Nimbex Side Effects

Please note - some side effects for Nimbex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Nimbex - for the Consumer

Nimbex

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with the proper use of Nimbex . If you notice any unusual effects, contact your doctor or pharmacist. Seek medical attention right away if any of these SEVERE side effects occur when using Nimbex:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; flushing; itching; muscle weakness; rash; slow or irregular heartbeat; tightening of the airway.

Nimbex Side Effects - for the Professional

Nimbex

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:

None.

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.

Histamine release, hypersensitivity reactions including anaphylactic or anaphylactoid responses which, in rare instances, were severe. 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.

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

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