Keppra combined with Valproate Sodium

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Urinary Retention Other Serious 12/1/2005 4 Female 1/20/2006 Physician Germany
Primary
Secondary
Unintended Pregnancy Other Serious 8/30/2005 19 Female 2/1/2006 Physician Germany
Primary
Concomitant
Platelet Count Decreased Life Threatening 1/10/2006 55 Female 132 lb 2/8/2006 United Kingdom
Primary
Secondary
Concomitant
Pallor Hospitalization 12/1/2005 17 Female 132 lb 2/21/2006 Norway
Primary
Concomitant
Status Epilepticus Other Serious Female 2/23/2006 Physician United Kingdom
Primary
Concomitant
Somnolence Other Serious 1/1/1994 32 Female 121 lb 3/29/2006 Physician Germany
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious Male 3/27/2006 Pharmacist United Kingdom
Primary
Concomitant
Psychotic Disorder Other Serious 14 Male 3/27/2006 Pharmacist United Kingdom
Primary
Concomitant
Refusal Of Treatment By Patient Other Serious 8/25/2005 44 Male 4/11/2006 Physician Germany
Primary
Concomitant
Psychotic Disorder Other Serious 3/14/2006 14 Male 80 lb 4/10/2006 Pharmacist United Kingdom
Primary
Concomitant
Pancytopenia Hospitalization Male 4/14/2006 Physician Germany
Primary
Secondary
Drug Level Decreased Other Serious 3/1/2006 10 Female 5/3/2006 Consumer United States
Primary
Concomitant
Vomiting Hospitalization 11/2/2004 52 Female 5/8/2006 Singapore
Primary
Secondary
Concomitant
Drug Level Decreased Other Serious 3/1/2006 10 Female 53 lb 5/31/2006 Other Health Professional United States
Primary
Concomitant
Ovarian Enlargement Other Serious 5/11/2006 34 Female 187 lb 6/20/2006 Physician Germany
Primary
Concomitant
Urinary Retention Other Serious 12/1/2005 Female 7/7/2006 Physician Germany
Primary
Secondary
Status Epilepticus Death 2/16/2006 44 Female 7/5/2006 Germany
Primary
Concomitant
Foetal Movements Decreased Other Serious NotSpecified 8/18/2006 Mexico
Primary
Concomitant
Unintended Pregnancy Other Serious 8/30/2005 19 Female 8/21/2006 Physician Germany
Primary
Concomitant
Tremor Other Serious 7/13/2006 7 Male 8/25/2006 Germany
Primary
Concomitant
Unevaluable Event Hospitalization 3 Female 9/26/2006 Pharmacist United Kingdom
Primary
Concomitant
Hepatic Adenoma Hospitalization Female 10/10/2006 Other Health Professional United Kingdom
Primary
Concomitant
Drug Exposure During Pregnancy Congenital Anomaly 7/27/2006 NotSpecified 10/13/2006 Physician United States
Primary
Concomitant
Epilepsy Other Serious 5 Female 10/28/2006 Norway
Primary
Secondary
Nonspecific Reaction Hospitalization 3 Female 10/26/2006 Pharmacist United Kingdom
Primary
Concomitant
Tumour Haemorrhage Hospitalization Female 10/30/2006 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Salivary Hypersecretion Hospitalization 1/1/2006 Female 88 lb 11/14/2006 Physician Germany
Primary
Concomitant
Sudden Unexplained Death In Epilepsy Death 9/6/2006 29 Male 12/22/2006 Consumer United Kingdom
Primary
Concomitant
Ocular Hyperaemia Hospitalization Female 12/22/2006 Consumer United Kingdom
Primary
Concomitant
Pregnancy Other Serious 2/13/2006 0 Male 12/23/2006 Physician Norway
Primary
Secondary
Concomitant
Drug Exposure During Pregnancy Congenital Anomaly 7/27/2006 Female 2/5/2007 Other Health Professional United States
Primary
Concomitant
Treatment Noncompliance Death 9/6/2006 29 Male 2/16/2007 United Kingdom
Primary
Concomitant
Salivary Hypersecretion Hospitalization 1/1/2006 Female 2/16/2007 Physician Germany
Primary
Concomitant
Supraventricular Extrasystoles Other Serious 11/4/2006 39 Female 2/26/2007 Germany
Primary
Concomitant
Fatigue Hospitalization Female 3/9/2007 Germany
Primary
Concomitant
Drug Exposure During Pregnancy Congenital Anomaly 7/27/2006 Female 3/27/2007 Physician United States
Primary
Concomitant
Ovarian Enlargement Other Serious 5/11/2006 34 Female 187 lb 4/2/2007 Physician Germany
Primary
Concomitant
