Topiramate combined with Valproic Acid

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Rhabdomyolysis Death 36 Female 2/28/2006 Other Health Professional Lebanon
Primary
Concomitant
Weight Decreased Other Serious 6/24/2004 39 Female 4/25/2006 Other Health Professional Canada
Primary
Secondary
Concomitant
Syndactyly Congenital Anomaly Female 5/15/2006 Physician Spain
Primary
Secondary
Concomitant
Subacute Sclerosing Panencephalitis Hospitalization 10 Male 5/26/2006 France
Primary
Secondary
Speech Disorder Required Intervention 6/23/2006 7/10/2006 Pharmacist United States
Primary
Secondary
Granulocytopenia Required Intervention 3/13/2006 56 Female 180 lb 5/11/2006 United States
Primary
Concomitant
Therapeutic Procedure Other Serious Female 9/1/2006 Physician Germany
Primary
Secondary
Concomitant
Haemodynamic Instability Required Intervention 9 Male 8/31/2006 Physician Belgium
Primary
Concomitant
Subacute Sclerosing Panencephalitis Hospitalization Female 10/12/2006 United States
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 10/15/2005 35 Male 8/18/2006 France
Primary
Secondary
Renal Failure Other Serious 10 Female 3/5/2007 France
Primary
Concomitant
Prostration Other Serious 1 Male 3/29/2007 France
Primary
Concomitant
Paradoxical Drug Reaction Other Serious 11 Female 4/12/2007 United States
Primary
Concomitant
Status Epilepticus Hospitalization 7/11/2006 Male 16 lb 5/3/2007 Physician Russian Federation
Primary
Concomitant
Blood Creatine Phosphokinase Increased Other Serious 7 Female 35 lb 5/11/2007 Israel
Primary
Concomitant
Status Epilepticus Hospitalization 7/11/2006 Male 16 lb 5/25/2007 Physician Russian Federation
Primary
Concomitant
Somnolence Hospitalization 2/5/2007 Female 20 lb 5/25/2007 Physician Netherlands
Primary
Concomitant
Confusional State Hospitalization 9/29/2006 51 Female 3/14/2007 Consumer United States
Primary
Concomitant
Rhabdomyolysis Death 36 Female 6/18/2007 Other Health Professional United States
Primary
Concomitant
Somnolence Hospitalization 2/5/2007 Female 20 lb 6/19/2007 Physician Netherlands
Primary
Concomitant
Superinfection Hospitalization 11 Female 7/6/2007 Physician Saudi Arabia
Primary
Secondary
Concomitant
Vomiting Other Serious 9 Male 7/17/2007 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Plasmodium Falciparum Infection Hospitalization 2 Female 7/30/2007 Other Health Professional United Kingdom
Primary
Concomitant
Interacting
Tachypnoea Hospitalization 2 Female 8/10/2007 Other Health Professional United Kingdom
Primary
Concomitant
Interacting
Restless Legs Syndrome Other Serious 50 Female 8/20/2007
Primary
Secondary
Pancytopenia Other Serious 9 Male 8/22/2007 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Pseudomembranous Colitis Other Serious 4/1/2005 9 Male 8/23/2007 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Pancytopenia Hospitalization 9 Male 8/25/2007 Korea, Republic Of
Primary
Secondary
Concomitant
Drug Exposure During Pregnancy Congenital Anomaly 8/7/2007 Female 150 lb 9/5/2007 Pharmacist United States
Primary
Secondary
Concomitant
Pancytopenia Hospitalization 9 Male 8/30/2007 Korea, Republic Of
Primary
Secondary
Concomitant
Pancytopenia Other Serious 8/1/2005 9 Male 9/14/2007 France
Primary
Secondary
Hepatotoxicity Hospitalization 1 Male 9/21/2007 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Transaminases Increased Hospitalization 1 Female 9/22/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Transaminases Increased Hospitalization 2 Female 9/22/2007 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 2/27/2007 Male 139 lb 10/19/2007 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Traumatic Brain Injury Other Serious 7/1/2004 24 Male 10/19/2007 Canada
Primary
Concomitant
