Loxonin combined with Nexavar

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Rash Life Threatening 4/20/2008 52 Male 106 lb 6/6/2008 Physician Japan
Primary
Concomitant
Hepatic Function Abnormal Hospitalization 6/3/2008 77 Male 146 lb 6/20/2008 Physician Japan
Primary
Concomitant
Rash Other Serious 4/29/2008 70 Male 6/25/2008 Japan
Primary
Concomitant
Platelet Count Decreased Death 6/6/2008 73 Male 141 lb 7/9/2008 Physician Japan
Primary
Concomitant
Rash Other Serious 4/29/2008 70 Male 7/14/2008 Japan
Primary
Concomitant
Renal Failure Death 5/28/2008 76 Male 132 lb 7/16/2008 Physician Japan
Primary
Concomitant
Seborrhoeic Dermatitis Life Threatening 4/20/2008 52 Male 106 lb 7/22/2008 Physician Japan
Primary
Concomitant
Seborrhoeic Dermatitis Life Threatening 4/20/2008 52 Male 106 lb 7/28/2008 Physician Japan
Primary
Concomitant
Seborrhoeic Dermatitis Life Threatening 4/20/2008 52 Male 106 lb 8/1/2008 Physician Japan
Primary
Concomitant
Rash Other Serious 4/29/2008 70 Male 8/11/2008 Japan
Primary
Concomitant
Rash Death 4/25/2008 78 Male 121 lb 8/18/2008 Physician Japan
Primary
Concomitant
Seborrhoeic Dermatitis Life Threatening 4/20/2008 52 Male 106 lb 9/2/2008 Physician Japan
Primary
Concomitant
Platelet Count Decreased Death 6/6/2008 73 Male 141 lb 9/9/2008 Physician Japan
Primary
Concomitant
Sepsis Other Serious 7/29/2008 71 Male 95 lb 9/11/2008 Physician Japan
Primary
Concomitant
Renal Failure Death 5/28/2008 76 Male 132 lb 9/24/2008 Physician Japan
Primary
Concomitant
Vomiting Other Serious 8/22/2008 81 Male 123 lb 9/30/2008 Physician Japan
Primary
Concomitant
Pulmonary Haemorrhage Hospitalization 7/17/2008 62 Male 154 lb 10/1/2008 Physician Japan
Primary
Concomitant
Platelet Count Decreased Death 6/5/2008 73 Male 141 lb 10/10/2008 Physician Japan
Primary
Concomitant
Seborrhoeic Dermatitis Hospitalization 4/20/2008 52 Male 106 lb 10/13/2008 Physician Japan
Primary
Concomitant
Renal Cell Carcinoma Stage Iv Hospitalization 7/15/2008 54 Male 108 lb 10/17/2008 Physician Japan
Primary
Concomitant
Rash Other Serious 7/2/2008 54 Male 128 lb 10/21/2008 Physician Japan
Primary
Concomitant
Rash Other Serious 7/2/2008 54 Male 128 lb 10/22/2008 Physician Japan
Primary
Concomitant
Weight Decreased Hospitalization 6/13/2008 62 Male 139 lb 10/31/2008 Physician Japan
Primary
Concomitant
Rash Other Serious 7/2/2008 54 Male 128 lb 10/31/2008 Physician Japan
Primary
Concomitant
Seborrhoeic Dermatitis Hospitalization 4/20/2008 52 Male 106 lb 11/17/2008 Physician Japan
Primary
Concomitant
Local Swelling Other Serious 8/19/2008 67 Male 154 lb 12/10/2008 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Other Serious 7/27/2008 64 Male 130 lb 12/11/2008 Physician Japan
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 11/5/2008 72 Male 128 lb 12/23/2008 Physician Japan
Primary
Concomitant
Weight Decreased Hospitalization 6/13/2008 62 Male 139 lb 12/29/2008 Physician Japan
Primary
Concomitant
Renal Cell Carcinoma Stage Iv Life Threatening 11/3/2008 40 Male 181 lb 1/9/2009 Physician Japan
Primary
Secondary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Hospitalization 8/13/2008 64 Male 137 lb 1/9/2009 Physician Japan
Primary
Concomitant
Renal Cell Carcinoma Stage Iv Life Threatening 11/3/2008 40 Male 181 lb 1/12/2009 Physician Japan
Primary
Secondary
Concomitant
Septic Shock Death 5/5/2008 59 Male 106 lb 1/23/2009 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Death 10/30/2008 59 Male 150 lb 1/27/2009 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Life Threatening 10/30/2008 59 Male 150 lb 2/3/2009 Physician Japan
Primary
Concomitant
Pulmonary Haemorrhage Hospitalization 7/17/2008 62 Male 154 lb 2/12/2009 Physician Japan
Primary
Concomitant
Sepsis Hospitalization 7/29/2008 71 Male 95 lb 2/19/2009 Physician Japan
