Fludara combined with Urso 250

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Cardiac Failure Other Serious 6/29/2006 2 Male 10/18/2007 Consumer United States
Primary
Secondary
Concomitant
Status Epilepticus Life Threatening 2/10/2005 39 Male 10/20/2007 Japan
Primary
Secondary
Concomitant
Status Epilepticus Life Threatening 2/10/2005 39 Male 10/26/2007 Japan
Primary
Secondary
Concomitant
Cardiac Failure Other Serious 6/29/2006 2 Male 12/7/2007 Consumer United States
Primary
Secondary
Concomitant
Interstitial Lung Disease Death 7/17/2007 65 Male 161 lb 2/29/2008 Physician Japan
Primary
Secondary
Concomitant
Cardiac Failure Congestive Disability 4/16/2007 46 Female 108 lb 4/17/2008 Physician Japan
Primary
Secondary
Concomitant
Cardiac Failure Congestive Disability 4/16/2007 46 Female 108 lb 4/22/2008 Physician Japan
Primary
Concomitant
Weight Decreased Hospitalization 3/13/2008 47 Male 141 lb 5/14/2008 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Death 7/17/2007 65 Male 161 lb 5/20/2008 Physician Japan
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 3/13/2008 47 Male 141 lb 6/24/2008 Physician Japan
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 3/13/2008 47 Male 141 lb 7/2/2008 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 4/21/2007 69 Female 82 lb 7/11/2008 Physician Japan
Primary
Concomitant
Cardiomegaly Disability 4/16/2007 46 Female 108 lb 7/15/2008 Physician Japan
Primary
Concomitant
Weight Increased Life Threatening 8/6/2007 23 Female 121 lb 8/25/2008 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 4/21/2007 69 Female 82 lb 9/12/2008 Physician Japan
Primary
Secondary
Concomitant
Cardiomegaly Disability 4/16/2007 46 Female 108 lb 9/19/2008 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 4/21/2007 69 Female 82 lb 11/4/2008 Physician Japan
Primary
Secondary
Concomitant
Weight Increased Life Threatening 8/6/2007 23 Female 121 lb 11/4/2008 Physician Japan
Primary
Secondary
Concomitant
Weight Increased Life Threatening 8/6/2007 23 Female 121 lb 1/9/2009 Physician Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 8/16/2008 51 Male 97 lb 2/13/2009 Physician Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 10/3/2008 60 Female 106 lb 3/12/2009 Physician Japan
Primary
Concomitant
Vomiting Other Serious 8/20/2008 45 Male 128 lb 3/12/2009 Physician Japan
Primary
Secondary
Concomitant
Nausea Life Threatening 9/28/2008 59 Female 123 lb 3/16/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Life Threatening 6/26/2008 49 4/6/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Life Threatening 8/27/2008 18 Male 104 lb 4/6/2009 Japan
Primary
Concomitant
Renal Impairment Hospitalization 9/22/2008 61 Female 93 lb 4/9/2009 Physician Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 6/26/2008 57 Male 137 lb 4/14/2009 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Life Threatening 7/21/2008 56 Male 132 lb 4/15/2009 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 1/16/2009 53 Male 112 lb 5/28/2009 Japan
Primary
Concomitant
Venoocclusive Disease Other Serious 8/1/2008 6 Male 42 lb 6/5/2009 Japan
Primary
Secondary
Concomitant
Renal Impairment Life Threatening 8/27/2008 18 Male 104 lb 6/22/2009 Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 8/18/2008 26 Female 117 lb 8/5/2009 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Life Threatening 9/23/2008 59 Female 123 lb 8/6/2009 Physician Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 6/26/2008 57 Male 137 lb 8/12/2009 Physician Japan
Primary
Concomitant
Venoocclusive Disease Other Serious 8/4/2008 6 Male 42 lb 8/28/2009 Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 8/8/2008 51 Male 97 lb 9/3/2009 Physician Japan
Primary
Secondary
Concomitant
Hepatic Function Abnormal Other Serious 8/1/2008 54 Male 128 lb 9/4/2009 Physician Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 6/26/2008 57 Male 137 lb 9/8/2009 Physician Japan
Primary
Concomitant
