Phenobarbital Tab combined with Topiramate

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
Hypothermia Other Serious 36 Female 5/11/2006 France
Primary
Secondary
Hypothermia Other Serious 36 Female 5/11/2006 France
Primary
Secondary
Photosensitivity Reaction Other Serious 1/1/2006 34 Female 7/14/2006 Physician France
Primary
Secondary
Concomitant
Toxic Skin Eruption Other Serious 1/1/2006 34 Female 8/4/2006 Physician France
Primary
Secondary
Concomitant
Oedema Peripheral Hospitalization Male 176 lb 12/21/2006 Consumer Brazil
Primary
Concomitant
Vision Blurred Life Threatening 9/13/2006 56 Female 162 lb 9/15/2006 United States
Primary
Concomitant
Convulsion Death 12/24/2006 Male 20 lb 2/9/2007 Physician United States
Primary
Concomitant
Gastrostomy Tube Insertion Hospitalization 2/5/2007 Male 21 lb 2/16/2007 Physician United States
Primary
Concomitant
Convulsion Death 12/24/2006 Male 20 lb 5/4/2007 Physician United States
Primary
Concomitant
Convulsion Hospitalization 1/16/2007 Female 11 lb 5/25/2007 Physician United States
Primary
Concomitant
Rhabdomyolysis Death 36 Female 6/18/2007 Other Health Professional United States
Primary
Concomitant
Gastrostomy Tube Insertion Hospitalization 1/16/2007 Female 11 lb 6/21/2007 Physician United States
Primary
Concomitant
Failure To Thrive Hospitalization 1/16/2007 Female 11 lb 7/16/2007 Physician United States
Primary
Concomitant
Failure To Thrive Hospitalization 1/16/2007 Female 11 lb 7/20/2007 Physician United States
Primary
Concomitant
Gastrostomy Tube Insertion Hospitalization 2/5/2007 Male 21 lb 7/20/2007 Physician United States
Primary
Concomitant
Delayed Recovery From Anaesthesia Other Serious 12/25/2005 12 Female 8/2/2007 Physician Thailand
Primary
Secondary
Failure To Thrive Hospitalization 1/16/2007 Female 11 lb 9/6/2007 Physician United States
Primary
Concomitant
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
Urinary Tract Infection Hospitalization 1/16/2007 Female 11 lb 9/27/2007 Physician United States
Primary
Concomitant
Failure To Thrive Hospitalization 2/5/2007 Male 21 lb 9/27/2007 Physician United States
Primary
Concomitant
Urinary Tract Infection Hospitalization 6/10/2007 Female 335 lb 10/19/2007 United Kingdom
Primary
Concomitant
Failure To Thrive Hospitalization 2/5/2007 Male 21 lb 11/8/2007 Physician United States
Primary
Concomitant
Failure To Thrive Hospitalization 2/5/2007 Male 21 lb 12/6/2007 Physician United States
Primary
Concomitant
Urosepsis Life Threatening 6/10/2007 Female 335 lb 12/7/2007 United Kingdom
Primary
Concomitant
Malaise Other Serious 6/2/2005 1 Male 22 lb 12/20/2007 Physician France
Primary
Concomitant
Petit Mal Epilepsy Other Serious 39 Female 1/10/2008 Other Health Professional France
Primary
Concomitant
Petit Mal Epilepsy Other Serious 39 Female 1/10/2008 Other Health Professional France
Primary
Concomitant
Intestinal Perforation Other Serious 1 Female 1/15/2008 Other Health Professional Japan
Primary
Concomitant
Interacting
Lethargy 7/4/2007 Male 43 lb 1/16/2008 Physician United States
Primary
Secondary
Concomitant
Stevens-johnson Syndrome Other Serious 3/23/2007 Male 30 lb 4/11/2008 Physician United States
Primary
Secondary
Concomitant
Hypokalaemia Hospitalization 52 Female 123 lb 5/8/2008 Physician France
Primary
Concomitant
Drug Exposure During Pregnancy Other Serious Female 7/8/2008 Physician Italy
Primary
Secondary
Nephrolithiasis Hospitalization 5/8/2008 Male 7/8/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Torticollis Congenital Anomaly 4/1/2004 7/9/2008 Other Health Professional United Kingdom
Primary
Secondary
Drug Exposure During Pregnancy Other Serious Female 7/9/2008 Other Health Professional Netherlands
Primary
Secondary
Stillbirth Other Serious Female 7/9/2008 Physician Italy
Primary
Secondary
