Keppra combined with Sabril (For Oral Solution)

Reports:


Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Death Death 3/12/2013 10 Male 9/25/2013 Physician Us
Primary
Concomitant
Viral Infection Other Serious 2/11/2013 1 Male 13 lb 4/29/2013 Physician Us
Primary
Concomitant
Viral Upper Respiratory Tract Infection Other Serious 3/21/2013 2 Male 15 lb 5/9/2013 Physician Us
Primary
Concomitant
Hydrocephalus Hospitalization 4/9/2013 1 Male 8/30/2013 Physician Us
Primary
Concomitant
Blood Sodium Decreased Hospitalization Female 5/8/2013 Other Health Professional Us
Primary
Concomitant
Death Death Female 4/17/2013 Consumer Us
Primary
Concomitant
Retinal Disorder Other Serious 2/11/2013 17 Female 4/18/2013 Consumer Us
Primary
Concomitant
Sedation Hospitalization 3/19/2013 2 Male 24 lb 4/22/2013 Physician Us
Primary
Secondary
Concomitant
Fall Hospitalization Male 4/25/2013 Consumer Us
Primary
Concomitant
Brain Lobectomy Hospitalization Male 4/25/2013 Consumer Us
Primary
Concomitant
Death Death Female 4/30/2013 Other Health Professional Us
Primary
Concomitant
Spinal Operation Hospitalization 4/20/2013 4 Female 5/24/2013 Physician Us
Primary
Concomitant
Respiratory Syncytial Virus Infection Hospitalization Male 6/4/2013 Other Health Professional Us
Primary
Concomitant
Respiratory Syncytial Virus Infection Hospitalization Male 5/9/2013 Physician Us
Primary
Concomitant
Death Death Female 5/14/2013 Other Health Professional Us
Primary
Concomitant
Hypoxia Hospitalization 5/18/2013 1 Male 271 lb 6/6/2013 Other Health Professional Us
Primary
Concomitant
Pneumonia Death 5/2013 4 Female 6/14/2013 Physician Us
Primary
Concomitant
Sudden Unexplained Death In Epilepsy Death 5/26/2013 1 Male 6/18/2013 Other Health Professional Us
Primary
Concomitant
Vomiting Hospitalization 5/22/2013 24 Male 6/14/2013 Other Health Professional Us
Primary
Concomitant
Pneumonia Hospitalization 6/4/2012 1 Male 6/19/2013 Physician Us
Primary
Concomitant
Feeding Disorder Other Serious Male 6/25/2013 Physician Us
Primary
Concomitant
Death Death Female 33 lb 9/19/2013 Physician Us
Primary
Concomitant
Malaise Hospitalization Female 6/28/2013 Consumer Us
Primary
Concomitant
Pneumonia Aspiration Hospitalization 6/26/2013 2 Female 10/21/2013 Physician Us
Primary
Concomitant
Staphylococcus Test Positive Hospitalization 5/2013 1 Female 18 lb 7/22/2013 Physician Us
Primary
Concomitant
Circumcision Hospitalization Male 7/30/2013 Physician Us
Primary
Concomitant
Weight Decreased Other Serious 2/2013 14 Female 53 lb 7/30/2013 Physician Us
Primary
Concomitant
Convulsion Hospitalization 7/2/2013 4 Female 10/29/2013 Physician Us
Primary
Concomitant
Tongue Discolouration Other Serious 1/4/2010 1 Female 8/8/2013 Physician Us
Primary
Concomitant
Early Infantile Epileptic Encephalopathy With Burst-suppression Death 4/29/2011 1 Male 11/14/2013 Physician Us
Primary
Concomitant
Fatigue Other Serious 9/14/2011 Female 8/8/2013 Consumer Us
Primary
Concomitant
Visual Field Defect Other Serious 9/20/2011 Female 8/8/2013 Other Health Professional Us
Primary
Concomitant
Irritability Other Serious Female 8/12/2013 Pharmacist Us
Primary
Concomitant
Urinary Retention Hospitalization 7/30/2013 14 Male 8/22/2013 Physician Us
Primary
Concomitant
Tonic Convulsion Death 4/16/2012 1 Female 13 lb 8/22/2013 Physician Us
