Phenytoin combined with Valproic Acid

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Multiple Congenital Abnormalities Other Serious 1/1/2005 6 Male 1/13/2006 Other Health Professional Finland
Primary
Secondary
Concomitant
Synostosis Other Serious 6 Male 1/23/2006 Other Health Professional Finland
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
Sputum Purulent Other Serious 46 Male 2/8/2006 Spain
Primary
Concomitant
Rash Maculo-papular Hospitalization 76 Male 4/27/2006 Pharmacist Singapore
Primary
Concomitant
Rheumatoid Factor Increased Hospitalization 67 Female 5/9/2006 Other Health Professional United States
Primary
Secondary
Drug Toxicity Hospitalization 1/10/2006 69 Female 99 lb 5/10/2006 Pharmacist Canada
Primary
Secondary
Concomitant
Hyperammonaemia Required Intervention 79 Male 8/29/2005 Other Health Professional United States
Primary
Concomitant
Status Epilepticus Hospitalization 17 Male 6/21/2006 Physician France
Primary
Secondary
Lethargy Hospitalization 5/16/2006 56 Male 157 lb 7/16/2006 Pharmacist United States
Primary
Concomitant
Sputum Culture Positive Other Serious 46 Male 8/18/2006 Other Health Professional Spain
Primary
Concomitant
Haemodynamic Instability Required Intervention 9 Male 8/31/2006 Physician Belgium
Primary
Concomitant
Loss Of Consciousness Other Serious 8/9/2006 54 Female 170 lb 9/7/2006 Pharmacist United States
Primary
Concomitant
Hepatitis Cholestatic Other Serious 70 Female 9/28/2006 Physician Singapore
Primary
Secondary
Wrist Fracture Other Serious 38 Male 10/4/2006 Pharmacist Canada
Primary
Concomitant
Tonsillar Disorder Hospitalization 40 Male 10/13/2006 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Tonsillar Hypertrophy Hospitalization 40 Male 12/19/2006 Korea, Republic Of
Primary
Secondary
Concomitant
Staphylococcal Scalded Skin Syndrome Hospitalization 11/24/2006 65 Female 1/22/2007 United Kingdom
Primary
Secondary
Anaemia Life Threatening 12/22/2006 48 Female 3/27/2007 Other Health Professional Spain
Primary
Secondary
Concomitant
Head Injury Other Serious 31 Female 5/4/2007 Hong Kong
Primary
Concomitant
Confusional State Hospitalization 9/29/2006 51 Female 3/14/2007 Consumer United States
Primary
Concomitant
Syndactyly Congenital Anomaly 0 6/9/2007 Taiwan, Province Of China
Primary
Secondary
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
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
Drug Ineffective Hospitalization 30 Male 8/24/2007 Serbia
Primary
Secondary
Pancytopenia Hospitalization 9 Male 8/25/2007 Korea, Republic Of
Primary
Secondary
Concomitant
Urine Ketone Body Present Death 36 Female 8/23/2007 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
Unresponsive To Stimuli Hospitalization 36 Female 135 lb 9/13/2007 Physician United States
Primary
Secondary
Concomitant
Hypoxic Encephalopathy Death Male 9/17/2007 Other Health Professional Germany
Primary
Concomitant
Neuroleptic Malignant Syndrome Hospitalization 1/1/2007 36 Female 10/17/2007 Physician United States
Primary
Secondary
Epilepsy Hospitalization 10/1/2007 55 Female 10/25/2007 Consumer Germany
Primary
Secondary
Status Epilepticus Life Threatening 9/3/2007 25 Female 11/12/2007 Other Health Professional Spain
Primary
Concomitant
Interacting
Unresponsive To Stimuli Other Serious 8/30/2006 Female 11/29/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Ventricular Tachycardia Death 18 Female 12/27/2007 Other Health Professional United States
Primary
Secondary
Nuclear Magnetic Resonance Imaging Brain Abnormal Other Serious 40 Male 1/7/2008 United Kingdom
Primary
Concomitant
Unresponsive To Stimuli Hospitalization 36 Female 135 lb 1/10/2008 Other Health Professional United States
Primary
Concomitant
Tachypnoea Hospitalization 2 Female 1/18/2008 Other Health Professional United Kingdom
Primary
Concomitant
Interacting
No Therapeutic Response Other Serious 60 Male 1/18/2008 Netherlands
Primary
Concomitant
