Valproate Sodium combined with Zonisamide

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Excitability Hospitalization 3/3/2006 5 Male 3/16/2006 Physician Japan
Primary
Concomitant
Psychotic Disorder Hospitalization 3/12/2006 5 Male 4/3/2006 Physician Japan
Primary
Concomitant
Psychotic Disorder Hospitalization 3/12/2006 5 Male 4/10/2006 Physician Japan
Primary
Concomitant
Therapy Non-responder Hospitalization 3/13/2004 63 Male 6/16/2006 Physician Japan
Primary
Concomitant
Vitamin D Abnormal Required Intervention 4 Male 7/14/2006 Physician Japan
Primary
Secondary
Rash Death 41 Female 8/1/2006 Japan
Primary
Concomitant
Status Epilepticus Hospitalization 41 Female 8/8/2006 Japan
Primary
Concomitant
Respiratory Failure Hospitalization 1/13/2005 Male 8/14/2006 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Hospitalization 6/7/2006 58 Male 8/24/2006 Physician Japan
Primary
Concomitant
Status Epilepticus Hospitalization Female 198 lb 9/14/2006 Physician United Kingdom
Primary
Concomitant
Renal Tubular Acidosis Required Intervention 4 Male 9/15/2006 Physician Japan
Primary
Secondary
Weight Decreased Required Intervention 15 Female 9/22/2006 Physician Japan
Primary
Concomitant
Nephrolithiasis Required Intervention 8/1/1998 Female 9/25/2006 Physician Japan
Primary
Concomitant
Thrombocytopenia Death 6/12/2006 58 Male 9/25/2006 Physician Japan
Primary
Concomitant
Stevens-johnson Syndrome Required Intervention 9/5/2006 11 Female 9/28/2006 Other Health Professional Japan
Primary
Concomitant
Weight Decreased Required Intervention 2/27/2006 15 Female 9/28/2006 Physician Japan
Primary
Concomitant
Respiratory Failure Hospitalization 1/13/2005 Male 10/9/2006 Physician Japan
Primary
Secondary
Concomitant
Nephrolithiasis Required Intervention 8/1/1998 Female 10/4/2006 Physician Japan
Primary
Concomitant
White Blood Cell Count Increased Death 6/12/2006 58 Male 11/13/2006 Physician Japan
Primary
Concomitant
Attention Deficit/hyperactivity Disorder Required Intervention 11/1/2006 9 Male 12/4/2006 Physician Japan
Primary
Concomitant
Pneumonia Hospitalization 1/10/2006 6 Female 29 lb 2/8/2007 Physician Japan
Primary
Concomitant
Respiratory Tract Infection Viral Other Serious 1 Female 3/12/2007 Japan
Primary
Secondary
Respiratory Tract Infection Viral Other Serious 1 Female 3/12/2007 Japan
Primary
Secondary
Tachycardia Hospitalization 2/9/2003 1 3/24/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Stridor Life Threatening 2/21/2004 Female 4/19/2007 United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 5/23/2006 5 Male 4/19/2007 Physician Japan
Primary
Concomitant
Cardio-respiratory Arrest Death 4/17/2007 Male 5/2/2007 Physician Japan
Primary
Concomitant
Cardio-respiratory Arrest Death 4/17/2007 Male 6/25/2007 Physician Japan
Primary
Concomitant
Cardio-respiratory Arrest Death 4/17/2007 Male 6/29/2007 Physician Japan
Primary
Concomitant
Urinary Tract Infection Hospitalization 10/23/2006 8 Female 26 lb 6/29/2007 Physician Japan
Primary
Concomitant
Transient Hypogammaglobulinaemia Of Infancy Other Serious 3 Male 8/28/2007
Primary
Secondary
Somnolence Hospitalization 22 Female 9/8/2007 Japan
Primary
Concomitant
Stevens-johnson Syndrome Life Threatening 7/21/2007 66 Male 9/4/2007 Physician Japan
Primary
Concomitant
Somnolence Hospitalization 22 Female 9/20/2007 Japan
Primary
Concomitant
Stevens-johnson Syndrome Hospitalization 7/21/2007 66 Male 10/9/2007 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 37 Female 10/15/2007
Primary
Secondary
Drug Ineffective Hospitalization 24 Female 10/15/2007
Primary
Secondary
Suicide Attempt Other Serious 36 Female 11/13/2007 Japan
Primary
Concomitant
Tremor Hospitalization 11/5/2007 6 Male 11/29/2007 Physician Japan
Primary
Concomitant
