Clobazam combined with Valproate Sodium

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Hypospadias Other Serious 1/19/2006 Consumer United Kingdom
Primary
Secondary
Concomitant
Vomiting Other Serious 42 Male 1/26/2006 United States
Primary
Secondary
Spina Bifida Congenital Anomaly NotSpecified 6 lb 2/3/2006 United Kingdom
Primary
Secondary
Status Epilepticus Other Serious Female 2/23/2006 Physician United Kingdom
Primary
Concomitant
Psychotic Disorder Other Serious 14 Male 3/27/2006 Pharmacist United Kingdom
Primary
Concomitant
Pyrexia Other Serious 7/1/2005 Male 4/13/2006 Physician Japan
Primary
Secondary
Concomitant
Psychotic Disorder Other Serious 3/14/2006 14 Male 80 lb 4/10/2006 Pharmacist United Kingdom
Primary
Concomitant
Tachycardia Other Serious 4/26/2004 57 Female 6/2/2006 France
Primary
Concomitant
Interacting
Petit Mal Epilepsy Other Serious 15 Male 6/15/2006 Consumer United Kingdom
Primary
Secondary
Polycystic Ovaries Other Serious 28 Female 8/4/2006 Japan
Primary
Concomitant
Status Epilepticus Hospitalization Female 198 lb 9/14/2006 Physician United Kingdom
Primary
Concomitant
Weight Decreased Required Intervention 15 Female 9/22/2006 Physician Japan
Primary
Concomitant
Myoclonic Epilepsy Other Serious 7 Female 10/17/2006 Japan
Primary
Concomitant
Abortion Spontaneous Other Serious Female 11/9/2006 Physician United Kingdom
Primary
Concomitant
Weight Increased Hospitalization 11/1/2006 12 Female 68 lb 12/18/2006 Physician Germany
Primary
Concomitant
Mental Impairment Other Serious 8 Male 12/20/2006 France
Primary
Concomitant
Transaminases Increased Hospitalization 11/23/2006 44 Male 1/11/2007 Other Health Professional France
Primary
Secondary
Vomiting Hospitalization 11/23/2006 44 Male 1/18/2007 Other Health Professional France
Primary
Secondary
Petit Mal Epilepsy Other Serious 15 Male 1/22/2007 Other Health Professional United Kingdom
Primary
Secondary
Petit Mal Epilepsy Other Serious 15 Male 1/29/2007 Other Health Professional France
Primary
Secondary
Spina Bifida Congenital Anomaly Female 6 lb 1/22/2007 United Kingdom
Primary
Secondary
Pyrexia Other Serious 12/18/2006 2/2/2007 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 12/18/2006 Male 150 lb 2/6/2007 Physician Japan
Primary
Concomitant
Acute Hepatic Failure Death 2/23/2006 17 Female 115 lb 2/21/2007 Consumer United Kingdom
Primary
Concomitant
Head Injury Other Serious Female 3/8/2007 Hong Kong
Primary
Secondary
Spina Bifida Congenital Anomaly Female 6 lb 3/9/2007 Consumer United Kingdom
Primary
Secondary
Sepsis Other Serious 2/2/2007 36 Male 3/30/2007 Consumer United Kingdom
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 2/2/2007 36 Male 4/12/2007 Consumer United Kingdom
Primary
Concomitant
Pancreatitis Acute Other Serious 5/9/2007 Female 6/11/2007 Physician Japan
Primary
Secondary
Concomitant
Haematochezia Other Serious 1/1/2003 25 Male 97 lb 6/11/2007 Japan
Primary
Concomitant
Somnolence Other Serious 12 Male 7/3/2007 Japan
Primary
Concomitant
Somnolence Other Serious 12 Male 7/17/2007 Japan
Primary
Concomitant
Epilepsy Hospitalization 13 Male 8/15/2007 Japan
Primary
Concomitant
Epilepsy Hospitalization 13 Male 8/28/2007 Japan
Primary
Concomitant
Electroencephalogram Abnormal Other Serious 16 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
Suicide Attempt Other Serious 36 Female 11/13/2007 Japan
Primary
Concomitant
Foetal Anticonvulsant Syndrome Congenital Anomaly Male 7 lb 12/7/2007 Other Health Professional France
Primary
Secondary
Foetal Anticonvulsant Syndrome Congenital Anomaly Male 7 lb 12/7/2007 United Kingdom
Primary
Secondary
Upper Respiratory Tract Inflammation Hospitalization 11/16/2006 Female 12/21/2007 Physician Japan
Primary
