Phenobarbital combined with Valproic Acid

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Petit Mal Epilepsy Other Serious 3 Male 6/27/2006 Physician Italy
Primary
Concomitant
Haemodynamic Instability Required Intervention 9 Male 8/31/2006 Physician Belgium
Primary
Concomitant
Drug Level Decreased Other Serious 0 Female 3/27/2009 Other Health Professional Spain
Primary
Interacting
Encephalitis Herpes Hospitalization 1 Male 3/27/2009 Japan
Primary
Secondary
Concomitant
Speech Disorder Hospitalization 1/1/2005 Male 4/17/2009 Physician Germany
Primary
Secondary
Concomitant
Status Epilepticus Hospitalization 34 Male 4/21/2009 Other Health Professional Japan
Primary
Concomitant
Speech Disorder Hospitalization 1/1/2005 Male 4/28/2009 Physician Germany
Primary
Secondary
Concomitant
Hepatomegaly Other Serious 13 Female 110 lb 5/11/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Hepatomegaly Other Serious 13 Female 6/18/2009 Physician United States
Primary
Secondary
Concomitant
Diabetic Retinopathy Other Serious 6/23/2003 31 Male 248 lb 7/14/2009 United States
Primary
Concomitant
Vomiting Other Serious 8/1/2009 33 Male 8/12/2009 Consumer United States
Primary
Concomitant
Splenomegaly Other Serious 18 Male 8/28/2009 Other Health Professional Serbia
Primary
Secondary
Concomitant
Stevens-johnson Syndrome Other Serious 12/1/2002 53 Male 8/28/2009
Primary
Secondary
Myoclonus Other Serious 19 Female 9/8/2009 Other Health Professional Japan
Primary
Concomitant
Propofol Infusion Syndrome Death 37 Male 9/14/2009 Pharmacist United States
Primary
Concomitant
Vomiting Other Serious 8/1/2009 Male 9/21/2009 Physician United States
Primary
Concomitant
Myoclonus Other Serious 19 Female 10/2/2009 Other Health Professional Japan
Primary
Concomitant
Maternal Drugs Affecting Foetus Congenital Anomaly 6/23/2009 9/29/2009 Physician Italy
Primary
Concomitant
Splenomegaly Other Serious 18 Male 10/21/2009 Other Health Professional Serbia
Primary
Secondary
Concomitant
Vomiting Hospitalization 11/4/2009 9 Male 66 lb 11/18/2009 Physician Spain
Primary
Concomitant
Nystagmus Other Serious 5 Female 11/27/2009 Physician Israel
Primary
Secondary
Concomitant
Vomiting Hospitalization 11/4/2009 9 Male 66 lb 12/4/2009 Physician Spain
Primary
Concomitant
Urinary Tract Infection Hospitalization 11/27/2009 Male 1/27/2010 Consumer United States
Primary
Concomitant
Urinary Tract Malformation Congenital Anomaly 1/1/2009 3/9/2010 Other Health Professional Israel
Primary
Secondary
Peritonitis Sclerosing Other Serious 14 Female 4/23/2010 Other Health Professional United States
Primary
Secondary
Metabolic Acidosis Hospitalization 9 Female 4/26/2010
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Life Threatening 3/17/2000 7 Male 5/10/2010 Brazil
Primary
Concomitant
Coma Hospitalization 1 Female 5/11/2010 Other Health Professional Japan
Primary
Concomitant
Metabolic Acidosis Hospitalization 9 Female 5/8/2010 Physician United States
Primary
Concomitant
Somnolence Other Serious 76 Female 6/1/2010 Other Health Professional France
Primary
Secondary
Concomitant
Somnolence Other Serious 76 Female 6/1/2010 Other Health Professional France
Primary
Secondary
Concomitant
Somnolence Other Serious 76 Female 6/1/2010 Other Health Professional France
Primary
Secondary
Concomitant
Drug Effect Decreased Hospitalization Female 22 lb 6/22/2010 United States
Primary
Concomitant
Peritonitis Sclerosing Hospitalization 14 Female 4/6/2010 Other Health Professional United States
Primary
Concomitant
Overdose Other Serious 6 Male 8/3/2010 Other Health Professional China
Primary
Secondary
Concomitant
Myoclonus Other Serious 11 Male 8/6/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Drug Resistance Other Serious 3 Female 8/19/2010 Other Health Professional Germany
Primary
Secondary
Hepatic Adenoma Other Serious 8/25/2010 Other Health Professional United States
