Topiramate combined with Valproate Sodium

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Convulsion Life Threatening 12/17/2005 53 Male 1/13/2006 United Kingdom
Primary
Concomitant
Tachypnoea Hospitalization 2 Female 1/13/2006 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vomiting Other Serious 17 Female 1/26/2006 United States
Primary
Secondary
Drug Interaction Hospitalization 1/1/2005 2 Female 1/25/2006 Physician United Kingdom
Primary
Secondary
Concomitant
Tachypnoea Hospitalization 2 Female 1/27/2006 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Status Epilepticus Hospitalization 2 Female 1/31/2006 United Kingdom
Primary
Secondary
Concomitant
Tachypnoea Other Serious 2 Female 2/6/2006 Other Health Professional United Kingdom
Primary
Concomitant
Tachypnoea Hospitalization 22 Female 2/6/2006 Physician United Kingdom
Primary
Secondary
Concomitant
Movement Disorder Other Serious 2/8/2006 42 Male 3/9/2006 Consumer United Kingdom
Primary
Concomitant
White Blood Cell Count Increased Life Threatening 3/16/2006 Male 11 lb 4/4/2006 Physician South Africa
Primary
Secondary
Tachypnoea Hospitalization 1 Female 4/27/2006 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Hiv Infection Death 2/13/2006 Male 5/10/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Hypothermia Other Serious 36 Female 5/11/2006 France
Primary
Secondary
Hypothermia Other Serious 36 Female 5/11/2006 France
Primary
Secondary
Hiv Infection Death 2/13/2006 Male 5/12/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Onychoclasis Other Serious 11/1/2005 60 Female 5/16/2006 Consumer Australia
Primary
Concomitant
Breast Cancer Required Intervention 2/1/2005 55 Female 159 lb 2/27/2006 Consumer United States
Primary
Concomitant
Convulsion Life Threatening 12/17/2005 53 Male 5/22/2006 United Kingdom
Primary
Concomitant
Petit Mal Epilepsy Other Serious 15 Male 6/15/2006 Consumer United Kingdom
Primary
Secondary
Tonic Convulsion Other Serious 15 Male 6/15/2006 United Kingdom
Primary
Secondary
Loss Of Consciousness Other Serious 5/1/2006 15 Female 110 lb 6/13/2006 Physician United Kingdom
Primary
Concomitant
Granulocytopenia Required Intervention 1/25/2006 23 Female 167 lb 5/17/2006 United States
Primary
Concomitant
Granulocytopenia Required Intervention 12/21/2005 29 Male 3/9/2006 United States
Primary
Concomitant
Tonic Convulsion 29 Male 212 lb 1/30/2006 Pharmacist United States
Primary
Secondary
Concomitant
Abortion Other Serious Female 7/28/2006 Australia
Primary
Secondary
Granulocytopenia Required Intervention 9/6/2005 19 Female 6/16/2006 United States
Primary
Concomitant
Hiv Infection Death 2/13/2006 Male 9/11/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Epilepsy Disability 5/9/2006 Female 9/18/2006 Consumer France
Primary
Concomitant
Muscle Spasms Disability 5/9/2006 Female 10/13/2006 Consumer France
Primary
Concomitant
Stress Other Serious 30 Female 12/2/2006 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Stress Other Serious 30 Female 12/21/2006 Consumer United Kingdom
Primary
Secondary
Concomitant
Sudden Death Death 2/13/2006 Male 12/22/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Mental Disorder Hospitalization 30 Female 12/30/2006 United Kingdom
Primary
Secondary
Concomitant
Petit Mal Epilepsy Other Serious 15 Male 1/29/2007 Other Health Professional France
Primary
Secondary
Muscle Spasms Disability 5/9/2006 Female 3/16/2007 Consumer France
Primary
Concomitant
Muscle Spasms Disability 5/9/2006 Female 3/19/2007 Consumer France
Primary
Concomitant
