Lendormin combined with Nexavar

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Palmar-plantar Erythrodysaesthesia Syndrome Life Threatening 4/1/2008 75 Male 117 lb 6/24/2008 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Life Threatening 4/1/2008 75 Male 117 lb 6/26/2008 Physician Japan
Primary
Concomitant
Rash Death 4/25/2008 78 Male 121 lb 8/18/2008 Physician Japan
Primary
Concomitant
Staphylococcal Infection Life Threatening 5/16/2008 71 Male 73 lb 9/8/2008 Physician Japan
Primary
Concomitant
Staphylococcal Infection Life Threatening 5/16/2008 71 Male 73 lb 10/7/2008 Physician Japan
Primary
Concomitant
Renal Cell Carcinoma Stage Iv Death 1/1/2008 64 Male 12/17/2008 Physician Japan
Primary
Concomitant
Septic Shock Death 5/5/2008 59 Male 106 lb 1/23/2009 Physician Japan
Primary
Concomitant
Pneumonia Life Threatening 5/16/2008 71 Male 73 lb 1/23/2009 Physician Japan
Primary
Concomitant
Rash Other Serious 11/21/2008 62 Male 148 lb 3/20/2009 Physician Japan
Primary
Concomitant
Renal Failure Hospitalization 12/17/2008 76 Male 143 lb 4/21/2009 Physician Japan
Primary
Concomitant
Skin Exfoliation Other Serious 2/11/2009 71 Male 143 lb 5/13/2009 Physician Japan
Primary
Concomitant
Renal Failure Hospitalization 12/17/2008 76 Male 143 lb 5/27/2009 Physician Japan
Primary
Concomitant
Skin Exfoliation Other Serious 2/11/2009 71 Male 143 lb 6/1/2009 Physician Japan
Primary
Concomitant
Thrombocytopenia Life Threatening 4/26/2009 88 Male 123 lb 7/17/2009 Physician Japan
Primary
Concomitant
Rash Hospitalization 8/29/2008 68 Male 146 lb 7/29/2009 Physician Japan
Primary
Concomitant
Pneumonia Life Threatening 5/16/2008 71 Male 73 lb 8/3/2009 Physician Japan
Primary
Concomitant
Metabolic Encephalopathy Hospitalization 6/8/2009 67 Male 112 lb 8/20/2009 Physician Japan
Primary
Concomitant
Rash Hospitalization 6/26/2009 77 Female 86 lb 8/31/2009 Physician Japan
Primary
Concomitant
Skin Exfoliation Other Serious 2/11/2009 71 Male 143 lb 8/31/2009 Physician Japan
Primary
Secondary
Concomitant
Thrombocytopenia Life Threatening 4/26/2009 88 Male 123 lb 9/3/2009 Physician Japan
Primary
Concomitant
Rash Other Serious 8/21/2008 68 Male 146 lb 9/8/2009 Physician Japan
Primary
Concomitant
Pneumonia Life Threatening 5/16/2008 71 Male 73 lb 9/9/2009 Physician Japan
Primary
Concomitant
Metabolic Encephalopathy Hospitalization 6/8/2009 67 Male 112 lb 9/18/2009 Physician Japan
Primary
Concomitant
Metabolic Encephalopathy Death 6/8/2009 67 Male 112 lb 10/26/2009 Physician Japan
Primary
Concomitant
Red Blood Cell Count Decreased Life Threatening 9/17/2009 Male 137 lb 11/2/2009 Physician Japan
Primary
Concomitant
Red Blood Cell Count Decreased Life Threatening 9/17/2009 Male 137 lb 11/5/2009 Physician Japan
Primary
Concomitant
Renal Failure Other Serious 12/17/2008 76 Male 143 lb 11/17/2009 Physician Japan
Primary
Concomitant
Metabolic Encephalopathy Death 6/8/2009 67 Male 112 lb 11/30/2009 Physician Japan
Primary
Concomitant
Photosensitivity Reaction Other Serious 4/17/2009 70 Female 97 lb 12/4/2009 Physician Japan
Primary
Concomitant
Red Blood Cell Count Decreased Life Threatening 9/17/2009 Male 137 lb 12/10/2009 Physician Japan
Primary
Concomitant
Pneumonia Life Threatening 5/16/2008 71 Male 73 lb 1/19/2010 Physician Japan
Primary
Concomitant
Renal Failure Life Threatening 9/17/2009 Male 137 lb 1/19/2010 Physician Japan
Primary
Concomitant
Liver Carcinoma Ruptured Hospitalization 12/10/2009 74 Male 2/4/2010 Physician Japan