Primary
Secondary
Myoclonus Other Serious 11 Male 8/27/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 14 Female 8/10/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Surgery Other Serious 22 Male 8/30/2010 Other Health Professional United States
Primary
Secondary
Hyperammonaemic Encephalopathy Hospitalization 5 Male 9/3/2010 Other Health Professional India
Primary
Secondary
Concomitant
Hepatic Adenoma Other Serious 22 Male 9/9/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Hepatic Adenoma Other Serious 22 Male 9/13/2010 Other Health Professional United States
Primary
Secondary
Hepatic Adenoma Other Serious 22 Male 9/23/2010 Other Health Professional United States
Primary
Secondary
Peritonitis Sclerosing Other Serious 14 Female 9/28/2010 Other Health Professional United States
Primary
Secondary
Salivary Hypersecretion Death 20 Female 92 lb 10/27/2010 Pharmacist United States
Primary
Secondary
Concomitant
Vomiting Other Serious 9/28/2010 51 Female 113 lb 10/18/2010 Japan
Primary
Concomitant
Restlessness Other Serious 9/28/2010 51 Female 113 lb 10/15/2010 Japan
Primary
Concomitant
Epilepsy Other Serious 11/3/2010 Physician Netherlands
Primary
Interacting
Hyperammonaemic Encephalopathy Hospitalization 5 Male 11/4/2010 Other Health Professional India
Primary
Secondary
Concomitant
Viral Infection Hospitalization 8/20/2010 20 Male 121 lb 11/9/2010 Other Health Professional United States
Primary
Concomitant
Interacting
Epilepsy Other Serious 11/17/2010 Physician Netherlands
Primary
Interacting
Pyrexia Hospitalization 8/20/2010 20 Male 121 lb 11/24/2010 Philippines
Primary
Concomitant
Interacting
Pyrexia Hospitalization 8/20/2010 20 Male 121 lb 12/1/2010 Philippines
Primary
Concomitant
Interacting
Hyperammonaemia Other Serious 1 Male 12/1/2010 Other Health Professional Israel
Primary
Secondary
Concomitant
Speech Disorder Developmental Congenital Anomaly 23 Male 12/8/2010 Other Health Professional France
Primary
Concomitant
Tibia Fracture Other Serious 53 Male 122 lb 12/22/2010 Physician United States
Primary
Concomitant
Drug Rash With Eosinophilia And Systemic Symptoms Hospitalization 6 Male 1/7/2011 Other Health Professional Portugal
Primary
Secondary
Concomitant
Enanthema Other Serious 6 Male 1/7/2011 Other Health Professional Portugal
Primary
Secondary
Neutropenia Hospitalization 7/27/2010 30 Male 1/11/2011 Physician France
Primary
Concomitant
Hiccups 1/18/2011 Male 1/21/2011 Pharmacist United States
Primary
Concomitant
Drug Rash With Eosinophilia And Systemic Symptoms Other Serious 6 Male 1/24/2011 Other Health Professional Portugal
Primary
Secondary
Tibia Fracture Other Serious Male 122 lb 1/21/2011 Consumer United States
Primary
Concomitant
Acute Myocardial Infarction 1/4/2011 45 Male 1/7/2011 Other Health Professional Greece
Primary
Secondary
Concomitant
Drug Rash With Eosinophilia And Systemic Symptoms Other Serious 6 Male 2/2/2011 Other Health Professional Portugal
Primary
Secondary
Somnolence Other Serious 1/26/2011 Other Health Professional China
Primary
Concomitant
Chest Discomfort Hospitalization 1/4/2011 45 Male 2/8/2011 Physician Greece
Primary
Secondary
Concomitant
Drug Interaction Other Serious 3/14/2011 Physician Netherlands
Primary
Secondary
Interacting
Thrombocytopenia Other Serious 12/1/2010 27 Male 176 lb 6/22/2011 Physician Brazil
Primary
Secondary
Concomitant
Stevens-johnson Syndrome Other Serious 8/27/2004 1 Male 1/31/2012 Lawyer United States
Primary
Concomitant
Wrong Technique In Drug Usage Process 3/1/2011 62 Female 5/18/2012 Pharmacist United States
Primary
Secondary
Concomitant
Drug Intolerance 3/1/2011 62 Female 6/18/2012 Pharmacist United States
Primary
Secondary
Concomitant
Protrusion Tongue Other Serious 31 Female 7/9/2012 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Human Herpesvirus 6 Infection Other Serious 34 Male 1/11/2013 Nl
Primary
Concomitant
