Fludarabine Phosphate combined with Prograf

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Scab Hospitalization 6/21/2004 11 Female 90 lb 12/30/2005 Physician Japan
Primary
Secondary
Venoocclusive Liver Disease Other Serious 69 Male 3/3/2006 Physician Japan
Primary
Concomitant
Serum Ferritin Increased Other Serious 57 Male 3/6/2006 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 59 Male 3/9/2006 Physician Japan
Primary
Concomitant
Serum Ferritin Increased Other Serious 57 Male 3/15/2006 Physician Japan
Primary
Concomitant
Bacterial Sepsis Death 5/7/2004 63 Female 4/12/2006 Physician Japan
Primary
Concomitant
Staphylococcal Sepsis Life Threatening 5/11/2004 63 Female 107 lb 4/28/2006 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Hospitalization 28 Male 10/6/2006 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 69 Male 11/2/2006 Physician Japan
Primary
Concomitant
Encephalopathy Death 53 Female 11/17/2006 Physician Japan
Primary
Concomitant
Encephalopathy Death 53 Female 12/1/2006 Physician Japan
Primary
Concomitant
Reversible Posterior Leukoencephalopathy Syndrome Other Serious 10 Male 12/13/2006 Physician Japan
Primary
Concomitant
Reversible Posterior Leukoencephalopathy Syndrome Other Serious 12/22/2005 10 Male 61 lb 1/17/2007 Physician Japan
Primary
Secondary
Concomitant
Therapeutic Agent Toxicity Other Serious 12/22/2005 10 Male 61 lb 3/22/2007 Physician Japan
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Other Serious Male 6/18/2007 Physician Japan
Primary
Concomitant
Splenomegaly Other Serious 46 Male 9/5/2007 Physician United States
Primary
Concomitant
Zygomycosis Other Serious 63 Male 9/5/2007 Physician United States
Primary
Concomitant
Skin Papilloma Other Serious 17 Male 12/21/2007 Physician Japan
Primary
Concomitant
Weight Increased Other Serious 7/15/2007 64 Male 198 lb 1/16/2008 France
Primary
Secondary
Concomitant
Interacting
Progressive Multifocal Leukoencephalopathy Death 1/1/2004 58 Male 4/28/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Death 13 Male 10/27/2008 Physician Japan
Primary
Concomitant
Respiratory Syncytial Virus Infection Death 0 Female 11/17/2008 Physician Japan
Primary
Concomitant
Venoocclusive Disease Death Male 11/17/2008 Physician Japan
Primary
Concomitant
Renal Failure Chronic Other Serious 14 Male 11/19/2008 Physician Japan
Primary
Concomitant
Respiratory Syncytial Virus Infection Life Threatening 2/23/2008 1 Female 10 lb 11/26/2008 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Disease Death Male 12/1/2008 Physician Japan
Primary
Concomitant
Rash Other Serious 12/27/2007 Female 44 lb 12/5/2008 Physician Japan
Primary
Secondary
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
Viral Haemorrhagic Cystitis Disability 10/1/2006 14 Male 88 lb 12/18/2008 Physician Japan
Primary
Secondary
Concomitant
Immune System Disorder Other Serious 65 Female 12/22/2008 Physician United States
Primary
Secondary
Concomitant
Rash Other Serious 12/27/2007 Female 44 lb 12/24/2008 Physician Japan
Primary
Secondary
Concomitant
Sepsis Death 12/24/2008 Physician Japan
Primary
Concomitant
Stem Cell Transplant Hospitalization 10/17/2008 47 Male 1/15/2009 Physician United States
Primary
Secondary
Concomitant
Skin Exfoliation Other Serious 57 Male 1/22/2009 Physician Japan
Primary
Concomitant
Tremor Hospitalization 10 Male 4/3/2009 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 16 Female 4/3/2009 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 59 Male 4/8/2009 Physician Japan
Primary
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
Fatigue Hospitalization 8/11/2009 Female 108 lb 8/13/2009 Consumer United States
Primary
Secondary
Concomitant
Progressive Multifocal Leukoencephalopathy Death 49 Female 10/23/2009 Physician Japan
Primary
Concomitant
Transplant Rejection Death 32 Male 10/23/2009 Physician Japan
Primary
Concomitant
Upper Gastrointestinal Haemorrhage Other Serious 9/24/2009 58 Female 118 lb 10/21/2009 Physician United States
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 1 Male 12/1/2009 Physician Japan
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Other Serious 6/26/2009 58 Female 118 lb 2/16/2010 Other Health Professional United States
Primary
Concomitant
Serum Ferritin Increased Life Threatening 59 Male 2/24/2010 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
