Lendormin combined with Urso 250

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Toxic Epidermal Necrolysis Other Serious 2/19/2007 72 Male 121 lb 5/21/2007 Physician Japan
Primary
Concomitant
Subdural Haematoma Other Serious 3/8/2007 66 Male 134 lb 5/24/2007 Physician Japan
Primary
Concomitant
Subdural Haematoma Other Serious 5/31/2006 66 Male 134 lb 6/15/2007 Physician Japan
Primary
Concomitant
Subdural Haematoma Other Serious 5/31/2006 66 Male 134 lb 7/6/2007 Physician Japan
Primary
Concomitant
Urine Output Decreased Other Serious 2/14/2007 67 Female 121 lb 8/6/2007 Physician Japan
Primary
Concomitant
Liver Disorder Hospitalization 9/27/2006 53 Male 8/17/2007 Physician Japan
Primary
Secondary
Concomitant
Subdural Haematoma Other Serious 5/31/2006 66 Male 134 lb 8/23/2007 Physician Japan
Primary
Concomitant
Liver Disorder Hospitalization 2/7/2005 73 Male 9/4/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Liver Disorder Other Serious 1/1/2006 53 Male 10/26/2007 Consumer United States
Primary
Secondary
Concomitant
Sepsis Hospitalization 9/21/2006 Male 123 lb 11/9/2007 Physician Japan
Primary
Concomitant
Hepatic Neoplasm Malignant Life Threatening 6/21/2007 60 Male 12/28/2007 Other Health Professional Japan
Primary
Concomitant
Urinary Incontinence Hospitalization 12/5/2007 60 Female 110 lb 2/14/2008 Physician Japan
Primary
Concomitant
Pneumothorax Other Serious 5/31/2006 54 Male 123 lb 2/29/2008 Physician Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 9/21/2006 Male 123 lb 3/12/2008 Physician Japan
Primary
Concomitant
Urinary Incontinence Hospitalization 12/5/2007 60 Female 110 lb 3/28/2008 Physician Japan
Primary
Concomitant
Pneumothorax Other Serious 5/31/2006 54 Male 123 lb 5/9/2008 Physician Japan
Primary
Secondary
Concomitant
Somnolence Hospitalization 3/20/2006 82 Female 79 lb 5/13/2008 Physician Japan
Primary
Concomitant
Somnolence Hospitalization 3/19/2006 82 Female 79 lb 5/22/2008 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 9/22/2006 68 Male 5/29/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Somnolence Hospitalization 3/19/2006 82 Female 79 lb 6/11/2008 Physician Japan
Primary
Concomitant
Purpura Hospitalization 5/10/2008 Male 155 lb 6/11/2008 Physician United Kingdom
Primary
Concomitant
Sepsis Hospitalization 9/21/2006 Male 123 lb 7/29/2008 Physician Japan
Primary
Concomitant
Intentional Overdose Hospitalization 3/21/2005 45 Male 154 lb 10/9/2008 Physician Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 9/21/2006 Male 123 lb 11/24/2008 Physician Japan
Primary
Concomitant
Subdural Haematoma Other Serious 10/17/2008 Male 112 lb 2/3/2009 Physician Japan
Primary
Concomitant
Subdural Haematoma Other Serious 10/17/2008 Male 112 lb 2/24/2009 Physician Japan
Primary
Concomitant
Pyrexia Life Threatening 1/22/2009 3/20/2009 Physician Japan
Primary
Concomitant
Hepatic Rupture Death 11/4/2007 81 Male 4/8/2009 Japan
Primary
Concomitant
Pyrexia Life Threatening 1/22/2009 4/9/2009 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 1/22/2009 69 5/12/2009 Physician Japan
Primary
Concomitant
