Fludarabine Phosphate combined with Prednisolone

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Visual Field Defect Other Serious 1/1/2005 49 Female 3/14/2006 Japan
Primary
Secondary
Concomitant
Mucous Membrane Disorder Hospitalization 8/26/2004 8 Male 51 lb 7/21/2006 Physician Japan
Primary
Concomitant
Cardiogenic Shock Other Serious 9/1/2006 68 Female 9/18/2006 Physician South Africa
Primary
Concomitant
Lung Neoplasm Hospitalization 8/23/2006 55 Male 9/27/2006 Physician United States
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Hospitalization 28 Male 10/6/2006 Physician Japan
Primary
Concomitant
Reversible Posterior Leukoencephalopathy Syndrome Other Serious 10 Male 12/13/2006 Physician Japan
Primary
Concomitant
White Blood Cell Count Increased Hospitalization 3/10/2005 62 Female 110 lb 12/20/2006 Physician Germany
Primary
Secondary
Concomitant
Reversible Posterior Leukoencephalopathy Syndrome Other Serious 12/22/2005 10 Male 61 lb 1/17/2007 Physician Japan
Primary
Secondary
Concomitant
Ventricular Tachycardia Hospitalization 56 Male 2/19/2007 Physician Japan
Primary
Secondary
Therapeutic Agent Toxicity Other Serious 12/22/2005 10 Male 61 lb 3/22/2007 Physician Japan
Primary
Secondary
Concomitant
Viral Dna Test Positive Other Serious 7/11/2004 15 Male 73 lb 6/22/2007 Japan
Primary
Secondary
Concomitant
Aortic Aneurysm Hospitalization 6/19/2007 Male 101 lb 7/2/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 4/26/2005 Male 181 lb 7/16/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Pulmonary Embolism Life Threatening 4/5/1993 56 Male 9/24/2007 Other Health Professional United Kingdom
Primary
Concomitant
Mental Status Changes Hospitalization 7/28/2007 Male 9/28/2007 Physician United States
Primary
Secondary
Concomitant
Aortic Aneurysm Hospitalization 6/19/2007 Male 101 lb 10/5/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Cytomegalovirus Infection Hospitalization 12/1/2005 59 Male 10/22/2007 Physician Netherlands
Primary
Concomitant
Febrile Neutropenia Hospitalization 8/1/2005 Male 170 lb 10/26/2007 Consumer United Kingdom
Primary
Secondary
Concomitant
Retinitis Viral Other Serious 67 Female 11/20/2007 Other Health Professional United Kingdom
Primary
Concomitant
Virus Serology Test Positive Other Serious 56 Male 11/20/2007 Japan
Primary
Secondary
Renal Tubular Necrosis Other Serious 53 Male 12/6/2007 Other Health Professional Portugal
Primary
Secondary
Venous Thrombosis Other Serious 53 Male 12/7/2007 Physician Portugal
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 7/20/2006 Male 170 lb 1/19/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Proteinuria Hospitalization 12/17/2007 63 Male 150 lb 1/22/2008 Physician Germany
Primary
Secondary
Concomitant
Pyrexia Hospitalization 12/20/2007 Male 1/22/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Vertigo Death 58 Male 3/29/2008 Physician Germany
Primary
Secondary
Venoocclusive Disease Other Serious 11 Male 4/9/2008 Japan
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Death 1/1/2004 58 Male 4/28/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Vertigo Death Male 5/2/2008 Germany
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Hospitalization 1/1/2004 Male 5/15/2008 Other Health Professional Germany
Primary
Secondary
Cytomegalovirus Colitis Other Serious 56 Male 6/6/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Vertigo Death 67 Male 6/6/2008 Germany
Primary
Secondary
Concomitant
Lymphoproliferative Disorder Death 17 6/30/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Death Death 52 Female 9/3/2008 Physician United Kingdom
Primary
Concomitant
Encephalitis Cytomegalovirus Life Threatening 6/1/2004 58 Female 9/26/2008 Other Health Professional United Kingdom
Primary
Secondary
Sepsis Other Serious 8/1/2005 31 Male 1/18/2008 Other Health Professional Japan
Primary