Primary
Concomitant
Renal Impairment Hospitalization 4/2/2008 56 Female 117 lb 2/26/2009 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Hospitalization 7/11/2008 65 Male 137 lb 3/3/2009 Physician Japan
Primary
Concomitant
Thrombocytopenia Other Serious 11/5/2008 72 Male 128 lb 3/11/2009 Physician Japan
Primary
Concomitant
Hepatic Function Abnormal Life Threatening 12/28/2008 50 Male 141 lb 3/13/2009 Physician Japan
Primary
Secondary
Concomitant
Rash Other Serious 11/21/2008 62 Male 148 lb 3/20/2009 Physician Japan
Primary
Concomitant
Generalised Oedema Life Threatening 3/1/2009 65 Male 141 lb 3/20/2009 Physician Japan
Primary
Concomitant
Renal Cell Carcinoma Other Serious 11/3/2008 40 Male 181 lb 3/25/2009 Physician Japan
Primary
Secondary
Concomitant
Hepatic Function Abnormal Life Threatening 12/28/2008 50 Male 141 lb 3/25/2009 Physician Japan
Primary
Secondary
Concomitant
Lower Gastrointestinal Haemorrhage Hospitalization 2/20/2009 67 Female 97 lb 3/30/2009 Physician Japan
Primary
Concomitant
Renal Impairment Hospitalization 4/2/2008 56 Female 117 lb 4/9/2009 Physician Japan
Primary
Concomitant
Renal Haemorrhage Other Serious 5/7/2008 70 Male 4/14/2009 Physician Japan
Primary
Concomitant
Renal Cell Carcinoma Other Serious 11/3/2008 40 Male 181 lb 4/14/2009 Physician Japan
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 6/13/2008 62 Male 139 lb 4/20/2009 Physician Japan
Primary
Concomitant
Hepatic Function Abnormal Hospitalization 3/23/2009 55 Female 4/22/2009 Physician Japan
Primary
Concomitant
Renal Cell Carcinoma Life Threatening 3/1/2009 65 Male 141 lb 5/20/2009 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Other Serious 8/1/2008 53 Male 154 lb 5/21/2009 Physician Japan
Primary
Concomitant
Renal Haemorrhage Other Serious 5/7/2008 70 Male 5/26/2009 Physician Japan
Primary
Concomitant
Renal Impairment Hospitalization 4/2/2008 56 Female 117 lb 5/27/2009 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Hospitalization 8/29/2008 62 Male 146 lb 5/28/2009 Physician Japan
Primary
Concomitant
Platelet Count Decreased Hospitalization 5/23/2009 81 Male 157 lb 6/1/2009 Physician Japan
Primary
Secondary
Concomitant
Hepatic Function Abnormal Other Serious 3/23/2009 55 Female 6/12/2009 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Other Serious 3/23/2009 55 Female 6/30/2009 Physician Japan
Primary
Concomitant
Weight Decreased Hospitalization 6/13/2008 62 Male 139 lb 7/8/2009 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Hospitalization 4/30/2009 84 Male 121 lb 7/8/2009 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Other Serious 4/20/2009 56 Male 159 lb 7/15/2009 Physician Japan
Primary
Secondary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Other Serious 3/23/2009 55 Female 7/30/2009 Physician Japan
Primary
Concomitant
Renal Cell Carcinoma Other Serious 5/1/2009 83 Male 110 lb 8/5/2009 Physician Japan
Primary
Concomitant
Sinus Bradycardia Life Threatening 6/23/2009 69 Male 157 lb 8/14/2009 Physician Japan
Primary
Concomitant
Metabolic Encephalopathy Hospitalization 6/8/2009 67 Male 112 lb 8/20/2009 Physician Japan
Primary
Concomitant
Hepatic Neoplasm Malignant Death 7/14/2009 58 Male 163 lb 8/24/2009 Physician Japan
Primary
Concomitant
Respiratory Disorder Life Threatening 4/9/2009 74 Male 139 lb 8/31/2009 Physician Japan
Primary
Concomitant
Sepsis Hospitalization 7/3/2009 77 Male 110 lb 9/4/2009 Physician Japan
Primary
Secondary
Concomitant
Varices Oesophageal Hospitalization 7/25/2009 55 Female 123 lb 9/9/2009 Physician Japan
Primary
Concomitant
Varices Oesophageal Other Serious 7/25/2009 55 Female 123 lb 9/16/2009 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Hospitalization 3/13/2008 73 Male 110 lb 9/16/2009 Physician Japan
