Takepron combined with Urso 250

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Thrombotic Microangiopathy Other Serious 7/7/2004 54 Male 117 lb 5/15/2007 Physician Japan
Primary
Secondary
Concomitant
Somnolence Hospitalization 4/30/2007 85 Female 5/23/2007 Physician Japan
Primary
Concomitant
Somnolence Hospitalization 4/30/2007 85 Female 6/4/2007 Physician Japan
Primary
Concomitant
Toxic Skin Eruption Hospitalization 5/11/2007 52 Male 6/5/2007 Physician Japan
Primary
Concomitant
Somnolence Life Threatening 4/30/2007 85 Female 6/14/2007 Physician Japan
Primary
Concomitant
Toxic Skin Eruption Hospitalization 5/11/2007 52 Male 6/16/2007 Physician Japan
Primary
Concomitant
Toxic Skin Eruption Hospitalization 5/23/2007 53 Male 139 lb 6/20/2007 Physician Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 6/11/2007 88 Female 6/22/2007 Pharmacist Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 6/11/2007 88 Female 6/27/2007 Pharmacist Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 6/27/2006 30 Female 90 lb 7/3/2007 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 6/27/2006 30 Female 90 lb 7/3/2007 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 6/27/2006 30 Female 90 lb 7/12/2007 Japan
Primary
Secondary
Concomitant
Hepatic Failure Death 10/22/2007 78 Female 11/8/2007 Physician Japan
Primary
Concomitant
Hepatic Neoplasm Malignant Other Serious 10/3/2007 55 Male 11/12/2007 Physician Japan
Primary
Concomitant
Hepatic Failure Death 10/22/2007 78 Female 11/19/2007 Physician Japan
Primary
Concomitant
Pancreatitis Acute Life Threatening 10/2/2007 59 Female 11/19/2007 Physician Japan
Primary
Concomitant
Skin Disorder Hospitalization 10/22/2007 78 Female 168 lb 12/12/2007 Physician Japan
Primary
Concomitant
Multi-organ Failure Death 11/8/2007 Male 129 lb 12/27/2007 Physician Japan
Primary
Concomitant
Thirst Hospitalization 11/21/2007 57 Male 117 lb 12/27/2007 Physician Japan
Primary
Concomitant
Pancreatitis Acute Life Threatening 10/2/2007 59 Female 12/28/2007 Physician Japan
Primary
Concomitant
Hepatic Neoplasm Malignant Other Serious 10/3/2007 55 Male 12/31/2007 Physician Japan
Primary
Concomitant
Melaena Hospitalization 6/1/2005 Male 160 lb 1/4/2008 Other Health Professional Japan
Primary
Concomitant
Thirst Hospitalization 11/26/2007 57 Male 117 lb 1/14/2008 Physician Japan
Primary
Concomitant
Renal Impairment Life Threatening 12/22/2007 64 Male 128 lb 1/16/2008 Physician Japan
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 11/9/2007 Male 72 lb 1/17/2008 Physician Japan
Primary
Secondary
Concomitant
Thirst Hospitalization 11/26/2007 57 Male 117 lb 1/24/2008 Physician Japan
Primary
Concomitant
Renal Impairment Life Threatening 12/22/2007 64 Male 128 lb 1/28/2008 Physician Japan
Primary
Secondary
Concomitant
Urine Output Decreased Life Threatening 11/18/2007 72 Female 106 lb 1/31/2008 Physician Japan
Primary
Secondary
Concomitant
Multi-organ Failure Death 11/8/2007 Male 129 lb 2/14/2008 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Other Serious 9/5/2007 78 Female 2/13/2008 Other Health Professional Japan
Primary
Concomitant
Pulmonary Tuberculosis Hospitalization 2/1/2008 Female 84 lb 2/29/2008 Physician Japan
Primary
Concomitant
Urine Output Decreased Life Threatening 11/18/2007 72 Female 106 lb 2/29/2008 Physician Japan
Primary
Secondary
Concomitant
Right Ventricular Failure Other Serious 9/21/2007 59 Female 84 lb 3/10/2008 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Tuberculosis Hospitalization 1/23/2008 Female 84 lb 3/17/2008 Physician Japan
Primary
Concomitant
Pulmonary Tuberculosis Hospitalization 1/23/2008 Female 84 lb 3/20/2008 Physician Japan
Primary
Concomitant
Renal Failure Acute Hospitalization 2/13/2008 64 Male 137 lb 3/27/2008 Physician Japan