Status Epilepticus Hospitalization 7/11/2006 Male 16 lb 11/14/2007 Physician Russian Federation
Primary
Concomitant
Spinal Operation Other Serious 2/6/2007 Male 139 lb 11/27/2007 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Spinal Operation Other Serious 2/6/2007 Male 139 lb 12/10/2007 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Malaise Other Serious 6/2/2005 1 Male 22 lb 12/20/2007 Physician France
Primary
Concomitant
Hepatotoxicity Hospitalization 1 Male 1/8/2008 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Hepatotoxicity Hospitalization 1 Female 1/8/2008 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Hepatotoxicity Hospitalization 2 Female 1/8/2008 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Hepatotoxicity Hospitalization 3 Female 1/8/2008 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Tachypnoea Hospitalization 2 Female 1/18/2008 Other Health Professional United Kingdom
Primary
Concomitant
Interacting
Thrombocytopenic Purpura Other Serious 7/1/2006 19 Male 3/4/2008 Other Health Professional United Kingdom
Primary
Secondary
Hyperkalaemia Life Threatening 2/18/2008 51 Female 3/27/2008 Other Health Professional Portugal
Primary
Concomitant
Status Epilepticus Hospitalization 1 Male 3/28/2008 Netherlands
Primary
Secondary
Concomitant
Inhibitory Drug Interaction Other Serious 1/1/2008 2 Female 5/12/2008 Netherlands
Primary
Secondary
Concomitant
Inhibitory Drug Interaction Other Serious 1/1/2008 3 Female 5/12/2008 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Inhibitory Drug Interaction Other Serious 1/1/2008 1 Male 5/12/2008 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Inhibitory Drug Interaction Other Serious 1/1/2008 1 Female 5/12/2008 Other Health Professional Netherlands
Primary
Secondary
Concomitant
No Adverse Event 2 Female 5/20/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Tachypnoea Hospitalization 1 Female 5/20/2008 United Kingdom
Primary
Concomitant
Interacting
Status Epilepticus Hospitalization 1 Male 5/30/2008 Netherlands
Primary
Concomitant
Aspartate Aminotransferase Increased Hospitalization 1 Female 5/30/2008 Netherlands
Primary
Concomitant
Aspartate Aminotransferase Increased Hospitalization 3 Female 6/2/2008 Netherlands
Primary
Concomitant
Aspartate Aminotransferase Increased Hospitalization 2 Female 6/2/2008 Other Health Professional Netherlands
Primary
Concomitant
Drug Exposure During Pregnancy Other Serious Female 7/9/2008 Other Health Professional Serbia
Primary
Secondary
Talipes Congenital Anomaly 10/1/2006 7/9/2008 Other Health Professional Serbia
Primary
Secondary
Talipes Congenital Anomaly 5/1/2004 7/9/2008 Other Health Professional Spain
Primary
Secondary
Pancytopenia Hospitalization 9 Male 8/8/2008 Korea, Republic Of
Primary
Secondary
Concomitant
Patent Ductus Arteriosus Other Serious Female 8/28/2008 Other Health Professional United Kingdom
Primary
Secondary
Hypospadias Congenital Anomaly Male 6 lb 9/3/2008 United Kingdom
Primary
Secondary
Patent Ductus Arteriosus Other Serious Female 9/10/2008 Other Health Professional United Kingdom
Primary
Secondary
Liver Injury Hospitalization 3 Female 9/3/2008 Physician Netherlands
Primary
Concomitant
Myoclonic Epilepsy Hospitalization 2 Female 9/3/2008 Physician Netherlands
Primary
Concomitant
International Normalised Ratio Increased Hospitalization 1 Male 9/3/2008 Physician Netherlands
Primary
Concomitant
Liver Injury Hospitalization 1 Female 9/3/2008 Physician Netherlands
Primary
Concomitant
Pancreatitis Necrotising Death 9/29/2008 Female 44 lb 10/8/2008 Pharmacist United States
Primary
Concomitant
Grand Mal Convulsion Other Serious 21 Female 11/4/2008 United Kingdom
Primary
Secondary
Somnolence Other Serious 7/1/2007 33 Female 11/20/2008 Physician Brazil
