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Nimbex (Cisatracurium Besylate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Observed in Clinical Trials of Surgical Patients

Adverse experiences were uncommon among the 945 surgical patients who received NIMBEX in conjunction with other drugs in US and European clinical studies in the course of a wide variety of procedures in patients receiving opioid, propofol, or inhalation anesthesia. The following adverse experiences were judged by investigators during the clinical trials to have a possible causal relationship to administration of NIMBEX:

Incidence Greater than 1%

None.

Incidence Less than 1%

Cardiovascular

bradycardia (0.4%)
hypotension (0.2%)
flushing (0.2%).

Respiratory

bronchospasm (0.2%).

Dermatological

rash (0.1%).

Observed in Clinical Trials of Intensive Care Unit Patients

Adverse experiences were uncommon among the 68 ICU patients who received NIMBEX in conjunction with other drugs in US and European clinical studies. 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 (167 and 270 minutes) among 28 patients administered NIMBEX and 13 reports of prolonged recovery (range: 90 minutes to 33 hours) among 30 patients administered vecuronium.

Observed During Clinical Practice

In addition to adverse events reported from clinical trials, 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.

General

Histamine release, hypersensitivity reactions including anaphylactic or anaphylactoid reactions which in some cases have been life threatening and fatal. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency (see WARNINGS and PRECAUTIONS). There are rare reports of wheezing, laryngospasm, bronchospasm, rash and itching following administration of NIMBEX in children. These reported adverse events were not serious and their etiology could not be established with certainty.

Musculoskeletal

Prolonged neuromuscular block, inadequate neuromuscular block, muscle weakness, and myopathy.



REPORTS OF SUSPECTED NIMBEX SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Nimbex. The information is not vetted and should not be considered as verified clinical evidence.

Possible Nimbex side effects / adverse reactions in female

Reported by a physician from France on 2011-10-07

Patient: female

Reactions: Bronchospasm, Anaphylactic Shock, Hypocapnia

Adverse event resulted in: life threatening event

Suspect drug(s):
Celocurine
    Dosage: 100 mg
    Start date: 2011-06-16
    End date: 2011-06-16

Sufentanil Citrate
    Dosage: 100 ug
    Start date: 2011-06-16
    End date: 2011-06-16

Nimbex
    Dosage: 10 mg
    Start date: 2011-06-16
    End date: 2011-06-16

Diprivan
    Dosage: 100 mg and then 200 mg
    Start date: 2011-06-16
    End date: 2011-06-16



Possible Nimbex side effects / adverse reactions in male

Reported by a physician from France on 2011-10-24

Patient: male

Reactions: Cardio-Respiratory Arrest, Hypotension, Anaphylactic Shock

Adverse event resulted in: death, life threatening event

Suspect drug(s):
Sufenta Preservative Free
    Indication: Anaesthesia
    Start date: 2010-09-27
    End date: 2010-09-27

Nimbex
    Indication: Anaesthesia
    Start date: 2010-09-27
    End date: 2010-09-27

Nimbex
    Dosage: once/single administration
    Start date: 2010-11-16
    End date: 2010-11-16

Sufenta Preservative Free
    Dosage: once/single administration
    Start date: 2010-11-16
    End date: 2010-11-16

Ephedrine Aguettant
    Indication: Resuscitation
    Start date: 2010-09-27
    End date: 2010-09-27

Diprivan
    Indication: Anaesthesia
    Start date: 2010-09-27
    End date: 2010-09-27

Diprivan
    Dosage: once/single administration
    Start date: 2010-11-16
    End date: 2010-11-16

Phenylephrine HCL
    Indication: Resuscitation
    Start date: 2010-09-27
    End date: 2010-09-27

Other drugs received by patient: Etomidate; Atropine; Adrenalin IN OIL INJ



Possible Nimbex side effects / adverse reactions in 55 year old male

Reported by a physician from France on 2011-11-02

Patient: 55 year old male

Reactions: Unwanted Awareness During Anaesthesia, Drug Ineffective

Suspect drug(s):
Suprane
    Indication: Maintenance of Anaesthesia
    Start date: 2011-10-25
    End date: 2011-10-25

Nimbex
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-25
    End date: 2011-10-25

Midazolam
    Indication: Induction of Anaesthesia
    Start date: 2011-10-25
    End date: 2011-10-25

Sufenta Preservative Free
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-25
    End date: 2011-10-25

Diprivan
    Indication: Induction of Anaesthesia
    Start date: 2011-10-25
    End date: 2011-10-25



See index of all Nimbex side effect reports >>

Drug label data at the top of this Page last updated: 2013-08-20

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