Toxic Epidermal Necrolysis Life Threatening 10/27/2004 76 Female 2/29/2008 Physician Germany
Primary
Secondary
Concomitant
Drug Level Below Therapeutic Other Serious 25 Female 4/16/2008 Other Health Professional Spain
Primary
Interacting
Hypomania Hospitalization Female 4/25/2008 Pharmacist France
Primary
Concomitant
Vomiting Other Serious 1/1/1997 28 Female 5/12/2008 Lawyer France
Primary
Concomitant
Drug Level Below Therapeutic Other Serious 25 Female 5/15/2008 Other Health Professional Spain
Primary
Interacting
Gait Disturbance Hospitalization 11/1/2007 29 Male 5/10/2008 Pharmacist United States
Primary
Secondary
Status Epilepticus Life Threatening 9/3/2007 25 Female 5/16/2008 Other Health Professional Spain
Primary
Concomitant
Interacting
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
Grand Mal Convulsion Other Serious 3/1/1984 Female 5/30/2008 Physician France
Primary
Secondary
Concomitant
Transaminases Increased Other Serious 10/10/2003 Female 6/13/2008 France
Primary
Concomitant
Stevens-johnson Syndrome Life Threatening 8/1/2007 42 Male 130 lb 6/25/2008 Pharmacist United States
Primary
Concomitant
Ventricular Septal Defect Congenital Anomaly Male 6 lb 7/8/2008 Physician Mexico
Primary
Secondary
Concomitant
Cytolytic Hepatitis Hospitalization 5/11/2008 Female 8/1/2008 Other Health Professional France
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
Drug Interaction Death 12 Female 126 lb 8/6/2008 Other Health Professional Spain
Primary
Concomitant
Interacting
Status Epilepticus Other Serious 4 Female 9/19/2008 United States
Primary
Secondary
Hepatotoxicity Other Serious 4 9/23/2008 Consumer United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 3 Female 9/29/2008 United States
Primary
Secondary
Concomitant
Vision Blurred Hospitalization 12/14/2007 Male 52 lb 11/4/2008 Other Health Professional Brazil
Primary
Concomitant
Vitamin B6 Decreased Other Serious 1/1/2007 81 Female 99 lb 1/5/2009
Primary
Secondary
Concomitant
Status Epilepticus Other Serious 1/1/2007 81 Female 99 lb 1/5/2009
Primary
Secondary
Concomitant
Vomiting Other Serious 11/1/2003 24 Female 1/5/2009 Physician Canada
Primary
Concomitant
Therapeutic Agent Toxicity Required Intervention 19 Male 1/19/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Partial Seizures 36 Female 3/4/2009 United States
Primary
Secondary
Status Epilepticus Hospitalization 29 Male 3/14/2009 Other Health Professional Japan
Primary
Secondary
Sepsis Hospitalization Female 3/10/2009 Physician United Kingdom
Primary
Concomitant
Vision Blurred Other Serious 3 Male 4/28/2009 Other Health Professional Germany
Primary
Secondary
Convulsion Hospitalization 4/15/2009 59 5/8/2009 Physician Argentina
Primary
Concomitant
Hepatomegaly Other Serious 13 Female 110 lb 5/11/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Unresponsive To Stimuli Hospitalization 6 Male 5/7/2009 United States
Primary
Concomitant
Vision Blurred Other Serious 9/15/2008 45 Male 5/18/2009 Other Health Professional United Kingdom
Primary
Secondary
Weight Decreased Hospitalization Female 5/19/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Epilepsy Other Serious 3/27/2006 48 Male 5/20/2009 Netherlands
Primary
Concomitant
Weight Decreased Other Serious Female 6/1/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Weight Decreased Other Serious Female 6/1/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vision Blurred Other Serious 1/23/2009 45 Male 6/8/2009 Other Health Professional United Kingdom
Primary
Secondary
Vision Blurred Other Serious 1/23/2009 45 Male 6/8/2009 Other Health Professional United Kingdom
Primary
Secondary
Vision Blurred Other Serious 9/15/2008 45 Male 6/8/2009 Other Health Professional France
Primary
Secondary
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 24 Female 7/16/2009 Other Health Professional Canada
Primary
Concomitant
Subcutaneous Nodule Other Serious 8/4/2006 23 Female 154 lb 8/4/2009 Physician United States
Primary
Secondary
Concomitant