Hepatic Neoplasm Malignant Life Threatening 6/21/2007 60 Male 5/28/2009 Other Health Professional Japan
Primary
Concomitant
Hepatic Rupture Death 11/4/2007 81 Male 7/29/2009 Japan
Primary
Concomitant
Pyrexia Other Serious 8/13/2008 Female 90 lb 8/3/2009 Physician Japan
Primary
Secondary
Concomitant
Hepatic Rupture Death 11/4/2007 81 Male 8/11/2009 Japan
Primary
Concomitant
Metabolic Encephalopathy Hospitalization 6/8/2009 67 Male 112 lb 8/20/2009 Physician Japan
Primary
Concomitant
Pericardial Effusion Other Serious 4/16/2009 Female 112 lb 8/26/2009 Physician Japan
Primary
Concomitant
Metabolic Encephalopathy Hospitalization 6/8/2009 67 Male 112 lb 9/18/2009 Physician Japan
Primary
Concomitant
Respiratory Failure Other Serious 8/10/2008 69 Male 134 lb 10/2/2009 Physician Japan
Primary
Concomitant
Pericardial Effusion Other Serious 4/16/2009 Female 112 lb 10/15/2009 Physician Japan
Primary
Concomitant
Metabolic Encephalopathy Death 6/8/2009 67 Male 112 lb 10/26/2009 Physician Japan
Primary
Concomitant
Sick Sinus Syndrome Hospitalization 10/11/2009 Male 10/30/2009 Physician
Primary
Secondary
Concomitant
Pericardial Effusion Other Serious 4/16/2009 Female 112 lb 11/11/2009 Physician Japan
Primary
Concomitant
Toxic Epidermal Necrolysis Death 8/24/2009 46 Male 11/30/2009 Physician Japan
Primary
Secondary
Concomitant
Metabolic Encephalopathy Death 6/8/2009 67 Male 112 lb 11/30/2009 Physician Japan
Primary
Concomitant
Sick Sinus Syndrome Hospitalization 10/13/2009 Male 12/1/2009 Physician
Primary
Secondary
Concomitant
Sick Sinus Syndrome Hospitalization 10/13/2009 Male 12/9/2009 Physician
Primary
Secondary
Concomitant
Physical Assault Other Serious 12/6/2009 Male 12/17/2009 Physician Japan
Primary
Secondary
Physical Assault Other Serious 12/6/2009 Male 12/30/2009 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 8/13/2008 Female 90 lb 1/5/2010 Physician Japan
Primary
Secondary
Concomitant
Physical Assault Other Serious 12/6/2009 Male 1/12/2010 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 8/13/2008 Female 90 lb 2/1/2010 Physician Japan
Primary
Secondary
Concomitant
Liver Carcinoma Ruptured Hospitalization 12/10/2009 74 Male 2/4/2010 Physician Japan
Primary
Concomitant
Septic Shock Hospitalization 12/9/2008 Male 2/12/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 8/13/2008 Female 90 lb 2/16/2010 Physician Japan
Primary
Secondary
Concomitant
Metabolic Encephalopathy Other Serious 6/8/2009 67 Male 112 lb 2/23/2010 Physician Japan
Primary
Concomitant
Pulmonary Arterial Pressure Increased Other Serious 7/16/2009 77 Male 117 lb 2/23/2010 Physician Japan
Primary
Concomitant
Skin Ulcer Hospitalization 12/20/2008 Female 95 lb 2/25/2010 Physician Japan
Primary
Concomitant
Speech Disorder Hospitalization 11/16/2009 68 Female 123 lb 2/22/2010 Physician Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 8/10/2008 69 Male 134 lb 2/25/2010 Physician Japan
Primary
Concomitant
Subileus Other Serious 8/13/2008 Female 90 lb 3/16/2010 Physician Japan
Primary
Secondary
Concomitant
Septic Shock Hospitalization 12/9/2008 Male 132 lb 3/23/2010 Physician Japan
Primary
Secondary
Concomitant