Primary
Secondary
Concomitant
Tonic Clonic Movements 2/5/2007 8 Female 3/27/2008 Japan
Primary
Secondary
Concomitant
Right Ventricular Failure Other Serious 9/21/2007 Female 84 lb 4/9/2008 Physician Japan
Primary
Secondary
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
Pleural Effusion Hospitalization 3/1/2008 Female 128 lb 6/2/2008 Physician Japan
Primary
Concomitant
Post Transplant Lymphoproliferative Disorder Death 12/5/2003 Male 6/30/2008 Physician Japan
Primary
Secondary
Concomitant
Lung Injury Life Threatening 3/31/2008 69 Female 7/9/2008 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 4/2/2008 19 Male 110 lb 7/16/2008 Physician Japan
Primary
Secondary
Concomitant
Hypoglycaemia Hospitalization 6/1/2008 85 Female 7/21/2008 Physician Japan
Primary
Concomitant
Neutropenia 6/23/2008 58 Female 7/24/2008 Physician Japan
Primary
Secondary
Stevens-johnson Syndrome Life Threatening 4/7/2008 70 Male 8/12/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Dyskinesia Other Serious 5/4/2008 Male 125 lb 10/13/2008 Physician Japan
Primary
Concomitant
Metastases To Meninges Hospitalization 8/7/2007 76 Female 64 lb 10/13/2008 Physician Japan
Primary
Concomitant
Blood Creatine Phosphokinase Increased 9/17/2008 74 Female 10/15/2008 Pharmacist Japan
Primary
Concomitant
Humerus Fracture Hospitalization 9/25/2005 Female 101 lb 11/25/2008 Physician Japan
Primary
Secondary
Concomitant
Stevens-johnson Syndrome Hospitalization 4/7/2008 Male 134 lb 12/8/2008 Physician Japan
Primary
Secondary
Concomitant
Shock Other Serious 10/2/2006 Female 108 lb 12/9/2008 Physician Japan
Primary
Concomitant
Sick Sinus Syndrome Other Serious 9/9/2008 48 Male 203 lb 12/5/2008 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Chronic Other Serious 10/14/2008 12/22/2008 Physician Japan
Primary
Concomitant
Renal Failure Chronic Other Serious 10/14/2008 Male 106 lb 1/5/2009 Physician Japan
Primary
Concomitant
Weight Increased Life Threatening 8/6/2007 23 Female 121 lb 1/9/2009 Physician Japan
Primary
Secondary
Concomitant
Mucormycosis Other Serious 10/1/2008 Male 110 lb 1/23/2009 Physician Japan
Primary
Concomitant
Renal Failure Chronic Other Serious 10/14/2008 Male 106 lb 2/5/2009 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Hospitalization 6/20/2008 65 Male 123 lb 2/17/2009 Physician Japan
Primary
Concomitant
Pleural Effusion Hospitalization 4/23/2008 Male 150 lb 2/25/2009 Physician Japan
Primary
Concomitant
Renal Impairment Life Threatening 12/22/2007 64 Male 128 lb 2/27/2009 Physician Japan
Primary
Secondary
Concomitant
Anaemia Hospitalization 1/16/2009 3/11/2009 Pharmacist Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 4/2/2008 19 Male 110 lb 3/20/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 7/22/2008 52 Female 3/23/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Spinal Cord Infarction Hospitalization 1/29/2009 Male 108 lb 3/25/2009 Physician Japan
Primary
Secondary
Concomitant
Diabetes Mellitus Hospitalization 63 Female 3/31/2009 Pharmacist United States
Primary
Concomitant
Renal Impairment Hospitalization 7/22/2008 52 Female 4/7/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Blood Urea Increased Hospitalization 51 Female 4/7/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Life Threatening 7/21/2008 56 Male 132 lb 4/15/2009 Physician Japan
Primary
Concomitant
Spinal Cord Infarction Hospitalization 1/29/2009 Male 108 lb 4/22/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 7/19/2008 51 Female 5/13/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 7/19/2008 51 Female 5/13/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Somnolence Death 3/21/2009 72 Male 5/15/2009 Pharmacist Japan
Primary
Secondary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Hospitalization 9/8/2008 53 Female 97 lb 5/19/2009 Physician Japan
