vials). Because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely.

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However, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs [see Contraindications (4), Warnings and Precautions (5.2), and Use in Specific Populations (8.4)] There are no available clinical trial data on cisatracurium use in pregnancy to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal studies conducted in rats administered cisatracurium besylate during organogenesis (Gestational Day 6 to 15) found no evidence of fetal harm at 0.8 times (ventilated rats) the exposure from a human starting IV bolus dose of 0.2 mg/kg (see Data). The estimated background risk for major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Labor or Delivery The action of neuromuscular blocking agents may be enhanced by magnesium salts administered for the management of preeclampsia or eclampsia of pregnancy. Data Animal Data Two embryofetal developmental reproductive toxicity studies were conducted in rats. In a non-ventilated rat study, pregnant animals were treated with cisatracurium besylate subcutaneously twice per day from Gestational Day 6 to 15 using subparalyzing doses (2 and 4 mg/kg daily; equivalent to 6- and 12-times, respectively, the AUC exposure in humans following a bolus dose of 0.2 mg/kg IV). In the ventilated rat study, pregnant animals were treated with cisatracurium besylate intravenously once a day between Gestational Day 6 to 15 using paralyzing doses (0.5 and 1 mg/kg; equivalent to 0.4- and 0.8-times, respectively, the exposure in humans following a bolus dose of 0.2 mg/kg IV based on mg/m 2 comparison). Neither of these studies revealed maternal or fetal toxicity or malformations.

— FDA label: Cisatracurium Besylate, Camber Pharmaceuticals Inc., effective April 30, 2026. Read the full label on DailyMed →

When Cisatracurium besylate should not be used

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

Cisatracurium besylate injection is contraindicated in patients with known hypersensitivity to cisatracurium. Severe anaphylactic reactions to Cisatracurium besylate injection have been reported [see Warnings and Precautions (5.4)].

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The use of 10 mL Cisatracurium besylate Injection multiple-dose vials is contraindicated for use in pediatric patients less than 1 month of age and low birth-weight infants because the formulation contains benzyl alcohol [see Warnings and Precautions (5.2) and Use in Specific Populations (8.4)] Known hypersensitivity to cisatracurium (4)

— FDA label: Cisatracurium Besylate, Camber Pharmaceuticals Inc., effective April 30, 2026. Read the full label on DailyMed →

Cisatracurium 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).

Overdosage with neuromuscular blocking agents may result in neuromuscular blockade beyond the time needed for surgery and anesthesia. The primary treatment is maintenance of a patent airway and controlled ventilation until recovery of normal neuromuscular function is assured.

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Once recovery from neuromuscular block begins, further recovery may be facilitated by administration of a cholinesterase inhibitor (e.g., neostigmine, edrophonium) in conjunction with an appropriate cholinergic inhibitor. Cholinesterase inhibitors should not be administered when complete neuromuscular blockade is evident or suspected because the reversal of paralysis may not be sufficient to maintain a patent airway and support an appropriate level of spontaneous ventilation. Neostigmine: Administration of 0.04 to 0.07 mg/kg of neostigmine at approximately 10% recovery from neuromuscular blockade (range: 0 to 15%) produced 95% recovery of the muscle twitch response and a T 4:T 1 ratio ≥ 70% in an average of 9 to 10 minutes. The times from 25% recovery of the muscle twitch response to a T 4:T 1 ratio ≥ 70% following these doses of neostigmine averaged 7 minutes. The mean 25% to 75% recovery index following reversal was 3 to 4 minutes. Edrophonium: Administration of 1 mg/kg of edrophonium at approximately 25% recovery from neuromuscular blockade (range: 16% to 30%) produced 95% recovery and a T 4:T 1 ratio ≥ 70% in an average of 3 to 5 minutes. For providers treating patients treated with cholinesterase inhibitors: Use a peripheral nerve stimulator to evaluate recovery and antagonism of neuromuscular blockade Evaluate for evidence of adequate clinical recovery (e.g., 5-second head lift and grip strength). Support ventilation until adequate spontaneous ventilation has resumed. The onset of antagonism may be delayed in the presence of debilitation, cachexia, carcinomatosis, and the concomitant use of certain broad spectrum antibiotics, or anesthetic agents and other drugs which enhance neuromuscular block or separately cause respiratory depression [see Drug Interactions (7.1)]. Under such circumstances the management is the same as that of prolonged neuromuscular block.