Concomitant
Respiratory Failure Other Serious 51 Male 7/19/2008 Other Health Professional Thailand
Primary
Secondary
Myelodysplastic Syndrome Disability 5/2/2007 67 Female 10/9/2008 Physician Canada
Primary
Secondary
Progressive Multifocal Leukoencephalopathy Hospitalization 4/1/2000 64 Male 10/10/2008 Physician Australia
Primary
Secondary
Concomitant
Pancytopenia Other Serious 1/1/2008 74 Female 10/22/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 8/28/2008 74 Female 10/21/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 1/1/2007 37 Male 10/29/2008 Other Health Professional India
Primary
Secondary
Concomitant
Pancytopenia Other Serious 74 Female 11/7/2008 United Kingdom
Primary
Secondary
Concomitant
Visual Acuity Reduced Other Serious 32 Female 11/17/2008 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Visual Acuity Reduced Other Serious 25 Female 11/18/2008 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 74 Female 11/18/2008 United Kingdom
Primary
Secondary
Concomitant
Splenectomy Hospitalization 7 Female 11/24/2008
Primary
Secondary
Concomitant
Leukaemia Other Serious 5/10/2008 69 Male 11/25/2008 Physician Japan
Primary
Concomitant
Renal Failure Chronic Other Serious 14 Male 11/19/2008 Physician Japan
Primary
Concomitant
Skin Nodule Other Serious 1/1/2006 36 Female 12/1/2008 Other Health Professional Germany
Primary
Concomitant
Reversible Posterior Leukoencephalopathy Syndrome Other Serious 4 Female 12/2/2008 Other Health Professional Japan
Primary
Concomitant
Respiratory Syncytial Virus Infection Life Threatening 2/23/2008 1 Female 10 lb 11/26/2008 Physician Japan
Primary
Secondary
Concomitant
Respiratory Disorder Death 43 Female 12/2/2008 Japan
Primary
Concomitant
Rash Other Serious 12/27/2007 Female 44 lb 12/5/2008 Physician Japan
Primary
Secondary
Concomitant
Cytomegalovirus Chorioretinitis 32 Female 12/8/2008 Korea, Republic Of
Primary
Concomitant
Cytomegalovirus Chorioretinitis 25 Female 12/8/2008 Physician Korea, Republic Of
Primary
Concomitant
Respiratory Syncytial Virus Infection Life Threatening 2/23/2008 1 Female 10 lb 12/8/2008 Physician Japan
Primary
Secondary
Concomitant
Rash Other Serious 12/27/2007 Female 44 lb 12/5/2008 Physician Japan
Primary
Secondary
Concomitant
Septic Shock Other Serious 6/1/2004 55 Male 12/17/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Other Serious 6/1/2008 Female 12/19/2008 Pharmacist United Kingdom
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Life Threatening 10/1/2008 Female 12/19/2008 Pharmacist United Kingdom
Primary
Concomitant
Viral Haemorrhagic Cystitis Disability 10/1/2006 14 Male 88 lb 12/18/2008 Physician Japan
Primary
Secondary
Concomitant
Progressive Multifocal Leukoencephalopathy Other Serious 6/1/2008 Female 12/24/2008 Physician Germany
Primary
Secondary
Concomitant
Progressive Multifocal Leukoencephalopathy Other Serious 10/8/2008 Male 12/24/2008 Other Health Professional United Kingdom
Primary
Concomitant
Rash Other Serious 12/27/2007 Female 44 lb 12/24/2008 Physician Japan
Primary
Secondary
Concomitant
Rheumatoid Factor Positive Other Serious 1/1/2005 36 Female 1/8/2009 Consumer United Kingdom
Primary
Secondary
Thrombotic Microangiopathy Other Serious 54 Male 1/15/2009 Physician Japan
Primary
Secondary
Thrombotic Microangiopathy Other Serious 11/1/2007 54 Male 1/20/2009 Physician Japan
Primary
Secondary
Septic Shock Hospitalization 55 Male 1/20/2009
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 11/17/2007 54 Male 2/2/2009 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 9/15/2007 66 Male 2/10/2009 Austria
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 1/1/2005 36 Female 2/27/2009 Consumer United Kingdom
Primary
Secondary
Immune System Disorder Other Serious 1/1/2008 43 Female 3/6/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Weight Increased Death 43 Female 3/3/2009 Japan