Primary
Secondary
Concomitant
Tremor Other Serious 3 Male 8/12/2013 Pharmacist Us
Primary
Secondary
Concomitant
Intensive Care Hospitalization 2 Female 8/12/2013 Other Health Professional Us
Primary
Concomitant
Status Epilepticus Death 8/15/2013 63 Female 10/11/2013 Physician Us
Primary
Concomitant
Insomnia 1/13/2010 Male 19 lb 8/12/2013 Consumer Us
Primary
Concomitant
Vomiting Hospitalization 1/29/2012 Male 8/12/2013 Consumer Us
Primary
Concomitant
Hospitalisation Hospitalization 2012 Male 8/12/2013 Consumer Us
Primary
Concomitant
Convulsion Hospitalization 2012 Male 9/25/2013 Physician Us
Primary
Concomitant
Pneumonia Hospitalization 2/28/2012 Female 8/12/2013 Other Health Professional Us
Primary
Concomitant
Drug Ineffective Male 8/12/2013 Consumer Us
Primary
Concomitant
Retching 2012 Male 8/12/2013 Consumer Us
Primary
Secondary
Concomitant
Respiratory Tract Infection Viral Hospitalization 3/12/2012 Male 19 lb 8/12/2013 Other Health Professional Us
Primary
Concomitant
Tracheitis Hospitalization 2/9/2012 Male 8/12/2013 Other Health Professional Us
Primary
Concomitant
Hospitalisation Hospitalization Female 8/12/2013 Other Health Professional Us
Primary
Concomitant
Convulsion Other Serious 3/2012 Male 9/25/2013 Consumer Us
Primary
Concomitant
Hospitalisation Hospitalization Female 8/12/2013 Consumer Us
Primary
Concomitant
Hospitalisation Hospitalization Male 8/12/2013 Consumer Us
Primary
Concomitant
Incorrect Dose Administered Other Serious 4/3/2012 Male 20 lb 8/12/2013 Consumer Us
Primary
Concomitant
Convulsion Other Serious 3/13/2012 Female 8/12/2013 Other Health Professional Us
Primary
Concomitant
Convulsion Other Serious 2/1/2012 Male 8/12/2013 Consumer Us
Primary
Concomitant
Movement Disorder Hospitalization 4/2/2012 Female 8/20/2013 Consumer Us
Primary
Concomitant
Hospitalisation Hospitalization 4/2012 Male 8/12/2013 Other Health Professional Us
Primary
Concomitant
Hospitalisation Hospitalization 2012 Female 8/12/2013 Consumer Us
Primary
Concomitant
Hospitalisation Hospitalization 4/2012 Female 8/12/2013 Other Health Professional Us
Primary
Concomitant
Drug Ineffective Male 8/12/2013 Consumer Us
Primary
Concomitant
Drug Ineffective Male 8/12/2013 Physician Us
Primary
Concomitant
Pneumonia Bacterial Hospitalization Female 8/12/2013 Other Health Professional Us
Primary
Concomitant
Convulsion Other Serious Male 8/12/2013 Consumer Us
Primary
Concomitant
Drug Ineffective Male 8/12/2013 Pharmacist Us
Primary
Concomitant
Pneumonia Hospitalization Female 8/20/2013 Other Health Professional Us
Primary
Concomitant
Lung Infection Hospitalization 5/24/2012 2 Male 8/20/2013 Other Health Professional Us
Primary
Concomitant
Sedation Male 8/20/2013 Other Health Professional Us
Primary
Concomitant
Pneumonia Hospitalization Female 9/25/2013 Consumer Us
Primary
Concomitant
Convulsion Other Serious Male 8/20/2013 Consumer Us
Primary
Concomitant
Hospitalisation Hospitalization Female 8/20/2013 Pharmacist Us
Primary
Concomitant
Irritability Other Serious Female 8/20/2013 Consumer Us
Primary
Concomitant
Infantile Spasms Other Serious 7/2012 3 Female 8/20/2013 Consumer Us
Primary
Concomitant
Convulsion Other Serious Male 8/20/2013 Consumer Us
Primary
Concomitant
Hospitalisation Hospitalization Female 8/20/2013 Other Health Professional Us
Primary