Primary
Concomitant
Medication Error Death 58 Male 12/23/2008 Physician United States
Primary
Secondary
Medication Error Death 58 Male 12/29/2008 Pharmacist United States
Primary
Secondary
Completed Suicide Death 39 Female 12/29/2008 Pharmacist United States
Primary
Secondary
Drug Toxicity Death 39 Female 1/8/2009 Other Health Professional United States
Primary
Secondary
Multiple Drug Overdose Accidental Death 58 Male 1/7/2009 United States
Primary
Secondary
Medication Error Death 1/1/2007 58 Male 1/15/2009 Other Health Professional United States
Primary
Secondary
Cardio-respiratory Arrest Death 39 Female 1/16/2009 United States
Primary
Secondary
Medication Error Death 58 Male 1/16/2009 United States
Primary
Secondary
Medication Error Death 58 Male 1/16/2009 Physician United States
Primary
Secondary
Drug Toxicity Death 39 Female 1/23/2009 Other Health Professional United States
Primary
Secondary
Respiratory Arrest Other Serious 39 Female 1/23/2009 Physician United States
Primary
Secondary
Accidental Overdose Death 1/27/2009 Other Health Professional United States
Primary
Secondary
Poisoning Death 58 Male 1/21/2009 Physician United States
Primary
Secondary
Accidental Overdose Death 58 Male 1/21/2009 Physician United States
Primary
Secondary
Completed Suicide Death 39 Female 1/28/2009 Other Health Professional United States
Primary
Secondary
Respiratory Arrest Death 39 Female 1/26/2009 Physician United States
Primary
Secondary
Death Death 1/1/2007 58 Male 2/3/2009 Pharmacist United States
Primary
Secondary
Cardio-respiratory Arrest Death 1/1/2007 39 Female 2/3/2009 Pharmacist United States
Primary
Secondary
Respiratory Arrest Death 39 Female 2/13/2009 Physician United States
Primary
Secondary
Respiratory Arrest Death 39 Female 3/5/2009 Physician United States
Primary
Secondary
Intra-uterine Death Other Serious Female 3/11/2009 Other Health Professional Netherlands
Primary
Secondary
Epilepsy Other Serious 6/2/2005 1 Male 22 lb 3/6/2009 Italy
Primary
Concomitant
Suicidal Ideation Hospitalization 4/1/2009 Male 261 lb 4/9/2009 United States
Primary
Concomitant
Medication Error Death 5/6/2009 Other Health Professional United States
Primary
Secondary
Medication Error Death 5/8/2009 Other Health Professional United States
Primary
Secondary
Spina Bifida Congenital Anomaly 5/31/1999 5/8/2009 Other Health Professional Australia
Primary
Secondary
Spina Bifida Congenital Anomaly 5/31/1999 5/8/2009 Other Health Professional Australia
Primary
Secondary
Rash Other Serious 4/6/2009 Male 41 lb 5/1/2009 Physician United States
Primary
Concomitant
Maculopathy Other Serious 41 Female 5/21/2009 Other Health Professional Luxembourg
Primary
Concomitant
Maculopathy Other Serious 41 Female 5/22/2009 Other Health Professional Luxembourg
Primary
Concomitant
Weight Increased Other Serious 49 Male 6/8/2009 Italy
Primary
Concomitant
Erectile Dysfunction Other Serious 37 Male 6/15/2009 Other Health Professional Germany
Primary
Concomitant
Ventricular Hypokinesia Other Serious 4/17/2009 1 Male 12 lb 6/22/2009 Physician Brazil
Primary
Concomitant
Abortion Spontaneous Other Serious Female 7/6/2009 Croatia (Local Name: Hrvatska)
Primary
Secondary
Pneumonia Other Serious 19 Female 7/16/2009 Netherlands
Primary
Secondary
Concomitant
Respiratory Syncytial Virus Bronchiolitis Other Serious 3 Female 7/16/2009 Netherlands
Primary
Secondary
Concomitant
Hepatotoxicity Other Serious 1 Female 7/16/2009 Netherlands
Primary
Secondary
Concomitant
Prothrombin Time Prolonged Other Serious 1 Male 7/16/2009 Netherlands
Primary
Secondary
Concomitant
Pneumonia Other Serious 2 Female 7/16/2009 Netherlands
Primary
Secondary
Concomitant
Weight Decreased Other Serious 48 Male 8/7/2009 Other Health Professional Australia
Primary
Concomitant
