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Sabril (Vigabatrin) - Convulsion - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Convulsion (27)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Sabril (Vigabatrin) where reactions include convulsion. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Sabril side effects in 44 year old female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: 44 year old female

Reactions: Central Nervous System Lesion, Condition Aggravated, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sabril

Other drugs received by patient: Lorazepam; Valium; Topamax; Neurontin; Vimpat



Possible Sabril side effects in 9 month old male

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

Patient: 9 month old male

Reactions: Treatment Noncompliance, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sabril



Possible Sabril side effects in 19 month old female

Reported by a physician from United States on 2012-07-17

Patient: 19 month old female, weighing 8.5 kg (18.7 pounds)

Reactions: Weight Decreased, Inappropriate Schedule of Drug Administration, Muscle Twitching, Failure To Thrive, Upper Respiratory Tract Congestion, Convulsion, Infantile Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sabril

Other drugs received by patient: Zonisamide; Topiramate; Phenobarbital TAB



Possible Sabril side effects in 6 month old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-03

Patient: 6 month old male, weighing 6.0 kg (13.2 pounds)

Reactions: Encephalopathy, Convulsion

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Sabril
    Dosage: 10 ml millilitre(s), 2 in 1 d, oral
    Administration route: Oral
    Indication: Grand MAL Convulsion
    Start date: 2012-03-03

Sabril
    Dosage: 10 ml millilitre(s), 2 in 1 d, oral
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2012-03-03

Other drugs received by patient: Phenobarbital TAB; Topamax



Possible Sabril side effects in 44 year old female

Reported by a consumer/non-health professional from United States on 2012-07-02

Patient: 44 year old female

Reactions: Central Nervous System Lesion, Condition Aggravated, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sabril



Possible Sabril side effects in 16 month old female

Reported by a physician from United Kingdom on 2012-06-15

Patient: 16 month old female

Reactions: Coma Blister, Swelling Face, Bronchiolitis, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sabril
    Indication: Convulsion

Onfi
    Indication: Infantile Spasms

Levetiracetam
    Indication: Infantile Spasms

Clonazepam
    Indication: Convulsion



Possible Sabril side effects in 10 year old male

Reported by a consumer/non-health professional from United States on 2012-05-22

Patient: 10 year old male

Reactions: Atonic Seizures, Inappropriate Affect, Convulsion

Drug(s) suspected as cause:
Sabril

Other drugs received by patient: Phenytoin; Celontin



Possible Sabril side effects in 4 year old female

Reported by a consumer/non-health professional from United States on 2012-05-08

Patient: 4 year old female

Reactions: Night Blindness, Convulsion

Drug(s) suspected as cause:
Sabril
    Dosage: see image
    Administration route: Oral
    Indication: Infantile Spasms
    Start date: 2010-06-29
    End date: 2011-01-01

Sabril
    Dosage: see image
    Administration route: Oral
    Indication: Infantile Spasms
    Start date: 2011-11-09

Sabril
    Dosage: see image
    Administration route: Oral
    Indication: Infantile Spasms
    Start date: 2011-01-01
    End date: 2011-01-01

Sabril
    Dosage: see image
    Administration route: Oral
    Indication: Infantile Spasms
    Start date: 2011-11-09

Sabril
    Dosage: see image
    Administration route: Oral
    Indication: Infantile Spasms
    Start date: 2011-08-01

Sabril
    Dosage: see image
    Administration route: Oral
    Indication: Infantile Spasms
    Start date: 2011-10-01

Other drugs received by patient: Lamictal



Possible Sabril side effects in 3 year old female

Reported by a physician from United States on 2012-04-23

Patient: 3 year old female

Reactions: Ultrasound Scan Abnormal, Kidney Enlargement, Urinary Tract Infection, Rash, Convulsion, Hepatomegaly, Cardio-Respiratory Arrest, Blood Potassium Decreased, Infection

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Sabril



Possible Sabril side effects in 16 month old female

Reported by a pharmacist from United States on 2012-04-23

Patient: 16 month old female

Reactions: Nuclear Magnetic Resonance Imaging Brain Abnormal, Convulsion

Drug(s) suspected as cause:
Sabril



Possible Sabril side effects in 16 month old female

Reported by a consumer/non-health professional from United States on 2012-04-11

Patient: 16 month old female

Reactions: Hypothalamo-Pituitary Disorder, Convulsion

Drug(s) suspected as cause:
Sabril



Possible Sabril side effects in 16 month old female

Reported by a physician from United States on 2012-04-05

Patient: 16 month old female

Reactions: Urinary Tract Infection Bacterial, Respiratory Distress, Enterobacter Test Positive, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sabril
    Dosage: 250 mg milligram(s), am; 500 mg milligram(s), pm
    Indication: Infantile Spasms
    Start date: 2011-08-18
    End date: 2012-03-01