Concomitant
Spinal Compression Fracture Other Serious 44 Female 12/22/2007 Japan
Primary
Secondary
Foetal Anticonvulsant Syndrome Congenital Anomaly Male 7 lb 12/28/2007 Other Health Professional France
Primary
Secondary
Drug Interaction Other Serious 1/1/2007 54 Female 1/24/2008 Other Health Professional United Kingdom
Primary
Secondary
Drug Interaction Other Serious 1/1/2007 1/1/2008 Other Health Professional United Kingdom
Primary
Secondary
Drug Interaction Other Serious 1/1/2007 54 Female 1/31/2008 Other Health Professional United Kingdom
Primary
Secondary
Toxic Epidermal Necrolysis Life Threatening 4/18/2003 Female 2/1/2008 Consumer Germany
Primary
Secondary
Drug Interaction Other Serious 1/1/2007 54 Female 2/5/2008 Other Health Professional France
Primary
Interacting
Drug Interaction Other Serious 1/1/2007 54 Female 3/7/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Unresponsive To Stimuli Life Threatening 2/1/2007 10 Male 3/13/2008 Other Health Professional France
Primary
Concomitant
Liver Injury Other Serious 3/24/2008 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Life Threatening 4/18/2003 Female 2/13/2008 Other Health Professional Germany
Primary
Secondary
Grand Mal Convulsion Other Serious 3/1/1984 Female 5/30/2008 Physician France
Primary
Secondary
Concomitant
Drug Interaction Other Serious 1/1/2007 6/4/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Drug Interaction Other Serious 1/1/2007 54 Female 6/6/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Drug Interaction Other Serious 1/1/2007 54 Female 6/16/2008 Other Health Professional France
Primary
Concomitant
Interacting
Vomiting Hospitalization 2/23/2006 17 Female 115 lb 8/5/2008 Consumer United Kingdom
Primary
Concomitant
Liver Injury Hospitalization 8/20/2008 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Hypospadias Congenital Anomaly Male 8/27/2008 Other Health Professional United Kingdom
Primary
Secondary
Maternal Drugs Affecting Foetus Congenital Anomaly Male 6 lb 9/4/2008 Other Health Professional United Kingdom
Primary
Secondary
Maternal Drugs Affecting Foetus Congenital Anomaly Male 6 lb 9/12/2008 Other Health Professional United Kingdom
Primary
Secondary
Weight Increased Hospitalization 3/1/2008 Female 9/16/2008 Other Health Professional France
Primary
Concomitant
Acute Hepatic Failure Life Threatening 9/29/2008 8 Male 55 lb 12/4/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Sleep Disorder Hospitalization 24 Male 1/29/2009 Other Health Professional Japan
Primary
Concomitant
Sweat Gland Disorder Other Serious 9 Male 2/4/2009
Primary
Secondary
Concomitant
Sweat Gland Disorder Other Serious 9 Male 2/11/2009 United Kingdom
Primary
Interacting
Sleep Disorder Hospitalization 12/1/2005 Male 3/5/2009 Physician Japan
Primary
Concomitant
Rash Other Serious 4/1/2008 65 Male 3/5/2009 Pharmacist France
Primary
Concomitant
Liver Transplant Required Intervention 33 Female 3/2/2009 United Kingdom
Primary
Concomitant
Mood Altered Other Serious 26 Female 3/27/2009 France
Primary
Concomitant
Mood Altered Other Serious 5 Male 3/30/2009 France
Primary
Concomitant
Metabolic Encephalopathy Other Serious 17 Male 4/1/2009 France
Primary
Concomitant
Metabolic Encephalopathy Other Serious 17 Male 4/2/2009 France
Primary
Concomitant
Rash Life Threatening 4/1/2008 65 Male 4/10/2009 Pharmacist France
Primary
Secondary
Concomitant
Blister Hospitalization 9 Male 5/4/2009 United Kingdom
Primary
Secondary
Concomitant
Rash Other Serious 5 Male 5/5/2009
Primary
Secondary
Concomitant
Hyperammonaemic Encephalopathy Other Serious 7 Male 5/12/2009 Brazil
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Hospitalization 10/1/2008 4 Male 6/2/2009 Japan
Primary
Secondary