Primary
Concomitant
Jaundice Hospitalization 7/25/2009 77 Male 132 lb 9/17/2009 Physician Japan
Primary
Concomitant
Metabolic Encephalopathy Hospitalization 6/8/2009 67 Male 112 lb 9/18/2009 Physician Japan
Primary
Concomitant
Rash Other Serious 6/30/2008 81 Male 121 lb 9/25/2009 Physician Japan
Primary
Concomitant
Rash Other Serious 6/30/2008 81 Male 121 lb 10/1/2009 Physician Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 3/23/2009 55 Female 10/5/2009 Physician Japan
Primary
Secondary
Concomitant
Rash Generalised Life Threatening 8/10/2009 51 Male 123 lb 10/5/2009 Physician Japan
Primary
Concomitant
Rash Hospitalization 7/25/2009 55 Female 123 lb 10/7/2009 Physician Japan
Primary
Concomitant
Weight Decreased Hospitalization 6/13/2008 62 Male 139 lb 10/7/2009 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Other Serious 7/30/2009 55 Male 161 lb 10/9/2009 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Other Serious 12/22/2008 73 Male 134 lb 10/14/2009 Physician Japan
Primary
Concomitant
Metabolic Encephalopathy Death 6/8/2009 67 Male 112 lb 10/26/2009 Physician Japan
Primary
Concomitant
Renal Failure Death 3/31/2009 88 Male 11/2/2009 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
Rash Hospitalization 7/3/2009 77 Male 121 lb 11/5/2009 Physician Japan
Primary
Concomitant
Vulval Cellulitis Life Threatening 7/2/2009 81 Female 150 lb 11/6/2009 Physician Japan
Primary
Concomitant
Sinus Bradycardia Life Threatening 6/9/2009 69 Male 157 lb 11/9/2009 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 4/2/2008 56 Female 117 lb 11/11/2009 Physician Japan
Primary
Concomitant
Renal Failure Other Serious 3/31/2009 88 Male 11/16/2009 Physician Japan
Primary
Concomitant
Metabolic Encephalopathy Death 6/8/2009 67 Male 112 lb 11/30/2009 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 7/31/2009 75 Male 117 lb 11/30/2009 Physician Japan
Primary
Secondary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Hospitalization 7/11/2008 65 Male 137 lb 12/1/2009 Physician Japan
Primary
Concomitant
Erythema Multiforme Hospitalization 11/7/2009 69 Male 12/2/2009 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 7/19/2009 61 Male 130 lb 12/3/2009 Physician Japan
Primary
Concomitant
Oesophageal Varices Haemorrhage Other Serious 8/15/2009 59 Male 139 lb 12/3/2009 Physician Japan
Primary
Concomitant
Rash Other Serious 9/16/2009 76 Male 99 lb 12/3/2009 Physician Japan
Primary
Secondary
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
Sinus Bradycardia Life Threatening 6/9/2009 69 Male 157 lb 12/10/2009 Physician Japan
Primary
Concomitant
Vulval Cellulitis Life Threatening 7/2/2009 81 Female 150 lb 12/14/2009 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Other Serious 8/14/2009 59 Male 139 lb 12/22/2009 Physician Japan
Primary
Secondary
Concomitant
Rectal Ulcer Life Threatening 7/7/2009 62 Male 150 lb 12/28/2009 Physician Japan
Primary
Concomitant
Pleural Effusion Hospitalization 5/19/2009 72 Male 165 lb 12/28/2009 Physician Japan
Primary
Concomitant
Pain Other Serious 11/16/2009 74 Male 152 lb 12/29/2009 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Life Threatening 11/18/2009 81 Female 95 lb 12/29/2009 Physician Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Life Threatening 11/18/2009 81 Female 95 lb 1/4/2010 Physician Japan
Primary
Secondary
Concomitant
Erythema Multiforme Other Serious 7/31/2009 68 Female 99 lb 1/5/2010 Physician Japan
Primary
Concomitant
Weight Decreased Hospitalization 6/13/2008 62 Male 139 lb 1/6/2010 Physician Japan
Primary
Concomitant
Weight Decreased Hospitalization 6/13/2008 62 Male 139 lb 1/7/2010 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Other Serious 8/14/2009 59 Male 139 lb 1/11/2010 Physician Japan
Primary
Secondary