Renal Impairment Hospitalization 9/10/2008 61 Female 93 lb 9/11/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Life Threatening 7/2/2008 49 Male 141 lb 9/11/2009 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Life Threatening 9/28/2008 59 Female 123 lb 9/15/2009 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Life Threatening 7/11/2008 56 Male 132 lb 9/24/2009 Physician Japan
Primary
Concomitant
Renal Impairment Life Threatening 7/2/2008 49 Male 141 lb 9/25/2009 Physician Japan
Primary
Secondary
Concomitant
Pseudomembranous Colitis Other Serious 8/25/2008 18 Male 128 lb 10/1/2009 Physician Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 8/8/2008 51 Male 97 lb 10/14/2009 Physician Japan
Primary
Secondary
Concomitant
Urticaria Other Serious 12/9/2008 7 Female 10/15/2009 Physician Japan
Primary
Concomitant
Hepatic Function Abnormal Hospitalization 1/24/2009 63 Female 10/26/2009 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 7/20/2008 44 Female 97 lb 8/3/2010 Physician Japan
Primary
Secondary
Concomitant
Fungaemia Death 6/22/2005 46 Male 126 lb 11/15/2010 Physician Japan
Primary
Secondary
Concomitant
Shock Life Threatening 11/11/2007 12 Female 80 lb 11/15/2010 Physician Japan
Primary
Secondary
Concomitant
Encephalitis Fungal Death Male 139 lb 11/15/2010 Physician Japan
Primary
Secondary
Concomitant
Shock Life Threatening 11/11/2007 12 Female 80 lb 12/6/2010 Physician Japan
Primary
Secondary
Concomitant
Mouth Haemorrhage Death 4/25/2009 4 Female 32 lb 12/8/2010 Physician Japan
Primary
Secondary
Concomitant
Acute Respiratory Distress Syndrome Life Threatening 11/11/2007 12 Female 80 lb 1/6/2011 Physician Japan
Primary
Secondary
Concomitant
Infection Death 4/25/2009 4 Female 32 lb 1/24/2011 Physician Japan
Primary
Secondary
Concomitant
Oedema Peripheral Other Serious Male 117 lb 1/26/2011 Physician Japan
Primary
Secondary
Concomitant
Sepsis Death 11/8/2007 56 Male 88 lb 1/31/2011 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Life Threatening 4/22/2007 41 Male 132 lb 2/4/2011 Physician Japan
Primary
Secondary
Concomitant
Cardiac Failure Life Threatening 2/14/2008 17 Female 134 lb 2/9/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Death 10/18/2009 39 Male 110 lb 2/11/2011 Physician Japan
Primary
Concomitant
Cardiac Failure Death 7/25/2010 60 Female 93 lb 2/14/2011 Physician Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 2/2/2008 61 Female 117 lb 2/14/2011 Physician Japan
Primary
Secondary
Concomitant
Systemic Mycosis Hospitalization 4/22/2007 41 Male 132 lb 3/2/2011 Physician Japan
Primary
Secondary
Concomitant
Blood Alkaline Phosphatase Increased Death 3/12/2009 16 Male 82 lb 3/2/2011 Physician Japan
Primary
Secondary
Concomitant
Hypernatraemia Life Threatening 6/8/2007 52 Male 130 lb 3/8/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Hospitalization 2/1/2009 41 Female 152 lb 3/8/2011 Physician Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 10/21/2008 61 Male 139 lb 3/11/2011 Physician Japan
Primary
Secondary
Concomitant
Alanine Aminotransferase Increased Life Threatening 1/24/2005 50 Male 121 lb 3/11/2011 Physician Japan
Primary
Secondary
Concomitant
Gamma-glutamyltransferase Increased Life Threatening 11/7/2008 59 Male 148 lb 3/11/2011 Physician Japan
Primary
Concomitant
Enterococcal Sepsis Life Threatening 3/9/2009 16 Male 82 lb 3/14/2011 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Life Threatening 3/9/2009 16 Male 82 lb 3/14/2011 Physician Japan
Primary
Secondary
Concomitant
Cardiac Disorder Disability 1/19/2010 2 Female 22 lb 3/24/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Liver Life Threatening 12/6/2010 53 Male 165 lb 3/28/2011 Physician Japan
Primary
Concomitant
Febrile Neutropenia Hospitalization 7/22/2007 54 Female 99 lb 3/31/2011 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 7/22/2007 54 Female 99 lb 4/5/2011 Physician Japan
Primary
Secondary
Concomitant
