Phenobarbital Tab combined with Valproate Sodium

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Pneumonia Life Threatening 11/15/2005 3 Female 34 lb 12/21/2005 Physician United Kingdom
Primary
Concomitant
Suicide Attempt Hospitalization 21 Female 2/2/2006 France
Primary
Concomitant
Suicide Attempt Hospitalization 21 Female 2/17/2006 France
Primary
Concomitant
Visual Field Defect Other Serious 1/26/2005 54 Male 3/13/2006 Consumer United States
Primary
Secondary
Suicide Attempt Other Serious 3/13/2006 Female 132 lb 3/23/2006 Physician Brazil
Primary
Secondary
Status Epilepticus Life Threatening 3/4/2005 Male 26 lb 3/24/2006 Physician Macedonia, The Former Yugoslav Republic Of
Primary
Secondary
Concomitant
Ventricular Fibrillation Life Threatening 42 Female 4/10/2006 France
Primary
Secondary
Hypothermia Other Serious 36 Female 5/11/2006 France
Primary
Secondary
Hypothermia Other Serious 36 Female 5/11/2006 France
Primary
Secondary
Pyrexia Hospitalization 4/26/2006 46 Male 121 lb 7/5/2006 Physician Japan
Primary
Concomitant
Polycystic Ovaries Other Serious 28 Female 8/4/2006 Japan
Primary
Concomitant
Status Epilepticus Hospitalization 41 Female 8/8/2006 Japan
Primary
Concomitant
Respiratory Failure Hospitalization 1/13/2005 Male 8/14/2006 Physician Japan
Primary
Secondary
Concomitant
Hepatotoxicity Other Serious 0 Male 8/29/2006 Germany
Primary
Concomitant
Sepsis Hospitalization 3/30/2006 5 Male 33 lb 8/23/2006 Physician Japan
Primary
Concomitant
White Blood Cell Count Increased Hospitalization 6/7/2006 58 Male 8/24/2006 Physician Japan
Primary
Concomitant
Rhabdomyolysis Hospitalization 31 Female 9/8/2006 Physician Japan
Primary
Secondary
Thrombocytopenia Death 6/12/2006 58 Male 9/25/2006 Physician Japan
Primary
Concomitant
Respiratory Failure Hospitalization 1/13/2005 Male 10/9/2006 Physician Japan
Primary
Secondary
Concomitant
Mobility Decreased Other Serious 1/1/2004 48 Male 11/10/2006 Pharmacist France
Primary
Secondary
Concomitant
Dyspnoea Life Threatening 6/8/2006 3 Male 15 lb 11/2/2006 Physician Japan
Primary
Concomitant
White Blood Cell Count Increased Death 6/12/2006 58 Male 11/13/2006 Physician Japan
Primary
Concomitant
Pneumonia Hospitalization 5/27/2005 3 Male 29 lb 12/14/2006 Physician Japan
Primary
Concomitant
Dizziness Other Serious 10/31/2006 55 Female 12/29/2006 Physician Japan
Primary
Secondary
Concomitant
Ocular Hyperaemia Hospitalization Female 12/22/2006 Consumer United Kingdom
Primary
Concomitant
Nephrolithiasis Hospitalization 8/11/2006 5 Female 1/29/2007 Physician Japan
Primary
Concomitant
Tachycardia Hospitalization 2/9/2003 1 3/24/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Stridor Life Threatening 2/21/2004 Female 4/19/2007 United States
Primary
Secondary
Concomitant
Haematochezia Hospitalization 1/1/2000 56 Female 77 lb 6/11/2007 Japan
Primary
Concomitant
Ventricular Dysfunction Death 36 Female 6/14/2007 Physician United States
Primary
Concomitant
Epilepsy Hospitalization 13 Male 8/15/2007 Japan
Primary
Concomitant
Transient Hypogammaglobulinaemia Of Infancy Other Serious 5/1/2007 3 Male 8/15/2007 Physician Japan
Primary
Secondary
Epilepsy Hospitalization 13 Male 8/28/2007 Japan
Primary
Concomitant
Transient Hypogammaglobulinaemia Of Infancy Other Serious 3 Male 8/28/2007
Primary
Secondary
Pruritus Other Serious 5/15/2007 55 Female 101 lb 8/22/2007 Physician Japan
Primary
Secondary
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 43 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 46 Male 9/6/2007 Belgium