— FDA label: Cisatracurium Besylate, Camber Pharmaceuticals Inc., effective April 30, 2026. 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.6 products
• Sandoz Inc3 products
• Camber Pharmaceuticals, Inc.3 products
• Fresenius Kabi USA, LLC3 products
• Gland Pharma Limited3 products
• Somerset Therapeutics, LLC3 products
• Slate Run Pharmaceuticals, LLC3 products
• Hikma Pharmaceuticals USA Inc.3 products
• Caplin Steriles Limited3 products
• Hospira, Inc.3 products
• Zydus Pharmaceuticals USA Inc.2 products
• Zydus Lifesciences Limited2 products
• Eugia US LLC2 products
• Armas Pharmaceuticals1 product
• Avenacy, LLC1 product

FDA approval history

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

Generic approvals (20)

• ANDA200154Sandoz Inc · February 3, 2012
• ANDA200159Sandoz Inc · February 3, 2012
• ANDA203182Fresenius Kabi USA · February 26, 2015
• ANDA203183Fresenius Kabi USA · February 26, 2015
• ANDA203236Hospira · March 30, 2018
• ANDA203238Hospira · March 30, 2018
• ANDA206791Somerset Theraps LLC · February 20, 2019
• ANDA209132Somerset · April 24, 2019
• ANDA211668Meitheal · April 25, 2019
• ANDA211669Meitheal · April 25, 2019
• ANDA212171Zydus Pharms · November 4, 2019
• ANDA209144Eugia Pharma · May 8, 2020
• ANDA209665Eugia Pharma · October 27, 2020
• ANDA212432Piramal · March 11, 2022
• ANDA215516Gland · May 24, 2022
• ANDA203078Hikma · June 28, 2022
• ANDA203079Hikma · April 19, 2023
• ANDA217725Caplin · June 9, 2023
• ANDA216538Hainan Poly · March 8, 2024
• ANDA216539Hainan Poly · August 27, 2024

Shortage status

To be discontinued · updated September 11, 2026 · first posted September 11, 2026

Ask your pharmacist whether your product is affected and what the options are.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

1. November 26, 2025 · Class III · Ongoing · D-0236-2026

   Subpotent product:out of specification assay results observed during long term stability testing.

   Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-dose 5 mL vial NDC 700 — SOMERSET THERAPEUTICS LLC

2. November 26, 2025 · Class III · Ongoing · D-0237-2026

   Subpotent product:out of specification assay results observed during long term stability testing.

   Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single dose 20mL vial NDC 70 — SOMERSET THERAPEUTICS LLC

3. November 26, 2025 · Class III · Ongoing · D-0238-2026

   Subpotent product:out of specification assay results observed during long term stability testing.

   Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL Multiple-dose vial, — SOMERSET THERAPEUTICS LLC

4. January 27, 2021 · Class I · Terminated · D-0286-2021

   Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine Hydrochloride Injection, USP, but confirmed to contain Cisatracurium

   Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dose Vial (NDC 71288-712-05), packaged as 10 x 5 mL Single-Dose Vials per carton (NDC 71288-712-06), Rx only, Mfd. for Meitheal Pharmaceuticals, C — Meitheal Pharmaceuticals Inc

5. April 5, 2016 · Class II · Terminated · D-0819-2016

   Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.

   Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-417-10 — Fresenius Kabi USA, LLC

Official identifiers

Next steps

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Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Cisatracurium Besylate, Camber Pharmaceuticals Inc., effective April 30, 2026; 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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