Primary
Concomitant
Pseudomembranous Colitis Other Serious 11/21/2009 78 Male 123 lb 2/9/2010 Physician Japan
Primary
Secondary
Concomitant
Thrombocytopenia Life Threatening 4/26/2009 88 Male 123 lb 2/12/2010 Physician Japan
Primary
Concomitant
Rash Other Serious 8/23/2009 74 Male 181 lb 2/17/2010 Physician Japan
Primary
Concomitant
Thrombocytopenia Life Threatening 4/26/2009 88 Male 123 lb 2/17/2010 Physician Japan
Primary
Concomitant
Septic Shock Death 5/5/2008 59 Male 106 lb 2/22/2010 Physician Japan
Primary
Concomitant
Metabolic Encephalopathy Other Serious 6/8/2009 67 Male 112 lb 2/23/2010 Physician Japan
Primary
Concomitant
Tri-iodothyronine Decreased Other Serious 7/2/2008 64 Male 121 lb 3/2/2010 Physician Japan
Primary
Concomitant
Stomatitis Other Serious 1/1/2009 76 Male 110 lb 3/3/2010 Physician Japan
Primary
Concomitant
Pseudomembranous Colitis Other Serious 11/21/2009 78 Male 123 lb 4/8/2010 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Life Threatening 9/17/2009 Male 137 lb 4/12/2010 Physician Japan
Primary
Concomitant
Skin Exfoliation Other Serious 2/11/2009 71 Male 143 lb 4/12/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 9/16/2009 61 Male 159 lb 4/20/2010 Physician Japan
Primary
Concomitant
Liver Disorder Other Serious 4/28/2009 69 Male 128 lb 5/3/2010 Physician Japan
Primary
Concomitant
Hepatic Function Abnormal Death 4/28/2009 69 Male 128 lb 5/7/2010 Physician Japan
Primary
Concomitant
Pleural Effusion Other Serious 11/23/2009 66 Male 141 lb 5/7/2010 Physician Japan
Primary
Concomitant
Renal Cell Carcinoma Death 5/1/2008 64 Male 5/20/2010 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Death 7/22/2009 73 Male 108 lb 5/27/2010 Physician Japan
Primary
Concomitant
Stomatitis Other Serious 1/1/2009 76 Male 110 lb 6/1/2010 Physician Japan
Primary
Concomitant
Rhabdomyolysis Hospitalization 9/1/2009 67 Male 6/23/2010 Physician Japan
Primary
Concomitant
Pleural Effusion Other Serious 11/23/2009 66 Male 141 lb 6/23/2010 Physician Japan
Primary
Concomitant
Pneumonia Life Threatening 5/16/2008 71 Male 73 lb 6/23/2010 Physician Japan
Primary
Concomitant
Pneumonia Life Threatening 5/16/2008 71 Male 73 lb 6/25/2010 Physician Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 8/23/2009 70 Male 143 lb 6/29/2010 Physician Japan
Primary
Concomitant
Hyperammonaemia Hospitalization 12/25/2009 73 Male 137 lb 7/12/2010 Physician Japan
Primary
Concomitant
Pneumonia Life Threatening 5/16/2008 71 Male 73 lb 7/13/2010 Physician Japan
Primary
Concomitant
Rhabdomyolysis Hospitalization 9/1/2009 67 Male 7/13/2010 Physician 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
Septic Shock Life Threatening 5/16/2008 71 Male 73 lb 7/20/2010 Physician Japan
Primary
Concomitant
Septic Shock Life Threatening 5/16/2008 71 Male 73 lb 7/20/2010 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
Rhabdomyolysis Other Serious 9/1/2009 67 Male 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
Thrombocytopenia Life Threatening 4/26/2009 88 Male 123 lb 8/11/2010 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 7/3/2009 64 Male 128 lb 8/12/2010 Physician Japan
Primary
Concomitant
Septic Shock Life Threatening 5/16/2008 71 Male 73 lb 8/24/2010 Physician Japan
Primary
Concomitant
Pyrexia Hospitalization 4/22/2010 72 Male 130 lb 8/24/2010 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Life Threatening 4/1/2008 75 Male 117 lb 8/24/2010 Physician Japan
