Fludarabine Phosphate combined with Methylprednisolone Sodium Succinate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Ventricular Dysfunction Other Serious 3/28/2006 7 Male 4/12/2007 United States
Primary
Secondary
Concomitant
Rash Hospitalization 2/20/2002 Female 128 lb 11/9/2007 Consumer Japan
Primary
Concomitant
Viral Haemorrhagic Cystitis Death 9/22/2007 63 Male 8/18/2008 Japan
Primary
Secondary
Concomitant
Pseudomonal Sepsis Other Serious 3/4/2009 60 Male 150 lb 6/15/2009 Physician Japan
Primary
Concomitant
Neutrophil Count Decreased Other Serious 11/21/2008 77 Female 12/4/2009 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 3/22/2009 15 Male 110 lb 2/26/2010 Physician Japan
Primary
Concomitant
Pseudomembranous Colitis Life Threatening 8/17/2009 59 Male 121 lb 1/29/2010 Physician Japan
Primary
Concomitant
Engraft Failure Hospitalization 9/2/2009 73 Female 126 lb 1/29/2010 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 2/16/2009 Male 161 lb 3/4/2010 Physician Japan
Primary
Concomitant
Hepatic Function Abnormal Life Threatening 6/28/2009 Male 3/30/2010 Physician Japan
Primary
Concomitant
Staphylococcal Infection Life Threatening 5/1/2007 65 Male 99 lb 5/26/2010 Consumer Japan
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 10/19/2009 54 Male 132 lb 6/21/2010 Other Health Professional Japan
Primary
Concomitant
Staphylococcal Infection Other Serious 4/14/2010 60 Male 110 lb 6/25/2010 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 2/16/2009 23 Male 161 lb 7/20/2010 Other Health Professional Japan
Primary
Concomitant
Visual Impairment Other Serious 3/11/2009 49 Female 84 lb 7/21/2010 Physician Japan
Primary
Secondary
Concomitant
Visual Impairment Other Serious 3/11/2009 49 Female 84 lb 7/27/2010 Physician Japan
Primary
Secondary
Concomitant
Multi-organ Failure Death 5/6/2009 33 Male 194 lb 7/28/2010 Physician Japan
Primary
Concomitant
Nephrotic Syndrome Other Serious 9/19/2009 69 Female 86 lb 8/13/2010 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Hospitalization 1/23/2010 66 Male 130 lb 8/13/2010 Consumer Japan
Primary
Concomitant
Herpes Zoster Other Serious 10/30/2009 31 Male 128 lb 8/16/2010 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 3/11/2009 23 Female 97 lb 8/17/2010 Physician Japan
Primary
Concomitant
Herpes Zoster Other Serious 10/30/2009 31 Male 8/24/2010 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 3/11/2009 23 Female 97 lb 8/31/2010 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 2/16/2009 23 Male 161 lb 9/1/2010 Other Health Professional Japan
Primary
Concomitant
Sepsis Other Serious 4/20/2010 1 Male 15 lb 9/3/2010 Physician Japan
Primary
Concomitant
Sepsis Other Serious 4/20/2010 1 Male 15 lb 9/8/2010 Physician United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 4/13/2009 4 Female 31 lb 9/9/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 4/10/2009 4 Female 31 lb 10/8/2010 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 4/10/2009 4 Female 31 lb 10/11/2010 Physician Japan
Primary
Secondary
Concomitant
Pruritus Hospitalization 9/30/2009 18 Female 137 lb 10/18/2010 Physician Japan
Primary
Concomitant
Herpes Zoster Other Serious 10/30/2009 31 Male 128 lb 10/20/2010 Physician Japan
Primary
Concomitant
Encephalopathy Other Serious 4/10/2010 35 Male 139 lb 10/20/2010 Physician Japan
Primary
Concomitant
Pneumonia Hospitalization 7/2/2010 62 Male 130 lb 10/21/2010 Physician Japan
Primary
Concomitant
Staphylococcal Sepsis Life Threatening 1/14/2009 67 Male 99 lb 10/26/2010 Consumer Japan
Primary
Concomitant
Thrombotic Microangiopathy Death 9/21/2009 62 Female 126 lb 11/3/2010 Physician Japan
Primary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Death 5/6/2010 59 Female 99 lb 11/3/2010 Physician Japan
Primary
Concomitant
Pyrexia Death 2/8/2010 38 Male 146 lb 11/8/2010 Physician Japan
Primary
Concomitant