Schizophrenia Hospitalization 11/16/2009 68 Female 123 lb 3/26/2010 Physician Japan
Primary
Secondary
Concomitant
Subileus Other Serious 8/13/2008 52 Female 90 lb 4/15/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 9/16/2009 61 Male 159 lb 4/20/2010 Physician Japan
Primary
Concomitant
Subileus Other Serious 8/13/2008 52 Female 90 lb 4/23/2010 Physician Japan
Primary
Secondary
Concomitant
Subileus Other Serious 8/13/2008 52 Female 90 lb 4/27/2010 Physician Japan
Primary
Secondary
Concomitant
Pleural Effusion Other Serious 11/23/2009 66 Male 141 lb 5/7/2010 Physician Japan
Primary
Concomitant
Upper Respiratory Tract Inflammation Hospitalization 5/10/2009 68 Female 128 lb 5/14/2010 Physician Japan
Primary
Secondary
Concomitant
Subileus Other Serious 8/13/2008 52 Female 90 lb 5/14/2010 Physician Japan
Primary
Secondary
Concomitant
Upper Respiratory Tract Inflammation Hospitalization 5/10/2009 68 Female 128 lb 5/17/2010 Physician Japan
Primary
Secondary
Concomitant
Subileus Other Serious 8/13/2008 52 Female 90 lb 5/20/2010 Physician Japan
Primary
Secondary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Death 7/22/2009 73 Male 108 lb 5/27/2010 Physician Japan
Primary
Concomitant
Malaise Other Serious 4/20/2010 79 Male 158 lb 5/27/2010 Pharmacist Japan
Primary
Concomitant
Schizophrenia Hospitalization 12/1/2009 68 Female 123 lb 5/26/2010 Physician Japan
Primary
Secondary
Concomitant
Upper Respiratory Tract Inflammation Hospitalization 5/10/2009 68 Female 128 lb 6/22/2010 Physician Japan
Primary
Secondary
Concomitant
Pleural Effusion Other Serious 11/23/2009 66 Male 141 lb 6/23/2010 Physician Japan
Primary
Concomitant
Subileus Other Serious 8/13/2008 52 Female 90 lb 6/25/2010 Physician Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Other Serious 8/23/2009 70 Male 143 lb 6/29/2010 Physician Japan
Primary
Concomitant
Malaise Other Serious 4/20/2010 79 Male 158 lb 6/28/2010 Pharmacist Japan
Primary
Concomitant
Drug Level Increased Other Serious 34 Male 7/9/2010 Pharmacist Japan
Primary
Concomitant
Hyperammonaemia Hospitalization 12/25/2009 73 Male 137 lb 7/12/2010 Physician Japan
Primary
Concomitant
Hepatic Neoplasm Malignant Life Threatening 6/21/2007 60 Male 7/12/2010 Other Health Professional Japan
Primary
Concomitant
Metabolic Encephalopathy Other Serious 6/8/2009 67 Male 112 lb 7/16/2010 Other Health Professional Japan
Primary
Concomitant
Malaise Hospitalization 4/15/2010 82 Male 115 lb 7/19/2010 Physician Japan
Primary
Concomitant
Rash Hospitalization 6/27/2009 73 Female 115 lb 7/26/2010 Physician Japan
Primary
Concomitant
Metabolic Encephalopathy Other Serious 6/8/2009 67 Male 112 lb 7/27/2010 Other Health Professional Japan
Primary
Concomitant
Hyperammonaemia Hospitalization 12/25/2009 73 Male 137 lb 7/28/2010 Physician Japan
Primary
Concomitant
Renal Disorder Life Threatening 7/23/2009 68 Male 141 lb 7/27/2010 Physician Japan
Primary
Concomitant
Pyrexia Life Threatening 9/15/2009 61 Male 159 lb 7/30/2010 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 7/3/2009 64 Male 128 lb 8/2/2010 Physician Japan
Primary
Concomitant
