Levetiracetam combined with Valproate Sodium

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Partial Seizures Other Serious 10/15/2005 36 Female 129 lb 1/4/2006 Physician Mexico
Primary
Concomitant
Foetal Valproate Syndrome Congenital Anomaly 0 2/9/2006 France
Primary
Secondary
Neutropenic Sepsis Life Threatening 1/10/2006 55 Female 2/10/2006 France
Primary
Secondary
Concomitant
Spina Bifida Congenital Anomaly NotSpecified 6 lb 2/3/2006 United Kingdom
Primary
Secondary
Migraine Other Serious 4/14/2006 42 Male 295 lb 7/25/2006 Consumer United States
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 36 Male 10/13/2006 France
Primary
Concomitant
Interacting
White Blood Cell Count Decreased Other Serious 36 Male 11/3/2006 France
Primary
Concomitant
Interacting
White Blood Cell Count Decreased Other Serious 36 Male 11/13/2006 France
Primary
Concomitant
Interacting
White Blood Cell Count Decreased Other Serious 36 Male 11/13/2006 France
Primary
Concomitant
Interacting
Thrombocytopenia Other Serious 9/15/2006 63 Female 112 lb 11/8/2006 United Kingdom
Primary
Concomitant
Spina Bifida Congenital Anomaly Female 6 lb 1/22/2007 United Kingdom
Primary
Secondary
Spina Bifida Congenital Anomaly Female 6 lb 3/9/2007 Consumer United Kingdom
Primary
Secondary
Nystagmus Hospitalization 2/25/2007 51 Female 120 lb 3/20/2007 Physician Taiwan, Province Of China
Primary
Concomitant
Weight Decreased Hospitalization 12/1/2006 45 Male 3/13/2007 Physician United Kingdom
Primary
Concomitant
No Therapeutic Response Other Serious 7/1/2006 19 Male 3/21/2007 Physician United Kingdom
Primary
Secondary
Mental Disorder Other Serious 3/24/2006 48 Female 128 lb 3/30/2007 France
Primary
Concomitant
Interacting
Dyskinesia Other Serious 3/1/2007 22 Female 5/16/2007 Other Health Professional United Kingdom
Primary
Concomitant
Leukopenia Hospitalization 3/1/2007 16 Female 115 lb 5/24/2007 Physician Czech Republic
Primary
Concomitant
Vomiting Hospitalization 1/20/2007 18 Female 155 lb 6/4/2007 United Kingdom
Primary
Concomitant
Therapeutic Agent Toxicity Hospitalization 4/18/2004 31 Female 7/9/2007 United States
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 2/1/2007 45 Male 377 lb 8/17/2007 Physician United Kingdom
Primary
Concomitant
Electroencephalogram Abnormal Other Serious 23 Female 9/6/2007 Belgium
Primary
Concomitant
Interacting
Electroencephalogram Abnormal Other Serious 41 Female 9/6/2007 Belgium
Primary
Concomitant
Interacting
Electroencephalogram Abnormal Other Serious 74 Male 9/6/2007 Belgium
Primary
Concomitant
Interacting
Electroencephalogram Abnormal Other Serious 43 Male 9/6/2007 Belgium
Primary
Concomitant
Interacting
Drug Ineffective Life Threatening 46 Male 10/2/2007 Physician Czech Republic
Primary
Concomitant
Tic Disability 2/1/2007 7 Female 59 lb 10/5/2007 United Kingdom
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 2/1/2007 45 Male 377 lb 11/1/2007 Other Health Professional United Kingdom
Primary
Concomitant
Erythema Multiforme Disability 6/27/2007 78 Female 104 lb 11/26/2007 Other Health Professional Switzerland
Primary
Secondary
Concomitant
Erythema Multiforme Disability 6/27/2007 78 Female 104 lb 11/23/2007 Other Health Professional Switzerland
Primary
Secondary
Concomitant
Foetal Anticonvulsant Syndrome Congenital Anomaly Male 7 lb 12/7/2007 Other Health Professional France
Primary
Secondary
Injection Site Pruritus 9/17/2007 Male 208 lb 12/14/2007 United States
Primary
Concomitant
Interstitial Lung Disease Hospitalization 4/19/2007 54 Female 12/18/2007 Physician Germany
Primary
Concomitant
Foetal Anticonvulsant Syndrome Congenital Anomaly Male 7 lb 12/28/2007 Other Health Professional France
Primary
Secondary
Spina Bifida Congenital Anomaly Female 6 lb 1/9/2008 United Kingdom
Primary
Secondary
Encephalopathy Other Serious 1/1/2006 28 Male 1/18/2008 France
Primary
Secondary
Concomitant
Lung Infiltration Hospitalization 4/19/2007 54 Female 1/23/2008 Physician Germany
