Fludara combined with Methotrexate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Weight Decreased Other Serious 6 Female 1/28/2006 Physician United States
Primary
Secondary
Hepatitis Fulminant Other Serious Unknown 1/31/2006 Germany
Primary
Secondary
Concomitant
Pulmonary Toxicity Other Serious Unknown 1/31/2006 Germany
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 Other Serious 62 Male 4/21/2006 Physician United States
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 69 Male 4/21/2006 Physician United States
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 47 Male 4/21/2006 Physician United States
Primary
Secondary
Concomitant
Hyperbilirubinaemia Other Serious 59 Male 4/21/2006 Physician United States
Primary
Secondary
Concomitant
Renal Failure Other Serious 51 Male 4/21/2006 Physician United States
Primary
Secondary
Concomitant
Graft Versus Host Disease Other Serious 55 Male 4/21/2006 Physician United States
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
Renal Tubular Acidosis Other Serious 5/5/2005 20 Male 8/3/2006 Consumer United States
Primary
Secondary
Concomitant
Renal Tubular Acidosis Other Serious 5/5/2005 20 Male 8/30/2006 Consumer United States
Primary
Secondary
Concomitant
Oral Mucosal Disorder Hospitalization 2/9/2006 10 Male 8/30/2006 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
Lymphoproliferative Disorder Death Unknown 12/1/2006 Physician Japan
Primary
Concomitant
Lymphoproliferative Disorder Death 6 Male 12/13/2006 Physician Japan
Primary
Concomitant
Staphylococcal Sepsis Other Serious 9/7/2005 5 Male 55 lb 3/6/2007 Physician Japan
Primary
Concomitant
Sepsis Other Serious 1/27/2006 8 Male 46 lb 4/20/2007 Physician Japan
Primary
Secondary
Concomitant
Transplant Rejection Death 5/16/2006 49 Female 109 lb 4/29/2007 Physician Japan
Primary
Concomitant
Respiratory Failure Death 5/8/2003 13 Female 8/20/2007 Other Health Professional Japan
Primary
Concomitant
Cardiac Failure Other Serious 6/29/2006 2 Male 10/18/2007 Consumer United States
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 8/27/2002 57 Male 165 lb 10/24/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Status Epilepticus Life Threatening 2/10/2005 39 Male 10/26/2007 Japan
Primary
Secondary
Concomitant
Reticulocyte Count Decreased Hospitalization 2/16/2004 54 Male 11/21/2007 Physician Japan
Primary
Secondary
Concomitant
Cardiac Failure Other Serious 6/29/2006 2 Male 12/7/2007 Consumer United States
Primary
Secondary
Concomitant
Reticulocyte Count Decreased Hospitalization 2/16/2004 54 Male 12/18/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 61 Male 12/18/2007 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Death 3/5/2005 64 Female 121 lb 1/9/2008 Physician Japan
Primary
Concomitant
Nausea Other Serious 9/26/2007 59 Male 121 lb 2/6/2008 Physician Japan
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 33 Male 2/15/2008 Other Health Professional Mexico
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
Venoocclusive Liver Disease Other Serious 11/1/2007 12 Male 5/6/2008 Physician Italy
Primary
Secondary
Concomitant
Systemic Candida Other Serious 11/5/2007 38 Male 5/5/2008 Other Health Professional Japan
Primary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 4/25/2007 Physician United States
Primary
Secondary
Concomitant
Pyrexia Death 7/17/2007 65 Male 161 lb 5/20/2008 Physician Japan
Primary
Secondary
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
Cardiomegaly Disability 4/16/2007 46 Female 108 lb 9/19/2008 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 3/5/2005 64 Female 121 lb 12/12/2008 Physician Japan
Primary
Secondary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 10/6/2004 Male 143 lb 12/23/2008 Physician Japan
Primary
Secondary
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
Loss Of Consciousness Life Threatening 11/13/2008 62 Male 12/22/2008 Japan