Primary
Concomitant
Interacting
Electroencephalogram Abnormal Other Serious 71 Male 9/6/2007 Belgium
Primary
Concomitant
Interacting
Somnolence Hospitalization 22 Female 9/8/2007 Japan
Primary
Concomitant
Somnolence Hospitalization 22 Female 9/20/2007 Japan
Primary
Concomitant
Respiratory Tract Infection Hospitalization 11/22/2006 Male 9/23/2007 Physician Japan
Primary
Concomitant
X-ray Abnormal Other Serious 6/3/2007 69 Female 9/24/2007 Pharmacist Japan
Primary
Secondary
Concomitant
X-ray Abnormal Other Serious 6/3/2007 69 Female 10/2/2007 Pharmacist Japan
Primary
Secondary
Concomitant
X-ray Abnormal Other Serious 6/3/2007 68 Female 10/6/2007 Japan
Primary
Secondary
Concomitant
Hypogammaglobulinaemia Required Intervention 3 Male 9/26/2007 Japan
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 6/10/2007 Female 335 lb 10/19/2007 United Kingdom
Primary
Concomitant
Sepsis Death 3/30/2006 5 Male 33 lb 10/17/2007 Physician Japan
Primary
Concomitant
Metabolic Acidosis Other Serious 0 Male 11/1/2007 Japan
Primary
Secondary
Concomitant
Metabolic Acidosis Other Serious 0 Male 11/13/2007 Japan
Primary
Secondary
Concomitant
Urosepsis Life Threatening 6/10/2007 Female 335 lb 12/7/2007 United Kingdom
Primary
Concomitant
Gingival Hypertrophy Disability 1/1/2004 5 Female 12/14/2007 Other Health Professional France
Primary
Concomitant
Suicide Attempt Life Threatening 11/29/2007 40 Male 12/11/2007 Physician Germany
Primary
Secondary
Status Epilepticus Hospitalization 41 Female 12/24/2007 Japan
Primary
Concomitant
Status Epilepticus Other Serious 41 Female 12/28/2007 Japan
Primary
Concomitant
Interacting
Metabolic Acidosis Other Serious 0 Male 2/15/2008 Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 11 Male 3/25/2008 Physician Japan
Primary
Secondary
Concomitant
Fall Other Serious 2/13/2008 47 Female 4/4/2008 Physician Japan
Primary
Secondary
Concomitant
Femoral Neck Fracture Hospitalization 11/10/2006 5 Male 33 lb 4/8/2008 Physician Japan
Primary
Concomitant
Rhabdomyolysis Hospitalization 16 Female 6/3/2008 Japan
Primary
Secondary
Concomitant
Feeling Abnormal Other Serious 2/8/2005 57 Male 6/9/2008 United States
Primary
Secondary
Concomitant
Ventricular Extrasystoles Hospitalization 16 Female 6/13/2008 Japan
Primary
Secondary
Concomitant
Tendonitis Other Serious 16 Male 7/9/2008 France
Primary
Secondary
Rhabdomyolysis Other Serious 11/1/2007 16 Female 62 lb 8/15/2008 Physician Japan
Primary
Secondary
Concomitant
Reye's Syndrome Other Serious 5 Male 8/19/2008 Spain
Primary
Secondary
Epilepsy Other Serious 72 Female 8/21/2008 Physician Germany
Primary
Concomitant
Tetany Other Serious 17 Female 128 lb 8/22/2008 Other Health Professional Turkey
Primary
Secondary
Concomitant
Systemic Lupus Erythematosus Other Serious 19 Female 95 lb 9/4/2008 Japan
Primary
Secondary
Systemic Lupus Erythematosus Other Serious 19 Female 95 lb 9/12/2008 Japan
Primary
Secondary
Reye's Syndrome Other Serious 5 Male 9/16/2008 Albania
Primary
Secondary
Systemic Lupus Erythematosus Other Serious 19 Female 95 lb 9/25/2008 Japan
Primary
Secondary
Neurectomy Other Serious 36 Male 10/14/2008 Other Health Professional Germany
Primary
Secondary
Femoral Neck Fracture Hospitalization 11/10/2006 5 Male 33 lb 10/27/2008 Physician Japan
Primary
Concomitant
Multiple Drug Overdose Intentional Life Threatening 3/28/2008 37 Female 11/19/2008 Physician France
Primary
Concomitant
