Clobazam combined with Valproic Acid

Reports:


Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Pyrexia Hospitalization 5/2/2003 36 Male 4/7/2006 Physician Japan
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 2/1/2006 Female 46 lb 4/18/2006 Physician Germany
Primary
Concomitant
Laryngospasm Other Serious 4/1/2005 Female 46 lb 4/18/2006 Physician Germany
Primary
Concomitant
Pyrexia Hospitalization 5/2/2003 36 Male 4/20/2006 Physician Japan
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 10/19/2005 8 Male 5/23/2006 Consumer Canada
Primary
Concomitant
Tachycardia Other Serious 4/26/2006 57 Female 5/31/2006 Consumer United Kingdom
Primary
Concomitant
Weight Increased Other Serious 3/1/2005 55 Female 160 lb 6/22/2006 Canada
Primary
Concomitant
Thrombocytopenia Hospitalization 5/1/2006 49 Female 6/14/2006 Physician Canada
Primary
Concomitant
Salivary Hypersecretion Other Serious 7 Male 6/27/2006 Physician Italy
Primary
Concomitant
Rash Hospitalization 5/1/2006 49 Female 6/26/2006 Physician Canada
Primary
Concomitant
Grand Mal Convulsion Other Serious 9/3/2002 Female 9/1/2006 Physician Germany
Primary
Secondary
Thrombocytopenia Other Serious 1/1/2006 50 Female 10/10/2006 Pharmacist Canada
Primary
Secondary
Concomitant
Treatment Noncompliance Hospitalization 4/1/2006 44 Female 12/22/2006 Other Health Professional France
Primary
Secondary
Concomitant
Treatment Noncompliance Hospitalization 4/1/2006 44 Female 12/30/2006 Other Health Professional France
Primary
Secondary
Concomitant
Weight Decreased Other Serious 23 Female 1/16/2007 Other Health Professional Chile
Primary
Concomitant
Treatment Noncompliance Hospitalization 4/1/2006 44 Female 2/9/2007 Other Health Professional France
Primary
Secondary
Concomitant
Spina Bifida Congenital Anomaly Female 3/9/2007 United Kingdom
Primary
Secondary
Head Injury Other Serious 31 Female 5/4/2007 Hong Kong
Primary
Concomitant
Blood Creatine Phosphokinase Increased Other Serious 7 Female 35 lb 5/11/2007 Israel
Primary
Concomitant
Pyrexia Hospitalization 5/2/2003 36 Male 6/26/2007 Physician Japan
Primary
Secondary
Concomitant
Convulsion Other Serious 7/27/2007 1 Male 18 lb 8/3/2007 Consumer Brazil
Primary
Concomitant
Pyrexia Hospitalization 5/2/2003 36 Male 8/7/2007 Physician Japan
Primary
Secondary
Concomitant
Weight Increased Other Serious 1/1/1997 Female 147 lb 12/7/2007 Consumer Canada
Primary
Secondary
Concomitant
Drug Interaction Other Serious 1/1/2007 54 Female 1/24/2008 Other Health Professional United Kingdom
Primary
Interacting
Gait Disturbance Other Serious 23 Male 2/12/2008 Other Health Professional France
Primary
Secondary
Concomitant
Gait Disturbance Other Serious 23 Male 2/26/2008 Other Health Professional France
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Life Threatening 4/18/2003 Female 3/19/2008 Germany
Primary
Secondary
Postpartum Haemorrhage Other Serious Female 5/9/2008 Physician France
Primary
Concomitant
Grand Mal Convulsion Other Serious 3/1/1984 Female 5/30/2008 Physician France
Primary
Secondary
Concomitant
Status Epilepticus Hospitalization 1 Male 5/30/2008 Netherlands
Primary
Concomitant
Aspartate Aminotransferase Increased Hospitalization 3 Female 6/2/2008 Netherlands
Primary
Concomitant
Renal Tubular Disorder Other Serious 10 Male 7/2/2008 Italy
Primary
Concomitant
Brain Neoplasm Other Serious 7/30/2008 Pharmacist Germany
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
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 Level Decreased Other Serious 4 Male 44 lb 8/5/2008 Pharmacist Spain
Primary
Concomitant
Interacting
Renal Tubular Disorder Other Serious 10 Male 8/5/2008 Italy
Primary
Concomitant
Drug Interaction Other Serious 4 Male 44 lb 8/8/2008 Pharmacist Spain
Primary
Concomitant
Interacting
Carnitine Deficiency Hospitalization 7 Female 8/15/2008 France
Primary
Secondary
Concomitant
Hypospadias Congenital Anomaly Male 6 lb 9/3/2008 United Kingdom
Primary
Secondary
Liver Injury Hospitalization 3 Female 9/3/2008 Physician Netherlands
Primary
Concomitant
Petit Mal Epilepsy Disability 7/2/2008 22 Female 119 lb 9/3/2008 Other Health Professional United Kingdom
Primary
Concomitant
Drug Toxicity Other Serious 23 Male 10/28/2008