Primary
Concomitant
Weight Increased Life Threatening 8/6/2007 23 Female 121 lb 1/9/2009 Physician Japan
Primary
Secondary
Concomitant
Loss Of Consciousness Life Threatening 11/13/2008 62 Male 12/23/2008 Physician Japan
Primary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 10/6/2004 Male 143 lb 1/16/2009 Physician Japan
Primary
Secondary
Concomitant
Rhabdomyolysis Other Serious 10/24/2008 2 Male 27 lb 1/20/2009 Physician Japan
Primary
Concomitant
Stomatitis Hospitalization 10/26/2007 10 Male 1/21/2009 Physician Japan
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Death 11/25/2008 62 Female 163 lb 1/23/2009 Consumer France
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Death 11/25/2008 62 Female 163 lb 1/27/2009 Consumer France
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Death 11/25/2008 Female 163 lb 1/28/2009 Other Health Professional France
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Hospitalization 11/1/2008 Female 163 lb 1/28/2009 Other Health Professional France
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Other Serious 11/28/2008 Female 163 lb 2/4/2009 Germany
Primary
Secondary
Concomitant
Respiratory Disorder Other Serious 8 Male 2/6/2009 Consumer Japan
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Hospitalization 11/25/2008 62 Female 163 lb 1/28/2009 Other Health Professional France
Primary
Concomitant
Toxic Epidermal Necrolysis Other Serious 11/28/2008 Female 163 lb 2/6/2009 Germany
Primary
Secondary
Concomitant
Sepsis Other Serious 8/16/2008 51 Male 97 lb 2/13/2009 Physician Japan
Primary
Secondary
Concomitant
Respiratory Disorder Other Serious 8 Male 2/16/2009 Consumer Japan
Primary
Secondary
Concomitant
Liver Disorder Other Serious 8/25/2008 18 Male 128 lb 2/18/2009 Physician Japan
Primary
Secondary
Concomitant
Rhabdomyolysis Other Serious 10/24/2008 2 Male 27 lb 2/20/2009 Physician Japan
Primary
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
Rhabdomyolysis Other Serious 10/24/2008 2 Male 27 lb 3/18/2009 Physician Japan
Primary
Concomitant
Sinusitis Hospitalization 2/26/2008 16 Male 117 lb 4/3/2009 Physician Japan
Primary
Concomitant
Sinusitis Hospitalization 2/26/2008 16 Male 117 lb 4/6/2009 Physician Japan
Primary
Concomitant
Renal Impairment Life Threatening 6/26/2008 49 4/6/2009 Physician Japan
Primary
Secondary
Concomitant
Sepsis Life Threatening 6/27/2008 36 Female 97 lb 4/9/2009 Physician Japan
Primary
Concomitant
Sinusitis Hospitalization 1/1/2008 16 Male 117 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
Splenic Abscess Other Serious 11/16/2008 39 Female 126 lb 4/15/2009 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 6/20/2008 62 Female 108 lb 4/27/2009 Physician Japan
Primary
Concomitant
Sepsis Hospitalization 6/24/2008 44 Female 93 lb 5/8/2009 Other Health Professional Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 1/22/2009 61 Female 143 lb 5/11/2009 Japan
Primary
Concomitant
Febrile Neutropenia Other Serious 7/25/2008 61 Male 146 lb 5/11/2009 Japan
Primary
Concomitant
Acute Graft Versus Host Disease Hospitalization 11/16/2008 41 Male 128 lb 5/11/2009 Japan
Primary
Concomitant
Cytomegalovirus Viraemia Other Serious 7/4/2008 65 Male 146 lb 5/11/2009 Japan
Primary
Concomitant
Cytomegalovirus Viraemia Other Serious 10/13/2008 50 Female 93 lb 5/11/2009 Japan
Primary
Concomitant
Sepsis Other Serious 8/11/2008 37 Female 99 lb 5/11/2009 Japan
Primary
Concomitant
Sepsis Other Serious 9/21/2008 30 Female 117 lb 5/11/2009 Japan
Primary
Concomitant
Sepsis Hospitalization 6/24/2008 44 Female 93 lb 5/12/2009 Other Health Professional Japan
Primary
Concomitant
Acute Graft Versus Host Disease Hospitalization 11/16/2008 41 Male 128 lb 5/12/2009 Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 1/22/2009 61 Female 143 lb 5/12/2009 Japan
Primary
Concomitant
Sepsis Other Serious 8/11/2008 37 Female 99 lb 5/12/2009 Japan