Multiple Drug Overdose Intentional Life Threatening 3/28/2008 37 Female 11/26/2008 Physician France
Primary
Concomitant
Status Epilepticus Death 12/27/2008 7 Female 37 lb 2/3/2009 Physician Japan
Primary
Concomitant
Status Epilepticus Death 7 Female 37 lb 2/6/2009 Physician Japan
Primary
Concomitant
Pyrexia Death 7 Female 37 lb 2/23/2009 Physician Japan
Primary
Concomitant
Urine Output Decreased Other Serious 1/14/2009 28 Male 3/6/2009 Consumer Switzerland
Primary
Concomitant
Liver Transplant Required Intervention 33 Female 3/2/2009 United Kingdom
Primary
Concomitant
Drug Interaction Hospitalization 12/5/2008 60 Female 3/11/2009 Physician United Kingdom
Primary
Concomitant
Interacting
Drug Interaction Other Serious 12/5/2008 60 Female 3/17/2009 Other Health Professional France
Primary
Concomitant
Interacting
Reye's Syndrome Hospitalization 5 Male 4/27/2009 Albania
Primary
Concomitant
Atrioventricular Block Complete Life Threatening 1/1/2005 57 Male 6/16/2009 Physician Japan
Primary
Secondary
Respiratory Distress Other Serious 8/20/2009 3 Male 10/7/2009 Other Health Professional United States
Primary
Concomitant
Osteomalacia Other Serious 3/1/2008 40 Female 2/4/2010 Other Health Professional Japan
Primary
Concomitant
Vomiting Hospitalization 14 Female 3/30/2010 Other Health Professional United States
Primary
Secondary
Peritonitis Sclerosing Hospitalization 14 Female 4/6/2010 Physician United States
Primary
Secondary
Peritonitis Sclerosing Hospitalization 14 Female 4/6/2010 Physician United States
Primary
Secondary
Peritonitis Sclerosing Hospitalization 14 Female 4/6/2010 Physician United States
Primary
Secondary
Peritonitis Sclerosing Hospitalization 1/1/2010 14 Female 4/7/2010 Physician United States
Primary
Secondary
Urinary Retention Other Serious 29 Male 4/12/2010 Other Health Professional China
Primary
Concomitant
Interacting
Respiratory Distress Hospitalization 14 Female 4/12/2010 France
Primary
Secondary
Concomitant
Pancreatitis Acute Death 4/11/2010 6 Female 7/9/2010 Physician Japan
Primary
Secondary
Concomitant
Pancreatitis Acute Death 4/11/2010 6 Female 7/15/2010 Physician Japan
Primary
Secondary
Concomitant
Hyperammonaemic Encephalopathy Life Threatening 5 Male 8/2/2010 Other Health Professional India
Primary
Interacting
Pancreatitis Acute Death 4/11/2010 6 Female 9/2/2010 Physician Japan
Primary
Secondary
Concomitant
Hyperammonaemic Encephalopathy Other Serious 5 Male 9/9/2010
Primary
Secondary
Psychomotor Retardation Hospitalization 7/21/2007 37 Female 129 lb 1/31/2011 Other Health Professional Korea, Republic Of
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
Cytolytic Hepatitis Hospitalization 10/28/2010 Male 18 lb 6/2/2011 Other Health Professional France
Primary
Secondary
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 6/8/2011 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
Renal Failure Death Female 6/17/2011 Other Health Professional United Kingdom
Primary
Secondary
Gliosis Other Serious 5 Male 6/13/2011 Other Health Professional India
Primary
Concomitant
Duodenal Ulcer Hospitalization 3/28/2011 56 Female 220 lb 6/28/2011 Physician Ireland
Primary
Concomitant
Status Epilepticus Other Serious 6/1/2011 23 Male 7/6/2011 Pharmacist Japan
Primary
Concomitant
Abdominal Discomfort Hospitalization 3/1/2011 56 Female 220 lb 7/13/2011 Pharmacist Ireland
Primary
Concomitant
Wrist Deformity Hospitalization 27 Female 7/26/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Status Epilepticus Death Female 8/8/2011 Other Health Professional United Kingdom