Drug Exposure During Pregnancy Congenital Anomaly 7/27/2006 Female 4/5/2007 Physician United States
Primary
Concomitant
Treatment Noncompliance Death 9/6/2006 29 Male 4/5/2007 Consumer United Kingdom
Primary
Concomitant
Drug Exposure During Pregnancy Congenital Anomaly 7/27/2006 Female 4/30/2007 Physician United States
Primary
Concomitant
Thrombocytopenia Other Serious Male 5/10/2007 Physician United Kingdom
Primary
Secondary
Suicidal Ideation Hospitalization 47 Male 5/21/2007 Consumer Germany
Primary
Concomitant
Thrombocytopenia Hospitalization 2/22/2007 3 Male 5/17/2007 Physician United Kingdom
Primary
Secondary
Tinnitus Hospitalization 3/1/2005 45 Male 5/25/2007 Consumer Germany
Primary
Concomitant
Tinnitus Hospitalization 3/1/2005 45 Male 6/14/2007 Consumer Germany
Primary
Concomitant
Premature Baby Congenital Anomaly 7/27/2006 Female 6 lb 6/29/2007 Physician United States
Primary
Concomitant
Tinnitus Hospitalization 3/1/2005 45 Male 207 lb 6/29/2007 Consumer Germany
Primary
Concomitant
Encephalitis Hospitalization 1/1/2006 28 Male 187 lb 7/13/2007 Physician Germany
Primary
Secondary
Puberty Hospitalization 1/1/2006 10 Female 115 lb 8/20/2007 Physician Germany
Primary
Concomitant
Tic Disability 3/23/2007 7 Female 59 lb 10/24/2007 Physician United Kingdom
Primary
Concomitant
Pregnancy Other Serious Female 11/9/2007 Other Health Professional Sweden
Primary
Concomitant
Foetal Anticonvulsant Syndrome Congenital Anomaly Male 7 lb 12/7/2007 United Kingdom
Primary
Secondary
Suicide Attempt Life Threatening 11/29/2007 40 Male 12/11/2007 Physician Germany
Primary
Secondary
Muscular Weakness Congenital Anomaly 7/27/2006 Female 6 lb 1/2/2008 Physician United States
Primary
Concomitant
Sudden Unexplained Death In Epilepsy Death 9/6/2006 29 Male 2/12/2008 Consumer United Kingdom
Primary
Concomitant
Encephalopathy Life Threatening 60 Female 2/15/2008 Germany
Primary
Concomitant
Psychotic Disorder Life Threatening Female 2/19/2008 Germany
Primary
Secondary
Thrombocytopenic Purpura Other Serious 7/1/2006 19 Male 3/3/2008 Consumer United Kingdom
Primary
Secondary
Disturbance In Attention Life Threatening 60 Female 2/27/2008 Germany
Primary
Concomitant
Thrombocytopenic Purpura Other Serious 7/1/2006 19 Male 3/7/2008 Physician United Kingdom
Primary
Secondary
Pancytopenia Other Serious 3/1/2008 53 Male 3/28/2008 Pharmacist United States
Primary
Concomitant
Visual Disturbance Hospitalization 9/26/2007 22 Male 251 lb 4/18/2008 Physician Germany
Primary
Concomitant
Paraesthesia Hospitalization 4/25/2008 47 Female 172 lb 5/7/2008 Physician Germany
Primary
Secondary
Concomitant
Myocardial Infarction Life Threatening 12/20/2007 68 Male 201 lb 5/7/2008 Consumer Ukraine
Primary
Concomitant
Suicide Attempt Life Threatening 11/29/2007 40 Male 5/9/2008 Other Health Professional Germany
Primary
Secondary
Paraesthesia Hospitalization 4/25/2008 47 Female 172 lb 5/19/2008 Physician Germany
Primary
Secondary
Concomitant
Personality Change Other Serious 10 Female 5/30/2008 Germany
Primary
Concomitant
Transaminases Increased Other Serious 8/1/2007 47 Female 132 lb 6/4/2008 Germany
Primary
Secondary
Concomitant
Mental Disorder Life Threatening 2/1/2008 55 Male 6/4/2008 Physician Germany
Primary
Secondary
Paraesthesia Hospitalization 4/25/2008 47 Female 172 lb 6/16/2008 Physician Germany
Primary
Secondary
Concomitant
Death Death 3/1/2008 Male 6/16/2008 Other Health Professional Germany
Primary
Concomitant
Thrombocytopenia Other Serious Male 6/24/2008 Other Health Professional Germany
Primary
Concomitant
Rash Other Serious 5/20/2008 17 Female 137 lb 7/9/2008 Physician Poland
Primary
Concomitant
Somnolence Life Threatening 5/1/2008 69 Female 143 lb 7/16/2008 Portugal
Primary
Secondary
Concomitant
Mania Hospitalization 1/10/2008 43 Female 176 lb 8/13/2008 Physician Germany
Primary
Concomitant
Epilepsy Other Serious 72 Female 8/21/2008 Physician Germany
