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Zemuron (Rocuronium Bromide) - Side Effects and Adverse Reactions

Zemuron Rx
Summary Description and Clinical Pharmacology Indications and Dosage Warnings and Precautions Side Effects and Adverse Reactions Drug Interactions, Overdosage, Contraindications, Other Rx Info Active Ingredients Side Effect Reports
 

Zemuron News
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ADVERSE REACTIONS

In clinical trials, the most common adverse reactions (2%) are transient hypotension and hypertension.

The following adverse reactions are described, or described in greater detail, in other sections:

  • Anaphylaxis [see Warnings and Precautions]
  • Residual paralysis [see Warnings and Precautions]
  • Myopathy [see Warnings and Precautions]
  • Increased pulmonary vascular resistance [see Warnings and Precautions]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical studies in the US (n=1137) and Europe (n=1394) totaled 2531 patients. The patients exposed in the US clinical studies provide the basis for calculation of adverse reaction rates. The following adverse reactions were reported in patients administered ZEMURON (all events judged by investigators during the clinical trials to have a possible causal relationship):

Adverse reactions in greater than 1% of patients: None

Adverse reactions in less than 1% of patients (probably related or relationship unknown):

  •  Cardiovascular: arrhythmia, abnormal electrocardiogram, tachycardia
  •  Digestive: nausea, vomiting
  •  Respiratory: asthma (bronchospasm, wheezing, or rhonchi), hiccup
  •  Skin and Appendages: rash, injection site edema, pruritus

In the European studies, the most commonly reported reactions were transient hypotension (2%) and hypertension (2%); these are in greater frequency than the US studies (0.1% and 0.1%). Changes in heart rate and blood pressure were defined differently from in the US studies in which changes in cardiovascular parameters were not considered as adverse events unless judged by the investigator as unexpected, clinically significant, or thought to be histamine related.

In a clinical study in patients with clinically significant cardiovascular disease undergoing coronary artery bypass graft, hypertension and tachycardia were reported in some patients, but these occurrences were less frequent in patients receiving beta or calcium channel-blocking drugs. In some patients, ZEMURON was associated with transient increases (30% or greater) in pulmonary vascular resistance. In another clinical study of patients undergoing abdominal aortic surgery, transient increases (30% or greater) in pulmonary vascular resistance were observed in about 24% of patients receiving ZEMURON 0.6 or 0.9 mg/kg.

In pediatric patient studies worldwide (n=704), tachycardia occurred at an incidence of 5.3% (n=37) and it was judged by the investigator as related in 10 cases (1.4%).

Post-marketing Experience

In clinical practice, there have been reports of severe allergic reactions (anaphylactic and anaphylactoid reactions and shock) with ZEMURON, including some that have been life-threatening and fatal [see Warnings and Precautions].

Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency.



REPORTS OF SUSPECTED ZEMURON SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Zemuron side effects / adverse reactions in 26 year old male

Reported by a pharmacist from Canada on 2011-10-04

Patient: 26 year old male

Reactions: Prothrombin Level Abnormal, International Normalised Ratio Increased, Operative Haemorrhage

Adverse event resulted in: life threatening event

Suspect drug(s):
Midazolam HCL
    Dosage: 5mg,
    Indication: Product Used FOR Unknown Indication

Lactated Ringer's
    Indication: Product Used FOR Unknown Indication

Sodium Chloride 0.9%
    Indication: Product Used FOR Unknown Indication

Sufentanil Citrate
    Indication: Product Used FOR Unknown Indication

Propofol
    Indication: Product Used FOR Unknown Indication

Zemuron

Other drugs received by patient: Toradol


Possible Zemuron side effects / adverse reactions in 45 year old female

Reported by a pharmacist from Canada on 2011-10-04

Patient: 45 year old female

Reactions: Intra-Abdominal Haemorrhage, Prothrombin Level Abnormal, International Normalised Ratio Increased

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Propofol
    Dosage: 20ml
    Indication: Product Used FOR Unknown Indication

Lactated Ringers (Lactated Ringers)
    Indication: Product Used FOR Unknown Indication

Sodium Chloride 0.9%
    Indication: Product Used FOR Unknown Indication

Midazolam HCL
    Dosage: 1mg/ml
    Indication: Product Used FOR Unknown Indication

Heparin
    Dosage: 5000ml
    Indication: Product Used FOR Unknown Indication

Sufentanil Citrate
    Indication: Product Used FOR Unknown Indication

Zemuron
    Dosage: 50 mg
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: (Calcium Gluconate); (Flagyl /00012501/); (Ancef /00288502/); (All Other Therapeutic Products); Nexium; Voluven; (Dexamethasone); Diovan HCT; Phenylephrine HCL; Plasma


Possible Zemuron side effects / adverse reactions in 60 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-16

Patient: 60 year old male weighing 91.0 kg (200.2 pounds)

Reactions: Electrocardiogram QT Prolonged, Bundle Branch Block

Suspect drug(s):
Suprane
    Indication: General Anaesthesia
    Start date: 2011-11-10
    End date: 2011-11-10

Propofol
    Indication: Product Used FOR Unknown Indication

Fentanyl Citrate
    Indication: Product Used FOR Unknown Indication

Zemuron
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Ephedrine; Lidocaine


See index of all Zemuron side effect reports >>
Drug label data at the top of this Page last updated: 2009-05-13

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