Tremor Hospitalization 11/5/2007 Male 33 lb 12/14/2007 Physician Japan
Primary
Concomitant
Status Epilepticus Hospitalization 41 Female 12/24/2007 Japan
Primary
Concomitant
Status Epilepticus Other Serious 41 Female 12/28/2007 Japan
Primary
Concomitant
Interacting
Tremor Hospitalization 11/5/2007 Male 33 lb 1/3/2008 Physician Japan
Primary
Concomitant
Tremor Hospitalization 11/5/2007 Male 33 lb 1/24/2008 Physician Japan
Primary
Concomitant
Status Epilepticus Life Threatening 11/2/2006 0 Male 15 lb 3/11/2008 Physician Japan
Primary
Concomitant
Transfusion Reaction Death 1/1/2008 22 Male 174 lb 3/17/2008 Physician China
Primary
Concomitant
Urinary Tract Infection Hospitalization 10/23/2006 8 26 lb 3/26/2008 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 11 Male 3/25/2008 Physician Japan
Primary
Secondary
Concomitant
Hyperthermia Life Threatening 11/1/2007 77 Female 95 lb 4/22/2008 Physician Japan
Primary
Secondary
Toxic Epidermal Necrolysis Other Serious 71 Male 5/6/2008
Primary
Concomitant
Treatment Noncompliance Life Threatening 4/26/2008 2 Female 13 lb 6/4/2008 Physician Japan
Primary
Concomitant
Shock Life Threatening 3/27/2008 2 Female 13 lb 6/18/2008 Physician Japan
Primary
Concomitant
Skin Test Positive Life Threatening 11/1/2007 77 Female 95 lb 6/30/2008 Physician Japan
Primary
Secondary
Shock Life Threatening 3/27/2008 2 Female 13 lb 7/16/2008 Physician Japan
Primary
Concomitant
Suicidal Ideation Hospitalization 8/10/2008 Male 209 lb 9/10/2008 Germany
Primary
Concomitant
Injection Site Pain 10/1/2008 Male 321 lb 12/12/2008 Physician United States
Primary
Concomitant
Onycholysis Other Serious 56 Female 12/26/2008 Consumer United States
Primary
Concomitant
Upper Respiratory Tract Inflammation Life Threatening 11/2/2008 0 Male 18 lb 1/5/2009 Physician Japan
Primary
Concomitant
Pneumonia Hospitalization 1/11/2009 50 Male 1/19/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Upper Respiratory Tract Inflammation Life Threatening 11/2/2006 0 Male 18 lb 1/22/2009 Physician Japan
Primary
Concomitant
Pseudomonas Infection Hospitalization 1/11/2009 50 Male 1/27/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Sleep Disorder Hospitalization 24 Male 1/29/2009 Other Health Professional Japan
Primary
Concomitant
Onycholysis Other Serious 56 Female 1/22/2009 Consumer United States
Primary
Concomitant
Pseudomonas Infection Hospitalization 1/11/2009 50 Male 2/10/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Sleep Disorder Hospitalization 12/1/2005 Male 3/5/2009 Physician Japan
Primary
Concomitant
Sudden Unexplained Death In Epilepsy Death 3/9/2009 Female 3/23/2009 Germany
Primary
Concomitant
Spastic Paraplegia Other Serious 2 Male 7/1/2009 Japan
Primary
Concomitant
Tremor Other Serious 2 Male 7/22/2009 Physician Japan
Primary
Concomitant
Wrong Technique In Drug Usage Process 10/1/2008 Male 321 lb 9/12/2009 Physician United States
Primary
Concomitant
Status Epilepticus Other Serious 5/17/2009 Female 10/12/2009 Other Health Professional Japan
Primary
Concomitant
Hallucination Other Serious 33 Male 11/4/2009 Physician Japan
Primary
Concomitant
Hallucination, Visual Hospitalization 9/26/2009 Male 12/3/2009 Other Health Professional Japan
Primary
Concomitant
Hallucination, Visual Hospitalization 9/26/2009 Male 12/8/2009 Other Health Professional Japan
Primary
Concomitant
Hallucination, Visual Hospitalization 9/26/2009 Male 12/9/2009 Other Health Professional Japan
Primary
Concomitant
Hallucination, Visual Hospitalization 9/26/2009 Male 12/10/2009 Other Health Professional Japan
Primary
Concomitant
Selective Mutism Other Serious 23 Male 12/30/2009 Physician Japan
Primary
Concomitant
Weight Increased Other Serious 9/20/2007 Male 183 lb 1/19/2010 Germany