Pseudomonas Infection Death 11/8/2007 56 Male 88 lb 4/6/2011 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Haemorrhage Death 2/2/2008 61 Female 117 lb 4/7/2011 Physician Japan
Primary
Secondary
Concomitant
Blood Urea Increased Hospitalization 1/24/2005 50 Male 121 lb 4/7/2011 Physician Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Hospitalization 8/30/2007 57 Female 82 lb 4/7/2011 Physician Japan
Primary
Secondary
Concomitant
Cytomegalovirus Viraemia Hospitalization 1/5/2009 53 Male 141 lb 4/13/2011 Physician Japan
Primary
Concomitant
Hepatic Vein Occlusion Death 9/17/2005 60 Male 119 lb 4/13/2011 Physician Japan
Primary
Secondary
Concomitant
Enterovesical Fistula Life Threatening 4/16/2010 62 Male 130 lb 4/13/2011 Physician Japan
Primary
Secondary
Concomitant
Diarrhoea Disability 11/24/2008 11 Male 93 lb 4/13/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Death 8/30/2002 6 Male 35 lb 4/13/2011 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Haemorrhage Death 3/28/2007 64 Female 112 lb 4/14/2011 Physician Japan
Primary
Secondary
Concomitant
Melaena Other Serious 10/18/2009 48 Female 97 lb 4/15/2011 Physician Japan
Primary
Secondary
Concomitant
Renal Disorder Hospitalization 7/25/2010 60 Female 93 lb 4/20/2011 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Other Serious 7/21/2008 38 Female 123 lb 4/20/2011 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Death 2/4/2008 73 Male 4/20/2011 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Other Serious 2/19/2009 55 Female 119 lb 4/20/2011 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 10/12/2006 57 Male 110 lb 4/22/2011 Physician Japan
Primary
Secondary
Concomitant
Glucose Tolerance Impaired Disability 6/5/2009 59 Male 146 lb 4/22/2011 Physician Japan
Primary
Secondary
Concomitant
Hepatic Function Abnormal Hospitalization 9/6/2006 56 Male 174 lb 4/22/2011 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 6/8/2010 57 Male 126 lb 4/25/2011 Physician Japan
Primary
Secondary
Concomitant
Blood Creatinine Increased Disability 7/26/2004 2 Male 22 lb 4/27/2011 Physician Japan
Primary
Secondary
Concomitant
Cystitis Disability 1/11/2005 7 Male 55 lb 4/28/2011 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization Male 112 lb 4/28/2011 Physician Japan
Primary
Secondary
Concomitant
Enterocolitis Death 8/26/2008 50 Male 141 lb 4/28/2011 Physician Japan
Primary
Secondary
Concomitant
Hepatic Function Abnormal Hospitalization 8/28/2007 62 Female 115 lb 4/28/2011 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 3/10/2007 40 Male 126 lb 4/29/2011 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Toxoplasmal Death 10/6/2009 22 Male 119 lb 4/29/2011 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 3/20/2008 58 Male 119 lb 4/29/2011 Physician Japan
Primary
Secondary
Concomitant
Pseudomembranous Colitis Hospitalization 11/11/2009 61 Male 143 lb 4/29/2011 Physician Japan
Primary
Secondary
Concomitant
Melaena Death 11/29/2007 65 Male 4/21/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 5/2/2007 56 Female 95 lb 5/2/2011 Physician Japan
Primary
Secondary
Concomitant
Ileus Paralytic Death 11/29/2007 65 Male 4/21/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Pleural Effusion Hospitalization 11/8/2010 2 Male 31 lb 5/4/2011 Physician Japan
Primary
Concomitant
Anaphylactic Reaction Hospitalization 4/3/2010 16 Female 95 lb 5/4/2011 Physician Japan
Primary
Secondary
Concomitant
Histiocytosis Haematophagic Death 8/30/2002 6 Male 35 lb 5/5/2011 Physician Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 10/12/2010 56 Male 130 lb 5/5/2011 Physician Japan
Primary
Concomitant
Systemic Candida Death 4/24/2009 38 Male 157 lb 5/5/2011 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Hospitalization 4/22/2007 41 Male 132 lb 5/6/2011 Physician Japan
Primary
Secondary
Concomitant
Renal Disorder Life Threatening 7/25/2010 60 Female 93 lb 5/24/2011 Physician Japan
Primary
Secondary
Concomitant
