Phenobarbital Tab combined with Valproic Acid

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Unevaluable Event Other Serious 39 Female 159 lb 1/23/2006 Netherlands
Primary
Secondary
Concomitant
Urine Calcium Increased Other Serious 38 Male 1/23/2006 Other Health Professional Netherlands
Primary
Secondary
Liver Disorder Hospitalization 54 Female 1/30/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Grand Mal Convulsion Other Serious 38 Male 187 lb 2/1/2006 Physician Netherlands
Primary
Secondary
Concomitant
Rhabdomyolysis Death 36 Female 2/28/2006 Other Health Professional Lebanon
Primary
Concomitant
Renal Tubular Disorder Other Serious 2/1/2004 15 Male 3/31/2006 France
Primary
Concomitant
Rhabdomyolysis Hospitalization 31 Female 7/28/2006 Physician Japan
Primary
Secondary
Concomitant
Therapy Non-responder Other Serious 40 Male 11/9/2006 Physician Brazil
Primary
Secondary
Concomitant
Tubulointerstitial Nephritis Other Serious 6/1/2005 76 Female 2/9/2007 Physician France
Primary
Secondary
Rhabdomyolysis Other Serious 19 Male 3/5/2007 France
Primary
Concomitant
Hepatotoxicity Other Serious 10 Female 3/5/2007 France
Primary
Concomitant
Cardio-respiratory Arrest Death 1/1/2004 45 Unknown 3/22/2007 Pharmacist United States
Primary
Secondary
Pancreatitis Acute Other Serious 11 Male 3/29/2007 France
Primary
Concomitant
Epilepsy Other Serious 16 Male 3/27/2007 Other Health Professional Brazil
Primary
Concomitant
Rhabdomyolysis Death 36 Female 6/18/2007 Other Health Professional United States
Primary
Concomitant
Convulsion Other Serious 7/27/2007 1 Male 18 lb 8/3/2007 Consumer Brazil
Primary
Concomitant
Drug Ineffective Hospitalization 30 Male 8/24/2007 Serbia
Primary
Secondary
Pyothorax Hospitalization 10 Female 8/30/2007 Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Life Threatening 6/11/2006 14 Female 9/6/2007 Physician United States
Primary
Concomitant
White Blood Cell Count Increased Other Serious 1/1/2006 14 Female 125 lb 9/26/2007 Physician United States
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 1/1/2006 14 Female 125 lb 10/2/2007 Physician United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 12 Male 10/17/2007
Primary
Secondary
Concomitant
Coma Hospitalization 10/25/2007 Female 88 lb 11/6/2007 Physician Romania
Primary
Concomitant
Coma Hospitalization 10/25/2007 Female 88 lb 11/20/2007 Physician Romania
Primary
Concomitant
Somnolence Other Serious 11/16/2007 50 Female 12/5/2007 Physician El Salvador
Primary
Concomitant
Coma Hospitalization 10/25/2007 Female 88 lb 12/7/2007 Physician Romania
Primary
Concomitant
Somnolence Other Serious 11/16/2007 50 Female 12/14/2007 Physician El Salvador
Primary
Concomitant
Malaise Other Serious 6/2/2005 1 Male 22 lb 12/20/2007 Physician France
Primary
Concomitant
Weight Increased Other Serious 1/1/2007 Female 126 lb 12/31/2007 Consumer United States
Primary
Secondary
Concomitant
Leukaemoid Reaction Other Serious 2 Female 3/6/2008 France
Primary
Concomitant
Withdrawal Syndrome Other Serious 3/1/2008 31 Male 143 lb 3/27/2008 Consumer Brazil
Primary
Concomitant
Human Herpesvirus 6 Infection Other Serious 34 Male 4/22/2008 Netherlands
Primary
Concomitant
Respiratory Arrest Other Serious 45 6/19/2008 Physician United States
Primary
Secondary
White Blood Cell Count Abnormal Other Serious 6/9/2008 34 Male 6/19/2008 Tunisia
Primary
Concomitant
Ventricular Septal Defect Congenital Anomaly Male 6 lb 7/8/2008 Physician Mexico
Primary
Secondary
Concomitant
Vesicoureteric Reflux Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Vesicoureteric Reflux Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Vesicoureteric Reflux Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Vesicoureteric Reflux Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Vesicoureteric Reflux Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Vesicoureteric Reflux Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Vesicoureteric Reflux Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Vesicoureteric Reflux Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Vesicoureteric Reflux Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Vesicoureteric Reflux Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Tracheo-oesophageal Fistula Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Tracheo-oesophageal Fistula Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Tracheo-oesophageal Fistula Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Tracheo-oesophageal Fistula Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Tracheo-oesophageal Fistula Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Tracheo-oesophageal Fistula Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Tracheo-oesophageal Fistula Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Tracheo-oesophageal Fistula Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Tracheo-oesophageal Fistula Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Tracheo-oesophageal Fistula Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Tracheo-oesophageal Fistula Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Tracheo-oesophageal Fistula Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Tracheo-oesophageal Fistula Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Pancreatitis Necrotising Death 9/29/2008 Female 44 lb 10/8/2008 Pharmacist United States