Primary
Concomitant
Vomiting Hospitalization 14 Female 3/30/2010 Other Health Professional United States
Primary
Secondary
Vomiting Other Serious 14 Female 4/6/2010 Other Health Professional United States
Primary
Secondary
Peritonitis Sclerosing Hospitalization 14 Female 4/6/2010 Physician United States
Primary
Secondary
Peritonitis Sclerosing Hospitalization 14 Female 4/6/2010 Physician United States
Primary
Secondary
Peritonitis Sclerosing Hospitalization 14 Female 4/6/2010 Physician United States
Primary
Secondary
Respiratory Distress Hospitalization 14 Female 4/12/2010 France
Primary
Secondary
Concomitant
Hallucination, Visual Hospitalization 9/26/2009 10 Male 4/16/2010 Other Health Professional Japan
Primary
Concomitant
Restlessness Other Serious 5/23/2008 62 Male 138 lb 4/13/2010 Other Health Professional Japan
Primary
Concomitant
Tubulointerstitial Nephritis Other Serious Male 143 lb 7/1/2010 Physician Japan
Primary
Concomitant
Tubulointerstitial Nephritis Other Serious Male 143 lb 7/23/2010 Physician Japan
Primary
Concomitant
Thrombophlebitis Hospitalization 6/7/2010 21 Female 7/23/2010 Pharmacist Ireland
Primary
Concomitant
Tubulointerstitial Nephritis Other Serious Male 143 lb 8/17/2010 Physician Japan
Primary
Concomitant
Infantile Spasms Other Serious Female 8/23/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Infantile Spasms Other Serious Female 8/31/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Hyperammonaemic Encephalopathy Other Serious 5 Male 9/9/2010
Primary
Secondary
Tubulointerstitial Nephritis Other Serious Male 143 lb 9/10/2010 Physician Japan
Primary
Concomitant
Pallor 8/9/2010 5 Male 9/8/2010 United States
Primary
Concomitant
Tubulointerstitial Nephritis Other Serious 4/27/2010 37 Male 143 lb 10/6/2010 Physician Japan
Primary
Concomitant
Paranoia Other Serious 22 Female 10/21/2010 Other Health Professional Japan
Primary
Concomitant
Paranoia Other Serious 22 Female 11/8/2010 Other Health Professional Japan
Primary
Concomitant
Tubulointerstitial Nephritis Other Serious 4/27/2010 37 Male 143 lb 11/16/2010 Physician Japan
Primary
Concomitant
Sudden Death Death 4/17/2007 7 Male 29 lb 1/6/2011 Consumer Japan
Primary
Concomitant
Encephalopathy Hospitalization 8/21/2007 37 Female 154 lb 1/14/2011 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Psychomotor Retardation Hospitalization 7/21/2007 37 Female 129 lb 1/31/2011 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Middle Ear Effusion Hospitalization 24 Male 86 lb 3/25/2011 Japan
Primary
Concomitant
Conversion Disorder Hospitalization 8 Female 3/28/2011 Other Health Professional Japan
Primary
Concomitant
Somnolence 8 Female 4/10/2011 Other Health Professional Japan
Primary
Concomitant
Liver Disorder Hospitalization 4/25/2011 66 Male 381 lb 5/2/2011 Physician Japan
Primary
Secondary
Concomitant
Pancytopenia Other Serious 5/1/2009 13 Female 5/24/2011 Other Health Professional Japan
Primary
Secondary
Pyrexia Hospitalization 2/18/2011 33 Female 6/6/2011 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 9/6/2001 4 Female 40 lb 7/26/2011 Other Health Professional Japan
Primary
Secondary
Blindness Disability 7/13/2011 30 Male 150 lb 7/28/2011 Physician United Kingdom
Primary
Concomitant
Acute Tonsillitis Hospitalization 7/19/2011 3 Male 8/5/2011 Physician Japan
Primary
Secondary
Concomitant
Grand Mal Convulsion Hospitalization 12 Male 8/8/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Fatigue Hospitalization 12 Male 8/12/2011 Physician United States
Primary
Secondary
Concomitant
Blood Potassium Decreased Hospitalization 3/17/2008 75 Female 111 lb 8/3/2011 Physician Japan
Primary
Concomitant
Status Epilepticus Hospitalization 8/7/2011 10 Male 42 lb 8/26/2011 Physician Japan
