Depakene combined with Phenobarbital Tab

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Epilepsy Hospitalization 9/19/2004 45 Female 3/17/2006 France
Primary
Secondary
Concomitant
Weight Increased Other Serious 8/8/2003 8 Male 4/19/2006 Other Health Professional United States
Primary
Concomitant
Hepatic Function Abnormal Hospitalization 1/1/2006 59 Male 4/21/2006 Other Health Professional Japan
Primary
Concomitant
Injury Other Serious 2/5/2006 46 Female 6/8/2006 Physician Belgium
Primary
Concomitant
Pneumonia Aspiration Other Serious 1/1/2006 6/26/2006 Physician Japan
Primary
Secondary
Drug Level Decreased Other Serious 5/2/2006 29 Male 68 lb 7/19/2006 Physician Japan
Primary
Secondary
Suicide Attempt Hospitalization 38 Female 115 lb 8/25/2006 Poland
Primary
Concomitant
Pyrexia Hospitalization 6/18/2006 33 Female 9/1/2006 Physician Japan
Primary
Secondary
Concomitant
Rash Papular Hospitalization 6/18/2006 33 Female 9/22/2006 Physician Japan
Primary
Secondary
Concomitant
Microcephaly Death 11/7/2006 Other Health Professional France
Primary
Secondary
Microcephaly Other Serious 11/7/2005 Female 11/7/2006 Other Health Professional France
Primary
Secondary
Osteonecrosis Hospitalization 66 Female 12/7/2006 Physician France
Primary
Concomitant
Loss Of Consciousness Life Threatening 11/19/2006 51 Female 121 lb 12/8/2006 Physician Japan
Primary
Concomitant
Oedema Peripheral Hospitalization Male 176 lb 12/21/2006 Consumer Brazil
Primary
Concomitant
Poisoning Hospitalization 7/12/2006 82 Female 84 lb 2/26/2007 Pharmacist Japan
Primary
Secondary
Concomitant
Arrhythmia Other Serious 2/26/2007 Male 4/9/2007 Physician Japan
Primary
Secondary
Concomitant
Skin Fissures Other Serious 11/10/2006 1 Male 3/30/2007 Physician Japan
Primary
Secondary
Concomitant
Disturbance In Attention Other Serious 65 Female 4/13/2007 Physician Brazil
Primary
Concomitant
Death Other Serious 3/5/2007 Male 176 lb 4/18/2007 Physician Japan
Primary
Concomitant
Epilepsy Other Serious 8/1/2006 47 Female 4/30/2007 Physician France
Primary
Secondary
Concomitant
Pyrexia 1/11/2006 3 Female 5/3/2007 Physician United States
Primary
Concomitant
Pneumonia Other Serious 4 Female 5/25/2007 Japan
Primary
Concomitant
Interacting
Malabsorption Other Serious 8/1/2006 Female 6/7/2007 Physician France
Primary
Secondary
Concomitant
Therapeutic Agent Toxicity Other Serious 7/5/2005 Female 93 lb 6/13/2007 Lawyer United States
Primary
Secondary
Concomitant
Renal Impairment Life Threatening 1/1/2007 57 Male 6/27/2007 Physician Japan
Primary
Concomitant
Therapeutic Agent Toxicity Other Serious 7/5/2005 Female 93 lb 7/10/2007 Lawyer United States
Primary
Secondary
Concomitant
Stevens-johnson Syndrome Hospitalization 5/26/2007 56 Female 7/20/2007 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Acute Life Threatening 5/1/2007 Male 123 lb 7/20/2007 Physician Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Hospitalization 6/10/2007 58 Male 7/27/2007 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Hospitalization 6/10/2007 58 Male 165 lb 8/13/2007 Physician Japan
Primary
Concomitant