No Therapeutic Response Other Serious 7/1/2006 19 Male 3/21/2007 Physician United Kingdom
Primary
Secondary
Middle Insomnia Hospitalization 1/8/2007 Female 33 lb 5/4/2007 Physician Finland
Primary
Secondary
Concomitant
Middle Insomnia Hospitalization 1/8/2007 Female 33 lb 5/15/2007 Physician Finland
Primary
Secondary
Concomitant
Tachypnoea Hospitalization 2 Female 8/3/2007 United Kingdom
Primary
Concomitant
Interacting
Mobility Decreased Other Serious 11/1/2006 Male 8/31/2007 Physician United Kingdom
Primary
Concomitant
Interacting
Electroencephalogram Abnormal Other Serious 16 Male 9/6/2007 Belgium
Primary
Concomitant
Interacting
Electroencephalogram Abnormal Other Serious 71 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
Somnolence Other Serious 7/1/2006 48 Male 10/5/2007 Other Health Professional France
Primary
Concomitant
Interacting
Urinary Tract Infection Hospitalization 6/10/2007 Female 335 lb 10/19/2007 United Kingdom
Primary
Concomitant
Urosepsis Life Threatening 6/10/2007 Female 335 lb 12/7/2007 United Kingdom
Primary
Concomitant
Tachypnoea Hospitalization 1 Female 12/20/2007 Other Health Professional United Kingdom
Primary
Concomitant
Interacting
Epistaxis Hospitalization 11/1/2006 62 Female 11/29/2007 Consumer United States
Primary
Secondary
Concomitant
Thrombocytopenic Purpura Other Serious 7/1/2006 19 Male 3/3/2008 Consumer United Kingdom
Primary
Secondary
Thrombocytopenic Purpura Other Serious 7/1/2006 19 Male 3/7/2008 Physician United Kingdom
Primary
Secondary
Thrombocytopenic Purpura Other Serious 7/1/2006 19 Male 3/14/2008 Other Health Professional France
Primary
Secondary
Liver Injury Other Serious 3/24/2008 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Hepatotoxicity Other Serious 3/24/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Liver Injury Other Serious 3/25/2008 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Liver Injury Other Serious 3/25/2008 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Liver Injury Hospitalization 3/25/2008 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Suicidal Ideation Other Serious 2/1/1999 Female 3/26/2008 Physician United Kingdom
Primary
Concomitant
Hyperkalaemia Life Threatening 2/18/2008 51 Female 3/27/2008 Other Health Professional Portugal
Primary
Concomitant
Suicidal Ideation Other Serious 2/1/1999 Female 4/11/2008 Physician United Kingdom
Primary
Concomitant
No Adverse Event 1 Female 5/20/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
No Adverse Event 1 Female 5/20/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Tachypnoea Hospitalization 1 Female 5/20/2008 United Kingdom
Primary
Concomitant
Interacting
Diabetes Mellitus Inadequate Control Other Serious 4/1/2008 57 Male 223 lb 5/22/2008 Other Health Professional United Kingdom
Primary
Concomitant
Maternal Drugs Affecting Foetus Congenital Anomaly Female 7 lb 8/18/2008 United Kingdom
Primary
Secondary
Maternal Drugs Affecting Foetus Required Intervention Male 9/2/2008 United Kingdom
Primary
Secondary
Foot Deformity Congenital Anomaly 0 Female 5 lb 10/9/2008 France
Primary
Secondary
Somnolence Other Serious 1/1/2005 13 Male 10/30/2008 Physician France
Primary
Secondary
Grand Mal Convulsion Other Serious 26 Female 11/6/2008 United Kingdom
Primary
Secondary
Grand Mal Convulsion Other Serious 32 Female 11/6/2008 United Kingdom
Primary
Secondary
Grand Mal Convulsion Other Serious 18 Female 11/6/2008 United Kingdom
Primary
Secondary
Head Injury Hospitalization 4 Male 29 lb 11/26/2008 Italy
Primary
Secondary