Malaise Hospitalization 4/15/2010 82 Male 115 lb 8/2/2010 Physician Japan
Primary
Concomitant
Platelet Count Decreased Life Threatening 11/30/2009 63 Male 110 lb 8/4/2010 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Death 7/22/2009 73 Male 108 lb 8/11/2010 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 7/3/2009 64 Male 128 lb 8/12/2010 Physician Japan
Primary
Concomitant
Drug Level Increased Other Serious 34 Male 8/17/2010 Pharmacist Japan
Primary
Concomitant
Tumour Haemorrhage Life Threatening 11/30/2009 63 Male 110 lb 8/30/2010 Physician Japan
Primary
Concomitant
Pruritus Hospitalization 4/6/2010 82 Male 115 lb 9/9/2010 Physician Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 8/23/2009 70 Male 143 lb 9/30/2010 Physician Japan
Primary
Concomitant
Hyponatraemia Hospitalization 8/24/2010 69 Female 10/8/2010 Physician Japan
Primary
Secondary
Concomitant
Hyponatraemia Hospitalization 8/24/2010 69 Female 11/3/2010 Physician Japan
Primary
Secondary
Concomitant
Pruritus Hospitalization 3/5/2010 82 Male 115 lb 11/10/2010 Physician Japan
Primary
Concomitant
Proteinuria Other Serious 9/11/2009 12/3/2010 Physician Japan
Primary
Concomitant
Pyrexia Hospitalization 2/18/2010 66 Male 119 lb 12/3/2010 Physician Japan
Primary
Concomitant
Stomatitis Hospitalization 5/6/2010 74 Female 79 lb 12/10/2010 Physician Japan
Primary
Concomitant
Peritonitis Other Serious 4/18/2010 59 Male 128 lb 12/16/2010 Physician Japan
Primary
Concomitant
Death Other Serious 11/19/2008 43 Female 116 lb 12/17/2010 Physician Japan
Primary
Concomitant
Stomatitis Hospitalization 4/7/2010 73 Female 79 lb 12/23/2010 Physician Japan
Primary
Concomitant
Ileus Other Serious 4/20/2010 79 Male 158 lb 1/21/2011 Pharmacist Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 7/21/2010 71 Male 126 lb 1/28/2011 Physician Japan
Primary
Concomitant
Decreased Appetite Death 12/11/2010 47 Male 148 lb 1/28/2011 Physician Japan
Primary
Concomitant
Hepatic Neoplasm Malignant Life Threatening 7/21/2010 55 Male 176 lb 1/28/2011 Physician Japan
Primary
Concomitant
Ileus Hospitalization 4/20/2010 79 Male 158 lb 2/3/2011 Physician Japan
Primary
Concomitant
Gastrointestinal Erosion Other Serious 9/1/2008 60 Male 141 lb 2/7/2011 Other Health Professional Japan
Primary
Concomitant
Hepatic Neoplasm Malignant Life Threatening 7/21/2010 55 Male 176 lb 2/7/2011 Physician Japan
Primary
Concomitant
Decreased Appetite Hospitalization 10/1/2010 84 Male 146 lb 2/9/2011 Physician Japan
Primary
Concomitant
Respiratory Failure Disability 7/21/2010 55 Male 176 lb 2/17/2011 Physician Japan
Primary
Concomitant
Gastrointestinal Haemorrhage Other Serious 8/5/2009 64 Female 150 lb 2/17/2011 Physician Japan
Primary
Concomitant
Hepatic Failure Life Threatening 12/8/2010 66 Female 163 lb 3/8/2011 Physician Japan
Primary
Secondary
Concomitant
Gamma-glutamyltransferase Increased Life Threatening 11/7/2008 59 Male 148 lb 3/11/2011 Physician Japan
Primary
Concomitant
Deafness Other Serious 4/7/2010 67 Male 117 lb 3/11/2011 Physician Japan
Primary
Secondary
Concomitant
Gait Disturbance Other Serious 2/9/2011 82 Male 3/14/2011 Pharmacist Japan