Stevens-johnson Syndrome Hospitalization 5/26/2007 56 Female 9/4/2007 Physician Japan
Primary
Secondary
Concomitant
X-ray Abnormal Other Serious 6/3/2007 69 Female 9/24/2007 Pharmacist Japan
Primary
Secondary
Concomitant
Tremor Other Serious 8/26/2007 1 Female 20 lb 9/26/2007 Consumer Brazil
Primary
Concomitant
X-ray Abnormal Other Serious 6/3/2007 69 Female 10/2/2007 Pharmacist Japan
Primary
Secondary
Concomitant
X-ray Abnormal Other Serious 6/3/2007 68 Female 10/6/2007 Japan
Primary
Secondary
Concomitant
Hypothermia Hospitalization 11/5/2007 39 Male 11/14/2007 Physician Japan
Primary
Concomitant
Renal Failure Acute Life Threatening 8/16/2003 3 Female 23 lb 11/26/2007 Physician Japan
Primary
Concomitant
Pancreatitis Chronic Hospitalization 1/1/2005 Female 12/11/2007 Other Health Professional France
Primary
Concomitant
Hypotonia Hospitalization 10/12/2007 83 Female 12/28/2007 Other Health Professional France
Primary
Secondary
Concomitant
Pharmaceutical Product Counterfeit Other Serious 12/1/2005 21 Male 1/31/2008 Consumer France
Primary
Secondary
Concomitant
Pancreatitis Chronic Hospitalization 1/1/2005 Female 3/7/2008 Other Health Professional France
Primary
Concomitant
Erectile Dysfunction Other Serious 5/1/2007 45 Male 3/13/2008 Physician France
Primary
Secondary
Loss Of Consciousness 11/2/2006 Male 3/24/2008 Other Health Professional United States
Primary
Concomitant
Platelet Count Decreased Other Serious 5/2/2007 22 Male 150 lb 3/25/2008 Physician Japan
Primary
Secondary
Concomitant
Purpura Other Serious 12/28/2007 Male 7/2/2008 Physician Japan
Primary
Secondary
Nephrolithiasis Hospitalization 5/8/2008 Male 7/8/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Weight Decreased Other Serious 7/8/2008 Female 8/6/2008 Other Health Professional Japan
Primary
Concomitant
Interacting
Leukocytoclastic Vasculitis 12/1/2007 39 Male 8/14/2008 Physician Japan
Primary
Secondary
Concomitant
Thirst Other Serious Male 141 lb 9/4/2008 Consumer Brazil
Primary
Concomitant
Weight Decreased Other Serious 7/8/2008 Female 9/8/2008 Other Health Professional Japan
Primary
Concomitant
Interacting
Headache Hospitalization 9/3/2008 20 Male 119 lb 9/17/2008 Consumer Brazil
Primary
Concomitant
Thirst Other Serious Male 141 lb 9/18/2008 Consumer Brazil
Primary
Concomitant
Weight Decreased 7/8/2008 Female 9/23/2008 Other Health Professional Japan
Primary
Concomitant
Interacting
Pancytopenia Other Serious 2/25/2008 52 Male 137 lb 9/24/2008 Physician France
Primary
Secondary
Concomitant
Neoplasm Progression Hospitalization 1/5/2007 59 Female 116 lb 9/29/2008 Physician Japan
Primary
Concomitant
Pulmonary Embolism Hospitalization 2/10/2008 53 Male 159 lb 10/3/2008 Physician Japan
Primary
Secondary
Concomitant
Drug Rash With Eosinophilia And Systemic Symptoms Hospitalization 4/3/2008 Female 10/22/2008 Japan
Primary
Concomitant
Drug Rash With Eosinophilia And Systemic Symptoms Hospitalization 4/3/2008 Female 10/30/2008 Japan
Primary
Concomitant
Somnolence Other Serious 10/1/2008 Male 185 lb 12/31/2008 Consumer Brazil
Primary
Concomitant
