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Sevoflurane (Sevoflurane) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Sevoflurane 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 (419)
Death (31)
Life Threatening Events (71)
Disability (9)

Reports by Reaction Type

Hyperthermia (135)Vomiting (73)Nausea (73)Electrocardiogram QT Prolonged (40)Foetal Exposure During Pregnancy (22)Hyperthermia Malignant (22)Stress Cardiomyopathy (20)Cardiac Arrest (20)Congenital Anomaly (18)Ventricular Fibrillation (18)Pulmonary Oedema (14)Torsade DE Pointes (14)

Below are a few examples of reports where side effects / adverse reactions may be related to Sevoflurane. For a complete list or a specific selection of reports, please use the links above.

Possible Sevoflurane side effects in male

Reported by a physician from France on 2012-08-20

Patient: male

Reactions: Anaphylactic Shock

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Augmentin '500'
    Start date: 2012-07-02
    End date: 2012-07-02

Diprivan
    Indication: General Anaesthesia
    Start date: 2012-07-02
    End date: 2012-07-02

Sevoflurane
    Indication: General Anaesthesia
    Start date: 2012-07-02
    End date: 2012-07-02

Sufentanyl Mylan
    Indication: General Anaesthesia
    Start date: 2012-07-02
    End date: 2012-07-02

Tracrium
    Indication: General Anaesthesia
    Start date: 2012-07-02
    End date: 2012-07-02



Possible Sevoflurane side effects in 67 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-20

Patient: 67 year old female, weighing 47.0 kg (103.4 pounds)

Reactions: Posterior Reversible Encephalopathy Syndrome

Drug(s) suspected as cause:
Fentanyl
    Dosage: intermittent doses for maintenance

Fentanyl
    Indication: General Anaesthesia

Ketamine HCL
    Dosage: induction
    Indication: General Anaesthesia

Ketamine HCL
    Dosage: during anesthesia

Propofol

Propofol

Propofol

Propofol

Propofol
    Indication: General Anaesthesia

Sevoflurane
    Dosage: 1.3%
    Indication: General Anaesthesia

Ultiva
    Dosage: continuous infusion of 0.15 mcg/kg/h
    Indication: General Anaesthesia

Other drugs received by patient: Warfarin Sodium; Sugammadex; Benidipine; Cipralan; Heparin; Rocuronium Bromide; Warfarin Sodium



Possible Sevoflurane side effects in male

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-14

Patient: male

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Sevoflurane



Possible Sevoflurane side effects in female

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-14

Patient: female

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Sevoflurane



Possible Sevoflurane side effects in 67 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-14

Patient: 67 year old female, weighing 47.0 kg (103.4 pounds)

Reactions: Posterior Reversible Encephalopathy Syndrome

Drug(s) suspected as cause:
Fentanyl
    Dosage: 0.1 mg, unk
    Indication: Induction of Anaesthesia

Fentanyl
    Dosage: 0.2 mg, intermittent

Ketalar
    Dosage: 50 mg, unk
    Indication: Induction of Anaesthesia

Ketalar
    Dosage: 40 mg, unk

Propofol
    Dosage: 50 mg, unk
    Indication: Induction of Anaesthesia

Remifentanil
    Indication: General Anaesthesia

Sevoflurane
    Dosage: 0.15 ?g/kg, hr
    Indication: General Anaesthesia

Other drugs received by patient: Benidipine; Rocuronium Bromide; Cipralan; Warfarin Sodium; Sugammadex; Heparin



Possible Sevoflurane side effects in female

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-14

Patient: female

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Sevoflurane



Possible Sevoflurane side effects in female

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-14

Patient: female

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Sevoflurane



Possible Sevoflurane side effects in male

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-14

Patient: male

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Sevoflurane



Possible Sevoflurane side effects in female

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-14

Patient: female

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Sevoflurane



Possible Sevoflurane side effects in 46 year old female

Reported by a physician from France on 2012-08-14

Patient: 46 year old female

Reactions: Myelitis, Central Nervous System Lesion, Occupational Exposure To Toxic Agent, Whipple's Disease, Cerebrovascular Accident, Paraesthesia, Neurotoxicity, Multiple Sclerosis

Drug(s) suspected as cause:
Nitrous Oxide
    Indication: Product Used FOR Unknown Indication