Primary
Secondary
Epilepsy Disability 1/1/1999 Female 309 lb 11/3/2008 Consumer Netherlands
Primary
Concomitant
Peripheral Coldness Other Serious 11/4/2008 3 Female 24 lb 11/24/2008 Physician Mexico
Primary
Concomitant
Sleep Disorder Hospitalization 24 Male 1/29/2009 Other Health Professional Japan
Primary
Concomitant
Sweat Gland Disorder Hospitalization 2/23/2009 Other Health Professional United Kingdom
Primary
Interacting
Sweat Gland Disorder Hospitalization 9 Male 2/24/2009 Consumer United Kingdom
Primary
Secondary
Sweat Gland Disorder Hospitalization 9 Male 2/27/2009 Consumer United Kingdom
Primary
Secondary
Sleep Disorder Hospitalization 12/1/2005 Male 3/5/2009 Physician Japan
Primary
Concomitant
Sweat Gland Disorder Hospitalization 9 Male 3/6/2009 Consumer United Kingdom
Primary
Secondary
Encephalitis Herpes Hospitalization 1 Male 3/13/2009 Japan
Primary
Secondary
Concomitant
Encephalitis Herpes Hospitalization 1 Male 3/27/2009 Japan
Primary
Secondary
Concomitant
Stevens-johnson Syndrome Hospitalization 4 Male 4/14/2009 Physician Turkey
Primary
Secondary
Prothrombin Time Prolonged Hospitalization 7 Female 4/24/2009 Other Health Professional Netherlands
Primary
Concomitant
Toxic Epidermal Necrolysis Other Serious 4 6/8/2009 Physician Japan
Primary
Secondary
Toxic Epidermal Necrolysis Other Serious 10/17/2008 4 6/23/2009 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 24 Female 7/16/2009 Other Health Professional Canada
Primary
Concomitant
Somnolence 5/9/2009 14 Female 119 lb 7/27/2009 Physician United States
Primary
Concomitant
Status Epilepticus Hospitalization Male 165 lb 8/10/2009 Physician Netherlands
Primary
Concomitant
Myoclonus Other Serious 19 Female 9/8/2009 Other Health Professional Japan
Primary
Concomitant
Sweat Gland Disorder Other Serious 8 Male 9/15/2009 United Kingdom
Primary
Concomitant
Myoclonus Other Serious 19 Female 10/2/2009 Other Health Professional Japan
Primary
Concomitant
Hypospadias Other Serious Male 11/11/2009 United Kingdom
Primary
Secondary
Hypospadias Other Serious Male 11/16/2009 Other Health Professional United Kingdom
Primary
Secondary
Nystagmus Other Serious 5 Female 11/27/2009 Physician Israel
Primary
Secondary
Concomitant
Haemoglobin Decreased Other Serious Female 120 lb 12/3/2009 Canada
Primary
Concomitant
Hypospadias Other Serious Male 12/16/2009 Other Health Professional United Kingdom
Primary
Secondary
Sweat Gland Disorder Hospitalization 9 Male 1/4/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Coma Hospitalization 1/1/2009 9 Male 1/15/2010 Other Health Professional United Kingdom
Primary
Secondary
Urticaria Hospitalization 9 Male 1/18/2010 Consumer United Kingdom
Primary
Secondary
Haemoglobin Decreased Other Serious Female 120 lb 2/11/2010 Canada
Primary
Concomitant
Myoclonic Epilepsy Other Serious 5 Female 2/12/2010 Netherlands
Primary
Interacting
Abnormal Behaviour Hospitalization 12 Female 77 lb 3/11/2010 India
Primary
Concomitant
Abnormal Behaviour Hospitalization 12 Female 77 lb 3/16/2010 India
Primary
Concomitant
Restlessness Hospitalization 12 Female 77 lb 3/22/2010 India
Primary
Concomitant
Stillbirth Death 4/2/2010 United Kingdom
Primary
Secondary
Pseudomonas Infection Hospitalization 37 Male 5/12/2010 Netherlands
Primary
Secondary
Concomitant
Severe Mental Retardation Other Serious 15 Female 5/17/2010 Physician Japan
Primary
Concomitant
Pseudomonas Infection Hospitalization 37 Male 5/20/2010 Physician Netherlands
Primary
Secondary
Concomitant
Visual Impairment Hospitalization 72 Male 6/8/2010 Spain
Primary
Secondary
Concomitant
Fanconi Syndrome Other Serious 15 Female 6/10/2010 Physician Japan
Primary
Secondary
Encephalitis Other Serious 70 Female 6/18/2010 Other Health Professional United Kingdom
Primary
Secondary
Fanconi Syndrome Other Serious 15 Female 7/29/2010 Physician Japan
Primary
Secondary
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
Myoclonus Other Serious 11 Male 8/27/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Pneumonia Aspiration Life Threatening 7/9/2010 8 Male 8/20/2010 Other Health Professional United Kingdom
Primary
Concomitant
Respiratory Disorder Other Serious 14 Male 10/1/2010 Other Health Professional Japan
Primary