Weight Increased Other Serious 1/17/2010 Male 168 lb 11/22/2010 Physician Japan
Primary
Concomitant
Thyroid Disorder Other Serious 7/17/2009 28 Male 110 lb 11/23/2010 Physician Japan
Primary
Concomitant
Pyrexia Life Threatening Male 112 lb 11/24/2010 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Hospitalization 5/26/2010 Male 18 lb 11/24/2010 Physician Japan
Primary
Concomitant
Staphylococcal Sepsis Other Serious 8/21/2009 13 Male 97 lb 12/8/2010 Physician Japan
Primary
Concomitant
Staphylococcal Sepsis Other Serious 4/20/2010 1 Male 15 lb 12/10/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 1/29/2010 49 Male 110 lb 12/13/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 1/29/2010 49 Male 110 lb 12/13/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 4/13/2009 4 Female 31 lb 12/20/2010 Physician Japan
Primary
Concomitant
Pneumonia Cytomegaloviral Death 5/6/2009 33 Male 194 lb 12/23/2010 Physician Japan
Primary
Concomitant
Liver Disorder Hospitalization 3/26/2010 54 Female 95 lb 12/28/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Life Threatening 12/12/2009 76 Male 119 lb 12/29/2010 Physician Japan
Primary
Concomitant
Pyrexia Death 3/25/2010 58 Male 150 lb 12/29/2010 Physician Japan
Primary
Concomitant
Staphylococcal Infection Death 10/10/2009 72 Male 112 lb 12/30/2010 Physician Japan
Primary
Concomitant
Pyrexia Death 11/28/2009 73 Male 112 lb 1/3/2011 Physician Japan
Primary
Concomitant
Bacterial Infection Death 8/20/2009 46 Male 161 lb 1/3/2011 Other Health Professional Japan
Primary
Concomitant
Urinary Tract Infection Fungal Hospitalization 7/26/2010 51 Male 198 lb 1/3/2011 Physician Japan
Primary
Secondary
Concomitant
Enterococcal Sepsis Death 5/5/2010 48 Male 137 lb 1/6/2011 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Death 10/23/2009 62 Male 130 lb 1/6/2011 Physician Japan
Primary
Concomitant
Haemorrhage Death 4/13/2009 4 Female 31 lb 1/7/2011 Physician Japan
Primary
Concomitant
Pneumonia Cytomegaloviral Death 5/6/2009 33 Male 194 lb 1/7/2011 Physician Japan
Primary
Concomitant
Staphylococcal Sepsis Death 1/1/2010 1/7/2011 Physician Japan
Primary
Concomitant
Cytomegalovirus Test Positive Death 5/1/2010 54 Female 119 lb 1/10/2011 Physician Japan
Primary
Concomitant
Infection Life Threatening 7/4/2010 73 Female 97 lb 1/10/2011 Physician Japan
Primary
Concomitant
Acute Myeloid Leukaemia Recurrent Other Serious 2/26/2010 56 Male 134 lb 1/10/2011 Physician Japan
Primary
Concomitant
Acute Myeloid Leukaemia Recurrent Other Serious 5/12/2009 56 Male 139 lb 1/10/2011 Physician Japan
Primary
Concomitant
Cystitis Haemorrhagic Hospitalization 5/17/2010 43 Female 1/10/2011 Physician Japan
Primary
Concomitant
Cardiac Failure Death 8/6/2010 35 Female 71 lb 1/10/2011 Physician Japan
Primary
Concomitant
Infection Life Threatening 7/4/2010 73 Female 97 lb 1/13/2011 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Infection Death 4/14/2010 60 Male 110 lb 1/20/2011 Physician Japan
Primary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Death 5/6/2010 59 Female 99 lb 1/26/2011 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Death 9/21/2009 62 Female 126 lb 1/26/2011 Physician Japan
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Hospitalization 5/17/2010 43 Female 119 lb 1/26/2011 Physician Japan
Primary
Concomitant
Graft Versus Host Disease Hospitalization 9/30/2009 18 Female 137 lb 1/28/2011 Physician Japan
Primary
Concomitant
Alanine Aminotransferase Increased Other Serious 3/12/2010 2 Male 22 lb 3/9/2011 Physician Japan
Primary
Concomitant
Cystitis Haemorrhagic Hospitalization 5/17/2010 43 Female 119 lb 3/10/2011 Physician Japan
Primary
Concomitant
Cystitis Haemorrhagic Hospitalization 5/17/2010 43 Female 119 lb 3/25/2011 Physician Japan
Primary
Concomitant
Petechiae Other Serious 1/29/2010 49 Male 110 lb 5/20/2011 Physician Japan
Primary
Concomitant
Candida Test Positive Hospitalization 3/12/2010 54 Female 95 lb 5/25/2011 Physician Japan