Maternal Drugs Affecting Foetus Required Intervention Male 9/2/2008 Other Health Professional United Kingdom
Primary
Secondary
Somnolence Required Intervention 6/25/2008 Male 172 lb 9/3/2008 Pharmacist United States
Primary
Concomitant
Cleft Lip And Palate Congenital Anomaly Male 8 lb 9/18/2008 United Kingdom
Primary
Secondary
Hemiplegia Hospitalization 9/11/2008 61 Male 9/24/2008 Physician Guatemala
Primary
Concomitant
Pancreatitis Necrotising Death 9/29/2008 Female 44 lb 10/8/2008 Pharmacist United States
Primary
Concomitant
Status Epilepticus Hospitalization 1/1/2007 14 Male 11/24/2008 China
Primary
Concomitant
Underdose 1/1/2006 Female 138 lb 12/12/2008 Consumer United States
Primary
Concomitant
Epilepsy Other Serious 6/2/2005 1 Male 22 lb 3/6/2009 Italy
Primary
Concomitant
Lethargy 7/4/2007 4 Male 43 lb 6/4/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Stubbornness Other Serious 10/1/2008 Male 6/17/2009 Physician United States
Primary
Concomitant
Torticollis Congenital Anomaly 9/14/2009 Other Health Professional Denmark
Primary
Concomitant
Stevens-johnson Syndrome Other Serious 7/2/2009 Male 10/7/2009 Pharmacist Japan
Primary
Concomitant
Stevens-johnson Syndrome Other Serious 7/2/2009 Male 10/26/2009 Pharmacist Japan
Primary
Secondary
Concomitant
Drug Exposure During Pregnancy Other Serious Male 8 lb 11/4/2009 Other Health Professional United Kingdom
Primary
Secondary
Tremor Hospitalization 2/1/2006 29 Male 185 lb 10/30/2009 Other Health Professional France
Primary
Secondary
Concomitant
Cleft Palate Congenital Anomaly 1 Male 8 lb 12/30/2009 Other Health Professional United Kingdom
Primary
Secondary
Biopsy Muscle Death Female 2/26/2010 Consumer United States
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Life Threatening 5/1/2009 48 Male 4/5/2010 Physician Japan
Primary
Concomitant
Metabolic Acidosis Other Serious 9 Female 4/7/2010 Physician United States
Primary
Concomitant
Overdose Death 43 Female 4/13/2010 Physician United States
Primary
Concomitant
Interacting
Restlessness Other Serious 44 Female 4/16/2010 Other Health Professional United Kingdom
Primary
Secondary
White Blood Cell Count Decreased Other Serious 5/18/2009 57 Female 5/27/2010 Other Health Professional Japan
Primary
Concomitant
Speech Disorder Hospitalization 29 Female 7/8/2010 Italy
Primary
Secondary
Hyperammonaemic Encephalopathy Life Threatening 5 Male 8/2/2010 Other Health Professional India
Primary
Interacting
Tremor Hospitalization 2/1/2006 29 Male 187 lb 8/5/2010 France
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 5/18/2009 57 Female 8/12/2010 Other Health Professional Japan
Primary
Concomitant
Pancreatitis Acute Other Serious 15 Female 8/17/2010 Physician United States
Primary
Secondary
Pneumonia Aspiration Life Threatening 7/9/2010 8 Male 8/20/2010 Other Health Professional United Kingdom
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 4/16/2010 43 Male 9/1/2010 Other Health Professional Japan
Primary
Secondary
Hyperammonaemic Encephalopathy Other Serious 5 Male 9/9/2010
Primary
Secondary
White Blood Cell Count Decreased Hospitalization 4/16/2010 43 Male 9/22/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Gamma-glutamyltransferase Increased Other Serious 5/25/2010 63 Female 9/29/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 6/1/2010 46 Female 160 lb 10/13/2010 United States
Primary
Concomitant
Blood Lactate Dehydrogenase Increased Other Serious 5/25/2010 63 Female 10/25/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Pancreatitis Acute Other Serious 15 Female 11/10/2010 Physician United States
Primary
Secondary
Psychomotor Retardation Hospitalization 7/21/2007 37 Female 129 lb 1/31/2011 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Acute Respiratory Failure Death 2/5/2011 2/24/2011 Physician Japan
Primary
Concomitant
