Prescription medicine
Cisatracurium First approved as Nimbex
Cisatracurium (Nimbex) is a prescription medicine with an FDA approval on record since 1995. FDA's NDC Directory lists it from 15 generic labelers.
- Generic listed
- A presentation discontinued
Check it at the source: the cisatracurium FDA label on DailyMed (effective April 4, 2025, Gland Pharma Limited); the NDA 20551 record on Drugs@FDA; every cisatracurium label on DailyMed.
Highlights of the record
FDA label of April 4, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageCisatracurium 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 old
Forms and strengths
- 2 mg/ml
- 10 mg/ml
- 10 mg/5ml
- 20 mg/10ml
- 200 mg/20ml
Injection; injection (solution).
On the market
- Earliest approval on file
- December 15, 1995 Nimbex Preservative Free, Abbvie; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 27 first February 3, 2012; 19 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 15 of which 15 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 3 past records
- Recalls by its makers (FDA)
- 5 since 2016 1 Class I among all firms' recalls; latest November 26, 2025
- FAERS reports
- 2,195 through July 30, 2026
What is cisatracurium used for?
From the label: indications and usageCisatracurium 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 Limitations of Use Cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action. […]
FDA pharmacologic class: Nondepolarizing Neuromuscular Blocker.
Source: FDA drug label (Cisatracurium besylate), Gland Pharma Limited, effective April 4, 2025 (SPL set 0bacc37a-5e7f-4f05-9206-56fc8041c1ad), via openFDA; the full label on DailyMed
Is there a generic for cisatracurium (Nimbex)?
The FDA approved the first generic cisatracurium on February 3, 2012. 27 generic applications are approved; 19 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists cisatracurium from 15 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1995 earliest approval on file
- 2012 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is cisatracurium in shortage?
No cisatracurium presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 3 records are all marked to be discontinued, the latest updated September 11, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Cisatracurium Besylate, Injection, 10 mg/5ml (2 mg/mL) Single Dose Vial (NDC 0409-1098-02) | Hospira, Inc., a Pfizer Company | To Be Discontinued | September 11, 2026 |
| Cisatracurium Besylate, Injection, 20 mg/10 mL (2 mg/mL) Multidose Vial (NDC 0409-1208-01) | Hospira, Inc., a Pfizer Company | To Be Discontinued | May 6, 2026 |
| Cisatracurium Besylate, Injection, 200 mg/20ml (10 mg/mL) Single Dose Vial (NDC 0409-1103-01) | Hospira, Inc., a Pfizer Company | To Be Discontinued | May 6, 2026 |
Every cisatracurium presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has cisatracurium been recalled?
The FDA's Enforcement Report lists 5 recalls naming cisatracurium since 2016: 1 Class I (the most serious), 1 Class II, 3 Class III; 3 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| November 26, 2025 | Class III | SOMERSET THERAPEUTICS LLC | Subpotent product:out of specification assay results observed during long term stability testing. |
| January 27, 2021 | Class I | Meitheal Pharmaceuticals Inc | Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine Hydrochloride Injection … |
| April 5, 2016 | Class II | Fresenius Kabi USA, LLC | Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the cisatracurium label say about other medicines?
The cisatracurium label names 12 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name cisatracurium. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Bacitracin | drug interactions | … adjustments need to be made to the dose with subsequent administration. † Examples: aminoglycosides, tetracyclines, bacitracin, polymyxins, lincomycin, clindamycin, colistin, sodium colistimethate |
| Carbamazepine | drug interactions | Use peripheral nerve stimulator and monitor clinical signs of neuromuscular blockade. (5.8, 7.1) Phenytoin and Carbamazepine: |
| Clindamycin | drug interactions | … subsequent administration. † Examples: aminoglycosides, tetracyclines, bacitracin, polymyxins, lincomycin, clindamycin, colistin, sodium colistimethate |
| Colistimethate | drug interactions | … Examples: aminoglycosides, tetracyclines, bacitracin, polymyxins, lincomycin, clindamycin, colistin, sodium colistimethate |
| Lincomycin | drug interactions | … the dose with subsequent administration. † Examples: aminoglycosides, tetracyclines, bacitracin, polymyxins, lincomycin, clindamycin, colistin, sodium colistimethate |
| Lithium | drug interactions | DRUG INTERACTIONS Succinylcholine: May decrease time to onset of maximum neuromuscular blockade. (7.1) I nhalational anesthetics, antibiotics, local anesthetics, magnesium salts, procainamide, lithium, quinidine: |
| Nitrous oxide | drug interactions | Inhalational Anesthetics Administration of inhalational anesthetics with nitrous oxide/oxygen for greater than 30 minutes to achieve |
| Phenytoin | drug interactions | Use peripheral nerve stimulator and monitor clinical signs of neuromuscular blockade. (5.8, 7.1) Phenytoin and Carbamazepine: |
| Procainamide | drug interactions | DRUG INTERACTIONS Succinylcholine: May decrease time to onset of maximum neuromuscular blockade. (7.1) I nhalational anesthetics, antibiotics, local anesthetics, magnesium salts, procainamide, lithium, quinidine: |
| Propofol | drug interactions | In clinical studies, propofol had no effect on the duration of action or dosing requirements for cisatracurium besylate injection. |
| Quinidine | drug interactions | DRUG INTERACTIONS Succinylcholine: May decrease time to onset of maximum neuromuscular blockade. (7.1) I nhalational anesthetics, antibiotics, local anesthetics, magnesium salts, procainamide, lithium, quinidine: |
| Succinylcholine | drug interactions | DRUG INTERACTIONS Succinylcholine: May decrease time to onset of maximum neuromuscular blockade. (7.1) I nhalational anesthetics, antibiotics, local anesthetics, magnesium salts, procainamide, lithium, quinidine: |
Source: FDA drug label (Cisatracurium besylate), Gland Pharma Limited, effective April 4, 2025 (SPL set 0bacc37a-5e7f-4f05-9206-56fc8041c1ad), via openFDA; the full label on DailyMed
What do FAERS reports show for cisatracurium?
The FDA Adverse Event Reporting System holds 2,195 reports that list cisatracurium among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 369 are coded as a death and 901 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other nondepolarizing neuromuscular blockers
- the pharmacologic class, with prices and generics
- Cisatracurium side effects
- the label's list beside FAERS reports
- Cisatracurium shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other