Acute Hepatic Failure Life Threatening 9/29/2008 8 Male 55 lb 12/4/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Memory Impairment Other Serious 20 Male 12/12/2008 Other Health Professional China
Primary
Concomitant
Somnambulism Other Serious 1/13/2009 40 Female 1/29/2009 Consumer United States
Primary
Concomitant
Psychotic Disorder Hospitalization Male 2/5/2009 Germany
Primary
Concomitant
Visual Acuity Reduced Other Serious 6/1/2004 41 Female 2/13/2009 Other Health Professional Luxembourg
Primary
Secondary
Concomitant
Drug Interaction 17 3/4/2009 Physician United States
Primary
Interacting
Tachycardia Hospitalization 4 Male 29 lb 4/1/2009 Other Health Professional Italy
Primary
Concomitant
Swelling Face 3 Female 29 lb 5/6/2009 Other Health Professional United Kingdom
Primary
Concomitant
Hyperammonaemic Encephalopathy Other Serious 7 Male 5/12/2009 Brazil
Primary
Secondary
Concomitant
Swelling Face Other Serious 3 Female 29 lb 5/8/2009 Other Health Professional United Kingdom
Primary
Concomitant
Drug Interaction Hospitalization 1/13/2009 Female 5/26/2009 Physician Germany
Primary
Concomitant
Grand Mal Convulsion Hospitalization 4/12/2009 Male 154 lb 6/5/2009 Germany
Primary
Concomitant
Mania Life Threatening 5/1/2009 62 156 lb 7/15/2009 Other Health Professional United Kingdom
Primary
Concomitant
Temperature Intolerance Other Serious 6 Male 7/16/2009 Italy
Primary
Concomitant
Mania Life Threatening 5/1/2009 62 156 lb 7/23/2009 Other Health Professional United Kingdom
Primary
Concomitant
Drug Interaction Hospitalization 7/14/2009 Female 7/27/2009 Consumer Germany
Primary
Concomitant
Psychotic Disorder Hospitalization 6/1/2009 32 Male 154 lb 8/7/2009 Physician Germany
Primary
Secondary
Concomitant
Convulsion Hospitalization 7/1/2009 Male 8/13/2009 Physician United Kingdom
Primary
Concomitant
Withdrawal Syndrome Other Serious 39 Female 8/24/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Physical Assault Other Serious 7/1/2009 Male 172 lb 8/19/2009 Other Health Professional United Kingdom
Primary
Concomitant
Encephalopathy Hospitalization 48 Male 8/27/2009 Other Health Professional Australia
Primary
Secondary
Concomitant
Drug Toxicity Hospitalization 48 Male 8/27/2009
Primary
Secondary
Concomitant
Weight Decreased Other Serious 48 Male 8/27/2009 Physician Australia
Primary
Secondary
Concomitant
Encephalopathy Hospitalization 48 Male 9/3/2009 Physician Australia
Primary
Concomitant
Interacting
Product Quality Issue Other Serious 7/1/2009 Male 172 lb 9/4/2009 Physician United Kingdom
Primary
Concomitant
Weight Decreased Other Serious 48 Male 9/8/2009 United States
Primary
Secondary
Concomitant
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
Weight Decreased Hospitalization 48 Male 9/29/2009 Other Health Professional Australia
Primary
Secondary
Concomitant
Maternal Drugs Affecting Foetus Other Serious Male 11/4/2009 Other Health Professional United Kingdom
Primary
Secondary
Pyloric Stenosis Other Serious Male 11/4/2009 Other Health Professional United Kingdom
Primary
Secondary
Convulsion Other Serious 7 Female 11/6/2009 Physician Japan
Primary
Secondary
Concomitant
Convulsion Other Serious 36 Female 11/6/2009 Physician Japan
Primary
Secondary
Concomitant
Oedema Peripheral Hospitalization 1/1/2008 Female 11/11/2009 Other Health Professional New Zealand
Primary
Secondary
Status Epilepticus Hospitalization 10/20/2009 8 Female 11/12/2009 Other Health Professional Japan
Primary
Concomitant
Epilepsy Other Serious 60 Female 11/18/2009 France
Primary
Concomitant
Status Epilepticus Hospitalization 10/20/2009 Female 11/20/2009 Other Health Professional Japan