Sabril
    Dosage: 250 mg milligram(s), am; 500 mg milligram(s), pm
    Indication: Infantile Spasms
    Start date: 2012-03-01

Sabril
    Dosage: 250 mg milligram(s), am; 500 mg milligram(s), pm
    Indication: Infantile Spasms
    Start date: 2012-03-01



Possible Sabril side effects in 11 month old female

Reported by a pharmacist from United States on 2012-04-02

Patient: 11 month old female

Reactions: Gastrointestinal Disorder, Apnoea, Tremor, Convulsion

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Sabril

Other drugs received by patient: Prevacid (Lansoprazole) (Tablet); Keppra (Levetiracetam) (100 MG / ML); Neocate Inft POW DHA / ARA (Neocate); Bactrim (Bactrim) (Tablet)



Possible Sabril side effects in 77 year old male

Reported by a physician from United States on 2012-03-23

Patient: 77 year old male

Reactions: Subdural Haematoma, Anaemia, Fall, Convulsion

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Sabril
    Dosage: 500 mg milligram(s), 2 in 1 d, oral ; 1500 mg milligram(s), 2 in 1 d, oral
    Administration route: Oral
    Indication: Complex Partial Seizures
    Start date: 2011-12-28

Sabril
    Dosage: 500 mg milligram(s), 2 in 1 d, oral ; 1500 mg milligram(s), 2 in 1 d, oral
    Administration route: Oral
    Indication: Complex Partial Seizures
    Start date: 2011-12-12
    End date: 2011-12-27

Other drugs received by patient: Precedex; Vimpat; Xanax; Keppra



Possible Sabril side effects in 11 month old female

Reported by a pharmacist from United States on 2012-02-10

Patient: 11 month old female

Reactions: Gastrointestinal Disorder, Apnoea, Convulsion, Tremor

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Sabril

Other drugs received by patient: Bactrim (Bactrim) (Tablet); Neocate Inft POW DHA / ARA (Neocate); Prevacid (Lansoprazole) (Tablet); Keppra (Levetiracetam) (100 MG / ML)



Possible Sabril side effects in 3 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-09

Patient: 3 year old male

Reactions: Drug Ineffective, Convulsion, Infantile Spasms

Drug(s) suspected as cause:
Sabril
    Dosage: see image
    Administration route: Oral
    Indication: Infantile Spasms
    Start date: 2011-07-01
    End date: 2011-07-01

Sabril
    Dosage: see image
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2011-07-01
    End date: 2011-07-01

Sabril
    Dosage: see image
    Administration route: Oral
    Indication: Infantile Spasms
    Start date: 2010-06-01
    End date: 2011-07-01

Sabril
    Dosage: see image
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2010-06-01
    End date: 2011-07-01

Sabril
    Dosage: see image
    Administration route: Oral
    Indication: Infantile Spasms
    Start date: 2011-07-01
    End date: 2011-12-01

Sabril
    Dosage: see image
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2011-07-01
    End date: 2011-12-01

Other drugs received by patient: Klonopin



Possible Sabril side effects in 8 month old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-26

Patient: 8 month old female, weighing 6.4 kg (14.0 pounds)

Reactions: Weight Increased, Irritability, Swelling, Somnolence, Gastrooesophageal Reflux Disease, Convulsion, Crying

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sabril
    Dosage: 250 mg milligram(s), 2 in 1 d, oral; 500 mg milligram(s), 2 in 1 d), oral;
    Indication: Infantile Spasms
    Start date: 2011-11-01
    End date: 2011-11-01

Sabril
    Dosage: 250 mg milligram(s), 2 in 1 d, oral; 500 mg milligram(s), 2 in 1 d), oral;
    Indication: Infantile Spasms

Other drugs received by patient: Clonazepam; Nystatin; Multivitamin (Vigran); Omeprazole; Topiramate



Possible Sabril side effects in 2 year old female

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

Patient: 2 year old female

Reactions: Pneumonia Aspiration, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sabril



Possible Sabril side effects in 53 year old

Reported by a consumer/non-health professional from Germany on 2012-01-04

Patient: 53 year old

Reactions: Grand MAL Convulsion, Coma, Aura, Status Epilepticus, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valproat 500 Chrono
    Dosage: 500
    Start date: 2010-08-13
    End date: 2010-08-19