Somnolence Other Serious 10/1/2008 Male 185 lb 1/28/2009 Consumer Brazil
Primary
Concomitant
Inappropriate Antidiuretic Hormone Secretion Hospitalization 1/1/2009 65 Female 2/11/2009 Physician Japan
Primary
Concomitant
Inappropriate Antidiuretic Hormone Secretion Hospitalization 1/1/2009 65 Female 2/16/2009 Physician Japan
Primary
Concomitant
Inappropriate Antidiuretic Hormone Secretion Hospitalization 1/1/2009 65 Female 2/23/2009 Physician Japan
Primary
Concomitant
Hyponatraemia Hospitalization 1/1/2009 65 Female 2/25/2009 Physician Japan
Primary
Concomitant
Platelet Count Decreased 40 Female 2/25/2009 Physician Japan
Primary
Concomitant
Hyponatraemia Hospitalization 1/1/2009 65 Female 3/5/2009 Physician Japan
Primary
Concomitant
Thrombocytopenia 6/27/2006 Female 3/6/2009 Physician Japan
Primary
Concomitant
Petit Mal Epilepsy Other Serious 31 Male 3/16/2009 Consumer Brazil
Primary
Concomitant
Liver Disorder Hospitalization 1/6/2009 Male 121 lb 3/25/2009 Physician Japan
Primary
Concomitant
Stevens-johnson Syndrome Other Serious 2/24/2009 44 Male 3/26/2009 Physician Japan
Primary
Secondary
Concomitant
Status Epilepticus Other Serious 10/21/2008 41 Female 3/26/2009 Other Health Professional Japan
Primary
Concomitant
Stevens-johnson Syndrome Disability 2/24/2009 Male 4/8/2009 Physician Japan
Primary
Secondary
Concomitant
Status Epilepticus Other Serious 11/6/2008 41 Female 4/10/2009 Other Health Professional Japan
Primary
Concomitant
Liver Disorder Hospitalization 1/6/2009 Male 121 lb 4/14/2009 Physician Japan
Primary
Concomitant
Cardiac Disorder Death 7/9/2007 75 Male 134 lb 6/1/2009 Physician Japan
Primary
Concomitant
Vomiting Other Serious 2/2/2006 Male 6/5/2009 France
Primary
Concomitant
Salivary Hypersecretion Other Serious 3/1/2009 14 Male 6/8/2009 Physician Japan
Primary
Concomitant
Regurgitation Hospitalization 0 6/16/2009 France
Primary
Concomitant
Encephalitis Herpes Life Threatening 2/27/2008 1 Male 19 lb 7/7/2009 Japan
Primary
Secondary
Concomitant
Muscle Tightness Hospitalization 5/30/2009 8 Male 7/13/2009 Physician Japan
Primary
Concomitant
Somnolence Other Serious 6/21/1930 58 7/15/2009 Pharmacist Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 4/24/2009 Male 7/21/2009 Physician Japan
Primary
Concomitant
Somnolence Other Serious 6/21/2009 58 7/27/2009 Pharmacist Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 4/24/2009 Male 8/18/2009 Physician Japan
Primary
Concomitant
Fanconi Syndrome Other Serious 4/5/2009 Female 8/18/2009 Physician Japan
Primary
Concomitant
Vomiting Other Serious 10/19/2008 67 Female 88 lb 8/14/2009 Physician Japan
Primary
Concomitant
White Blood Cell Count Increased Hospitalization 4/24/2009 Male 9/1/2009 Physician Japan
Primary
Concomitant
Muscle Tightness Hospitalization 5/30/2009 Male 9/9/2009 Physician Japan
Primary
Concomitant
Renal Tubular Disorder Other Serious 4/5/2009 Female 9/11/2009 Physician Japan
Primary
Concomitant
Stevens-johnson Syndrome Other Serious 7/2/2009 Male 10/7/2009 Pharmacist Japan
Primary
Concomitant
Stevens-johnson Syndrome Other Serious 7/2/2009 Male 10/26/2009 Pharmacist Japan