Primary
Concomitant
Status Epilepticus Hospitalization 10/20/2009 Female 11/24/2009 Other Health Professional Japan
Primary
Concomitant
Thrombocytopenia Hospitalization 11/11/2009 6 Male 12/10/2009 Physician Germany
Primary
Concomitant
Interacting
Oedema Peripheral Other Serious 32 Female 12/10/2009 Other Health Professional United Kingdom
Primary
Concomitant
Maternal Drugs Affecting Foetus Congenital Anomaly 1 Male 6 lb 12/30/2009 Other Health Professional United Kingdom
Primary
Secondary
Weight Decreased Other Serious 11/20/2009 Male 12/31/2009 Other Health Professional Australia
Primary
Concomitant
Thrombocytopenia Other Serious 9/9/2009 Male 1/5/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 9/9/2009 Male 1/8/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Status Epilepticus Other Serious 53 Female 1/22/2010
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 9 Female 2/2/2010
Primary
Secondary
Concomitant
Metabolic Disorder Hospitalization 53 Female 1/23/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Drug Exposure During Pregnancy Other Serious Female 3/4/2010 France
Primary
Secondary
Vomiting Hospitalization 10 Male 3/5/2010 Other Health Professional France
Primary
Concomitant
Interacting
Urinary Sediment Abnormal Other Serious 9/9/2009 Male 3/9/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Drug Toxicity Hospitalization 10 Male 3/12/2010 France
Primary
Concomitant
Interacting
Pregnancy Other Serious Female 3/10/2010 Norway
Primary
Secondary
Vomiting Hospitalization 10 Male 4/14/2010 Other Health Professional France
Primary
Concomitant
Interacting
Hallucination, Visual Hospitalization 9/26/2009 10 Male 4/16/2010 Other Health Professional Japan
Primary
Concomitant
Vomiting Hospitalization 10 Male 4/19/2010 Physician France
Primary
Secondary
Hepatic Enzyme Increased Other Serious Male 4/29/2010 France
Primary
Secondary
Concomitant
Loss Of Consciousness Other Serious 13 Male 6/9/2010 Other Health Professional Japan
Primary
Secondary
Ventricular Septal Defect Congenital Anomaly 0 Female 6/23/2010 Other Health Professional France
Primary
Secondary
Loss Of Consciousness Other Serious 3/30/2009 13 Male 7/14/2010 Other Health Professional Japan
Primary
Secondary
Pancreatitis Other Serious 20 Female 7/19/2010 Other Health Professional Finland
Primary
Concomitant
Loss Of Consciousness Other Serious 3/30/2009 13 Male 7/22/2010 Other Health Professional Japan
Primary
Secondary
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
White Blood Cell Count Increased Other Serious 3/13/2009 30 Male 7/29/2010 Other Health Professional Australia
Primary
Concomitant
Hyperammonaemic Encephalopathy Life Threatening 5 Male 8/2/2010 Other Health Professional India
Primary
Interacting
Pancreatitis Other Serious 20 Female 8/9/2010 Other Health Professional Finland
Primary
Concomitant
Hyperammonaemic Encephalopathy Other Serious 5 Male 9/9/2010
Primary
Secondary
Gastric Ulcer Other Serious 9/10/2010 Other Health Professional South Africa
Primary
Concomitant
Convulsion Other Serious 4 Male 9/14/2010 Physician United Kingdom
Primary
Concomitant
Grand Mal Convulsion Other Serious 56 Female 9/29/2010 Other Health Professional France
Primary
Concomitant
Paranoia Other Serious 22 Female 10/21/2010 Other Health Professional Japan
Primary
Concomitant
Loss Of Consciousness Other Serious 3/30/2009 13 Male 10/26/2010 Other Health Professional Japan
Primary
Secondary
Renal Disorder Other Serious 2/1/2009 14 Female 10/26/2010 Other Health Professional Japan
Primary
Concomitant

Drug Data