Primary
Secondary
Concomitant
Weight Increased Hospitalization 1/17/2010 55 Male 168 lb 6/7/2011 Physician Japan
Primary
Secondary
Concomitant
Memory Impairment Hospitalization 2/10/2010 23 Male 117 lb 7/6/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Neutropenia Other Serious 6/9/2010 10 Female 88 lb 7/18/2011 Physician Japan
Primary
Secondary
Concomitant
Epstein-barr Virus Test Positive Other Serious 9/13/2009 7 Female 44 lb 8/1/2011 Physician Japan
Primary
Concomitant
Febrile Neutropenia Hospitalization 11/10/2010 49 Female 97 lb 8/2/2011 Physician Japan
Primary
Secondary
Concomitant
Neutropenia Life Threatening 1/17/2011 27 Female 95 lb 8/5/2011 Physician Japan
Primary
Concomitant
Insomnia Other Serious 11/23/2010 62 Female 108 lb 8/8/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 12/24/2010 69 Male 115 lb 8/11/2011 Physician Japan
Primary
Concomitant
Cystitis Haemorrhagic Hospitalization 7/2/2010 62 Female 130 lb 8/12/2011 Physician Japan
Primary
Concomitant
Lymphoma Death 4/15/2011 60 Male 143 lb 8/15/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 4/15/2011 60 Male 143 lb 8/16/2011 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 2/7/2011 20 Male 196 lb 8/22/2011 Physician Japan
Primary
Concomitant
Enterococcal Bacteraemia Hospitalization 10/11/2009 21 Female 101 lb 9/2/2011 Physician Japan
Primary
Concomitant
Haemolytic Anaemia Hospitalization 2/3/2010 6 Male 35 lb 9/19/2011 Physician Japan
Primary
Concomitant
Idiopathic Thrombocytopenic Purpura Death 11/17/2009 6 Male 33 lb 9/19/2011 Physician Japan
Primary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Death 5/19/2009 10 Male 49 lb 9/19/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Hospitalization 1/16/2011 11 Male 84 lb 9/29/2011 Physician Japan
Primary
Concomitant
Thrombocytopenia Other Serious 3/11/2009 23 Female 97 lb 9/29/2011 Physician Japan
Primary
Concomitant
Pyrexia Death 10/16/2009 38 Female 110 lb 9/29/2011 Physician Japan
Primary
Concomitant
Enterocolitis Bacterial Death 4/27/2009 70 Female 75 lb 10/3/2011 Physician Japan
Primary
Concomitant
Engraft Failure Death 6/9/2010 10 Female 88 lb 10/13/2011 Physician Japan
Primary
Secondary
Concomitant
Corynebacterium Infection Life Threatening 10/27/2010 70 Male 110 lb 10/20/2011 Physician Japan
Primary
Concomitant
Bronchopulmonary Aspergillosis Hospitalization 2/26/2010 56 Male 134 lb 10/25/2011 Physician Japan
Primary
Concomitant
Liver Disorder Hospitalization 4/5/2011 8 Female 53 lb 11/2/2011 Physician Japan
Primary
Concomitant
Staphylococcal Sepsis Life Threatening 8/21/2009 13 Male 97 lb 11/4/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 5/31/2009 58 Female 134 lb 11/8/2011 Physician Japan
Primary
Concomitant
Blood Glucose Increased Other Serious 2/11/2011 55 Female 123 lb 11/11/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 5/12/2011 6 Female 31 lb 11/22/2011 Physician Japan
Primary
Concomitant
Hepatomegaly Hospitalization 5/10/2010 56 Male 132 lb 11/22/2011 Physician Japan
Primary
Concomitant
Acute Respiratory Distress Syndrome Death 4/15/2011 3 Female 29 lb 11/23/2011 Physician Japan
Primary
Concomitant
Chronic Myeloid Leukaemia Death 1/4/2011 30 Male 137 lb 11/23/2011 Physician Japan
Primary
Concomitant
Hypoxia Other Serious 5/18/2011 50 Female 84 lb 11/23/2011 Physician Japan
Primary
Concomitant
Multi-organ Failure Hospitalization 6/24/2009 15 Male 126 lb 11/23/2011 Physician Japan
Primary
Concomitant
Neutropenia Death 6/1/2011 10 Female 60 lb 11/29/2011 Physician Japan
Primary
Concomitant
Pneumonia Staphylococcal Death 6/10/2010 33 Female 101 lb 11/29/2011 Physician Japan
Primary
Concomitant
Hypoalbuminaemia Other Serious 5/24/2011 50 Male 128 lb 12/7/2011 Physician Japan
Primary
Concomitant
Chronic Graft Versus Host Disease Other Serious 8/18/2009 18 Female 108 lb 12/9/2011 Physician Japan
Primary