Primary
Concomitant
Pyrexia Hospitalization 4/19/2007 54 Female 2/4/2008 Germany
Primary
Concomitant
Osteoporosis Hospitalization 1/27/2008 33 Male 2/25/2008 Other Health Professional France
Primary
Secondary
Concomitant
Unresponsive To Stimuli Life Threatening 2/1/2007 10 Male 3/13/2008 Other Health Professional France
Primary
Concomitant
Thrombocytopenic Purpura Other Serious 7/1/2006 19 Male 3/14/2008 Other Health Professional France
Primary
Secondary
Muscle Spasms Hospitalization 4/25/2008 Female 5/19/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Hypokalaemia Hospitalization 4/25/2008 Female 5/30/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 10/17/2006 78 Male 199 lb 6/12/2008 Physician United States
Primary
Secondary
Concomitant
Protein Total Decreased Hospitalization 4/25/2008 Female 6/18/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Urinary Retention Required Intervention 3/18/2008 47 Female 8/13/2008 Physician Germany
Primary
Concomitant
Diarrhoea 1/1/2007 Male 250 lb 9/12/2008 Consumer United States
Primary
Concomitant
Drug Toxicity Hospitalization 66 Male 9/24/2008 Australia
Primary
Concomitant
False Negative Laboratory Result Other Serious 47 Female 10/23/2008 Physician Belgium
Primary
Secondary
Concomitant
Acute Hepatic Failure Life Threatening 9/29/2008 8 Male 55 lb 12/4/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Diarrhoea 1/1/2007 Male 250 lb 12/12/2008 Consumer United States
Primary
Concomitant
Onycholysis Other Serious 56 Female 12/26/2008 Consumer United States
Primary
Concomitant
Toxic Epidermal Necrolysis Life Threatening 10/3/2006 Female 1/22/2009 Other Health Professional Germany
Primary
Secondary
Rash Pustular Other Serious 12/24/2008 21 Female 73 lb 1/26/2009 Other Health Professional United Kingdom
Primary
Concomitant
Therapeutic Response Unexpected With Drug Substitution Other Serious 39 Male 280 lb 1/16/2009 United States
Primary
Concomitant
Onycholysis Other Serious 56 Female 1/22/2009 Consumer United States
Primary
Concomitant
Therapeutic Response Unexpected With Drug Substitution Other Serious 39 Male 280 lb 2/20/2009 United States
Primary
Concomitant
Myelodysplastic Syndrome Hospitalization 11/17/2008 74 Female 2/25/2009 Physician Italy
Primary
Secondary
Concomitant
Therapeutic Response Unexpected With Drug Substitution Other Serious 39 Male 280 lb 2/28/2009 Consumer United States
Primary
Concomitant
Urine Output Decreased Other Serious 1/14/2009 28 Male 3/6/2009 Consumer Switzerland
Primary
Concomitant
Myelodysplastic Syndrome Hospitalization 11/17/2008 74 Female 3/11/2009 Italy
Primary
Secondary
Concomitant
Sudden Unexplained Death In Epilepsy Death 3/9/2009 Female 3/23/2009 Germany
Primary
Concomitant
Status Epilepticus Other Serious 3/20/2009 40 Male 256 lb 4/6/2009 Physician Spain
Primary
Concomitant
Lung Infiltration Hospitalization 4/19/2007 54 Female 4/13/2009 Germany
Primary
Concomitant
Urine Output Decreased Other Serious 1/14/2009 Male 5/1/2009 Consumer Switzerland
Primary
Concomitant
Rash Other Serious 5 Male 5/5/2009
Primary
Secondary
Concomitant
Product Substitution Issue Other Serious Female 5/12/2009 Physician United States
Primary
Secondary
Status Epilepticus Death 81 Female 6/12/2009 Physician Germany
Primary
Secondary
Spina Bifida Required Intervention 6/18/2009 United Kingdom
Primary
Secondary
Psychotic Disorder Hospitalization 6/1/2009 32 Male 154 lb 8/7/2009 Physician Germany
Primary
Secondary
Concomitant
Sleep Apnoea Syndrome Other Serious 2/1/2009 52 Male 212 lb 8/25/2009 Physician Spain
Primary
Secondary
Treatment Failure Other Serious 0 Male 9/21/2009
Primary
Secondary
Psychotic Disorder Hospitalization 6/1/2009 32 Male 154 lb 9/15/2009 Germany
Primary
Secondary
Concomitant
Grand Mal Convulsion Other Serious Female 9/23/2009 Other Health Professional Norway
Primary
Secondary
Viral Upper Respiratory Tract Infection Required Intervention 21 Female 128 lb 10/6/2009 Switzerland