Primary
Concomitant
Unintended Pregnancy Other Serious 31 Female 9/2/2008 Other Health Professional Germany
Primary
Secondary
Maternal Drugs Affecting Foetus Other Serious 6/16/2008 Male 1 lb 9/2/2008 Other Health Professional Germany
Primary
Secondary
Platelet Count Decreased Other Serious 70 Female 10/2/2008 Germany
Primary
Concomitant
Vomiting Other Serious 5/20/2008 2 Male 15 lb 10/14/2008 Physician Germany
Primary
Concomitant
Tooth Loss Other Serious Female 11/13/2008 Physician Germany
Primary
Concomitant
Pregnancy Of Partner Other Serious 4/1/2008 38 Male 154 lb 12/1/2008 Germany
Primary
Secondary
Vitamin B12 Increased Hospitalization 12/4/2008 80 Female 1/21/2009 Consumer France
Primary
Concomitant
Status Epilepticus Hospitalization 11/2/2008 30 Female 1/23/2009 Physician Belgium
Primary
Concomitant
Salivary Hypersecretion Other Serious 1/1/2008 30 Female 132 lb 1/26/2009 Consumer Germany
Primary
Concomitant
Muscular Weakness Congenital Anomaly 7/27/2006 Female 6 lb 1/23/2009 Physician United States
Primary
Concomitant
Drug Ineffective Other Serious 10/21/2008 35 Female 254 lb 2/13/2009 Physician United Kingdom
Primary
Concomitant
No Therapeutic Response Hospitalization 10/21/2008 35 Female 2/4/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Therapeutic Response Unexpected With Drug Substitution Other Serious Female 2/13/2009 Physician United States
Primary
Secondary
Metastases To Lung Hospitalization 10/21/2008 35 Female 254 lb 2/13/2009 United Kingdom
Primary
Secondary
Concomitant
Neutrophil Count Decreased Other Serious 10/14/2008 53 Male 2/16/2009 Physician United States
Primary
Secondary
Concomitant
Toxic Encephalopathy Death Male 2/13/2009 Physician Germany
Primary
Secondary
No Therapeutic Response Hospitalization 10/21/2008 35 Female 254 lb 2/23/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Psychiatric Symptom Life Threatening Female 2/25/2009 Other Health Professional United Kingdom
Primary
Concomitant
Rash Other Serious 4/1/2008 65 Male 3/5/2009 Pharmacist France
Primary
Concomitant
Vomiting Hospitalization 2 Female 33 lb 3/3/2009 Pharmacist United Kingdom
Primary
Concomitant
Tremor Hospitalization 1/1/2009 13 Male 135 lb 3/18/2009 Physician Jamaica
Primary
Concomitant
Urinary Tract Infection Hospitalization 1/1/2008 30 Female 132 lb 3/17/2009 Consumer Germany
Primary
Concomitant
Haemoglobin Decreased 3/20/2009 United States
Primary
Concomitant
Muscle Spasticity Hospitalization 3/12/2009 25 Female 3/27/2009 Germany
Primary
Concomitant
Rash Life Threatening 4/1/2008 65 Male 4/10/2009 Pharmacist France
Primary
Secondary
Concomitant
Status Epilepticus Death 4/26/2009 22 Male 165 lb 4/29/2009 Pharmacist United States
Primary
Concomitant
Physical Assault Other Serious 3/1/2009 18 Male 4/30/2009 Other Health Professional France
Primary
Secondary
Leukopenia Other Serious 4/29/2009 Physician Switzerland
Primary
Concomitant
Tremor Other Serious 5/7/2009 13 Male 135 lb 5/14/2009 Physician Jamaica
Primary
Concomitant
Physical Assault Other Serious 3/1/2009 18 Male 5/26/2009 Other Health Professional France
Primary
Secondary
Self Esteem Decreased Life Threatening 9/1/2008 17 Female 128 lb 5/18/2009 Other Health Professional United Kingdom
Primary
Concomitant
Parkinson's Disease Other Serious 1/1/2009 70 Male 5/19/2009 Physician United Kingdom
Primary
Concomitant
Parkinson's Disease Other Serious 1/1/2009 70 Male 5/19/2009 Physician United Kingdom
Primary
Concomitant
Convulsion Hospitalization Female 6/24/2009 Germany
Primary
Concomitant
Thrombocytopenia Other Serious 4/1/2009 66 Male 7/6/2009 Physician Germany
Primary
Secondary
Pancytopenia Life Threatening 5/1/2009 50 Female 7/22/2009 Physician Germany
Primary
Secondary
Concomitant
Granulocytopenia Other Serious 10/14/2008 53 Male 7/27/2009 Physician United States
Primary
Secondary
Concomitant