Sepsis Death 64 Male 2/26/2010 Physician Japan
Primary
Concomitant
Visual Impairment Life Threatening 7/27/2009 54 Male 135 lb 3/5/2010 Physician Japan
Primary
Secondary
Concomitant
Pleuritic Pain Other Serious 52 Female 3/12/2010 Other Health Professional United States
Primary
Secondary
Pneumatosis Intestinalis Other Serious 60 Male 3/12/2010 Physician Japan
Primary
Concomitant
Organising Pneumonia Hospitalization 4/16/2009 Male 3/25/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 12/16/2008 73 Male 117 lb 3/24/2010 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 40 Female 4/2/2010 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 9/25/2007 48 Female 115 lb 4/5/2010 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Other Serious 6/30/2009 15 Male 88 lb 4/5/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Failure Other Serious 6/30/2009 15 Male 88 lb 4/7/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Splenomegaly Other Serious 59 150 lb 4/19/2010 Physician Japan
Primary
Secondary
Concomitant
Oxygen Saturation Decreased Other Serious 4/18/2010 57 Male 183 lb 5/3/2010 Physician United States
Primary
Concomitant
Pancreatitis Acute Hospitalization 6/24/2009 15 Male 88 lb 5/3/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Po2 Decreased Other Serious 4/18/2010 57 Male 183 lb 5/14/2010 Physician United States
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 70 Male 9/17/2010 Physician Japan
Primary
Concomitant
Pneumonia Cytomegaloviral Death Male 10/12/2010 Physician Japan
Primary
Secondary
Concomitant
Leukoencephalopathy Other Serious 53 Female 10/20/2010 Physician Japan
Primary
Concomitant
Reversible Posterior Leukoencephalopathy Syndrome Other Serious 12/22/2005 10 Male 61 lb 10/27/2010 Physician Japan
Primary
Secondary
Concomitant
Sepsis Life Threatening 11/8/2009 15 Male 157 lb 11/11/2010 Physician Japan
Primary
Secondary
Concomitant
Sepsis Life Threatening 11/8/2009 15 Male 157 lb 12/6/2010 Physician Japan
Primary
Secondary
Concomitant
Pericardial Effusion Other Serious 16 Female 11/22/2010 Physician Japan
Primary
Secondary
Concomitant
Pericardial Effusion Other Serious 16 Female 12/9/2010 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 9 Female 12/28/2010 Physician Japan
Primary
Concomitant
Sepsis Life Threatening 11/8/2009 15 Male 157 lb 1/6/2011 Physician Japan
Primary
Secondary
Concomitant
Cytomegalovirus Gastroenteritis Death 55 Male 4/20/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 56 Female 4/28/2011 Physician Japan
Primary
Concomitant
Cytomegalovirus Infection Other Serious 6 Male 5/13/2011 Other Health Professional China
Primary
Concomitant
Chronic Graft Versus Host Disease Other Serious 56 Male 5/17/2011 Physician Japan
Primary
Concomitant
Ischaemia Hospitalization 1/16/2011 18 Female 6/13/2011 Other Health Professional Switzerland
Primary
Secondary
Concomitant
Orthostatic Hypotension Other Serious 10/9/2008 60 Male 6/22/2011 Physician United States
Primary
Secondary
Concomitant
Escherichia Sepsis Other Serious 54 Female 6/22/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 34 Female 6/29/2011 Physician Japan
Primary
Concomitant
Interacting
Bacterial Infection Life Threatening 11/8/2009 15 Male 157 lb 7/5/2011 Physician Japan
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 56 Female 7/6/2011 Physician Japan
Primary
Concomitant
Cytomegalovirus Infection Other Serious 1/1/2008 26 Female 7/19/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 8 Male 9/12/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 10/13/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 10/13/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 10/13/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 10/13/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 10/13/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 2 Male 10/18/2011 Physician Japan
Primary
Concomitant
Chronic Graft Versus Host Disease Other Serious Male 10/18/2011 Physician Japan
Primary
Concomitant
Febrile Neutropenia Other Serious 10/19/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 10/19/2011 Physician Japan
Primary
Concomitant