Primary
Secondary
Concomitant
Weight Decreased Other Serious 2/1/2008 74 Female 3/13/2009 Physician Germany
Primary
Secondary
Concomitant
Proteinuria Hospitalization 12/1/2007 63 Male 150 lb 3/13/2009 Physician Germany
Primary
Secondary
Concomitant
Immune System Disorder Other Serious 1/1/2008 43 Female 101 lb 4/3/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Immune System Disorder Other Serious 1/1/2008 43 Female 101 lb 4/8/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Herpes Zoster Other Serious 11/1/2005 25 Female 3/31/2009 Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 59 Male 4/8/2009 Physician Japan
Primary
Concomitant
Stem Cell Transplant Other Serious 11/1/2005 25 Female 4/3/2009 Japan
Primary
Secondary
Concomitant
Pancytopenia Other Serious 11/1/2005 25 Female 4/7/2009 Japan
Primary
Secondary
Concomitant
Pancytopenia Other Serious 11/1/2005 25 Female 4/8/2009 Japan
Primary
Secondary
Concomitant
Pancytopenia Other Serious 1/1/2008 74 Female 4/20/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Respiratory Distress Other Serious 58 Male 4/20/2009 Japan
Primary
Secondary
Concomitant
Immune System Disorder Death 1/15/2008 43 Female 101 lb 4/22/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Respiratory Distress Other Serious 58 Male 5/4/2009 Japan
Primary
Secondary
Concomitant
Transplant Other Serious 2 Male 5/1/2009 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 8/5/2008 59 Male 5/5/2009 Physician Japan
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Other Serious 2/1/2004 61 Female 6/23/2009 Consumer Japan
Primary
Secondary
Progressive Multifocal Leukoencephalopathy Other Serious 1/1/2006 69 Male 6/26/2009 Other Health Professional Czech Republic
Primary
Secondary
Progressive Multifocal Leukoencephalopathy Other Serious 1/1/2006 69 Male 6/30/2009 Other Health Professional Czech Republic
Primary
Secondary
Renal Tubular Necrosis Other Serious 10/27/2007 57 Male 7/6/2009 Other Health Professional Netherlands
Primary
Concomitant
Rash Death 11/1/2005 25 Female 7/1/2009 Japan
Primary
Secondary
Concomitant
Renal Failure Chronic Other Serious 8/1/2008 14 Male 7/20/2009 Japan
Primary
Secondary
Concomitant
Pancytopenia Life Threatening 51 Male 7/24/2009
Primary
Secondary
Concomitant
Renal Failure Chronic Other Serious 8/1/2008 14 Male 8/14/2009 Japan
Primary
Secondary
Concomitant
Staphylococcal Bacteraemia Hospitalization 84 Male 8/17/2009 Consumer Turkey
Primary
Secondary
Concomitant
Vomiting Other Serious 7/1/2006 64 Male 8/28/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Overdose Life Threatening 7/5/2008 14 Male 101 lb 9/21/2009 Physician Poland
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 9/1/2006 52 Male 9/24/2009 United Kingdom
Primary
Secondary
Concomitant
Graft Versus Host Disease Other Serious 2/1/2006 45 Female 9/24/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Transplant Other Serious 10 Male 10/5/2009 Physician Japan
Primary
Secondary
Concomitant
Graft Versus Host Disease In Lung Other Serious 2/1/2006 45 Female 10/10/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Oral Disorder Other Serious 9/1/2006 52 Male 10/10/2009 United Kingdom
Primary
Secondary
Concomitant
Viral Infection Life Threatening 9/17/2008 70 Male 10/14/2009 Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Death 5/2/2008 72 Male 10/14/2009 Japan
Primary
Concomitant
Viral Infection Life Threatening 9/17/2008 70 Male 11/3/2009 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 64 Male 12/7/2009 Physician Germany
Primary
Secondary
Concomitant
Non-hodgkin's Lymphoma Death 10/8/2008 88 Male 12/2/2009 Physician Japan
Primary
Concomitant
Thrombocytopenia Hospitalization 12/1/2008 74 Female 12/16/2009 Physician Australia
Primary
Secondary
Concomitant
Drug Effect Decreased Death 8/1/2009 66 Female 12/18/2009 Physician Japan