Primary
Secondary
Concomitant
Tremor Hospitalization 2/1/2006 29 Male 185 lb 10/30/2009 Other Health Professional France
Primary
Secondary
Concomitant
White Blood Cell Count Increased Hospitalization 4/24/2009 Male 11/6/2009 Physician Japan
Primary
Concomitant
Tooth Deposit Other Serious 18 Male 11/11/2009 Other Health Professional Japan
Primary
Concomitant
Pneumonia Death 6/13/2009 15 11/3/2009 Physician Brazil
Primary
Concomitant
Status Epilepticus Hospitalization 8/1/2009 85 Male 11/23/2009 Physician Japan
Primary
Concomitant
Tooth Resorption Other Serious 7/1/2003 18 Male 11/25/2009 Other Health Professional Japan
Primary
Concomitant
Tooth Resorption Other Serious 1/1/1992 18 Male 12/31/2009 Physician Japan
Primary
Secondary
Concomitant
Splenomegaly Hospitalization 18 Male 1/12/2010 France
Primary
Concomitant
Interacting
Fall Hospitalization 4/10/2009 65 Female 1/13/2010 Other Health Professional France
Primary
Secondary
Interacting
Platelet Count Decreased Other Serious 5/2/2007 22 Male 136 lb 1/19/2010 Physician Japan
Primary
Secondary
Concomitant
Status Epilepticus Hospitalization 8/1/2009 85 Male 2/15/2010 Physician Japan
Primary
Concomitant
Fall Hospitalization 4/10/2009 65 Female 3/1/2010 Other Health Professional France
Primary
Secondary
Interacting
Diarrhoea Male 3/2/2010 Pharmacist United States
Primary
Concomitant
Thrombocytopenia Other Serious 1/13/2010 60 Female 3/12/2010 Japan
Primary
Concomitant
Pregnancy Other Serious Female 136 lb 2/19/2010 Physician Italy
Primary
Concomitant
Pulmonary Hypertension Other Serious 75 Male 134 lb 3/10/2010 Physician Japan
Primary
Concomitant
Toxic Epidermal Necrolysis Life Threatening 5/1/2009 Male 3/18/2010 Physician Japan
Primary
Concomitant
Toxic Epidermal Necrolysis Life Threatening 5/1/2009 48 Male 4/5/2010 Physician Japan
Primary
Concomitant
Anaphylactic Shock Life Threatening 11/4/2009 70 Male 5/3/2010 Physician Japan
Primary
Secondary
Concomitant
Shock Death 4/11/2010 6 Female 6/18/2010 Physician Japan
Primary
Secondary
Concomitant
Sudden Death Other Serious 4/11/2010 6 Female 7/1/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Pancreatitis Acute Death 4/11/2010 6 Female 7/16/2010 Physician Japan
Primary
Secondary
Concomitant
Shock Other Serious 3/6/2009 40 Male 132 lb 8/4/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Tremor Hospitalization 2/1/2006 29 Male 187 lb 8/5/2010 France
Primary
Secondary
Concomitant
Liver Disorder Other Serious 1/25/2008 53 Female 8/13/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Shock Other Serious 3/6/2009 40 Male 132 lb 8/23/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Hepatitis Acute Other Serious 1/25/2008 53 Female 8/23/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 8/8/2009 74 Female 130 lb 9/8/2010 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Embolism Hospitalization 4/17/2011 75 Female 247 lb 5/12/2011 Other Health Professional France
Primary
Secondary
Concomitant
Drug Interaction Hospitalization 4/17/2011 75 Female 247 lb 5/13/2011 Other Health Professional France
Primary
Concomitant
Interacting