Concomitant
Convulsion Hospitalization Male 8/20/2013 Consumer Us
Primary
Concomitant
Weight Increased Other Serious 6/14/2012 0 Female 18 lb 8/20/2013 Physician Us
Primary
Secondary
Concomitant
Convulsion Hospitalization Female 8/20/2013 Physician Us
Primary
Concomitant
Convulsion Other Serious Male 8/20/2013 Consumer Us
Primary
Concomitant
Visual Acuity Reduced Other Serious Female 8/20/2013 Consumer Us
Primary
Concomitant
Acute Respiratory Failure Hospitalization Female 8/20/2013 Other Health Professional Us
Primary
Concomitant
Convulsion Other Serious 7/2012 22 Female 8/20/2013 Consumer Us
Primary
Concomitant
Hospitalisation Hospitalization Female 8/20/2013 Consumer Us
Primary
Concomitant
Drug Ineffective Male 8/20/2013 Other Health Professional Us
Primary
Concomitant
Hospitalisation Hospitalization Female 8/20/2013 Other Health Professional Us
Primary
Concomitant
Drug Ineffective Hospitalization 7/8/2012 1 Female 8/20/2013 Other Health Professional Us
Primary
Concomitant
Sepsis Hospitalization 6/2013 2 Male 9/6/2013 Physician Us
Primary
Concomitant
Cataract Other Serious 2/21/2013 6 Male 11/26/2013 Physician Us
Primary
Concomitant
Upper Respiratory Tract Infection Other Serious 6/22/2013 6 Male 37 lb 9/17/2013 Physician Us
Primary
Concomitant
Lung Disorder Hospitalization Female 9/19/2013 Consumer Us
Primary
Concomitant
Respiratory Distress Hospitalization 12/13/2012 1 Male 9/19/2013 Consumer Us
Primary
Concomitant
Death Death 7/18/2013 2 Male 10/18/2013 Physician Us
Primary
Concomitant
Status Epilepticus Other Serious 7/29/2012 6 Male 71 lb 9/26/2013 Physician Us
Primary
Concomitant
Death Death Female 9/27/2013 Consumer Us
Primary
Concomitant
Status Epilepticus Hospitalization 7/12/2013 36 Female 9/25/2013 Other Health Professional Us
Primary
Concomitant
Sleep Apnoea Syndrome Other Serious Female 9/27/2013 Consumer Us
Primary
Concomitant
Death Death 9/26/2013 1 Female 10/15/2013 Physician Us
Primary
Concomitant
Nuclear Magnetic Resonance Imaging Abnormal Other Serious 2/2012 1 Female 10/9/2013 Physician Us
Primary
Concomitant
Upper Respiratory Tract Infection Other Serious 6/2012 0 Female 9/25/2013 Other Health Professional Us
Primary
Concomitant
Convulsion Other Serious Female 9/25/2013 Other Health Professional Us
Primary
Concomitant
Convulsion Other Serious 8/17/2012 2 Female 9/25/2013 Consumer Us
Primary
Concomitant
Convulsion Hospitalization 9/11/2012 1 Female 9/25/2013 Consumer Us
Primary
Concomitant
Upper Respiratory Tract Infection Hospitalization 9/26/2012 2 Male 9/25/2013 Consumer Us
Primary
Concomitant
Drug Ineffective Male 9/25/2013 Consumer Us
Primary
Concomitant
Listless Other Serious 10/2012 1 Female 9/25/2013 Consumer Us
Primary
Secondary
Drug Ineffective Male 9/25/2013 Physician Us
Primary
Concomitant
Convulsion Other Serious Male 9/25/2013 Consumer Us
Primary
Concomitant
Drug Ineffective Female 9/25/2013 Consumer Us
Primary
Concomitant
Infantile Spasms Other Serious 11/15/2012 1 Male 9/25/2013 Consumer Us
Primary
Concomitant
Drug Ineffective Male 9/25/2013 Consumer Us
Primary
Concomitant
Pneumonia Hospitalization 10/18/2012 2 Female 9/25/2013 Physician Us
Primary
Concomitant
Nasopharyngitis Male 9/25/2013 Pharmacist Us
Primary
Concomitant
Insomnia Female 9/25/2013 Other Health Professional Us
Primary
Concomitant