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 12/1/2008 74 Female 12/23/2009 Other Health Professional Australia
Primary
Secondary
Concomitant
Shock Life Threatening 2/16/2009 59 Male 1/8/2010 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 12/31/2009 Female 183 lb 1/14/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Toxic Shock Syndrome Life Threatening 2/1/2009 59 Male 1/21/2010 Physician France
Primary
Secondary
Concomitant
Pyrexia Other Serious 3/22/2009 15 Male 110 lb 2/26/2010 Physician Japan
Primary
Concomitant
Pneumatosis Intestinalis Other Serious 60 Male 2/26/2010 Physician Japan
Primary
Concomitant
Respiratory Failure Other Serious 70 Male 2/26/2010 Physician Japan
Primary
Concomitant
Cardiac Failure Death 3/9/2010 Physician Germany
Primary
Secondary
Concomitant
Pneumatosis Intestinalis Other Serious 60 Male 3/12/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Increased Other Serious 50 Male 3/23/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Refractoriness To Platelet Transfusion Other Serious 51 Female 3/25/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 2/1/2009 56 Male 3/25/2010 Other Health Professional Japan
Primary
Concomitant
Respiratory Failure Hospitalization 12/16/2008 73 Male 117 lb 3/24/2010 Physician Japan
Primary
Concomitant
Leukopenia Other Serious 9/30/2008 53 Female 4/1/2010 Physician Russian Federation
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 2/1/2009 56 Male 3/31/2010 Other Health Professional Japan
Primary
Concomitant
Varicella Death 7/1/2009 64 Female 4/8/2010 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 9/25/2007 48 Female 115 lb 4/5/2010 Physician Japan
Primary
Secondary
Concomitant
Splenomegaly Other Serious 59 150 lb 4/19/2010 Physician Japan
Primary
Secondary
Concomitant
Leukoencephalopathy Death 2/1/2009 71 Female 110 lb 5/13/2010 Physician Netherlands
Primary
Secondary
Concomitant
Pyrexia Other Serious 5/10/2010 64 Male 6/4/2010 Other Health Professional United Kingdom
Primary
Concomitant
Visual Impairment Disability 3/11/2009 48 Female 84 lb 4/29/2010 Physician Japan
Primary
Concomitant
Sweat Gland Tumour Other Serious 32 Female 6/15/2010 Physician United Kingdom
Primary
Secondary
White Blood Cell Count Decreased Hospitalization 10/19/2009 54 Male 132 lb 6/21/2010 Other Health Professional Japan
Primary
Concomitant
Cytarabine Syndrome Life Threatening 5/10/2010 64 Male 6/18/2010 Other Health Professional United Kingdom
Primary
Concomitant
Staphylococcal Infection Other Serious 4/14/2010 60 Male 110 lb 6/25/2010 Physician Japan
Primary
Concomitant
Sweat Gland Tumour Required Intervention 28 Male 6/17/2010 Consumer United Kingdom
Primary
Secondary
Rash Other Serious 2/25/2009 55 Male 6/28/2010 Physician Japan
Primary
Secondary
Concomitant
Sepsis Life Threatening 10/23/2008 72 Male 7/2/2010 Other Health Professional Japan
Primary
Concomitant
Proteinuria Hospitalization 12/1/2007 63 Male 150 lb 7/26/2010 Physician Germany
Primary
Secondary
Concomitant
Proteinuria Hospitalization 12/1/2007 63 Male 150 lb 7/27/2010 Physician Germany
Primary
Secondary
Concomitant
Sweat Gland Tumour Other Serious 12/1/2002 32 Male 7/28/2010 Other Health Professional United Kingdom
Primary
Secondary
Staphylococcal Infection Hospitalization 2/1/2009 50 Female 110 lb 7/29/2010 Other Health Professional Japan
Primary
Concomitant
Stem Cell Transplant Other Serious 3/11/2009 48 Female 84 lb 7/19/2010 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
Staphylococcal Infection Hospitalization 2/1/2009 50 Female 110 lb 8/19/2010 Other Health Professional Japan
Primary
Concomitant
Herpes Zoster Other Serious 10/30/2009 31 Male 8/24/2010 Physician Japan
Primary
Secondary
Concomitant
Refractory Anaemia With An Excess Of Blasts Other Serious 8/30/2010 Physician United Kingdom
Primary
Concomitant

Drug Data