Primary
Concomitant
Renal Impairment Hospitalization 7/22/2008 52 Female 6/26/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Cholangitis Other Serious 6/4/2009 79 Female 7/8/2009 Physician
Primary
Concomitant
Renal Failure Acute Other Serious 6/21/2009 Female 152 lb 7/9/2009 Physician Japan
Primary
Secondary
Concomitant
Cholangitis Other Serious 6/4/2009 79 Female 7/9/2009 Physician
Primary
Concomitant
Vomiting 5/1/2009 77 Male 7/10/2009 Physician Japan
Primary
Concomitant
Cholangitis Other Serious 6/4/2009 79 Female 7/14/2009 Physician
Primary
Concomitant
Renal Failure Chronic Other Serious 6/7/2009 79 Female 82 lb 7/23/2009 Physician
Primary
Concomitant
Drug Eruption Hospitalization 6/14/2009 72 Female 7/30/2009 Other Health Professional Japan
Primary
Secondary
Stomatitis Death 3/12/2008 Male 126 lb 7/31/2009 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Other Serious 6/24/2009 Female 152 lb 8/4/2009 Physician Japan
Primary
Secondary
Concomitant
Calculus Ureteric Hospitalization 7/28/2009 Female 8/12/2009 Physician Japan
Primary
Concomitant
Staphylococcal Sepsis Other Serious 6/21/2009 Female 152 lb 8/13/2009 Physician Japan
Primary
Secondary
Concomitant
Oedema 5/1/2009 77 Male 8/17/2009 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 6/2/2009 46 Male 157 lb 8/24/2009 Physician Japan
Primary
Concomitant
Pericardial Effusion Other Serious 4/16/2009 Female 112 lb 8/26/2009 Physician Japan
Primary
Concomitant
Unevaluable Event Other Serious 5/26/2009 79 Female 82 lb 8/28/2009 Physician
Primary
Concomitant
Somnolence Other Serious 6/2/2009 79 Female 82 lb 9/1/2009 Physician
Primary
Concomitant
Hyponatraemia Hospitalization 8/7/2009 81 Female 139 lb 9/4/2009 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 1/1/2009 79 Female 9/16/2009 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Other Serious 7/24/2009 76 Male 119 lb 9/18/2009 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Life Threatening 7/11/2008 56 Male 132 lb 9/24/2009 Physician Japan
Primary
Concomitant
Hyperhidrosis Hospitalization 53 9/30/2009 Pharmacist Japan
Primary
Secondary
Concomitant
Pericardial Effusion Other Serious 4/16/2009 Female 112 lb 10/15/2009 Physician Japan
Primary
Concomitant
Gastric Cancer Other Serious 10/31/2009 66 Male 161 lb 11/24/2009 Japan
Primary
Concomitant
Toxic Epidermal Necrolysis Death 8/24/2009 46 Male 11/30/2009 Physician Japan
Primary
Secondary
Concomitant
Respiratory Failure Death 9/12/2009 65 Male 12/3/2009 Physician Japan
Primary
Concomitant
Renal Failure Chronic Other Serious 5/1/2009 77 Male 12/3/2009 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 3/16/2006 Male 146 lb 12/1/2009 Physician Japan
Primary
Concomitant
Upper Gastrointestinal Haemorrhage Other Serious 10/13/2009 66 Male 157 lb 12/4/2009 Physician Japan
Primary
Concomitant
Liver Disorder Other Serious 9/22/2009 67 Male 126 lb 12/8/2009 Physician Japan
Primary
Concomitant
Lung Disorder Disability 2/2/2009 63 Female 108 lb 12/10/2009 Other Health Professional Japan
Primary
Concomitant
Pulmonary Haemorrhage Life Threatening 4/3/2008 Male 148 lb 12/10/2009 Physician Japan
Primary
Concomitant
Lung Disorder Other Serious 2/2/2009 63 Female 108 lb 12/15/2009 Physician Japan
Primary
Concomitant
Rash Hospitalization 9/25/2009 77 Male 152 lb 12/15/2009 Physician Japan
Primary
Concomitant
Renal Failure Acute Life Threatening 2/24/2009 Male 99 lb 12/18/2009 Other Health Professional Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Other Serious 6/24/2009 68 Female 106 lb 12/18/2009 Physician Japan
Primary
Secondary
Concomitant
Rash Hospitalization 9/28/2009 77 Male 152 lb 12/22/2009 Physician Japan
Primary
Concomitant
