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Zemuron (Rocuronium) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Zemuron (Rocuronium) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (5)
Life Threatening Events (2)

Reports by Reaction Type

Prothrombin Level Abnormal (2)International Normalised Ratio Increased (2)Hyperthermia Malignant (2)Electrocardiogram QT Prolonged (1)Intra-Abdominal Haemorrhage (1)Bundle Branch Block (1)Operative Haemorrhage (1)

Possible Zemuron side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-09

Patient:

Reactions: Hyperthermia Malignant

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zemuron
    Dosage: 8 microgram per kilogram per minute
    Indication: Respiration Abnormal

Zemuron
    Dosage: 50 mg, 2 bolus dose

Other drugs received by patient: Desflurane; Atropine; Meropenem; Amiodarone HCL; Amiodarone HCL; Insulin; Meropenem; Epinephrine; Tigecycline; Norepinephrine; Lorazepam; Albuterol Sulfate; Sodium Chloride; Fentanyl; Pantoprazole; Meropenem; Acetylcysteine; Vasopressin



Possible Zemuron side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-20

Patient:

Reactions: Hyperthermia Malignant

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zemuron

Other drugs received by patient: Insulin; Vancomycin; Epinephrine; Propofol; Propofol; Famotidine; Acetaminophen; Propofol; Piperacillin and Tazobactam; Lorazepam; Fentanyl; Methylprednisolone; Enoxaparin Sodium; Atropine; Indomethacin; Fluconazole; Diltiazem HCL



Possible Zemuron side effects 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

Drug(s) suspected as cause:
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



Possible Zemuron side effects 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

Drug(s) suspected as cause:
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 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

Drug(s) suspected as cause:
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

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