Hepatic Adenoma Other Serious 22 Male 9/6/2013 Other Health Professional Us
Primary
Secondary
Refusal Of Treatment By Relative Hospitalization 3/19/2011 3 Male 2/28/2013 Pharmacist Us
Primary
Concomitant
Drug Ineffective Other Serious 6 Male 10/16/2012 Physician Country Not Specified
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 1 Female 10/16/2012 Physician Country Not Specified
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 8 Female 10/16/2012 Physician Country Not Specified
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 17 Female 10/16/2012 Physician Country Not Specified
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 7 Male 10/16/2012 Physician Country Not Specified
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 20 Male 10/16/2012 Physician Country Not Specified
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 6 Female 10/16/2012 Physician Country Not Specified
Primary
Secondary
Concomitant
Injury Other Serious Male 8/16/2012 Other Health Professional Jp
Primary
Secondary
Concomitant
Head Injury Other Serious Male 8/16/2012 Other Health Professional Jp
Primary
Secondary
Concomitant
Head Injury Other Serious Female 8/16/2012 Other Health Professional Jp
Primary
Secondary
Concomitant
Head Injury Other Serious Female 8/16/2012 Other Health Professional Jp
Primary
Secondary
Concomitant
Toxicity To Various Agents Other Serious 20 Male 8/31/2012 Other Health Professional Country Not Specified
Primary
Secondary
Toxicity To Various Agents Other Serious 57 Female 11/1/2012 Physician Us
Primary
Secondary
Concomitant
Drug Ineffective Hospitalization 52 Female 9/15/2012 Physician Country Not Specified
Primary
Secondary
Concomitant
Toxicity To Various Agents Other Serious 20 Male 9/12/2012 Other Health Professional Cu
Primary
Secondary
No Therapeutic Response Other Serious 0 9/28/2012 Physician Es
Primary
Secondary
Concomitant
Hyperammonaemic Encephalopathy Hospitalization 42 Male 9/29/2012 Other Health Professional Co
Primary
Concomitant
Interacting
Potentiating Drug Interaction Hospitalization 45 Male 9/29/2012 Other Health Professional Co
Primary
Concomitant
Interacting
Potentiating Drug Interaction Hospitalization 32 Female 9/29/2012 Other Health Professional Co
Primary
Concomitant
Interacting
Ventricular Septal Defect Congenital Anomaly 10/3/2012 Physician Us
Primary
Secondary
Stevens-johnson Syndrome Other Serious 31 Male 104 lb 10/5/2012 Other Health Professional Jp
Primary
Secondary
Concomitant
Hyperammonaemic Encephalopathy Hospitalization 45 Male 10/18/2012 Physician Co
Primary
Interacting
Hyperammonaemic Encephalopathy Hospitalization 42 Male 10/18/2012 Physician Co
Primary
Concomitant
Interacting
Hyperammonaemic Encephalopathy Hospitalization 32 Female 10/19/2012 Physician Co
Primary
Secondary
Interacting
Convulsion Hospitalization 10/13/2012 15 Male 62 lb 12/21/2012 Physician Ve
Primary
Concomitant
Drug Hypersensitivity Female 10/28/2012 Physician Us
Primary
Secondary
Vomiting Hospitalization 31 Female 11/12/2012 Other Health Professional De
Primary
Secondary
Hyperammonaemic Encephalopathy Other Serious 32 Female 12/5/2012 Other Health Professional Co
Primary
Concomitant
Interacting
Hyperammonaemic Encephalopathy Other Serious 45 Male 12/5/2012 Other Health Professional Co
Primary
Concomitant
Interacting
Hyperammonaemic Encephalopathy Other Serious 42 Male 12/5/2012 Other Health Professional Co
Primary
Concomitant
Interacting
Nystagmus Hospitalization 42 Female 12/10/2012 Other Health Professional Jp
Primary
Secondary
Status Epilepticus Death 56 Female 12/12/2012 Other Health Professional Ar
Primary
Secondary
Concomitant
Interacting
Status Epilepticus Other Serious 56 Female 12/7/2012 Other Health Professional Ar
Primary
Secondary
Concomitant
Physical Disability Other Serious 36 Female 1/4/2013 Physician Ch
Primary
Secondary
Concomitant