Cytomegalovirus Infection Disability 10/14/2005 8 Male 55 lb 5/26/2011 Physician Japan
Primary
Secondary
Concomitant
Gamma-glutamyltransferase Increased Life Threatening 12/6/2010 53 Male 165 lb 5/27/2011 Physician Japan
Primary
Concomitant
Decreased Appetite Hospitalization 1/17/2010 55 Male 168 lb 6/6/2011 Consumer Japan
Primary
Secondary
Concomitant
Pneumonia Death 2/4/2008 73 Male 6/14/2011 Physician Japan
Primary
Secondary
Concomitant
Hepatic Vein Occlusion Death 9/17/2005 60 Male 119 lb 6/16/2011 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Death 2/4/2008 73 Male 6/16/2011 Physician Japan
Primary
Secondary
Concomitant
Aspartate Aminotransferase Increased Hospitalization 12/20/2003 27 Female 108 lb 6/16/2011 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 12/14/2007 19 Male 112 lb 6/20/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Hospitalization 2/1/2009 41 Female 152 lb 6/22/2011 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 7/22/2007 54 Female 99 lb 6/24/2011 Physician Japan
Primary
Secondary
Concomitant
Constipation Hospitalization 12/10/2003 27 Female 108 lb 6/24/2011 Physician Japan
Primary
Secondary
Concomitant
Hepatic Failure Death 8/30/2002 6 Male 35 lb 6/27/2011 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Disability 11/24/2008 11 Male 93 lb 6/28/2011 Physician Japan
Primary
Secondary
Concomitant
C-reactive Protein Life Threatening 6/8/2007 52 Male 130 lb 7/1/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Respiratory Distress Syndrome Life Threatening 11/11/2007 12 Female 80 lb 7/5/2011 Physician Japan
Primary
Secondary
Concomitant
Arrhythmia Life Threatening 2/14/2008 17 Female 134 lb 7/5/2011 Physician Japan
Primary
Secondary
Concomitant
Melaena Other Serious 10/18/2009 48 Female 97 lb 7/8/2011 Physician Japan
Primary
Secondary
Concomitant
Histiocytosis Haematophagic Death 4/25/2009 4 Female 32 lb 7/18/2011 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Bacterial Death 10/1/2010 60 Male 183 lb 7/19/2011 Physician Japan
Primary
Concomitant
Febrile Neutropenia Hospitalization 5/2/2007 56 Female 95 lb 7/21/2011 Physician Japan
Primary
Secondary
Concomitant
Aspartate Aminotransferase Increased Hospitalization 12/10/2003 27 Female 108 lb 7/21/2011 Physician Japan
Primary
Secondary
Concomitant
Diarrhoea Hospitalization 6/8/2010 57 Male 126 lb 7/27/2011 Physician Japan
Primary
Secondary
Concomitant
Adenovirus Infection Hospitalization 8/26/2008 50 Male 141 lb 7/27/2011 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Death 10/6/2009 22 Male 119 lb 7/27/2011 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 8/28/2007 62 Female 115 lb 7/27/2011 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 11/11/2009 61 Male 143 lb 7/27/2011 Physician Japan
Primary
Secondary
Concomitant
Cytomegalovirus Viraemia Hospitalization 10/12/2006 57 Male 110 lb 7/29/2011 Physician Japan
Primary
Secondary
Concomitant
Encephalitis Fungal Death Male 139 lb 8/1/2011 Physician Japan
Primary
Secondary
Concomitant
Fungaemia Death 6/22/2005 46 Male 126 lb 8/2/2011 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Other Serious 7/21/2008 38 Female 123 lb 8/4/2011 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Death 2/4/2008 73 Male 8/4/2011 Physician Japan
Primary
Secondary
Concomitant
Cardiac Failure Life Threatening 2/14/2008 17 Female 134 lb 8/10/2011 Physician Japan
Primary
Secondary
Concomitant
Hyperkalaemia Disability 6/8/2007 52 Male 130 lb 8/17/2011 Physician Japan
Primary
Secondary
Concomitant
C-reactive Protein Increased Death 1/18/2006 35 Male 110 lb 9/20/2011 Physician Japan
Primary
Secondary
Concomitant
C-reactive Protein Increased Hospitalization 6/8/2007 52 Male 130 lb 10/6/2011 Physician Japan
Primary
Secondary
Concomitant
Neoplasm Progression Other Serious 1/20/2011 51 Male 132 lb 11/1/2011 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 7/14/2011 51 Male 132 lb 12/19/2011 Physician Japan
Primary
Secondary
Concomitant

Drug Data