Sevoflurane
    Indication: Product Used FOR Unknown Indication



Possible Sevoflurane side effects in female

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-14

Patient: female

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Sevoflurane



Possible Sevoflurane side effects in male

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-14

Patient: male

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Sevoflurane



Possible Sevoflurane side effects in male

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-14

Patient: male

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Sevoflurane



Possible Sevoflurane side effects in female

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-14

Patient: female

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Sevoflurane



Possible Sevoflurane side effects in female

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-14

Patient: female

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Sevoflurane



Possible Sevoflurane side effects in male

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-14

Patient: male

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Sevoflurane



Possible Sevoflurane side effects in male

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-14

Patient: male

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Sevoflurane



Possible Sevoflurane side effects in male

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-14

Patient: male

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Sevoflurane



Possible Sevoflurane side effects in male

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-14

Patient: male

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Sevoflurane



Possible Sevoflurane side effects in male

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-14

Patient: male

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Sevoflurane



Possible Sevoflurane side effects in 7 year old female

Reported by a physician from Chile on 2012-08-13

Patient: 7 year old female

Reactions: Hypoxic-Ischaemic Encephalopathy, Bronchospasm, Hypoxia

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Sevoflurane



Possible Sevoflurane side effects in 60 year old female

Reported by a physician from Japan on 2012-08-09

Patient: 60 year old female, weighing 47.0 kg (103.4 pounds)

Reactions: Posterior Reversible Encephalopathy Syndrome

Drug(s) suspected as cause:
Diprivan
    Indication: Induction of Anaesthesia

Fentanyl
    Indication: General Anaesthesia

Fentanyl
    Dosage: dose unknown

Ketamine HCL
    Indication: General Anaesthesia

Ketamine HCL

Remifentanil Hydrochloride
    Dosage: dose unknown

Sevoflurane
    Dosage: dose unknown

Other drugs received by patient: Rocuronium Bromide



Possible Sevoflurane side effects in 18 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-07

Patient: 18 year old male

Reactions: Bloody Discharge, Puncture Site Haemorrhage, Haemorrhage, Coagulopathy, Hyperthermia Malignant, Ventricular Arrhythmia, Organ Failure, Cardiac Failure, NO Therapeutic Response, Pulmonary Oedema, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Dantrolene Sodium
    Dosage: 2.5 mg/kg, initial dose
    Indication: Hyperthermia Malignant

Sevoflurane
    Dosage: gas anesthetic
    Indication: Anaesthesia

Succinylcholine Chloride



Possible Sevoflurane side effects in male

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-03

Patient: male

Reactions: Hepatitis Acute

Drug(s) suspected as cause:
Alfentanil
    Indication: Product Used FOR Unknown Indication

Amoxicillin Trihydrate
    Indication: Product Used FOR Unknown Indication

Dexamethasone
    Indication: Product Used FOR Unknown Indication

Granisetron
    Indication: Product Used FOR Unknown Indication

Hartmann's Solution
    Indication: Product Used FOR Unknown Indication

Metoclopramide Hydrochloride
    Indication: Product Used FOR Unknown Indication

Midazolam Hydrochloride
    Indication: Product Used FOR Unknown Indication

Propofol
    Indication: Product Used FOR Unknown Indication

Sevoflurane
    Indication: Product Used FOR Unknown Indication



Possible Sevoflurane side effects in 17 year old female

Reported by a physician from United States on 2012-08-03

Patient: 17 year old female, weighing 49.0 kg (107.8 pounds)

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Sevoflurane

Other drugs received by patient: Propofol; Fentanyl Citrate; Nitrous Oxide; Midazolam; Labetalol HCL; Bupivacaine HCL; Neostigmine Methylsulfate; Lidocaine; Rocuronium Bromide



Possible Sevoflurane side effects in 70 year old female

Reported by a physician from Japan on 2012-08-02

Patient: 70 year old female, weighing 50.0 kg (110.0 pounds)

Reactions: Electrocardiogram QT Prolonged, Torsade DE Pointes, Drug Ineffective

Drug(s) suspected as cause:
Isoflurane
    Dosage: 1.0-1.5%
    Indication: Anaesthesia

Lidocaine
    Indication: Ventricular Extrasystoles

Sevoflurane
    Indication: Anaesthesia

Other drugs received by patient: Hydroxyzine; Propofol; Nitrous Oxide; Oxygen; Atropine; Vecuronium Bromide; Levodopa



Possible Sevoflurane side effects in

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-01

Patient:

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Sevoflurane



Possible Sevoflurane side effects in

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-01

Patient:

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Sevoflurane



Possible Sevoflurane side effects in

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-01

Patient:

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Sevoflurane



Possible Sevoflurane side effects in

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-01

Patient:

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Sevoflurane

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