Secondary
Sweat Gland Disorder Hospitalization 9 Male 10/11/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Status Epilepticus Other Serious 7 Female 10/26/2010 Other Health Professional Japan
Primary
Concomitant
Tachycardia Other Serious 4/26/2006 57 Female 1/3/2011 Consumer United Kingdom
Primary
Concomitant
Speech Disorder Other Serious 21 Female 2/2/2011 Other Health Professional Denmark
Primary
Secondary
Concomitant
Psychomotor Skills Impaired Hospitalization Male 142 lb 2/24/2011 Germany
Primary
Concomitant
Drug Rash With Eosinophilia And Systemic Symptoms Other Serious 15 Female 4/15/2011 Other Health Professional Argentina
Primary
Concomitant
Maternal Drugs Affecting Foetus Congenital Anomaly 4/14/2011 Germany
Primary
Concomitant
Cardiac Siderosis Other Serious 6/11/2011 Canada
Primary
Concomitant
Feeding Disorder Disability 2 Male 6/15/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Asphyxia Death 29 Male 214 lb 6/22/2011 Other Health Professional United Kingdom
Primary
Concomitant
Product Substitution Issue Death 12/18/2010 29 Male 214 lb 6/27/2011 Other Health Professional United Kingdom
Primary
Concomitant
Urinary Tract Infection Hospitalization Male 8/8/2011 Physician United Kingdom
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
Fanconi Syndrome Hospitalization 2 Female 24 lb 8/26/2011 Physician Japan
Primary
Concomitant
Incorrect Route Of Drug Administration Hospitalization 10 Male 9/8/2011 Other Health Professional Turkey
Primary
Secondary
Petit Mal Epilepsy Other Serious 10 Female 11/9/2011 Other Health Professional Japan
Primary
Secondary
Petit Mal Epilepsy Other Serious 10 Female 11/8/2011 Other Health Professional Japan
Primary
Secondary
Petit Mal Epilepsy Other Serious 1/1/2006 10 Female 11/17/2011 Other Health Professional Japan
Primary
Secondary
Clonic Convulsion Other Serious 1/1/2006 10 Female 11/17/2011 Other Health Professional Japan
Primary
Secondary
Inappropriate Antidiuretic Hormone Secretion Other Serious 8 Male 1/3/2012 United States
Primary
Secondary
Concomitant
Epidermal Necrosis Other Serious 1/9/2012 Consumer Japan
Primary
Secondary
Convulsion Other Serious 6 Female 3/30/2012 Other Health Professional Japan
Primary
Secondary
Pemphigoid Hospitalization 4/4/2012 55 Female 119 lb 4/18/2012 Physician India
Primary
Concomitant
Cytomegalovirus Infection Hospitalization 14 Female 4/19/2012 Other Health Professional Japan
Primary
Secondary
Concomitant
Drug Rash With Eosinophilia And Systemic Symptoms Hospitalization 14 Female 4/19/2012 Other Health Professional Japan
Primary
Secondary
Concomitant
Epstein-barr Virus Infection Hospitalization 14 Female 4/19/2012 Other Health Professional Japan
Primary
Secondary
Concomitant
Asthenia Other Serious 46 Male 5/24/2012 Other Health Professional Canada
Primary
Secondary
Interacting
Cardiac Murmur Hospitalization Female 6 lb 5/28/2012 Physician Germany
Primary
Secondary
Concomitant
Congenital Arterial Malformation Congenital Anomaly Female 6 lb 5/28/2012 Physician Germany
Primary
Secondary
Concomitant
Small For Dates Baby Congenital Anomaly 10/13/2011 Female 6 lb 5/29/2012 Other Health Professional Germany
Primary
Secondary
Concomitant
Small For Dates Baby Hospitalization 10/13/2011 Female 6 lb 6/4/2012 Physician Germany
Primary
Secondary
Congenital Arterial Malformation Congenital Anomaly 10/13/2011 Female 6 lb 6/5/2012 Other Health Professional Germany
Primary
Secondary
Concomitant
Joint Dislocation Congenital Anomaly Male 6/6/2012 Physician United Kingdom
Primary
Secondary
Concomitant
Maternal Exposure During Pregnancy Congenital Anomaly Male 7 lb 6/7/2012 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Hypospadias Congenital Anomaly Male 7 lb 6/7/2012 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Death Death 27 Female 6/12/2012 Other Health Professional Canada
Primary
Secondary
Death Death 27 Female 6/12/2012 Other Health Professional Canada
Primary
Secondary
Abdominal Distension Hospitalization 5/18/2012 60 Female 168 lb 6/28/2012 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Abdominal Pain Hospitalization 5/18/2012 60 Female 168 lb 6/29/2012 Other Health Professional United Kingdom
Primary
Secondary
Concomitant