Convulsion Other Serious Male 9/25/2013 Consumer Us
Primary
Concomitant
Infantile Spasms Hospitalization Female 9/25/2013 Other Health Professional Us
Primary
Concomitant
Somnolence Female 9/25/2013 Consumer Us
Primary
Concomitant
Nasopharyngitis Male 9/25/2013 Consumer Us
Primary
Concomitant
Convulsion Other Serious Male 9/25/2013 Other Health Professional Us
Primary
Concomitant
Drug Dose Omission Other Serious Male 9/25/2013 Other Health Professional Us
Primary
Concomitant
Pneumonia Hospitalization 1/9/2013 1 Female 9/25/2013 Physician Us
Primary
Concomitant
Influenza Hospitalization Female 9/25/2013 Physician Us
Primary
Concomitant
Convulsion Hospitalization Male 9/25/2013 Physician Us
Primary
Concomitant
Psychomotor Hyperactivity Male 9/25/2013 Consumer Us
Primary
Concomitant
Weight Increased Other Serious Male 9/25/2013 Other Health Professional Us
Primary
Concomitant
Convulsion Other Serious 2/2011 2 Male 9/25/2013 Other Health Professional Us
Primary
Concomitant
Pneumonia Hospitalization 2/11/2013 1 Female 9/25/2013 Other Health Professional Us
Primary
Concomitant
Convulsion Hospitalization 2/11/2013 0 Female 9/25/2013 Consumer Us
Primary
Concomitant
Pneumonia Other Serious 3/2013 1 Female 9/25/2013 Consumer Us
Primary
Concomitant
Rash Hospitalization 3/4/2013 5 Female 9/25/2013 Other Health Professional Us
Primary
Concomitant
Muscle Spasms Hospitalization 2/1/2013 4 Female 9/25/2013 Other Health Professional Us
Primary
Concomitant
Drug Ineffective Male 9/25/2013 Consumer Us
Primary
Concomitant
Drug Ineffective Male 9/25/2013 Consumer Us
Primary
Concomitant
Pyrexia Hospitalization Male 18 lb 9/25/2013 Physician Us
Primary
Concomitant
Pyrexia 3/2013 5 Male 9/25/2013 Consumer Us
Primary
Concomitant
Convulsion Hospitalization 4/1/2013 1 Male 9/25/2013 Other Health Professional Us
Primary
Concomitant
Muscle Twitching Male 9/25/2013 Physician Us
Primary
Concomitant
Convulsion Other Serious Male 9/25/2013 Physician Us
Primary
Concomitant
Nuclear Magnetic Resonance Imaging Brain Abnormal Other Serious 12/2012 1 Female 9/25/2013 Physician Us
Primary
Concomitant
Convulsion Hospitalization 2/11/2013 4 Male 9/25/2013 Consumer Us
Primary
Concomitant
Drug Ineffective Male 9/25/2013 Consumer Us
Primary
Concomitant
Convulsion Other Serious 3/25/2013 3 Female 9/25/2013 Consumer Us
Primary
Concomitant
Visual Field Defect Other Serious Female 9/25/2013 Consumer Us
Primary
Concomitant
Irritability Female 9/25/2013 Other Health Professional Us
Primary
Concomitant
Convulsion Other Serious Male 9/25/2013 Other Health Professional Us
Primary
Secondary
Concomitant
Muscle Twitching Female 9/25/2013 Physician Us
Primary
Concomitant
Drug Ineffective Hospitalization 5/7/2013 1 Male 9/25/2013 Other Health Professional Us
Primary
Concomitant
Drug Dose Omission Male 9/25/2013 Consumer Us
Primary
Concomitant
Convulsion Other Serious Female 9/25/2013 Physician Us
Primary
Concomitant
Pneumonia Hospitalization 5/9/2013 4 Female 9/25/2013 Consumer Us
Primary
Concomitant
Convulsion Hospitalization 5/16/2013 1 Male 9/25/2013 Other Health Professional Us
Primary
Concomitant
Convulsion Other Serious Male 9/25/2013 Pharmacist Country Not Specified
Primary
Concomitant
Abnormal Behaviour Hospitalization 5/3/2013 3 Male 9/25/2013 Other Health Professional Us
Primary
Concomitant