Amnestic Disorder Other Serious 71 Male 5/3/2011 Physician Germany
Primary
Secondary
Concomitant
Status Epilepticus Hospitalization 8/26/2010 73 Male 5/23/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Status Epilepticus Death Female 5/25/2011 Other Health Professional United Kingdom
Primary
Secondary
Status Epilepticus Death Female 5/27/2011 Other Health Professional United Kingdom
Primary
Secondary
Diarrhoea Hospitalization 9/16/2010 21 Female 141 lb 5/28/2011 Consumer Brazil
Primary
Concomitant
Acute Hepatic Failure Death 7/14/2010 7 Female 5/31/2011 Other Health Professional France
Primary
Secondary
Concomitant
Hepatic Failure Hospitalization 1/7/2011 2 Male 5/25/2011 Physician United States
Primary
Concomitant
Status Epilepticus Death Female 6/7/2011 Other Health Professional United Kingdom
Primary
Secondary
Status Epilepticus Death Female 6/7/2011 Other Health Professional United Kingdom
Primary
Secondary
Status Epilepticus Death Female 6/7/2011 Other Health Professional United Kingdom
Primary
Secondary
Status Epilepticus Death Female 6/8/2011 Other Health Professional United Kingdom
Primary
Secondary
Sudden Unexplained Death In Epilepsy Other Serious Female 6/9/2011 United Kingdom
Primary
Secondary
Status Epilepticus Death Female 6/2/2011 Other Health Professional United Kingdom
Primary
Secondary
Status Epilepticus Death Female 6/13/2011 Other Health Professional United Kingdom
Primary
Secondary
Mitochondrial Enzyme Deficiency Death Female 6/14/2011 Other Health Professional United Kingdom
Primary
Concomitant
Status Epilepticus Death Female 6/7/2011 Other Health Professional United Kingdom
Primary
Secondary
Pneumonia Aspiration Other Serious 3/21/2011 23 Female 90 lb 6/16/2011 Pharmacist United States
Primary
Secondary
Concomitant
Renal Failure Death Female 6/17/2011 Other Health Professional United Kingdom
Primary
Secondary
Mitochondrial Enzyme Deficiency Death Female 6/20/2011 Other Health Professional United Kingdom
Primary
Concomitant
Alanine Aminotransferase Increased Other Serious 5/25/2010 63 Female 6/24/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Haematocrit Decreased Other Serious 9/10/2009 21 Female 6/24/2011 Physician Japan
Primary
Concomitant
Abdominal Distension Other Serious 9/16/2010 21 Female 137 lb 6/28/2011 Consumer Brazil
Primary
Concomitant
Nausea Other Serious 9/16/2010 21 Female 137 lb 7/6/2011 Consumer Brazil
Primary
Concomitant
Multi-organ Failure Hospitalization 1/7/2011 2 Male 7/5/2011 Physician United States
Primary
Concomitant
Rash Hospitalization 76 Female 7/14/2011 Other Health Professional Taiwan, Province Of China
Primary
Secondary
Concomitant
Hepatic Failure Hospitalization 5/15/2011 2 Male 7/6/2011 Physician United States
Primary
Concomitant
Hyperammonaemic Encephalopathy Hospitalization 1/1/2011 46 Female 7/15/2011 Other Health Professional Spain
Primary
Secondary
Hypomenorrhoea Hospitalization 9/16/2010 21 Female 137 lb 7/26/2011 Consumer Brazil
Primary
Concomitant
Ammonia Increased Other Serious Female 7/18/2011 Other Health Professional
Primary
Secondary
Cardiac Arrest Death 5/16/2011 2 Female 24 lb 7/29/2011 Physician Brazil
Primary
Concomitant
Toxicity To Various Agents Life Threatening 24 Male 7/29/2011 Other Health Professional India
Primary
Secondary
Status Epilepticus Death Female 8/8/2011 Other Health Professional United Kingdom
Primary
Concomitant
Hepatic Function Abnormal Other Serious 11 Male 8/2/2011 Other Health Professional Japan
Primary
Concomitant
Status Epilepticus Death Female 8/10/2011 Other Health Professional United Kingdom
Primary
Secondary
Rhabdomyolysis Other Serious 4/13/2011 13 Male 8/12/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Status Epilepticus Death Female 8/8/2011 Other Health Professional United Kingdom
Primary
Secondary
Pancreatitis Death Female 8/15/2011 Other Health Professional United Kingdom