Gastrointestinal Haemorrhage Hospitalization 3/5/2010 68 Female 137 lb 5/16/2011 Physician France
Primary
Concomitant
Gamma-glutamyltransferase Increased Other Serious 12/1/2010 26 Male 5/9/2011 Other Health Professional Croatia (Local Name: Hrvatska)
Primary
Concomitant
Cytolytic Hepatitis Hospitalization 10/28/2010 Male 18 lb 6/2/2011 Other Health Professional France
Primary
Secondary
Concomitant
Confusional State Hospitalization 5/12/2011 51 Male 237 lb 6/17/2011 Consumer France
Primary
Concomitant
Sinusitis Hospitalization 1/1/2003 53 Male 202 lb 7/1/2011 Other Health Professional United States
Primary
Concomitant
Status Epilepticus Other Serious 6/1/2011 23 Male 7/6/2011 Pharmacist Japan
Primary
Concomitant
Blood Electrolytes Abnormal Hospitalization 11/22/2010 59 Male 106 lb 7/12/2011 Physician Japan
Primary
Secondary
Concomitant
Compartment Syndrome Hospitalization 5/16/2011 1 Male 20 lb 7/29/2011 Other Health Professional France
Primary
Secondary
Concomitant
Renal Disorder Hospitalization 10/1/2010 Male 8/1/2011 Pharmacist Belgium
Primary
Concomitant
Myoglobin Urine Present Hospitalization 3/7/2010 5 Female 8/5/2011 Physician Japan
Primary
Secondary
Concomitant
Hepatocellular Injury Hospitalization 12/3/2010 51 Female 8/5/2011 Other Health Professional France
Primary
Concomitant
Rhabdomyolysis Life Threatening 3/7/2010 5 Female 8/22/2011 Physician Japan
Primary
Secondary
Concomitant
Nervousness Hospitalization 6/8/2011 36 Female 9/13/2011 Consumer Brazil
Primary
Concomitant
Epilepsy Hospitalization 6/8/2011 36 Female 9/19/2011 Consumer Brazil
Primary
Concomitant
Drug Interaction Hospitalization 8/1/2011 47 Male 9/29/2011 Other Health Professional France
Primary
Concomitant
Interacting
Nervousness Hospitalization 6/8/2011 36 Female 10/4/2011 Consumer Brazil
Primary
Concomitant
Tachycardia Hospitalization 5/12/2011 51 Male 237 lb 10/7/2011 Consumer France
Primary
Concomitant
Oedema Peripheral Hospitalization 6/8/2011 36 Female 10/11/2011 Consumer Brazil
Primary
Concomitant
Scleroderma Hospitalization 9/24/2011 58 Male 10/13/2011 Physician Japan
Primary
Concomitant
Leukopenia Death 11/22/2010 60 Male 106 lb 10/10/2011 Physician Japan
Primary
Secondary
Concomitant
Somnolence Other Serious 6/1/2011 69 Female 10/14/2011 Pharmacist Japan
Primary
Concomitant
Osteopenia Other Serious 2/1/2006 29 Male 187 lb 10/18/2011 Physician France
Primary
Secondary
Concomitant
Colitis Hospitalization 8/10/2011 63 Male 10/31/2011 Physician Japan
Primary
Concomitant
Oedema Peripheral Other Serious 6/8/2011 36 Female 11/4/2011 Consumer Brazil
Primary
Concomitant
Convulsion Other Serious 1/1/2010 12 Female 33 lb 11/14/2011 Consumer Brazil
Primary
Concomitant
Anaemia Other Serious 3/1/2011 69 Male 115 lb 11/23/2011 Consumer Brazil
Primary
Secondary
Concomitant
Dizziness Hospitalization 6/8/2011 36 Female 11/23/2011 Consumer Brazil
Primary
Concomitant
Oliguria Death 8/8/2009 74 Female 130 lb 11/23/2011 Physician Japan
Primary
Secondary
Concomitant
Pancreatitis Acute Hospitalization 5/19/2010 53 Male 12/2/2011 Physician France
Primary
Secondary

Drug Data