Gastric Cancer Other Serious 10/31/2009 66 Male 161 lb 12/23/2009 Japan
Primary
Concomitant
Renal Failure Acute Life Threatening 2/24/2009 Male 99 lb 1/4/2010 Other Health Professional Japan
Primary
Concomitant
Pulmonary Thrombosis Hospitalization 1/4/2010 Female 160 lb 1/13/2010 Physician Japan
Primary
Secondary
Concomitant
Hepatic Failure Death 11/21/2009 71 Male 1/25/2010 Physician Japan
Primary
Concomitant
Renal Failure Acute Life Threatening 2/24/2009 Male 99 lb 1/26/2010 Other Health Professional Japan
Primary
Concomitant
Vomiting Other Serious 9/24/2009 Female 121 lb 1/28/2010 Physician Japan
Primary
Secondary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Other Serious 9/10/2009 63 Male 141 lb 2/1/2010 Physician Japan
Primary
Secondary
Concomitant
Hyperammonaemia Death 12/24/2009 69 Male 2/4/2010 Physician Japan
Primary
Concomitant
Osmotic Demyelination Syndrome Hospitalization 6/24/2009 Female 112 lb 2/8/2010 Physician Japan
Primary
Concomitant
Renal Failure Chronic Hospitalization 5/1/2009 77 Male 2/8/2010 Physician Japan
Primary
Concomitant
Rash Hospitalization 9/28/2009 77 Male 152 lb 2/9/2010 Physician Japan
Primary
Concomitant
Hyperammonaemia Death 12/24/2009 69 Male 2/9/2010 Physician Japan
Primary
Concomitant
Pulmonary Alveolar Haemorrhage Life Threatening 4/3/2008 Male 148 lb 2/9/2010 Physician Japan
Primary
Concomitant
Septic Shock Hospitalization 12/9/2008 Male 2/12/2010 Physician Japan
Primary
Secondary
Concomitant
Osmotic Demyelination Syndrome Hospitalization 6/24/2009 Female 112 lb 2/15/2010 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Hospitalization 5/1/2008 65 Male 123 lb 2/16/2010 Physician Japan
Primary
Concomitant
Rash Hospitalization 9/28/2009 77 Male 152 lb 2/16/2010 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 12/22/2009 Male 2/19/2010 Physician Japan
Primary
Concomitant
Vomiting Other Serious 9/24/2009 Female 121 lb 2/23/2010 Physician Japan
Primary
Secondary
Concomitant
Septic Shock Hospitalization 1/1/2009 Male 130 lb 2/24/2010 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 1/30/2010 Male 126 lb 3/1/2010 Physician Japan
Primary
Concomitant
Intestinal Obstruction Hospitalization 12/17/2009 61 Male 132 lb 3/3/2010 Physician Japan
Primary
Concomitant
Gastric Cancer Hospitalization 10/31/2009 66 Male 161 lb 3/4/2010 Japan
Primary
Concomitant
Renal Failure Chronic Hospitalization 5/1/2009 77 Male 3/5/2010 Physician Japan
Primary
Concomitant
Vasculitis Life Threatening 3/25/2008 Male 146 lb 3/8/2010 Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 8/23/2009 70 Male 143 lb 3/9/2010 Physician Japan
Primary
Concomitant
Stomatitis Death 3/12/2008 Male 126 lb 3/9/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 12/22/2009 Male 3/9/2010 Physician Japan
Primary
Secondary
Concomitant
Gastric Cancer Hospitalization 10/31/2009 66 Male 161 lb 3/12/2010 Japan
Primary
Concomitant
Shock Haemorrhagic Life Threatening 12/12/2009 75 Male 134 lb 3/15/2010 Physician Japan
Primary
Concomitant
Sudden Death Death 12/30/2008 68 Male 152 lb 3/15/2010 Physician Japan
Primary
Concomitant
Pulmonary Alveolar Haemorrhage Life Threatening 1/1/2008 Male 146 lb 3/18/2010 Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome 7/13/2009 76 Male 119 lb 3/19/2010 Physician Japan
Primary
Concomitant
Rash Life Threatening 9/21/2009 71 Male 168 lb 4/15/2010 Physician Japan
Primary
Concomitant
Pleural Effusion Other Serious 6/17/2009 62 Male 119 lb 4/20/2010 Japan
Primary
Secondary
Concomitant
Gastric Cancer Hospitalization 10/31/2009 66 Male 159 lb 4/20/2010 Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 7/24/2009 83 Male 115 lb 4/20/2010 Physician Japan
Primary
Concomitant
Stomatitis Life Threatening 11/14/2009 76 Female 115 lb 4/20/2010 Physician Japan
Primary
Concomitant

Drug Data