Parkinson's Disease Death 1/1/2009 70 Male 7/30/2009 Physician United Kingdom
Primary
Concomitant
Psychotic Disorder Life Threatening 6/18/2009 32 Male 163 lb 8/31/2009 Physician Germany
Primary
Secondary
Concomitant
Pancytopenia Life Threatening 5/1/2009 50 Female 9/9/2009 Physician Germany
Primary
Secondary
Concomitant
Ill-defined Disorder Disability 1/1/2007 64 Male 9/17/2009 France
Primary
Secondary
Concomitant
Psychotic Disorder Life Threatening 6/18/2009 32 Male 163 lb 9/15/2009 Physician Germany
Primary
Secondary
Concomitant
Paranoia Other Serious 53 Female 9/28/2009 Physician Germany
Primary
Secondary
Psychotic Disorder Other Serious 9/11/2008 62 Male 174 lb 10/6/2009 Consumer United Kingdom
Primary
Concomitant
Post Procedural Complication Other Serious 53 Female 10/15/2009 Physician Germany
Primary
Secondary
Leukopenia Other Serious 3/23/2009 35 Female 10/22/2009 Physician Switzerland
Primary
Concomitant
Gamma-glutamyltransferase Increased Hospitalization 10/1/2009 79 Female 11/5/2009 Physician France
Primary
Concomitant
Interacting
Drug Ineffective Other Serious 10/21/2008 35 Female 254 lb 12/1/2009 Physician United Kingdom
Primary
Concomitant
Vomiting Hospitalization Female 33 lb 12/9/2009 Other Health Professional United Kingdom
Primary
Concomitant
Weight Increased Other Serious 9/20/2007 Male 183 lb 1/19/2010 Germany
Primary
Concomitant
Petit Mal Epilepsy Congenital Anomaly Female 2/15/2010 Physician France
Primary
Secondary
Talipes Congenital Anomaly 2/15/2010 Other Health Professional France
Primary
Secondary
Maternal Drugs Affecting Foetus Congenital Anomaly 3/16/2010 France
Primary
Secondary
Maternal Drugs Affecting Foetus Congenital Anomaly 3/16/2010 France
Primary
Secondary
Vomiting Hospitalization 2/1/2010 35 Female 4/28/2010 Other Health Professional Australia
Primary
Concomitant
Hirsutism Hospitalization 1/1/1999 30 Female 190 lb 5/19/2010 Physician Germany
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 1/1/2007 41 Male 5/19/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Hirsutism Hospitalization 1/1/1999 30 Female 190 lb 6/1/2010 Other Health Professional Germany
Primary
Concomitant
Somnolence Other Serious 5/1/2002 32 Male 6/4/2010 Physician Belgium
Primary
Concomitant
Encephalopathy Other Serious Male 6/15/2010 Other Health Professional Belgium
Primary
Concomitant
Hirsutism Hospitalization 1/1/1999 30 Female 190 lb 6/22/2010 Physician Germany
Primary
Secondary
Concomitant
Hirsutism Hospitalization 1/1/1999 30 Female 190 lb 7/6/2010 Other Health Professional Germany
Primary
Concomitant
Somnolence Life Threatening 2/10/2010 13 Male 104 lb 7/28/2010 Germany
Primary
Concomitant
White Blood Cell Count Increased Other Serious 1/1/2007 41 Male 8/2/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Somnolence Life Threatening 2/10/2010 13 Male 104 lb 8/6/2010 Other Health Professional Germany
Primary
Concomitant
Petit Mal Epilepsy Other Serious 3/1/2010 40 Male 7/29/2010 United Kingdom
Primary
Concomitant
Cyanosis Other Serious 7/13/2010 11 Female 8/5/2010 Pharmacist Denmark
Primary
Concomitant
Rash Erythematous Hospitalization 59 Male 143 lb 8/12/2010 Physician Switzerland
Primary
Secondary
Convulsion Death 7/31/2010 4 Female 8/9/2010 Physician United States
Primary
Concomitant
Palpitations Disability 9/1/2009 13 Female 100 lb 8/30/2010 United Kingdom
Primary
Concomitant
Convulsion Hospitalization 7/23/2010 4 Female 9/1/2010 Other Health Professional United Kingdom
Primary
Concomitant
White Blood Cell Count Increased Other Serious 1/1/2007 41 Male 9/8/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Convulsion Hospitalization 7/20/2010 4 Female 40 lb 9/7/2010 Other Health Professional United Kingdom
Primary
Concomitant
Product Label Issue Hospitalization Female 40 lb 9/13/2010 Other Health Professional United Kingdom
Primary
Concomitant

Drug Data