Primary
Concomitant
Ileostomy Other Serious 1/1/2009 41 Male 10/12/2009 United Kingdom
Primary
Concomitant
Oedema Peripheral Hospitalization 1/1/2008 Female 11/11/2009 Other Health Professional New Zealand
Primary
Secondary
Unresponsive To Stimuli Hospitalization 5 Male 11/25/2009 Physician France
Primary
Concomitant
Phlebotomy Other Serious 18 1/5/2010 Other Health Professional United States
Primary
Secondary
Sweat Gland Disorder Other Serious 9 Male 1/11/2010 United Kingdom
Primary
Concomitant
Interacting
Iron Overload Other Serious 18 1/12/2010 Other Health Professional United States
Primary
Secondary
Sweat Gland Disorder Other Serious 9 Male 1/13/2010 United Kingdom
Primary
Concomitant
Interacting
Grand Mal Convulsion Hospitalization 9/18/2009 59 Female 1/15/2010 Other Health Professional France
Primary
Secondary
Concomitant
Stevens-johnson Syndrome Hospitalization 12/10/2009 Female 95 lb 1/19/2010 Other Health Professional Portugal
Primary
Concomitant
Status Epilepticus Other Serious 53 Female 1/22/2010
Primary
Secondary
Concomitant
Sweat Gland Disorder Other Serious 9 Male 1/18/2010 United Kingdom
Primary
Secondary
Concomitant
Swelling Face Other Serious 9 Male 1/21/2010 United Kingdom
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 9 Female 2/2/2010
Primary
Secondary
Concomitant
Iron Overload Other Serious 18 1/23/2010 Other Health Professional United States
Primary
Secondary
Metabolic Disorder Hospitalization 53 Female 1/23/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Status Epilepticus Other Serious 53 Female 2/17/2010
Primary
Secondary
Toxic Epidermal Necrolysis Life Threatening 4/21/2009 65 Female 2/22/2010 Physician Germany
Primary
Secondary
Concomitant
Drug Exposure During Pregnancy Other Serious Female 3/4/2010 France
Primary
Secondary
Pregnancy Other Serious Female 3/10/2010 Norway
Primary
Secondary
Self Injurious Behaviour Other Serious 8 Female 3/23/2010 United States
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Hospitalization 9/1/2009 44 Female 132 lb 4/6/2010 Other Health Professional Switzerland
Primary
Concomitant
Self Injurious Behaviour Other Serious 8 Female 4/12/2010
Primary
Secondary
Self Injurious Behaviour Other Serious 8 Female 4/13/2010 Other Health Professional United States
Primary
Concomitant
Self Injurious Behaviour Other Serious 8 Female 4/24/2010 Physician United States
Primary
Concomitant
Weight Increased Other Serious 36 Male 4/27/2010 Austria
Primary
Concomitant
Inappropriate Antidiuretic Hormone Secretion Hospitalization 37 Male 5/13/2010 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Psychotic Disorder Other Serious 53 Female 6/3/2010 Other Health Professional Australia
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Hospitalization 9/1/2009 44 Female 132 lb 6/18/2010 Other Health Professional Switzerland
Primary
Concomitant
Therapeutic Response Unexpected Other Serious 6/6/2010 26 Female 99 lb 7/6/2010 Physician Belgium
Primary
Concomitant
Pancreatitis Other Serious 20 Female 7/19/2010 Other Health Professional Finland
Primary
Concomitant
Vomiting Hospitalization 7/4/2010 46 Male 192 lb 7/12/2010 Physician Japan
Primary
Secondary
Concomitant
Thrombophlebitis Hospitalization 6/7/2010 21 Female 7/23/2010 Pharmacist Ireland
Primary
Concomitant
Ventricular Fibrillation Other Serious 7/14/2010 26 Female 176 lb 7/26/2010 Physician Portugal
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Hospitalization 9/1/2009 44 Female 132 lb 8/3/2010 Other Health Professional Switzerland
Primary
Concomitant
Pancreatitis Other Serious 20 Female 8/9/2010 Other Health Professional Finland
Primary
Concomitant
Hypotonia Other Serious 3/19/2010 31 Female 148 lb 8/4/2010 Consumer Belgium
Primary
Concomitant
Myoclonus Other Serious 2 Male 8/17/2010 United Kingdom
Primary
Secondary
Psychotic Disorder Hospitalization Female 123 lb 8/17/2010 Other Health Professional United Kingdom
Primary