Valproat 500 Chrono
    Dosage: 1750
    Indication: Epilepsy
    Start date: 2010-07-14
    End date: 2010-07-15

Valproat 500 Chrono
    Dosage: 750
    Start date: 2010-08-06
    End date: 2010-08-12

Carbamazepine
    Indication: Convulsion

Vimpat
    Dosage: 400

Sabril
    Indication: Convulsion

Valproat 500 Chrono
    Dosage: 1500
    Start date: 2010-07-16
    End date: 2010-07-22

Valproat 500 Chrono
    Dosage: 1250
    Start date: 2010-07-23
    End date: 2010-07-29

Valproat 500 Chrono
    Dosage: 250
    Start date: 2010-08-20

Valproat 500 Chrono
    Dosage: 1000
    Start date: 2010-07-30
    End date: 2010-08-05

Keppra
    Dosage: 2500
    Indication: Epilepsy

Other drugs received by patient: Lamictal; Topama; Oxcarbamacepin; Neurontin; Lyrica; Zonegran; Valproate Sodium



Possible Sabril side effects in 53 year old

Reported by a consumer/non-health professional from Germany on 2012-01-03

Patient: 53 year old

Reactions: Grand MAL Convulsion, Coma, Status Epilepticus, Aura, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Keppra
    Dosage: 2500
    Indication: Epilepsy

Sabril
    Indication: Convulsion

Carbamazepine
    Indication: Convulsion

Valproate Sodium
    Dosage: 750
    Start date: 2010-08-06
    End date: 2010-08-12

Vimpat
    Dosage: 400

Valproate Sodium
    Dosage: 1500
    Start date: 2010-07-16
    End date: 2010-07-22

Valproate Sodium
    Dosage: 1000
    Start date: 2010-07-30
    End date: 2010-08-05

Valproate Sodium
    Dosage: 1250
    Start date: 2010-07-23
    End date: 2010-07-29

Valproate Sodium
    Dosage: 500
    Start date: 2010-08-13
    End date: 2010-08-19

Valproate Sodium
    Dosage: 1750
    Indication: Epilepsy
    Start date: 2010-07-14
    End date: 2010-07-15

Valproate Sodium
    Dosage: 250
    Start date: 2010-08-20

Other drugs received by patient: Lamictal; Lyrica; Zonegran; Topama; Oxcarbamacepin; Valproate Sodium; Neurontin



Possible Sabril side effects in 11 year old female

Reported by a consumer/non-health professional from United States on 2011-12-27

Patient: 11 year old female

Reactions: Convulsion

Drug(s) suspected as cause:
Sabril



Possible Sabril side effects in 22 month old female

Reported by a consumer/non-health professional from United States on 2011-12-21

Patient: 22 month old female

Reactions: Incorrect Dose Administered, Convulsion, Loss of Consciousness

Drug(s) suspected as cause:
Sabril
    Dosage: 500 mg milligram(s), 3 in 1 d, oral
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2011-12-01

Sabril
    Dosage: 500 mg milligram(s), 3 in 1 d, oral
    Administration route: Oral
    Indication: Infantile Spasms
    Start date: 2011-12-01



Possible Sabril side effects in 11 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-01

Patient: 11 year old female

Reactions: Fear, Insomnia, Abnormal Behaviour, Intentional Self-Injury, Convulsion

Drug(s) suspected as cause:
Sabril

Other drugs received by patient: Tegretol; Topamax



Possible Sabril side effects in 8 month old female

Reported by a individual with unspecified qualification from United States on 2011-11-09

Patient: 8 month old female

Reactions: Fatigue, Dehydration, Convulsion, Decreased Appetite, Lethargy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sabril

Other drugs received by patient: Phenobarbital TAB; Keppra



Possible Sabril side effects in 21 year old female

Reported by a pharmacist from United States on 2011-11-02

Patient: 21 year old female

Reactions: Weight Increased, Convulsion

Adverse event resulted in: death

Drug(s) suspected as cause:
Sabril

Other drugs received by patient: Keppra; Primidone; Lorazepam; Clonazepam



Possible Sabril side effects in 20 month old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-21

Patient: 20 month old female

Reactions: Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sabril

Other drugs received by patient: Topamax; Keppra; Zantac; Vitamin B6



Possible Sabril side effects in 19 year old female

Reported by a pharmacist from United States on 2011-10-18

Patient: 19 year old female

Reactions: Grand MAL Convulsion, Bradycardia, Fall, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sabril

Other drugs received by patient: Diamox; Vimpat

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