Primary
Concomitant
Status Epilepticus Death Female 8/10/2011 Other Health Professional United Kingdom
Primary
Secondary
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
Pancreatitis Death Female 8/24/2011 Other Health Professional United Kingdom
Primary
Secondary
Status Epilepticus Hospitalization 8/7/2011 10 Male 42 lb 8/26/2011 Physician Japan
Primary
Concomitant
Interacting
Anaemia Hospitalization 9 Female 8/23/2011 Other Health Professional
Primary
Concomitant
Dyskinesia Other Serious 8/1/2007 4 Male 8/31/2011 Other Health Professional Ireland
Primary
Secondary
Concomitant
Hypokalaemia Other Serious 60 Female 9/1/2011 Physician Japan
Primary
Concomitant
Death Death Female 9/15/2011 Other Health Professional United Kingdom
Primary
Concomitant
Status Epilepticus Hospitalization 7/1/2011 2 Male 9/22/2011 Physician Ireland
Primary
Concomitant
Cardio-respiratory Arrest Hospitalization 9/7/2011 8 9/26/2011 Physician Japan
Primary
Secondary
Monocyte Count Increased Other Serious 9/10/2010 45 Female 10/5/2011 Physician Japan
Primary
Concomitant
Psychomotor Retardation Other Serious Male 10/24/2011 Other Health Professional India
Primary
Secondary
Concomitant
Single Photon Emission Computerised Tomogram Abnormal Hospitalization 1 Female 11/8/2011 Other Health Professional Japan
Primary
Secondary
Abdominal Discomfort Hospitalization 3/1/2011 56 Female 220 lb 11/11/2011 Physician Ireland
Primary
Concomitant
Drug Interaction Other Serious 15 Female 11/15/2011 Other Health Professional Czech Republic
Primary
Secondary
Drug Rash With Eosinophilia And Systemic Symptoms Hospitalization 54 Male 12/6/2011 Other Health Professional Tunisia
Primary
Secondary
Delirium Other Serious 15 Female 12/13/2011 Other Health Professional Czech Republic
Primary
Secondary
Rash Pruritic Hospitalization 50 Female 12/16/2011 Physician China
Primary
Concomitant
Heart Rate Decreased Death 4/1/2010 6 Female 57 lb 12/22/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Status Epilepticus Hospitalization 8/7/2011 10 Male 42 lb 1/12/2012 Physician Japan
Primary
Concomitant
Interacting
Bradycardia Hospitalization 8/1/2010 3 Female 29 lb 1/26/2012 Other Health Professional Australia
Primary
Secondary
Psychiatric Symptom Other Serious 10/10/2011 45 Female 2/1/2012 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 7/16/2011 54 Male 2/9/2012 Other Health Professional Japan
Primary
Secondary
Acidosis Death 4/1/2010 6 Female 57 lb 2/7/2012 Other Health Professional Japan
Primary
Secondary
Concomitant
Adverse Event Hospitalization 10/21/2011 79 Female 115 lb 2/15/2012 Physician Japan
Primary
Secondary
Concomitant
Convulsion Other Serious 1 2/16/2012 Other Health Professional Turkey
Primary
Concomitant
Platelet Count Decreased Hospitalization 1/9/2012 8 Male 62 lb 2/21/2012 Physician Japan
Primary
Concomitant
Rhabdomyolysis Other Serious 7/16/2011 54 Male 2/22/2012 Other Health Professional Japan
Primary
Secondary
C-reactive Protein Increased Hospitalization 1/9/2012 8 Male 62 lb 2/27/2012 Physician Japan
Primary
Concomitant
Dizziness Other Serious 10/10/2011 45 Female 3/2/2012 Physician Japan
Primary
Secondary
Concomitant
Rhabdomyolysis Other Serious 7/16/2011 54 Male 3/14/2012 Other Health Professional Japan
Primary
Secondary
Psychiatric Symptom Other Serious 10/10/2011 45 Female 3/16/2012 Physician Japan
Primary
Secondary
Concomitant

Drug Data