Fludara combined with Prograf

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Supraventricular Tachycardia Hospitalization 2/1/2004 23 Male 108 lb 12/30/2005 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Hospitalization 2/19/2005 0 Male 12 lb 3/20/2006 Physician Japan
Primary
Secondary
Concomitant
Refractoriness To Platelet Transfusion Hospitalization 2/12/2005 0 Male 12 lb 4/7/2006 Physician Japan
Primary
Secondary
Concomitant
Weight Decrease Neonatal Hospitalization 2/12/2005 0 Male 12 lb 4/7/2006 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Hospitalization 2/1/2005 0 Male 5/10/2006 Consumer United States
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Disability 1/1/2004 61 Female 98 lb 5/15/2006 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Hospitalization 2/1/2005 0 Male 6/5/2006 Consumer United States
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Disability 1/1/2004 61 Female 98 lb 6/7/2006 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 2/1/2005 0 Male 7/3/2006 Consumer United States
Primary
Secondary
Concomitant
Visual Acuity Reduced Other Serious 2/25/2006 42 Male 165 lb 10/24/2006 Physician Japan
Primary
Concomitant
Urinary Retention Hospitalization 12/27/2005 58 Male 101 lb 11/9/2006 Physician Japan
Primary
Concomitant
Visual Acuity Reduced Other Serious 2/25/2006 42 Male 165 lb 11/1/2006 Physician Japan
Primary
Concomitant
Urinary Retention Hospitalization 12/24/2005 58 Male 101 lb 12/4/2006 Physician Japan
Primary
Concomitant
Lymphoproliferative Disorder Death Unknown 12/1/2006 Physician Japan
Primary
Concomitant
Lymphoproliferative Disorder Death 6 Male 12/13/2006 Physician Japan
Primary
Concomitant
Streptococcal Infection Other Serious 9/7/2005 5 Male 55 lb 12/29/2006 Physician Japan
Primary
Concomitant
Staphylococcal Sepsis Other Serious 9/7/2005 5 Male 55 lb 3/6/2007 Physician Japan
Primary
Concomitant
Oral Candidiasis Other Serious 11/17/2004 58 Male 160 lb 4/24/2007 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 4/23/2005 63 Male 140 lb 4/25/2007 Physician Japan
Primary
Concomitant
Oral Candidiasis Other Serious 11/17/2004 58 Male 160 lb 4/24/2007 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 4/23/2005 63 Male 140 lb 4/25/2007 Physician Japan
Primary
Concomitant
Transplant Rejection Death 5/16/2006 49 Female 109 lb 4/29/2007 Physician Japan
Primary
Concomitant
Cardiac Failure Other Serious 6/29/2006 2 Male 10/18/2007 Consumer United States
Primary
Secondary
Concomitant
Cardiac Failure Other Serious 6/29/2006 2 Male 12/7/2007 Consumer United States
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 8/31/2005 41 Female 106 lb 4/6/2008 Physician Japan
Primary
Concomitant
Cardiac Failure Congestive Disability 4/16/2007 46 Female 108 lb 4/17/2008 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 8/31/2005 41 Female 106 lb 4/14/2008 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 8/31/2005 41 Female 106 lb 4/14/2008 Physician Japan
Primary
Concomitant
Cardiac Failure Congestive Disability 4/16/2007 46 Female 108 lb 4/22/2008 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 12/22/2006 7 Female 72 lb 4/21/2008 Physician Japan
Primary
Secondary
Concomitant
Systemic Candida Other Serious 11/5/2007 38 Male 5/5/2008 Other Health Professional Japan
Primary
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
Renal Disorder Other Serious 11/1/2007 38 Male 7/8/2008 Other Health Professional Japan
Primary
Concomitant
White Blood Cell Count Increased Other Serious 10/4/2007 13 Female 71 lb 7/29/2008 Physician Japan
Primary
Secondary
Concomitant
Rales Other Serious 10/4/2007 13 Female 71 lb 7/29/2008 Physician Japan
Primary
Secondary
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
Thrombotic Microangiopathy Death 8/1/2007 Female 112 lb 9/18/2008 Physician Japan
Primary
Concomitant
Cardiomegaly Disability 4/16/2007 46 Female 108 lb 9/19/2008 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 5/11/2008 44 Female 137 lb 9/17/2008 Physician Japan
Primary
Concomitant
Tachycardia Other Serious 6/20/2008 49 10/8/2008 Pharmacist Japan
Primary
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
Urinary Sediment Abnormal Other Serious 10/4/2007 13 Female 71 lb 10/31/2008 Physician Japan
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 1/17/2008 9 Male 88 lb 11/7/2008 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Death 5/21/2008 9 Female 46 lb 11/13/2008 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Death 8/1/2007 Female 112 lb 12/10/2008 Physician Japan
Primary
Concomitant
Hypertension Other Serious 1/17/2008 9 Male 88 lb 12/26/2008 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Hospitalization 9/30/2007 14 Female 1/5/2009 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Hospitalization 10/26/2007 10 Male 1/6/2009 Physician Japan