Concomitant
Hyperammonaemic Encephalopathy Other Serious 5 Male 9/9/2010
Primary
Secondary
Progressive Multifocal Leukoencephalopathy Hospitalization 9/1/2009 44 Female 132 lb 9/15/2010 Other Health Professional United States
Primary
Concomitant
Sweat Gland Disorder Other Serious 9 Male 9/21/2010 United Kingdom
Primary
Secondary
Concomitant
Sweat Gland Disorder Other Serious 9 Male 9/21/2010 United Kingdom
Primary
Secondary
Concomitant
Grand Mal Convulsion Other Serious 56 Female 9/29/2010 Other Health Professional France
Primary
Concomitant
Hyponatraemia Hospitalization 9/7/2010 44 Female 168 lb 9/24/2010 United Kingdom
Primary
Concomitant
Sweat Gland Disorder Hospitalization 9 Male 10/11/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Diarrhoea Haemorrhagic Other Serious 8/9/2010 5 Female 50 lb 10/13/2010 Other Health Professional United Kingdom
Primary
Concomitant
Vomiting Hospitalization 6/16/2010 45 Male 192 lb 10/12/2010 Physician Japan
Primary
Secondary
Concomitant
Drug Level Decreased Other Serious 3 Female 11/11/2010 Other Health Professional Italy
Primary
Concomitant
Interacting
Vertigo Other Serious 5/13/2010 55 Male 151 lb 11/29/2010 United States
Primary
Secondary
Concomitant
Hallucination, Auditory Hospitalization 6/18/2009 32 Male 154 lb 12/3/2010 Germany
Primary
Secondary
Concomitant
Dizziness Hospitalization 5/13/2010 55 Male 152 lb 1/4/2011 United States
Primary
Secondary
Concomitant
Hallucination Hospitalization 12/1/2010 33 Female 84 lb 1/21/2011 Consumer Japan
Primary
Secondary
Encephalopathy Hospitalization 8/21/2007 37 Female 154 lb 1/14/2011 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Psychomotor Retardation Hospitalization 7/21/2007 37 Female 129 lb 1/31/2011 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Encephalopathy Other Serious 71 Male 2/15/2011 Germany
Primary
Secondary
Myoclonus Other Serious 71 Male 2/23/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Tubulointerstitial Nephritis Other Serious 2/9/2011 24 Male 3/9/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Tubulointerstitial Nephritis Other Serious 24 Male 180 lb 3/1/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Hallucination Hospitalization 12/9/2010 33 Female 84 lb 3/29/2011 Physician Japan
Primary
Secondary
Sudden Unexplained Death In Epilepsy Death 7 Female 3/22/2011 Physician United States
Primary
Secondary
Agitation Other Serious 20 Male 4/25/2011 Other Health Professional India
Primary
Concomitant
Drug Interaction Other Serious 3 Female 5/17/2011 Other Health Professional Italy
Primary
Concomitant
Interacting
Convulsion Other Serious 3 Female 5/27/2011 Other Health Professional Italy
Primary
Concomitant
Interacting
Drug Interaction Other Serious 3 Female 5/31/2011 Other Health Professional Italy
Primary
Concomitant
Interacting
Off Label Use 57 Male 5/3/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Urinary Tract Infection Other Serious Male 6/3/2011 Other Health Professional United Kingdom
Primary
Concomitant
Injury Other Serious 15 Female 6/8/2011 Other Health Professional Denmark
Primary
Concomitant
Purple Glove Syndrome Other Serious 5/1/2011 65 Female 6/16/2011 Pharmacist United Kingdom
Primary
Concomitant
Gliosis Other Serious 5 Male 6/13/2011 Other Health Professional India
Primary
Concomitant
Multiple Injuries Other Serious 54 Female 168 lb 7/7/2011 Other Health Professional United States
Primary
Concomitant
Interacting
Aggression Other Serious 51 Male 7/7/2011 Physician Germany
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 9 Female 7/11/2011 Other Health Professional United States
Primary
Secondary
Epilepsy Other Serious 51 Male 6/22/2011 Consumer United Kingdom
Primary
Concomitant
Rash Generalised Other Serious 7/4/2011 6 Female 7/15/2011 Other Health Professional Italy
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 8 Male 7/19/2011 Other Health Professional France
Primary
Secondary

Drug Data