Toxic Epidermal Necrolysis Hospitalization 10/1/2008 4 Male 6/26/2009 Japan
Primary
Secondary
Concomitant
Stevens-johnson Syndrome Other Serious 9 Male 8/27/2009
Primary
Secondary
Concomitant
Oculogyric Crisis Other Serious 4 Male 9/8/2009 Physician United Kingdom
Primary
Secondary
Oculogyric Crisis Other Serious 4 Male 9/9/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Oculogyric Crisis Other Serious 4 Male 9/15/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Pathogen Resistance 8/14/2009 40 Female 214 lb 9/28/2009 Physician Hong Kong
Primary
Concomitant
Oculogyric Crisis Hospitalization 4 Male 9/28/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Pyrexia Hospitalization 6 Female 9/29/2009 Other Health Professional Japan
Primary
Secondary
Tic Other Serious 4 Male 9/30/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Drug Interaction Other Serious 1/1/2007 54 Female 10/23/2009 Other Health Professional United Kingdom
Primary
Concomitant
Maternal Drugs Affecting Foetus Other Serious Male 11/4/2009 Other Health Professional United Kingdom
Primary
Secondary
Hallucination Other Serious 33 Male 11/4/2009 Physician Japan
Primary
Concomitant
Epilepsy Other Serious 60 Female 11/18/2009 France
Primary
Concomitant
Vomiting Hospitalization 11/26/2009 11 Female 77 lb 12/7/2009 Physician United Kingdom
Primary
Concomitant
Vomiting Hospitalization 11/26/2009 Female 77 lb 12/23/2009 Physician United Kingdom
Primary
Concomitant
Maternal Drugs Affecting Foetus Congenital Anomaly 1 Male 6 lb 12/30/2009 Other Health Professional United Kingdom
Primary
Secondary
Selective Mutism Other Serious 23 Male 12/30/2009 Physician Japan
Primary
Concomitant
Sweat Gland Disorder Other Serious 9 Male 1/11/2010 United Kingdom
Primary
Concomitant
Interacting
Sweat Gland Disorder Other Serious 9 Male 1/13/2010 United Kingdom
Primary
Concomitant
Interacting
Swelling Face Other Serious 9 Male 1/21/2010 United Kingdom
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 9 Female 2/2/2010
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 32 Male 3/9/2010
Primary
Secondary
Transaminases Increased Hospitalization 8/19/2008 75 Female 143 lb 4/29/2010 Other Health Professional Germany
Primary
Secondary
Transaminases Increased Hospitalization 8/19/2008 75 Female 143 lb 5/7/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Inappropriate Antidiuretic Hormone Secretion Hospitalization 37 Male 5/13/2010 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Transaminases Increased Hospitalization 8/19/2008 75 Female 5/14/2010 Physician France
Primary
Concomitant
Interacting
Pneumonia Mycoplasmal Life Threatening 9/1/2009 14 Male 95 lb 6/3/2010 Other Health Professional United Kingdom
Primary
Concomitant
Vomiting Hospitalization 24 Male 7/2/2010 Other Health Professional Japan
Primary
Concomitant
Pancreatitis Other Serious 20 Female 7/19/2010 Other Health Professional Finland
Primary
Concomitant
Pancreatitis Other Serious 20 Female 8/9/2010 Other Health Professional Finland
Primary
Concomitant
Psychotic Disorder Hospitalization Female 123 lb 8/17/2010 Other Health Professional United Kingdom
Primary
Concomitant
Transplant Rejection Other Serious 32 Male 9/1/2010 Other Health Professional India
Primary
Concomitant
Interacting
Somnolence 5/23/2010 33 Female 9/8/2010 Other Health Professional Ireland
Primary
Concomitant
Convulsion Other Serious 4 Male 9/14/2010 Physician United Kingdom
Primary
Concomitant
Grand Mal Convulsion Other Serious 56 Female 9/29/2010 Other Health Professional France
Primary
Concomitant
Hyponatraemia Hospitalization 9/7/2010 44 Female 168 lb 9/24/2010 United Kingdom
Primary
Concomitant