Febrile Neutropenia Other Serious 10/19/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 10/19/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 55 Female 10/19/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 34 Female 10/19/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 9 Male 10/19/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Death 1/1/2005 59 Male 126 lb 11/4/2011 Physician Japan
Primary
Secondary
Concomitant
Infection Other Serious 10 Male 11/9/2011 Physician Japan
Primary
Concomitant
Cerebral Atrophy Other Serious 11/19/2007 24 Female 11/7/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 11/22/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 11/22/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 11/22/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 11/22/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 11/22/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 11/22/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 11/22/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 11/22/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 11/22/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 11/22/2011 Physician Japan
Primary
Concomitant
Abdominal Pain Other Serious 9 Male 11/29/2011 Other Health Professional Australia
Primary
Secondary
Hepatitis Viral Death 60 Male 12/6/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Death 19 Male 12/9/2011 Physician Japan
Primary
Concomitant
Chronic Graft Versus Host Disease Other Serious 10 Female 12/12/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 18 Female 12/12/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 17 Male 12/12/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 6 Female 12/12/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 13 Male 12/12/2011 Physician Japan
Primary
Concomitant
Herpes Zoster Other Serious 11 Female 12/12/2011 Physician Japan
Primary
Concomitant
Food Allergy Disability 9/1/2010 Male 18 lb 12/12/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 9 Male 12/13/2011 Physician Japan
Primary
Concomitant
Chronic Graft Versus Host Disease Other Serious 5 Male 12/12/2011 Physician Japan
Primary
Concomitant
Pancreatitis Acute Death 5 Male 12/9/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 29 Female 12/13/2011 Physician Japan
Primary
Concomitant
Oral Herpes Other Serious 4/27/2011 60 Female 82 lb 12/13/2011 Physician Japan
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 3 Male 12/13/2011 Physician Japan
Primary
Concomitant
Oral Herpes Life Threatening 4/27/2011 60 Female 82 lb 12/13/2011 Physician Japan
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Hospitalization 6 Male 12/9/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious Female 12/14/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 19 Male 12/12/2011 Physician Japan
Primary
Concomitant
Herpes Zoster Other Serious 13 Male 12/12/2011 Physician Japan
Primary
Concomitant
Abscess Neck Other Serious 3 Female 12/12/2011 Physician Japan
Primary
Concomitant
Toxicity To Various Agents Other Serious 12/22/2005 10 Male 61 lb 12/13/2011 Physician Japan
Primary
Secondary
Concomitant
Hypertension Hospitalization 12/1/2007 36 Female 119 lb 1/18/2012 Other Health Professional United States
Primary
Concomitant
Drug Ineffective Other Serious 6/13/2011 3 Male 29 lb 2/7/2012 Physician Japan
Primary
Concomitant
Herpes Zoster Other Serious 2 Female 2/21/2012 Physician Japan
Primary
Concomitant
Encephalitis Herpes Other Serious 20 Male 2/21/2012 Physician Japan
Primary
Concomitant
Chronic Graft Versus Host Disease Other Serious Male 2/21/2012 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 7 Male 2/21/2012 Physician Japan
Primary
Concomitant
Hepatitis Other Serious 6 Male 2/21/2012 Physician Japan
Primary
Concomitant
Cerebral Toxoplasmosis Life Threatening 10/1/2010 59 Female 82 lb 2/21/2012 Physician Japan
Primary
Secondary
Concomitant
Cytomegalovirus Test Positive Other Serious 5 Male 3/5/2012 Physician Japan
Primary
Concomitant
Zygomycosis Death 62 Female 3/6/2012 Physician Japan
Primary
Concomitant
Pneumonia Toxoplasmal Death 22 Male 3/7/2012 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 51 Female 3/8/2012 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 1 Male 3/8/2012 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 58 Male 3/8/2012 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 35 Female 3/9/2012 Physician Japan
Primary
Concomitant

Drug Data