Concomitant
Staphylococcal Sepsis Life Threatening 3/2/2011 12 Male 84 lb 12/9/2011 Physician Japan
Primary
Concomitant
Tumour Lysis Syndrome Life Threatening 7/28/2010 71 Male 159 lb 12/12/2011 Physician Japan
Primary
Concomitant
Cytomegalovirus Hepatitis Hospitalization 2/25/2011 2 Male 33 lb 12/12/2011 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Death 2/7/2009 57 Male 139 lb 12/14/2011 Physician Japan
Primary
Concomitant
Acute Myeloid Leukaemia Recurrent Other Serious 2/26/2010 56 Male 134 lb 12/19/2011 Physician Japan
Primary
Concomitant
Disseminated Intravascular Coagulation Life Threatening 7/22/2011 51 Male 161 lb 12/20/2011 Physician Japan
Primary
Concomitant
Bronchopulmonary Aspergillosis Life Threatening 8/3/2011 60 Male 121 lb 12/22/2011 Physician Japan
Primary
Concomitant
Renal Disorder Disability 2/7/2011 57 Female 99 lb 12/22/2011 Physician Japan
Primary
Concomitant
Liver Abscess Death 5/20/2011 25 Female 93 lb 12/22/2011 Physician Japan
Primary
Concomitant
Cytomegalovirus Test Positive Other Serious 8/29/2010 63 Male 168 lb 12/23/2011 Physician Japan
Primary
Concomitant
Aspergillus Test Positive Life Threatening 4/14/2010 60 Male 110 lb 12/23/2011 Physician Japan
Primary
Concomitant
Acute Myeloid Leukaemia Recurrent Death 8/5/2011 68 Female 88 lb 12/23/2011 Physician Japan
Primary
Concomitant
Candidiasis Hospitalization 1/1/2010 23 Male 117 lb 12/28/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Cytomegalovirus Test Positive Death 1/23/2010 66 Male 130 lb 12/30/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 4/15/2011 60 Male 143 lb 12/30/2011 Physician Japan
Primary
Concomitant
Haemolytic Anaemia Life Threatening 11/17/2009 6 Male 33 lb 12/30/2011 Physician Japan
Primary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Death 3/11/2009 9 Male 49 lb 12/30/2011 Physician Japan
Primary
Concomitant
Engraft Failure Life Threatening 10/3/2011 40 Female 88 lb 1/3/2012 Physician Japan
Primary
Concomitant
Myelodysplastic Syndrome Life Threatening 3/7/2011 53 Female 139 lb 1/3/2012 Physician Japan
Primary
Concomitant
Post Transplant Lymphoproliferative Disorder Death 8/4/2009 30 Female 110 lb 1/3/2012 Physician Japan
Primary
Concomitant
Gastrointestinal Necrosis Other Serious 6/26/2011 66 Male 132 lb 1/3/2012 Physician Japan
Primary
Concomitant
Staphylococcal Sepsis Disability 3/14/2011 25 Male 123 lb 1/3/2012 Physician Japan
Primary
Concomitant
Pancreatitis Death 6/5/2009 1/23/2012 Physician Japan
Primary
Concomitant
Abdominal Infection Other Serious 10/11/2011 57 Female 79 lb 1/23/2012 Physician Japan
Primary
Concomitant
Pyrexia Life Threatening 7/13/2010 6 Female 44 lb 2/6/2012 Physician Japan
Primary
Concomitant
Multi-organ Failure Death 2/7/2011 20 Male 196 lb 2/7/2012 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Death 2/7/2009 57 Male 139 lb 2/7/2012 Physician Japan
Primary
Concomitant
Staphylococcal Infection Other Serious 8/21/2009 13 Male 97 lb 2/9/2012 Physician Japan
Primary
Concomitant
Cerebral Haemorrhage Life Threatening 6/8/2009 6 Male 33 lb 2/9/2012 Physician Japan
Primary
Concomitant
Infection Other Serious 8/21/2009 6 Male 35 lb 2/9/2012 Physician Japan
Primary
Concomitant
Haemolytic Anaemia Other Serious 8/21/2009 6 Male 35 lb 2/9/2012 Physician Japan
Primary
Concomitant
Post Transplant Lymphoproliferative Disorder Death 3/6/2009 9 Male 49 lb 2/10/2012 Physician Japan
Primary
Concomitant
Infection Hospitalization 1/29/2009 3 Female 35 lb 2/10/2012 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 5/12/2011 6 Female 31 lb 2/13/2012 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 6/10/2010 33 Female 101 lb 2/15/2012 Physician Japan
Primary
Concomitant
Rash Hospitalization 1/16/2011 11 Male 84 lb 2/17/2012 Physician Japan
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Death 10/12/2010 24 Male 123 lb 2/24/2012 Physician Japan
Primary
Concomitant

Drug Data