Sweat Gland Disorder Hospitalization 9 Male 10/11/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Diarrhoea Haemorrhagic Other Serious 8/9/2010 5 Female 50 lb 10/13/2010 Other Health Professional United Kingdom
Primary
Concomitant
Paranoia Other Serious 22 Female 10/21/2010 Other Health Professional Japan
Primary
Concomitant
Somnolence Other Serious 5/23/2010 33 Female 10/21/2010 Other Health Professional Ireland
Primary
Concomitant
Paranoia Other Serious 22 Female 11/8/2010 Other Health Professional Japan
Primary
Concomitant
White Blood Cell Count Increased Hospitalization 8/12/2010 38 Male 154 lb 12/17/2010 Other Health Professional Japan
Primary
Secondary
White Blood Cell Count Increased Hospitalization 8/12/2010 38 Male 154 lb 12/29/2010 Other Health Professional Japan
Primary
Secondary
Tachycardia Other Serious 4/26/2004 57 Female 12/29/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Tachycardia Hospitalization 4/26/2004 57 Female 12/29/2010 Consumer United Kingdom
Primary
Concomitant
Delirium Hospitalization 10/18/2010 62 Male 173 lb 1/11/2011 Physician Canada
Primary
Secondary
Concomitant
Encephalopathy Hospitalization 8/21/2007 37 Female 154 lb 1/14/2011 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Ataxia Other Serious 1/1/2009 4 Male 2/2/2011 Consumer India
Primary
Secondary
Concomitant
Toxicity To Various Agents Hospitalization 10 Male 2/3/2011 Other Health Professional India
Primary
Concomitant
Psychomotor Retardation Hospitalization 7/21/2007 37 Female 129 lb 1/31/2011 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Decreased Appetite Hospitalization Female 2/25/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Nausea Hospitalization 58 Female 3/8/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Tubulointerstitial Nephritis Other Serious 2/9/2011 24 Male 3/9/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Tubulointerstitial Nephritis Other Serious 24 Male 180 lb 3/1/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Altered State Of Consciousness Hospitalization 24 Male 3/15/2011 Other Health Professional Japan
Primary
Concomitant
Middle Ear Effusion Hospitalization 24 Male 86 lb 3/25/2011 Japan
Primary
Concomitant
Sudden Unexplained Death In Epilepsy Death 7 Female 3/22/2011 Physician United States
Primary
Secondary
Delirium Hospitalization 10/18/2010 62 Male 173 lb 4/21/2011 Physician Canada
Primary
Secondary
Concomitant
Hypotonia Hospitalization 5 5/6/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Hypoxic-ischaemic Encephalopathy Hospitalization 5 5/16/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Brain Oedema Hospitalization 5 Male 5/20/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Aphasia Hospitalization 5 Male 5/20/2011 Consumer United Kingdom
Primary
Secondary
Concomitant
Movement Disorder Hospitalization 5 Male 5/22/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Movement Disorder Hospitalization 5 Male 5/22/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Learning Disorder Hospitalization 5 Male 5/22/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Hypotonia Hospitalization 5 Male 5/22/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Aphasia Hospitalization 5 Male 5/23/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Pancytopenia Other Serious 5/1/2009 13 Female 5/24/2011 Other Health Professional Japan
Primary
Secondary
Hypoxic-ischaemic Encephalopathy Hospitalization 5 Male 5/24/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Movement Disorder Other Serious Male 5/25/2011 United Kingdom
Primary
Secondary
Concomitant
Ischaemia Other Serious Male 5/25/2011 United Kingdom
Primary
Secondary
Concomitant
Brain Oedema Other Serious Male 5/25/2011 United Kingdom
Primary
Secondary
Concomitant

Drug Data