Drug Ineffective For Unapproved Indication Other Serious 58 Male 1/4/2013 Physician Ch
Primary
Secondary
Concomitant
Hyperammonaemia Other Serious 25 Male 1/25/2013 Other Health Professional Kr
Primary
Interacting
Toxic Encephalopathy Other Serious 51 Female 1/25/2013 Other Health Professional Kr
Primary
Interacting
White Blood Cell Count Increased Hospitalization 19 Female 2/5/2013 Other Health Professional Ma
Primary
Secondary
Traumatic Intracranial Haemorrhage Hospitalization 1/15/2010 18 Male 121 lb 3/15/2013 Physician Ph
Primary
Concomitant
Status Epilepticus Death 2 Female 2/21/2013 Other Health Professional Jp
Primary
Secondary
Concomitant
Weight Decreased Other Serious NotSpecified 2/22/2013 Other Health Professional De
Primary
Concomitant
Status Epilepticus Other Serious 53 Male 2/6/2013 Other Health Professional Us
Primary
Secondary
Concomitant
Hepatic Enzyme Increased Other Serious 1 Male 2/27/2013 Physician Us
Primary
Concomitant
Neurological Decompensation Death 16 Female 3/15/2013 Other Health Professional De
Primary
Secondary
Rash Maculo-papular Other Serious 10 Male 4/11/2013 Other Health Professional Country Not Specified
Primary
Secondary
Hepatic Failure Death 6 Male 4/12/2013 Other Health Professional De
Primary
Secondary
Hepatic Failure Death 23 Male 4/24/2013 Physician De
Primary
Secondary
Drug Ineffective For Unapproved Indication Death 32 Male 4/29/2013 Physician Be
Primary
Secondary
Concomitant
Vertigo Other Serious 80 Female 5/6/2013 Other Health Professional De
Primary
Concomitant
Staphylococcus Test Positive Other Serious 36 Female 117 lb 5/3/2013 Pharmacist Us
Primary
Secondary
Vomiting Hospitalization 6 Male 6/11/2013 Other Health Professional Country Not Specified
Primary
Concomitant
Congenital Anomaly Congenital Anomaly NotSpecified 6/14/2013 Other Health Professional It
Primary
Secondary
Pancreatitis Acute Hospitalization 6 Male 44 lb 6/17/2013 Physician Tr
Primary
Concomitant
Respiratory Depression Other Serious NotSpecified 7/12/2013 Pharmacist Ca
Primary
Secondary
Concomitant
Overdose Death NotSpecified 7/31/2013 Physician Country Not Specified
Primary
Secondary
Drug Ineffective For Unapproved Indication Death 20 Female 8/2/2013 Physician Th
Primary
Concomitant
Brain Operation Hospitalization 7/24/2013 3 Male 8/2/2013 Consumer Us
Primary
Concomitant
Convulsion Other Serious 1/18/2012 Female 9/25/2013 Consumer Us
Primary
Concomitant
Stevens-johnson Syndrome Other Serious 4 Male 8/27/2013 Other Health Professional It
Primary
Secondary
Convulsion Hospitalization 2/29/2012 Male 8/12/2013 Other Health Professional Us
Primary
Concomitant
Hypoaesthesia Other Serious 32 Male 8/28/2013 Other Health Professional Pl
Primary
Secondary
Concomitant
Status Epilepticus Hospitalization 5 Female 49 lb 9/5/2013 Other Health Professional Kr
Primary
Concomitant
Interacting
Weight Increased Other Serious NotSpecified 10/11/2013 Other Health Professional Si
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 9/18/2012 71 Male 9/23/2013 Other Health Professional Cn
Primary
Secondary
Concomitant
Drug Ineffective 45 Female 9/30/2013 Physician Us
Primary
Secondary
Toxic Encephalopathy Other Serious 25 Male 9/25/2013 Other Health Professional Us
Primary
Secondary
Hyperammonaemic Encephalopathy 32 Female 9/25/2013 Us
Primary
Secondary
Concomitant
Potentiating Drug Interaction Other Serious 42 Male 9/25/2013 Other Health Professional Co
Primary
Secondary
Status Epilepticus Hospitalization 12 Male 10/4/2013 Physician Sk
Primary
Concomitant
Metabolic Acidosis Other Serious 36 Female 10/7/2013 Physician Es
Primary
Concomitant
Status Epilepticus Other Serious 10 Female 10/8/2013 Physician Us
Primary
Secondary
Concomitant
Hyperkinesia Other Serious 2/1/1978 16 Male 10/15/2013 Physician Us
Primary
Concomitant
Caesarean Section Other Serious 9/8/2013 21 Female 194 lb 10/18/2013 Physician Us
Primary
Concomitant

Drug Data