Primary
Concomitant
Interacting
Micturition Urgency Life Threatening 8/1/2011 Female 9/1/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Thirst Other Serious 60 Female 9/2/2011 Consumer Japan
Primary
Concomitant
Altered State Of Consciousness Life Threatening 8/13/2011 33 Male 9/7/2011 Physician Japan
Primary
Concomitant
Polydipsia Other Serious 60 Female 9/7/2011 Consumer Japan
Primary
Secondary
Concomitant
Hyperventilation Life Threatening 8/1/2011 Female 9/8/2011 Pharmacist United Kingdom
Primary
Secondary
Concomitant
Foot Fracture Hospitalization 9/16/2011 Female 186 lb 9/22/2011 Physician Ukraine
Primary
Concomitant
Pyrexia Hospitalization 24 Male 86 lb 9/23/2011 Japan
Primary
Concomitant
Stevens-johnson Syndrome Other Serious 7/9/2011 59 Male 9/26/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Foot Fracture Hospitalization 9/16/2011 Female 186 lb 9/27/2011 Physician Ukraine
Primary
Concomitant
Renal Tubular Disorder Other Serious 3 Male 10/5/2011 Other Health Professional Japan
Primary
Concomitant
Foot Fracture Hospitalization 9/15/2011 17 Female 186 lb 10/7/2011 Physician Ukraine
Primary
Concomitant
Psychomotor Retardation Other Serious Male 10/24/2011 Other Health Professional India
Primary
Secondary
Concomitant
Cellulitis Hospitalization 1/9/2010 35 Male 11/4/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Foot Fracture Hospitalization 9/15/2011 17 Female 186 lb 11/8/2011 Physician Ukraine
Primary
Concomitant
Drug Interaction Other Serious 8/1/2011 33 Male 132 lb 11/10/2011 Physician Japan
Primary
Concomitant
Interacting
Single Photon Emission Computerised Tomogram Abnormal Hospitalization 1 Female 11/8/2011 Other Health Professional Japan
Primary
Secondary
Skin Necrosis Other Serious 9/21/2011 22 Male 12/5/2011 Physician Japan
Primary
Concomitant
Liver Disorder Hospitalization 3/28/2011 66 Male 381 lb 12/15/2011 Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 7/19/2011 3 Male 12/19/2011 Physician Japan
Primary
Secondary
Concomitant
Hand Fracture Hospitalization 4/29/2007 50 Female 93 lb 12/19/2011 Physician Japan
Primary
Concomitant
Pyrexia Hospitalization 12/13/2011 3 Male 18 lb 12/27/2011 Physician Japan
Primary
Concomitant
Status Epilepticus Hospitalization 8/7/2011 10 Male 42 lb 1/12/2012 Physician Japan
Primary
Concomitant
Interacting
Foot Fracture Hospitalization 9/15/2011 17 Female 186 lb 2/6/2012 Physician Ukraine
Primary
Concomitant
Renal Failure Acute Other Serious 7/16/2011 54 Male 2/9/2012 Other Health Professional Japan
Primary
Secondary
Rhabdomyolysis Other Serious 7/16/2011 54 Male 2/22/2012 Other Health Professional Japan
Primary
Secondary
White Blood Cell Count Decreased Hospitalization 1/20/2011 51 Male 3/1/2012 Physician Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 9/6/2001 4 Female 40 lb 3/9/2012 Japan
Primary
Secondary
Rhabdomyolysis Other Serious 7/16/2011 54 Male 3/14/2012 Other Health Professional Japan
Primary
Secondary
Dyspnoea Hospitalization 2/5/2012 15 Male 3/29/2012 Physician Japan
Primary
Concomitant
Hypogonadism Hospitalization 23 Male 4/3/2012 Other Health Professional Japan
Primary
Concomitant
Pancreatitis Other Serious 7/1/2007 11 Female 5/4/2012 Physician Finland
Primary
Concomitant
Decreased Interest Other Serious Female 5/15/2012 Physician Japan
Primary
Concomitant
Sepsis Hospitalization 48 Male 6/15/2012 Other Health Professional Japan
Primary
Secondary
Status Epilepticus Hospitalization 8/7/2011 10 Male 43 lb 6/15/2012 Physician Japan
Primary
Concomitant
Interacting
Partial Seizures Other Serious 31 Female 6/20/2012 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Acute Hepatic Failure Other Serious 7/16/2011 54 Male 6/20/2012 Other Health Professional Japan
Primary
Secondary

Drug Data