Primary
Secondary
Concomitant
Weight Increased Life Threatening 8/6/2007 23 Female 121 lb 1/9/2009 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Hospitalization 10/26/2007 10 Male 1/21/2009 Physician Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 8/16/2008 51 Male 97 lb 2/13/2009 Physician Japan
Primary
Secondary
Concomitant
Liver Disorder Other Serious 8/25/2008 18 Male 128 lb 2/18/2009 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
Gastric Cancer Other Serious 8/6/2008 52 Male 119 lb 4/6/2009 Physician Japan
Primary
Concomitant
Renal Impairment Life Threatening 8/27/2008 18 Male 104 lb 4/6/2009 Japan
Primary
Concomitant
Sepsis Other Serious 6/26/2008 57 Male 137 lb 4/14/2009 Physician Japan
Primary
Concomitant
Splenic Abscess Other Serious 11/16/2008 39 Female 126 lb 4/15/2009 Physician Japan
Primary
Secondary
Concomitant
Sepsis Life Threatening 9/8/2008 62 Female 106 lb 5/8/2009 Other Health Professional Japan
Primary
Concomitant
Sepsis Life Threatening 9/8/2008 62 Female 106 lb 5/12/2009 Other Health Professional Japan
Primary
Concomitant
Venoocclusive Liver Disease Hospitalization 9/2/2008 56 Male 108 lb 5/18/2009 Japan
Primary
Concomitant
Pneumonia Other Serious 10/10/2008 56 Male 121 lb 5/20/2009 Japan
Primary
Secondary
Concomitant
Renal Disorder Other Serious 8/14/2008 15 Female 110 lb 5/20/2009 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Other Serious 10/10/2008 56 Male 121 lb 5/21/2009 Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 1/30/2009 42 Male 139 lb 5/28/2009 Japan
Primary
Concomitant
Pyrexia Other Serious 1/16/2009 53 Male 112 lb 5/28/2009 Japan
Primary
Concomitant
Stomatitis Other Serious 9/17/2008 56 Male 139 lb 5/28/2009 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 1/17/2009 59 Male 139 lb 5/28/2009 Physician Japan
Primary
Concomitant
Stomatitis Other Serious 12/19/2008 59 Male 123 lb 5/28/2009 Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 10/29/2008 64 Male 126 lb 5/29/2009 Japan
Primary
Secondary
Concomitant
Renal Failure Death 12/12/2008 68 Male 101 lb 5/29/2009 Other Health Professional Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 3/4/2009 Male 5/29/2009 Physician Japan
Primary
Concomitant
Septic Shock Other Serious 5/30/2008 41 Male 130 lb 6/1/2009 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Hospitalization 9/1/2008 57 Male 108 lb 6/5/2009 Japan
Primary
Concomitant
Venoocclusive Disease Other Serious 8/1/2008 6 Male 42 lb 6/5/2009 Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Other Serious 12/26/2008 15 Female 99 lb 6/5/2009 Physician Japan
Primary
Concomitant
Pneumonia Hospitalization 11/20/2008 44 Female 99 lb 6/8/2009 Physician Japan
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Other Serious 3/24/2009 56 Male 115 lb 6/8/2009 Japan
Primary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 2/2/2009 59 Female 88 lb 6/9/2009 Physician Japan
Primary
Concomitant
Encephalitis Herpes Other Serious 1/8/2009 56 Female 104 lb 6/9/2009 Japan
Primary
Concomitant
Sepsis Other Serious 1/31/2009 31 Male 95 lb 6/9/2009 Japan
Primary
Concomitant
Sepsis Life Threatening 10/24/2008 42 Male 121 lb 6/11/2009 Physician Japan
Primary
Secondary
Concomitant
Bone Marrow Transplant Other Serious 3/1/2009 37 Male 99 lb 6/17/2009 Physician Japan
Primary
Concomitant
Renal Impairment Life Threatening 8/27/2008 18 Male 104 lb 6/22/2009 Japan
Primary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Other Serious 1/11/2009 1 Male 15 lb 7/30/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Disorder Other Serious 8/14/2008 15 Female 110 lb 8/4/2009 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Life Threatening 9/23/2008 59 Female 123 lb 8/6/2009 Physician Japan
Primary
Secondary
Concomitant
Tachycardia Other Serious 6/20/2008 Male 8/7/2009 Pharmacist Japan
Primary
Concomitant
Sepsis Other Serious 6/26/2008 57 Male 137 lb 8/12/2009 Physician Japan
Primary
Concomitant
Gastric Cancer Life Threatening 8/6/2008 52 Male 119 lb 8/25/2009 Physician Japan
Primary
Concomitant
Hypertension Other Serious 12/16/2008 15 Female 99 lb 8/27/2009 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 8/4/2008 6 Male 42 lb 8/28/2009 Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Life Threatening 6/9/2008 62 Male 154 lb 9/1/2009 Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 8/8/2008 51 Male 97 lb 9/3/2009 Physician Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 6/26/2008 57 Male 137 lb 9/8/2009 Physician Japan
Primary
Concomitant
Gastric Cancer Life Threatening 8/6/2008 52 Male 119 lb 9/8/2009 Physician Japan