Primary
Concomitant
Acute Graft Versus Host Disease In Liver Life Threatening 12/6/2010 53 Male 165 lb 3/28/2011 Physician Japan
Primary
Concomitant
Septic Shock Death 12/8/2010 66 Female 163 lb 3/29/2011 Physician Japan
Primary
Secondary
Concomitant
Liver Carcinoma Ruptured Death 12/10/2009 74 Male 4/1/2011 Physician Japan
Primary
Concomitant
Pulmonary Tuberculosis Other Serious 2/1/2009 63 Male 4/4/2011 Physician Japan
Primary
Secondary
Concomitant
Hyperbilirubinaemia Other Serious 7/21/2010 55 Male 176 lb 4/5/2011 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Death 2/21/2011 62 Male 146 lb 4/1/2011 Consumer Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Other Serious 10/14/2009 58 Female 90 lb 4/5/2011 Physician Japan
Primary
Concomitant
Hypoglycaemia Other Serious 4/7/2010 67 Male 117 lb 4/18/2011 Physician Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Death 2/21/2011 62 Male 146 lb 4/13/2011 Consumer Japan
Primary
Secondary
Concomitant
Drug Eruption Other Serious 2/1/2009 63 Male 4/22/2011 Physician Japan
Primary
Secondary
Concomitant
Rash Hospitalization 6/27/2009 73 Female 115 lb 4/18/2011 Physician Japan
Primary
Concomitant
Abdominal Pain Death 7/23/2009 68 Male 140 lb 4/19/2011 Physician Japan
Primary
Concomitant
Systemic Candida Death 4/24/2009 38 Male 157 lb 5/5/2011 Physician Japan
Primary
Secondary
Concomitant
Gamma-glutamyltransferase Increased Life Threatening 12/6/2010 53 Male 165 lb 5/27/2011 Physician Japan
Primary
Concomitant
Cholangitis Suppurative Death 3/18/2011 76 Female 121 lb 5/30/2011 Physician Japan
Primary
Secondary
Concomitant
Oral Herpes Other Serious 5/20/2010 65 Male 110 lb 5/26/2011 Physician Japan
Primary
Concomitant
Cholangitis Life Threatening 7/21/2010 55 Male 176 lb 6/2/2011 Physician Japan
Primary
Concomitant
Liver Disorder Hospitalization 2/18/2010 66 Male 119 lb 6/3/2011 Physician Japan
Primary
Concomitant
Drug Eruption Other Serious 2/1/2009 63 Male 6/14/2011 Physician Japan
Primary
Secondary
Concomitant
Hypertransaminasaemia Other Serious 5/2/2011 36 Male 6/28/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Hepatorenal Syndrome Hospitalization 7/23/2009 68 Male 140 lb 8/5/2011 Physician Japan
Primary
Concomitant
Pneumonia Hospitalization 3/14/2011 78 Male 112 lb 8/9/2011 Physician Japan
Primary
Concomitant
Gastrointestinal Erosion Other Serious 9/1/2008 60 Male 141 lb 8/25/2011 Physician Japan
Primary
Concomitant
Oesophageal Ulcer Other Serious 6/14/2011 61 Female 98 lb 9/9/2011 Physician Japan
Primary
Concomitant
Dissociative Disorder Hospitalization 12/1/2009 68 Female 123 lb 8/26/2011 Physician Japan
Primary
Secondary
Concomitant
Graft Versus Host Disease Disability 6/6/2011 13 Female 88 lb 9/20/2011 Physician Japan
Primary
Concomitant
Pyrexia Life Threatening 9/15/2009 61 Male 159 lb 9/23/2011 Physician Japan
Primary
Concomitant
Nikolsky's Sign Other Serious 8/15/2009 45 Male 176 lb 10/5/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Nikolsky's Sign Death 8/22/2009 45 Male 176 lb 10/7/2011 Other Health Professional Japan
Primary
Secondary
Concomitant

Drug Data