Interacting
Drug Exposure During Pregnancy Other Serious Female 8/13/2009 Other Health Professional Croatia (Local Name: Hrvatska)
Primary
Secondary
Psychotic Disorder Other Serious 42 Female 8/28/2009
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 48 Male 8/25/2009 Physician Australia
Primary
Secondary
Weight Decreased Hospitalization 48 Male 8/24/2009 Physician Australia
Primary
Secondary
Concomitant
Withdrawal Syndrome Other Serious 39 Female 8/27/2009 United Kingdom
Primary
Secondary
Concomitant
Thinking Abnormal Hospitalization 42 Female 9/10/2009 Physician United States
Primary
Concomitant
Withdrawal Syndrome Other Serious 39 Female 9/10/2009 United Kingdom
Primary
Secondary
Concomitant
Pancreatitis Other Serious 3/30/2001 48 Male 265 lb 9/23/2009 United States
Primary
Concomitant
Blood Creatine Phosphokinase Increased Other Serious 42 Female 9/24/2009 Physician United States
Primary
Concomitant
Psychotic Disorder Other Serious 1/1/2002 57 Female 10/14/2009 Physician France
Primary
Secondary
Hemiparesis Other Serious 12 Female 10/20/2009 Other Health Professional Poland
Primary
Secondary
Hypospadias Other Serious Male 11/11/2009 United Kingdom
Primary
Secondary
Withdrawal Syndrome Other Serious 39 Female 11/4/2009 United Kingdom
Primary
Secondary
Concomitant
Judgement Impaired Other Serious 26 Male 192 lb 11/8/2009 Other Health Professional United States
Primary
Concomitant
Hypospadias Other Serious Male 11/16/2009 Other Health Professional United Kingdom
Primary
Secondary
Pyloric Stenosis Other Serious Male 11/17/2009 Other Health Professional United Kingdom
Primary
Secondary
Nystagmus Other Serious 5 Female 11/27/2009 Physician Israel
Primary
Secondary
Concomitant
Tonic Convulsion Hospitalization Male 154 lb 12/3/2009 Germany
Primary
Concomitant
Maternal Drugs Affecting Foetus Congenital Anomaly Female 12/7/2009 United Kingdom
Primary
Concomitant
Pyloric Stenosis Congenital Anomaly Male 12/7/2009 United Kingdom
Primary
Concomitant
Hypospadias Other Serious Male 12/16/2009 Other Health Professional United Kingdom
Primary
Secondary
Pyloric Stenosis Other Serious Male 12/16/2009 Other Health Professional United Kingdom
Primary
Secondary
Hyperammonaemic Encephalopathy Other Serious 53 Female 1/1/2010 Other Health Professional United States
Primary
Secondary
Hyperammonaemic Encephalopathy Other Serious 53 Female 1/6/2010 Other Health Professional United States
Primary
Secondary
Drug Toxicity Death 45 Female 120 lb 3/1/2010 Physician United States
Primary
Secondary
Drug Toxicity Death 45 Female 120 lb 3/2/2010 Physician United States
Primary
Secondary
Metabolic Acidosis Other Serious 9 Female 4/7/2010 Physician United States
Primary
Concomitant
Weight Increased Other Serious 35 Male 4/9/2010
Primary
Secondary
Vomiting Hospitalization 10 Male 4/20/2010 Other Health Professional France
Primary
Secondary
Concomitant
Vomiting Hospitalization 10 Male 4/20/2010 France
Primary
Secondary
Concomitant
Patent Ductus Arteriosus Other Serious 4/26/2010 Physician Denmark
Primary
Secondary
Drug Exposure During Pregnancy Other Serious Female 4/26/2010 Other Health Professional Sweden
Primary
Secondary
Drug Exposure During Pregnancy Other Serious Female 4/26/2010 Other Health Professional Sweden
Primary
Secondary
Metabolic Acidosis Hospitalization 9 Female 4/26/2010
Primary
Secondary
Concomitant
Intra-uterine Death Other Serious 1/1/2008 23 Female 4/26/2010 Physician Sweden
Primary
Secondary
Talipes Congenital Anomaly 10/1/2006 4/26/2010 Other Health Professional Serbia
Primary
Secondary
Vomiting Hospitalization 10 Male 4/27/2010 Other Health Professional France
Primary
Concomitant
Interacting
Polydactyly Congenital Anomaly 19 4/30/2010 Physician Sweden
Primary
Secondary

Drug Data