Primary
Concomitant
Rhabdomyolysis Other Serious 9/1/2009 67 Male 8/24/2010 Physician Japan
Primary
Concomitant
Septic Shock Life Threatening 5/16/2008 71 Male 73 lb 8/25/2010 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Life Threatening 4/1/2008 75 Male 117 lb 8/26/2010 Physician Japan
Primary
Concomitant
Splenic Infarction Hospitalization 11/21/2009 75 Male 137 lb 9/1/2010 Physician Japan
Primary
Secondary
Concomitant
Pruritus Hospitalization 4/6/2010 82 Male 115 lb 9/9/2010 Physician Japan
Primary
Concomitant
Rash Hospitalization 6/16/2009 61 Male 143 lb 9/13/2010 Physician Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Other Serious 5/20/2010 51 Male 150 lb 9/14/2010 Physician Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Other Serious 8/23/2009 70 Male 143 lb 9/30/2010 Physician Japan
Primary
Concomitant
Stomatitis Other Serious 1/1/2009 76 Male 110 lb 10/6/2010 Physician Japan
Primary
Concomitant
Rhabdomyolysis Other Serious 9/1/2009 67 Male 10/7/2010 Physician Japan
Primary
Concomitant
Rash Hospitalization 8/11/2009 71 Male 143 lb 10/20/2010 Physician Japan
Primary
Concomitant
Rash Other Serious 8/11/2009 71 Male 143 lb 10/22/2010 Physician Japan
Primary
Concomitant
Rash Other Serious 8/11/2009 71 Male 143 lb 10/29/2010 Physician Japan
Primary
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
Rash Hospitalization 3/5/2009 75 Male 141 lb 12/28/2010 Physician Japan
Primary
Concomitant
Stomatitis Other Serious 1/1/2009 75 Male 110 lb 12/22/2010 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 7/21/2010 71 Male 126 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
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
Protein Urine Present Hospitalization 7/2/2008 64 Male 122 lb 3/4/2011 Physician Japan
Primary
Concomitant
Deafness Other Serious 4/7/2010 67 Male 117 lb 3/11/2011 Physician Japan
Primary
Secondary
Concomitant
Aortic Dissection Other Serious 4/1/2008 74 Male 116 lb 3/23/2011 Physician Japan
Primary
Concomitant
Aortic Dissection Other Serious 4/1/2008 74 Male 116 lb 3/23/2011 Physician Japan
Primary
Concomitant
Liver Carcinoma Ruptured Death 12/10/2009 74 Male 4/1/2011 Physician Japan
Primary
Concomitant
Hyperbilirubinaemia Other Serious 7/21/2010 55 Male 176 lb 4/5/2011 Physician Japan
Primary
Concomitant
Renal Cell Carcinoma Hospitalization 11/21/2009 75 Male 136 lb 4/13/2011 Physician Japan
Primary
Secondary
Concomitant
Hypoglycaemia Other Serious 4/7/2010 67 Male 117 lb 4/18/2011 Physician Japan
Primary
Secondary
Concomitant
Rash Hospitalization 6/27/2009 73 Female 115 lb 4/18/2011 Physician Japan
Primary
Concomitant
Abdominal Pain Hospitalization 11/21/2009 75 Male 136 lb 4/19/2011 Physician Japan
Primary
Secondary
Concomitant
Abdominal Pain Death 7/23/2009 68 Male 140 lb 4/19/2011 Physician Japan
Primary
Concomitant
Splenic Infarction Death 11/21/2009 75 Male 136 lb 4/25/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Sudden Death Death 1/5/2011 60 Male 141 lb 5/17/2011 Physician Japan
Primary
Secondary
Concomitant
Sudden Death Death 1/5/2011 60 Male 141 lb 5/21/2011 Physician Japan
Primary
Concomitant
Renal Cell Carcinoma Hospitalization 8/29/2009 63 Female 128 lb 5/21/2011 Physician Japan
Primary
Concomitant
Cholangitis Life Threatening 7/21/2010 55 Male 176 lb 6/2/2011 Physician Japan
Primary
Concomitant
Hepatic Function Abnormal Other Serious 5/8/2009 68 Male 102 lb 6/3/2011 Physician Japan
Primary