Primary
Secondary
Ammonia Increased Hospitalization Male 8/18/2011 Other Health Professional Lebanon
Primary
Secondary
Hyporeflexia Hospitalization Male 8/18/2011 Other Health Professional Lebanon
Primary
Secondary
Status Epilepticus Death Female 8/15/2011 Other Health Professional United Kingdom
Primary
Secondary
Pancreatitis Death Female 8/24/2011 Other Health Professional United Kingdom
Primary
Secondary
Respiratory Failure Hospitalization 5/15/2011 2 Male 8/30/2011 Physician United States
Primary
Concomitant
Aphasia Hospitalization 46 Female 9/6/2011 Physician Spain
Primary
Interacting
Incorrect Route Of Drug Administration Hospitalization 10 Male 9/8/2011 Other Health Professional Turkey
Primary
Secondary
Drug Administered To Patient Of Inappropriate Age Death 1 Male 9/8/2011 Other Health Professional Turkey
Primary
Secondary
Incorrect Route Of Drug Administration Hospitalization 4 Female 9/8/2011 Other Health Professional Turkey
Primary
Secondary
Metabolic Acidosis Hospitalization 7 Male 9/8/2011 Other Health Professional Turkey
Primary
Secondary
Drug Effect Decreased Hospitalization 5 Female 9/8/2011 Other Health Professional Turkey
Primary
Secondary
Increased Appetite Other Serious 9/1/2008 35 Female 204 lb 9/12/2011 Brazil
Primary
Concomitant
Incorrect Route Of Drug Administration Other Serious 5 Female 9/12/2011 Other Health Professional Turkey
Primary
Secondary
Bradykinesia Hospitalization 46 Male 9/12/2011 Physician Japan
Primary
Secondary
Oedema Peripheral Hospitalization 7/27/2011 19 Female 9/14/2011 Physician Japan
Primary
Concomitant
Death Death Female 9/15/2011 Other Health Professional United Kingdom
Primary
Concomitant
Status Epilepticus Death 7/14/2010 7 Female 9/19/2011 Other Health Professional France
Primary
Secondary
Concomitant
Neuroleptic Malignant Syndrome Other Serious 46 Male 9/21/2011 Physician Japan
Primary
Secondary
Status Epilepticus Hospitalization 7/1/2011 2 Male 9/22/2011 Physician Ireland
Primary
Concomitant
Myoclonus Hospitalization Female 6 lb 9/30/2011 Physician United States
Primary
Secondary
Myoclonus Other Serious Male 5 lb 10/4/2011 Physician United States
Primary
Secondary
Rhabdomyolysis Other Serious 4/13/2011 13 Male 10/12/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Neuroleptic Malignant Syndrome Other Serious 46 Male 10/17/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Epilepsy Death 10/1/2009 23 Female 10/17/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Osteopenia Other Serious 2/1/2006 29 Male 187 lb 10/18/2011 Physician France
Primary
Secondary
Concomitant
Liver Disorder Hospitalization 10/1/2009 23 Female 10/19/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Liver Disorder Death 10/1/2009 23 Female 10/20/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Psychomotor Retardation Other Serious Male 10/24/2011 Other Health Professional India
Primary
Secondary
Concomitant
Epilepsy Hospitalization 1/1/2011 54 Male 11/7/2011 Consumer United States
Primary
Concomitant
Hyperammonaemia Death 10/1/2009 23 Female 11/14/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Rhabdomyolysis Disability 4/13/2011 13 Male 12/23/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Completed Suicide Death 1/1/2010 45 Female 12/23/2011 Physician United States
Primary
Secondary
Decreased Activity Other Serious 2/13/2009 36 Male 1/3/2012 Other Health Professional Japan
Primary
Concomitant
Aphasia Hospitalization 1/1/2006 17 Female 134 lb 1/3/2012 Physician Germany
Primary
Concomitant
Completed Suicide Death 45 Female 1/4/2012 Physician United States
Primary
Secondary
Toxicity To Various Agents Death 45 Female 1/4/2012 Physician United States
Primary
Secondary
Epilepsy Life Threatening 30 Male 12/30/2011 Other Health Professional United States
Primary
Secondary

Drug Data