Primary
Concomitant
Vomiting Hospitalization 5 Male 10/24/2008 Other Health Professional Albania
Primary
Secondary
Calculus Bladder Hospitalization 30 Female 10/24/2008 Japan
Primary
Concomitant
Vision Blurred Hospitalization 12/14/2007 Male 52 lb 11/4/2008 Other Health Professional Brazil
Primary
Concomitant
Liver Disorder Other Serious 34 Male 11/3/2008 Tunisia
Primary
Concomitant
Calculus Bladder Hospitalization Female 11/19/2008 Japan
Primary
Concomitant
Convulsion Other Serious 52 Male 12/8/2008 Pharmacist United States
Primary
Concomitant
Convulsion Other Serious 51 Female 12/8/2008 Pharmacist United States
Primary
Concomitant
Convulsion Other Serious 57 Female 12/8/2008 Pharmacist United States
Primary
Concomitant
Convulsion Other Serious 55 Female 12/8/2008 Pharmacist United States
Primary
Concomitant
Somnolence Other Serious 11/26/2008 6 53 lb 12/8/2008 Physician Brazil
Primary
Secondary
Therapeutic Agent Toxicity Required Intervention 19 Male 1/19/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Fibromatosis Other Serious 42 Male 1/28/2009 Switzerland
Primary
Secondary
Epilepsy Other Serious 6/2/2005 1 Male 22 lb 3/6/2009 Italy
Primary
Concomitant
Encephalitis Herpes Hospitalization 1 Male 3/13/2009 Japan
Primary
Secondary
Concomitant
Vision Blurred Other Serious 3 Male 4/28/2009 Other Health Professional Germany
Primary
Secondary
Inappropriate Antidiuretic Hormone Secretion Other Serious 71 Female 1/12/2010 Other Health Professional Netherlands
Primary
Concomitant
Weight Decreased Other Serious 88 Female 1/12/2010 Netherlands
Primary
Concomitant
No Therapeutic Response Hospitalization 9 Male 1/21/2010 Physician United States
Primary
Concomitant
Ischaemic Cerebral Infarction Life Threatening 6 Male 53 lb 2/5/2010 Other Health Professional Canada
Primary
Concomitant
Peritonitis Sclerosing Other Serious 14 Female 3/23/2010 United States
Primary
Secondary
Hepatotoxicity Other Serious 3 Female 3/22/2010 Other Health Professional United States
Primary
Concomitant
Peritonitis Sclerosing Other Serious 14 Female 3/26/2010 Other Health Professional United States
Primary
Secondary
Metabolic Acidosis Other Serious 9 Female 4/7/2010 Physician United States
Primary
Concomitant
White Blood Cell Count Increased Hospitalization 14 Female 4/6/2010 Other Health Professional United States
Primary
Concomitant
Renal Tubular Disorder Other Serious 3/1/2008 40 Female 4/26/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Tubular Disorder Other Serious 3/1/2008 40 Female 5/7/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Pancreatitis Acute Hospitalization 10/24/2008 15 Male 6/22/2010 Physician Japan
Primary
Secondary
Concomitant
Protrusion Tongue 13 Male 6/15/2010 Consumer United States
Primary
Concomitant
Pancreatitis Acute Hospitalization 10/24/2008 15 Male 8/4/2010 Physician Japan
Primary
Secondary
Concomitant
Grand Mal Convulsion Life Threatening 10 Female 8/11/2010 Other Health Professional China
Primary
Secondary
Concomitant
Somnolence Female 8/20/2010 Consumer United States
Primary
Interacting
Pyrexia Hospitalization 30 Female 8/13/2010 Other Health Professional Italy
Primary
Secondary
Concomitant
Pneumonia Aspiration Life Threatening 7/9/2010 8 Male 8/20/2010 Other Health Professional United Kingdom
Primary
Concomitant
Somnolence Hospitalization 28 Female 11/30/2010 Other Health Professional Iran (Islamic Republic Of)
Primary
Secondary
Somnolence Hospitalization 28 Female 11/30/2010 Other Health Professional Iran (Islamic Republic Of)
Primary
Secondary
Somnolence Hospitalization 28 Female 11/30/2010 Other Health Professional Iran (Islamic Republic Of)
Primary
Secondary
Visual Acuity Reduced Other Serious 2 Male 12/8/2010 Canada
Primary
Concomitant
Aspartate Aminotransferase Increased Other Serious 34 Male 1/24/2011 Physician Tunisia
Primary
Secondary
Concomitant
Completed Suicide Death 42 Male 3/3/2011 Physician United States
Primary
Secondary
Smooth Muscle Antibody Positive Hospitalization 6 Male 3/25/2011 Other Health Professional Portugal
Primary
Secondary
Tonsillitis Hospitalization 6 Male 4/4/2011 Other Health Professional Portugal
Primary
Secondary
