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Banzel (Rufinamide) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Banzel (Rufinamide) 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 (12)
Death (2)

Reports by Reaction Type

Vomiting (4)Pneumonia Aspiration (3)Dehydration (3)Aphasia (2)Sudden Unexplained Death in Epilepsy (2)Blood Potassium Decreased (2)Emotional Disorder (2)Crying (2)Confusional State (1)Nausea (1)Excessive Eye Blinking (1)Dyskinesia (1)

Possible Banzel side effects in male

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

Patient: male

Reactions: Vomiting, Pneumonia Aspiration, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Banzel
    Dosage: unknown
    Administration route: Oral
    End date: 2012-01-01

Sabril
    Administration route: Oral
    Start date: 2011-10-19
    End date: 2012-06-25

Sabril
    Administration route: Oral
    Indication: Infantile Spasms
    Start date: 2011-09-02
    End date: 2011-10-18

Sabril
    Dosage: 1250 mg in am and 1000 mg in pm
    Administration route: Oral
    Start date: 2012-06-26

Other drugs received by patient: Leucovorin Calcium; Phenobarbital TAB; Vitamin B6; Keppra



Possible Banzel side effects in male

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

Patient: male

Reactions: Vomiting, Pneumonia Aspiration, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Banzel
    Dosage: unknown
    Administration route: Oral
    End date: 2012-01-01

Sabril
    Administration route: Oral
    Indication: Infantile Spasms
    Start date: 2011-09-02

Sabril
    Administration route: Oral
    Start date: 2011-10-19

Sabril
    Dosage: 1200 mg in am and 1000 mg in pm
    Administration route: Oral
    Start date: 2012-06-25

Other drugs received by patient: Leucovorin Calcium; Vitamin B6; Phenobarbital TAB; Keppra



Possible Banzel side effects in 26 year old male

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: 26 year old male, weighing 102.1 kg (224.5 pounds)

Reactions: Vomiting, Nausea, Constipation, Abdominal Pain Upper

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Banzel



Possible Banzel side effects in 13 month old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-26

Patient: 13 month old male

Reactions: Pneumonia Aspiration, Vomiting, Dehydration

Adverse event resulted in: hospitalization

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

Sabril
    Dosage: see image oral
    Administration route: Oral
    Indication: Infantile Spasms
    Start date: 2011-09-02

Sabril
    Dosage: see image oral
    Administration route: Oral
    Indication: Infantile Spasms
    Start date: 2011-10-19

Sabril
    Dosage: see image oral
    Administration route: Oral
    Indication: Infantile Spasms
    Start date: 2012-06-26

Sabril
    Dosage: see image oral
    Administration route: Oral
    Indication: Infantile Spasms
    Start date: 2012-06-26

Other drugs received by patient: Leucovorin (Folinic Acid); Keppra; Phenobarbital TAB; Vitamin B6



Possible Banzel side effects in

Reported by a physician from United States on 2012-07-06

Patient:

Reactions: Blood Potassium Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Banzel



Possible Banzel side effects in

Reported by a physician from United States on 2012-06-29

Patient:

Reactions: Blood Potassium Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Banzel



Possible Banzel side effects in 20 year old male

Reported by a individual with unspecified qualification from Canada on 2012-06-09

Patient: 20 year old male

Reactions: Confusional State, Dyskinesia, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Banzel



Possible Banzel side effects in 17 year old female

Reported by a physician from United States on 2012-06-07

Patient: 17 year old female, weighing 63.2 kg (139.0 pounds)

Reactions: Sudden Unexplained Death in Epilepsy

Adverse event resulted in: death

Drug(s) suspected as cause:
Banzel

Other drugs received by patient: Ativan; Sabril; Lamictal



Possible Banzel side effects in 17 year old female

Reported by a physician from United States on 2012-03-29

Patient: 17 year old female, weighing 63.2 kg (139.0 pounds)

Reactions: Sudden Unexplained Death in Epilepsy

Adverse event resulted in: death

Drug(s) suspected as cause:
Banzel

Other drugs received by patient: Lamictal; Ativan; Sabril



Possible Banzel side effects in 14 year old female

Reported by a physician from United States on 2012-01-25

Patient: 14 year old female, weighing 24.3 kg (53.5 pounds)

Reactions: Aphasia, Emotional Disorder, Crying

Drug(s) suspected as cause:
Banzel
    Dosage: titrated down to 200 mg twice daily
    Administration route: Oral
    Start date: 2011-08-01

Banzel
    Dosage: titrated up to 400 mg twice daily
    Administration route: Oral
    Indication: Myoclonic Epilepsy
    Start date: 2011-03-24
    End date: 2011-08-01

Other drugs received by patient: Keppra; Depakote; Topamax



Possible Banzel side effects in 14 year old female

Reported by a physician from United States on 2012-01-20

Patient: 14 year old female, weighing 24.3 kg (53.5 pounds)

Reactions: Aphasia, Emotional Disorder, Crying

Drug(s) suspected as cause:
Banzel
    Dosage: titrated up to 400 mg twice daily
    Administration route: Oral
    Indication: Myoclonic Epilepsy
    Start date: 2011-03-24
    End date: 2011-08-01

Banzel
    Dosage: titrated down to 200 mg twice daily
    Administration route: Oral
    Start date: 2011-08-01

Other drugs received by patient: Keppra; Depakote; Topamax



Possible Banzel side effects in 17 year old female

Reported by a pharmacist from United States on 2011-10-24

Patient: 17 year old female, weighing 36.6 kg (80.5 pounds)

Reactions: Excessive Eye Blinking, Chorea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Banzel
    Administration route: Oral
    Start date: 2011-08-01
    End date: 2011-08-20

Banzel
    Administration route: Oral
    Start date: 2011-08-22
    End date: 2011-08-22

Banzel
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2011-07-19
    End date: 2011-08-01

Banzel
    Administration route: Oral
    Start date: 2011-08-23

Other drugs received by patient: Keppra; Baclofen; Clonazepam

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