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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