Amnestic Disorder Other Serious 71 Male 5/3/2011 Physician Germany
Primary
Secondary
Concomitant
Bronchopneumonia Other Serious 10/1/2010 Male 20 lb 5/26/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Cheilitis Hospitalization 6 Male 5/31/2011 Other Health Professional Portugal
Primary
Secondary
Acute Hepatic Failure Death 7/14/2010 7 Female 5/31/2011 Other Health Professional France
Primary
Secondary
Concomitant
Status Epilepticus Death Female 6/7/2011 Other Health Professional United Kingdom
Primary
Secondary
Pneumonia Life Threatening Female 154 lb 5/3/2011 Pharmacist United States
Primary
Secondary
Concomitant
Complex Partial Seizures Other Serious 8 Male 6/2/2011 Other Health Professional Italy
Primary
Concomitant
Mitochondrial Enzyme Deficiency Death Female 6/14/2011 Other Health Professional United Kingdom
Primary
Concomitant
Mitochondrial Enzyme Deficiency Death Female 6/20/2011 Other Health Professional United Kingdom
Primary
Concomitant
Musculoskeletal Pain Other Serious 22 Male 6/13/2011 Other Health Professional United States
Primary
Concomitant
Haematocrit Decreased Other Serious 9/10/2009 21 Female 6/24/2011 Physician Japan
Primary
Concomitant
Rash Hospitalization 76 Female 7/14/2011 Other Health Professional Taiwan, Province Of China
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization Female 7/18/2011 Other Health Professional Germany
Primary
Concomitant
Rhabdomyolysis Hospitalization Female 7/19/2011 Physician Germany
Primary
Concomitant
Rhabdomyolysis Other Serious Female 7/21/2011 Other Health Professional Germany
Primary
Concomitant
Ammonia Increased Other Serious Female 7/18/2011 Other Health Professional
Primary
Secondary
Rhabdomyolysis Other Serious Female 7/28/2011 Other Health Professional Germany
Primary
Concomitant
Drug Ineffective Life Threatening 2 Male 8/2/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Hepatic Function Abnormal Other Serious 11 Male 8/2/2011 Other Health Professional Japan
Primary
Concomitant
Rhabdomyolysis Other Serious 4/13/2011 13 Male 8/12/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Status Epilepticus Death Female 8/15/2011 Other Health Professional United Kingdom
Primary
Secondary
Renal Tubular Disorder Hospitalization 8 Female 51 lb 8/26/2011 Physician Japan
Primary
Concomitant
Dyskinesia Other Serious 8/1/2007 4 Male 8/31/2011 Other Health Professional Ireland
Primary
Secondary
Concomitant
Hypothermia Hospitalization 5/3/2011 64 Male 9/2/2011 Physician France
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
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
Aphasia Hospitalization 1/1/2002 40 Female 151 lb 9/12/2011 Physician Spain
Primary
Interacting
Incorrect Route Of Drug Administration Other Serious 5 Female 9/12/2011 Other Health Professional Turkey
Primary
Secondary
Hallucination Life Threatening 15 Female 9/16/2011 Other Health Professional Czech Republic
Primary
Interacting
Status Epilepticus Death 7/14/2010 7 Female 9/19/2011 Other Health Professional France
Primary
Secondary
Concomitant
Aphasia Hospitalization 1/1/2002 40 Female 151 lb 9/23/2011 Physician Spain
Primary
Interacting
Myoclonus Hospitalization Female 6 lb 9/30/2011 Physician United States
Primary
Secondary
Anaemia Hospitalization 5/10/2011 8 Male 10/4/2011 Physician Japan
Primary
Secondary
Concomitant
Hyperammonaemia Hospitalization 15 Female 10/6/2011 Other Health Professional Czech Republic
Primary
Interacting
Rhabdomyolysis Other Serious 4/13/2011 13 Male 10/12/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Ileus Death 1/1/2008 38 Male 10/14/2011 Physician Japan
Primary
Secondary
Wrong Technique In Drug Usage Process Disability 5/10/2011 8 Male 10/21/2011 Physician Japan
Primary
Secondary
Concomitant
Apallic Syndrome Hospitalization Male 10/24/2011 Physician Japan
Primary
Secondary
Concomitant
Cardio-respiratory Arrest Death 38 Male 10/14/2011 Consumer Japan
Primary
Concomitant
Respiratory Depression Death 1/1/2007 38 Male 10/25/2011 Consumer Japan
Primary
Concomitant
Abnormal Faeces Hospitalization 6/26/2007 38 Male 181 lb 12/8/2011 Physician Japan
Primary
Secondary
Concomitant
Ileus Paralytic Life Threatening 6/28/2007 38 Male 181 lb 12/9/2011 Physician Japan
Primary
Concomitant
Interacting
Intestinal Obstruction Hospitalization 6/26/2007 38 Male 181 lb 12/14/2011 Physician Japan
Primary
Secondary
Concomitant
Sepsis Life Threatening 6/28/2007 38 Male 181 lb 12/16/2011 Physician Japan
Primary
Concomitant
Interacting
Sepsis Death 6/27/2007 38 Male 181 lb 12/13/2011 Consumer Japan
Primary
Concomitant
Rhabdomyolysis Disability 4/13/2011 13 Male 12/23/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Postresuscitation Encephalopathy Life Threatening 6/27/2007 38 Female 12/27/2011 Physician Japan
Primary
Secondary

Drug Data