Primary
Concomitant
Gastric Cancer Life Threatening 8/6/2008 52 Male 119 lb 9/14/2009 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Hospitalization 9/2/2008 56 Male 108 lb 9/15/2009 Japan
Primary
Concomitant
Pneumonia Other Serious 10/3/2008 56 Male 121 lb 9/15/2009 Japan
Primary
Secondary
Concomitant
Stomatitis Life Threatening 9/28/2008 59 Female 123 lb 9/15/2009 Physician Japan
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Other Serious 3/24/2009 56 Male 115 lb 9/17/2009 Other Health Professional Japan
Primary
Concomitant
Pneumonia Respiratory Syncytial Viral Death 10/21/2008 56 Male 121 lb 9/17/2009 Other Health Professional Japan
Primary
Concomitant
Cytomegalovirus Viraemia Other Serious 2/2/2009 59 Female 88 lb 9/17/2009 Physician Japan
Primary
Concomitant
Systemic Candida Death 12/27/2008 22 Male 110 lb 9/18/2009 Physician Japan
Primary
Concomitant
Systemic Candida Other Serious 9/29/2008 22 Male 97 lb 9/18/2009 Other Health Professional Japan
Primary
Concomitant
Renal Failure Acute Death 12/1/2008 68 Male 101 lb 9/21/2009 Other Health Professional Japan
Primary
Concomitant
Cytomegalovirus Viraemia Hospitalization 12/27/2008 67 Male 139 lb 9/24/2009 Other Health Professional Japan
Primary
Concomitant
Splenic Abscess Other Serious 11/4/2008 39 Female 126 lb 9/25/2009 Physician Japan
Primary
Secondary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Other Serious 1/11/2009 1 Male 15 lb 9/25/2009 Physician Japan
Primary
Secondary
Concomitant
Systemic Candida Other Serious 9/29/2008 22 Male 97 lb 9/29/2009 Other Health Professional Japan
Primary
Concomitant
Systemic Candida Death 12/27/2008 22 Male 110 lb 10/1/2009 Physician Japan
Primary
Concomitant
Pseudomembranous Colitis Other Serious 8/25/2008 18 Male 128 lb 10/1/2009 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Other Serious 6/4/2008 62 Male 154 lb 10/7/2009 Physician Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 8/8/2008 51 Male 97 lb 10/14/2009 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Other Serious 6/4/2008 62 Male 154 lb 11/23/2009 Physician Japan
Primary
Secondary
Concomitant
Precursor T-lymphoblastic Lymphoma/leukaemia Death 2/1/2009 12 Male 1/18/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Death 12/25/2008 1 Male 15 lb 1/22/2010 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 1/4/2010 56 Male 117 lb 2/12/2010 Physician Japan
Primary
Concomitant
Stomatitis Other Serious 9/25/2008 39 Male 157 lb 3/3/2010 Physician Japan
Primary
Secondary
Concomitant
Systemic Candida 12/27/2008 22 Male 110 lb 10/15/2009 Physician Japan
Primary
Concomitant
Stomatitis Other Serious 9/25/2008 39 Male 157 lb 3/22/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 2/22/2010 65 Female 6/7/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Liver Disorder Hospitalization 4/27/2005 30 Female 110 lb 8/3/2010 Physician Japan
Primary
Secondary
Concomitant
Liver Disorder Hospitalization 4/27/2005 30 Female 110 lb 9/24/2010 Physician Japan
Primary
Secondary
Concomitant
Liver Disorder Hospitalization 6/26/2006 54 Female 115 lb 10/12/2010 Physician Japan
Primary
Secondary
Concomitant
Shock Life Threatening 11/11/2007 12 Female 80 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
Acute Respiratory Distress Syndrome Life Threatening 11/11/2007 12 Female 80 lb 1/6/2011 Physician Japan
Primary
Secondary
Concomitant
Oedema Peripheral Other Serious Male 117 lb 1/26/2011 Physician Japan
Primary
Secondary
Concomitant
Bronchopulmonary Aspergillosis Other Serious 12/1/2008 64 Female 1/28/2011 Physician Japan
Primary
Concomitant
Pneumonia Life Threatening 4/22/2007 41 Male 132 lb 2/4/2011 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Death 53 Female 2/4/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 68 Male 2/8/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 20 Male 2/8/2011 Physician Japan
Primary
Concomitant
Pseudomonal Sepsis Other Serious 42 Male 2/8/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 34 Male 2/8/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 12/1/2008 64 Female 2/8/2011 Physician Japan
Primary
Concomitant
Sepsis Hospitalization 2/2/2008 61 Female 117 lb 2/14/2011 Physician Japan
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Other Serious 49 Male 2/23/2011 Physician Japan
Primary
Concomitant
Precursor T-lymphoblastic Lymphoma/leukaemia Death 2/1/2009 12 Male 3/2/2011 Physician Japan
Primary
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
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
Drug Ineffective Other Serious 3 Female 3/18/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 16 Female 3/18/2011 Physician Japan
Primary
Concomitant

Drug Data