Primary
Concomitant
Febrile Neutropenia Other Serious 7/25/2008 61 Male 146 lb 5/12/2009 Japan
Primary
Concomitant
Cytomegalovirus Viraemia Other Serious 7/4/2008 65 Male 146 lb 5/12/2009 Japan
Primary
Concomitant
Cytomegalovirus Viraemia Other Serious 10/13/2008 50 Female 93 lb 5/12/2009 Japan
Primary
Concomitant
Sepsis Other Serious 9/21/2008 30 Female 117 lb 5/12/2009 Japan
Primary
Concomitant
Sepsis Other Serious 12/22/2008 43 Female 97 lb 5/12/2009 Other Health Professional Japan
Primary
Concomitant
Sepsis Other Serious 1/30/2009 40 Male 110 lb 5/14/2009 Japan
Primary
Concomitant
Cystitis Haemorrhagic Other Serious 10/29/2008 60 Female 148 lb 5/14/2009 Japan
Primary
Concomitant
Engraft Failure Death 11/20/2008 57 Female 104 lb 5/15/2009 Japan
Primary
Concomitant
Pneumonia Other Serious 7/31/2008 62 Male 165 lb 5/18/2009 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
Sepsis Death 9/18/2008 64 Male 117 lb 5/26/2009 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 1/30/2009 42 Male 139 lb 5/28/2009 Japan
Primary
Concomitant
Cytomegalovirus Viraemia Other Serious 10/27/2008 49 Male 115 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
Stomatitis Other Serious 12/19/2008 59 Male 123 lb 5/28/2009 Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Intestine Other Serious 3/12/2009 61 Male 117 lb 5/29/2009 Physician Japan
Primary
Concomitant
Myelodysplastic Syndrome Other Serious 6/28/2008 65 Male 148 lb 6/1/2009 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Hospitalization 9/1/2008 57 Male 108 lb 6/5/2009 Japan
Primary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 9/26/2008 46 Male 123 lb 6/5/2009 Physician Jordan
Primary
Secondary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 9/26/2008 46 Male 123 lb 6/8/2009 Physician Jordan
Primary
Secondary
Concomitant
Nausea Other Serious 10/27/2008 58 Female 106 lb 6/9/2009 Physician Japan
Primary
Secondary
Concomitant
Systemic Mycosis Other Serious 12/9/2008 25 Female 99 lb 6/9/2009 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 2/2/2009 59 Female 88 lb 6/9/2009 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 2/10/2009 39 Male 150 lb 6/9/2009 Japan
Primary
Concomitant
Renal Failure Acute Life Threatening 2/2/2009 60 Male 157 lb 6/12/2009 Japan
Primary
Secondary
Concomitant
Bone Marrow Transplant Other Serious 3/1/2009 37 Male 99 lb 6/17/2009 Physician Japan
Primary
Concomitant
Urticaria Other Serious 12/9/2008 7 Female 7/13/2009 Other Health Professional Japan
Primary
Concomitant
Renal Disorder Other Serious 8/14/2008 15 Female 110 lb 8/4/2009 Physician Japan
Primary
Secondary
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
Pneumonia Life Threatening 10/8/2008 65 Male 132 lb 8/6/2009 Physician 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
Weight Increased Other Serious 12/9/2008 25 Female 99 lb 9/8/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Death 12/1/2008 61 Male 115 lb 9/8/2009 Physician Japan
Primary
Concomitant
Nausea Other Serious 10/29/2008 58 Female 106 lb 9/8/2009 Physician Japan
Primary
Secondary
Concomitant
Sepsis Life Threatening 1/30/2009 40 Male 110 lb 9/9/2009 Japan
Primary
Concomitant
Sepsis Other Serious 1/30/2009 40 Male 110 lb 9/11/2009 Japan
Primary
Concomitant
Renal Impairment Life Threatening 7/2/2008 49 Male 141 lb 9/11/2009 Physician Japan
Primary
Secondary
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
Nausea Other Serious 10/29/2008 58 Female 106 lb 9/15/2009 Physician Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Other Serious 8/18/2008 26 Female 117 lb 9/15/2009 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Life Threatening 9/28/2008 59 Female 123 lb 9/15/2009 Physician Japan
Primary
Secondary
Concomitant
Cytomegalovirus Viraemia Other Serious 2/2/2009 59 Female 88 lb 9/17/2009 Physician Japan
Primary
Concomitant

Drug Data