Wound Haemorrhage Death 69 Female 137 lb 8/11/2009 Other Health Professional Netherlands
Primary
Concomitant
Propofol Infusion Syndrome Death 37 Male 9/14/2009 Pharmacist United States
Primary
Concomitant
Drug Ineffective Other Serious 9/8/2009 Physician United States
Primary
Secondary
Drug Ineffective Other Serious 9/8/2009 Physician United States
Primary
Secondary
Drug Ineffective Other Serious 9/8/2009 Physician United States
Primary
Secondary
Subcutaneous Abscess Other Serious 9/18/2009 24 Male 174 lb 10/22/2009 Other Health Professional United Kingdom
Primary
Secondary
Peritonitis Death 40 10/30/2009 Colombia
Primary
Concomitant
Drug Ineffective Other Serious 11 Female 11/5/2009 Physician Spain
Primary
Concomitant
Neutropenia Hospitalization Female 12/1/2009 Physician Germany
Primary
Secondary
Tonic Convulsion Hospitalization Male 154 lb 12/3/2009 Germany
Primary
Concomitant
Subcutaneous Nodule Other Serious 8/4/2006 23 Female 154 lb 12/18/2009 Physician United States
Primary
Secondary
Concomitant
Subcutaneous Nodule Other Serious 8/4/2006 23 Female 154 lb 12/28/2009 Physician United States
Primary
Secondary
Concomitant
Febrile Neutropenia Required Intervention 10/19/2009 56 Female 151 lb 10/27/2009 United States
Primary
Secondary
Concomitant
Subcutaneous Nodule Other Serious 8/4/2006 23 Female 154 lb 12/31/2009 Physician United States
Primary
Secondary
Concomitant
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
Vision Blurred Other Serious 1/23/2009 45 Male 1/25/2010 Other Health Professional United Kingdom
Primary
Secondary
Vision Blurred Other Serious 1/23/2009 45 Male 1/25/2010 Other Health Professional United Kingdom
Primary
Secondary
Vision Blurred Other Serious 9/15/2008 45 Male 1/19/2010 United Kingdom
Primary
Concomitant
Ventricular Septal Defect Congenital Anomaly 2/9/2010 Other Health Professional United Kingdom
Primary
Secondary
Ventricular Septal Defect Congenital Anomaly 2/9/2010 Other Health Professional United Kingdom
Primary
Secondary
Ventricular Septal Defect Congenital Anomaly 2/16/2010 Other Health Professional United Kingdom
Primary
Secondary
Subcutaneous Abscess Other Serious 9/18/2009 24 Male 174 lb 3/8/2010 Other Health Professional United Kingdom
Primary
Secondary
Urinary Tract Malformation Congenital Anomaly 1/1/2009 3/9/2010 Other Health Professional Israel
Primary
Secondary
Haemolysis Hospitalization 4/2/2006 15 Female 3/18/2010 Other Health Professional Spain
Primary
Secondary
Haemolysis Hospitalization 4/2/2006 15 Female 3/18/2010 Other Health Professional Spain
Primary
Secondary
Metabolic Acidosis Other Serious 9 Female 4/7/2010 Physician United States
Primary
Concomitant
Vomiting Other Serious 8/1/2009 72 Female 4/15/2010 Netherlands
Primary
Secondary
Concomitant
Subcutaneous Nodule Other Serious 8/4/2006 23 Female 154 lb 4/22/2010 Physician United States
Primary
Secondary
Concomitant
Metabolic Acidosis Hospitalization 9 Female 4/26/2010
Primary
Secondary
Concomitant
Vomiting Other Serious 8/1/2009 72 Female 4/27/2010 Netherlands
Primary
Secondary
Concomitant
Coma Hospitalization 1 Female 5/11/2010 Other Health Professional Japan
Primary
Concomitant
Rash Hospitalization 33 Male 5/10/2010 Physician Japan
Primary
Concomitant
Metabolic Acidosis Hospitalization 9 Female 5/8/2010 Physician United States
Primary
Concomitant
Quadriplegia Other Serious 6 Male 5/17/2010 Physician Japan
Primary
Concomitant
Hypocalcaemia Hospitalization 57 Male 5/17/2010 Physician United States
Primary
Concomitant
Nervous System Disorder Other Serious 11 Female 6/1/2010 Other Health Professional United States
Primary
Concomitant
Death Death 4/11/2010 10 Female 6/10/2010 Other Health Professional United States
Primary
Concomitant
Therapeutic Agent Toxicity Other Serious 7/7/2010 26 Female 176 lb 8/2/2010 Physician Portugal
Primary
Secondary
Concomitant
Severe Mental Retardation Other Serious Male 7/26/2010 Physician Japan
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 Data