Concomitant
Rash Hospitalization 7/2/2008 54 Male 128 lb 1/14/2010 Physician Japan
Primary
Concomitant
Radiation Pneumonitis Other Serious 9/8/2009 74 Female 97 lb 1/14/2010 Physician Japan
Primary
Concomitant
Liver Disorder Other Serious 9/4/2009 66 Male 128 lb 1/15/2010 Physician Japan
Primary
Concomitant
Renal Failure Life Threatening 9/17/2009 Male 137 lb 1/19/2010 Physician Japan
Primary
Concomitant
Thyroiditis Hospitalization 12/11/2009 74 Male 130 lb 2/1/2010 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Life Threatening 11/18/2009 81 Female 95 lb 2/1/2010 Physician Japan
Primary
Secondary
Concomitant
Thrombocytopenia Death 12/16/2009 73 Female 130 lb 2/4/2010 Physician Japan
Primary
Concomitant
Yellow Skin Other Serious 8/6/2008 56 Female 99 lb 2/9/2010 Physician Japan
Primary
Concomitant
Hepatic Function Abnormal Hospitalization 11/6/2009 86 Male 148 lb 2/9/2010 Physician Japan
Primary
Secondary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Other Serious 7/30/2009 55 Male 161 lb 2/9/2010 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Hospitalization 7/15/2009 46 Female 2/9/2010 Physician Japan
Primary
Concomitant
Pulmonary Haemorrhage Hospitalization 7/17/2008 62 Male 154 lb 2/11/2010 Physician Japan
Primary
Concomitant
Platelet Count Decreased Life Threatening 1/4/2010 65 Male 101 lb 2/11/2010 Physician Japan
Primary
Concomitant
Thrombocytopenia Death 12/16/2009 73 Female 130 lb 2/11/2010 Physician Japan
Primary
Concomitant
Radiation Pneumonitis Other Serious 9/8/2009 74 Female 97 lb 2/12/2010 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
Seborrhoeic Dermatitis Hospitalization 4/20/2008 52 Male 106 lb 2/24/2010 Physician Japan
Primary
Concomitant
Respiratory Disorder Life Threatening 4/9/2009 74 Male 139 lb 3/1/2010 Physician Japan
Primary
Concomitant
Tri-iodothyronine Decreased Other Serious 7/2/2008 64 Male 121 lb 3/2/2010 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 7/31/2009 75 Male 117 lb 3/3/2010 Physician Japan
Primary
Secondary
Concomitant
Renal Cell Carcinoma Other Serious 3/23/2009 55 Female 3/9/2010 Physician Japan
Primary
Secondary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Other Serious 7/30/2009 55 Male 161 lb 3/10/2010 Physician Japan
Primary
Concomitant
Pneumonia Death 8/24/2009 75 Male 117 lb 3/10/2010 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Hospitalization 3/13/2008 73 Male 110 lb 3/11/2010 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 7/19/2009 61 Male 130 lb 3/15/2010 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Other Serious 6/2/2009 70 Male 132 lb 3/19/2010 Physician Japan
Primary
Concomitant
Renal Cell Carcinoma Hospitalization 8/26/2009 50 Male 106 lb 3/22/2010 Physician Japan
Primary
Concomitant
Vomiting Other Serious 4/2/2008 56 Female 117 lb 3/23/2010 Physician Japan
Primary
Concomitant
Sinus Bradycardia Life Threatening 6/9/2009 69 Male 157 lb 3/24/2010 Physician Japan
Primary
Concomitant
Rash Other Serious 11/2/2009 74 Male 148 lb 3/26/2010 Physician Japan
Primary
Secondary
Concomitant
Renal Cell Carcinoma Other Serious 11/3/2008 40 Male 181 lb 4/1/2010 Physician Japan
Primary
Secondary
Concomitant
Vulval Cellulitis Life Threatening 7/2/2009 81 Female 150 lb 4/1/2010 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Other Serious 4/20/2009 56 Male 159 lb 4/7/2010 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Death 5/28/2008 76 Male 132 lb 4/7/2010 Physician Japan
Primary
Concomitant
Pain Other Serious 11/16/2009 74 Male 152 lb 4/9/2010 Physician Japan
Primary
Concomitant
Vomiting Other Serious 4/2/2008 56 Female 119 lb 4/12/2010 Physician Japan
Primary
Concomitant
Renal Failure Life Threatening 9/17/2009 Male 137 lb 4/12/2010 Physician Japan
Primary
Concomitant

Drug Data