Concomitant
Diarrhoea Disability 1/1/2009 76 Male 110 lb 6/3/2011 Physician Japan
Primary
Concomitant
Liver Disorder Hospitalization 2/18/2010 66 Male 119 lb 6/3/2011 Physician Japan
Primary
Concomitant
Arthritis Other Serious 4/13/2009 70 Female 97 lb 6/3/2011 Physician Japan
Primary
Concomitant
Hepatic Function Abnormal Hospitalization 4/26/2011 74 Male 130 lb 8/5/2011 Physician Japan
Primary
Secondary
Concomitant
Hepatorenal Syndrome Hospitalization 7/23/2009 68 Male 140 lb 8/5/2011 Physician Japan
Primary
Concomitant
Diarrhoea Other Serious 8/23/2009 74 Male 181 lb 8/16/2011 Physician Japan
Primary
Concomitant
Gastrointestinal Erosion Other Serious 9/1/2008 60 Male 141 lb 8/25/2011 Physician Japan
Primary
Concomitant
Pleural Effusion Hospitalization 2/2/2010 62 Male 117 lb 8/31/2011 Physician Japan
Primary
Concomitant
Hepatic Encephalopathy Life Threatening 4/27/2011 74 Male 130 lb 9/9/2011 Physician Japan
Primary
Secondary
Concomitant
Hallucination, Auditory Other Serious 3/18/2011 72 Male 148 lb 10/15/2011 Physician Japan
Primary
Concomitant
Nausea Death 6/27/2009 73 Female 115 lb 10/20/2011 Physician Japan
Primary
Concomitant
Hepatic Function Abnormal Life Threatening 7/23/2009 68 Male 141 lb 10/21/2011 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Other Serious 7/4/2009 54 Male 150 lb 11/10/2011 Physician Japan
Primary
Concomitant
Coagulopathy Other Serious 4/27/2011 74 Male 130 lb 12/30/2011 Physician Japan
Primary
Secondary
Concomitant
Aspartate Aminotransferase Increased Hospitalization 6/28/2011 69 Female 157 lb 1/16/2012 Physician Japan
Primary
Concomitant
Alanine Aminotransferase Increased Other Serious 5/6/2010 75 Male 124 lb 1/19/2012 Physician Japan
Primary
Concomitant
Alanine Aminotransferase Increased Other Serious 9/1/2009 66 Male 1/20/2012 Physician Japan
Primary
Concomitant
Renal Failure Acute Other Serious 9/1/2009 66 Male 1/24/2012 Physician Japan
Primary
Concomitant
Alanine Aminotransferase Increased Other Serious 9/1/2009 66 Male 1/27/2012 Physician Japan
Primary
Concomitant
Hyperammonaemia Hospitalization 11/12/2009 67 Male 101 lb 2/8/2012 Other Health Professional Japan
Primary
Concomitant
Diarrhoea Hospitalization 10/1/2010 63 Male 119 lb 2/9/2012 Physician Japan
Primary
Concomitant
Hepatic Encephalopathy Death 10/20/2010 76 Male 95 lb 3/12/2012 Physician Japan
Primary
Concomitant
Renal Cell Carcinoma Death 8/29/2009 63 Female 128 lb 3/29/2012 Physician Japan
Primary
Concomitant
Hepatic Function Abnormal Hospitalization 4/27/2011 74 Male 130 lb 4/4/2012 Physician Japan
Primary
Secondary
Concomitant
Hepatic Function Abnormal Other Serious 12/19/2011 62 Male 99 lb 4/11/2012 Physician Japan
Primary
Concomitant
Aspartate Aminotransferase Increased Hospitalization 10/1/2010 63 Male 119 lb 5/9/2012 Physician Japan
Primary
Concomitant
Pain In Extremity Hospitalization 2/1/2011 72 Female 150 lb 5/18/2012 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Hospitalization 9/1/2009 66 Male 6/5/2012 Physician Japan
Primary
Concomitant
C-reactive Protein Increased Hospitalization 5/16/2012 65 Male 139 lb 6/11/2012 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Life Threatening 9/26/2011 76 Male 108 lb 6/11/2012 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Life Threatening 9/26/2011 76 Male 108 lb 6/14/2012 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 10/20/2011 62 Female 110 lb 7/18/2012 Physician Japan
Primary
Concomitant

Drug Data