Fludarabine Phosphate combined with Itraconazole

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Febrile Neutropenia Other Serious 5/15/2006 83 Female 9/13/2006 United States
Primary
Secondary
Concomitant
Sinus Bradycardia Hospitalization 3/22/2006 67 Female 148 lb 9/28/2006 Other Health Professional Italy
Primary
Secondary
Concomitant
Neutropenia Other Serious 5/15/2006 83 Female 2/26/2007 Japan
Primary
Secondary
Concomitant
Pneumonia Other Serious 5/15/2006 83 Female 3/19/2007 Japan
Primary
Secondary
Concomitant
Pneumonia Other Serious 5/15/2006 83 Female 4/13/2007 Japan
Primary
Secondary
Concomitant
Pneumonia Other Serious 5/15/2006 83 Female 6/21/2007 United States
Primary
Secondary
Concomitant
Viraemia Other Serious 12 Male 9/21/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 1/1/2005 60 Male 10/16/2007 Physician Japan
Primary
Secondary
Concomitant
Weight Increased Death 60 Male 10/15/2007 Japan
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 1/1/2005 60 Male 11/5/2007 Physician Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 7/14/2007 40 Female 4/2/2008 Japan
Primary
Secondary
Concomitant
Neuropathy Peripheral Disability 34 Female 194 lb 4/25/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Neuropathy Peripheral Disability 34 Female 194 lb 4/30/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Neuropathy Peripheral Disability 34 Female 194 lb 5/23/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 7/1/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Transplant Failure Other Serious 39 185 lb 7/2/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Transplant Failure Other Serious 39 185 lb 7/3/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Vomiting Hospitalization 5/27/2007 52 Male 7/16/2008 Japan
Primary
Concomitant
Supraventricular Extrasystoles Other Serious 11 Male 51 lb 4/8/2008 Other Health Professional China
Primary
Secondary
Concomitant
Mucosal Inflammation Death 6 40 lb 6/18/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Pyrexia Hospitalization 10/21/2008 Male 187 lb 11/7/2008 Physician Mexico
Primary
Secondary
Concomitant
Pyrexia Hospitalization 10/21/2008 Male 187 lb 11/14/2008 Physician Mexico
Primary
Secondary
Concomitant
Pneumonia Hospitalization 11/29/2008 Male 183 lb 12/12/2008 Physician Mexico
Primary
Secondary
Concomitant
Sinusitis Hospitalization 1/1/2007 60 Male 143 lb 12/16/2008 Physician Spain
Primary
Secondary
Concomitant
Sinusitis Hospitalization 1/1/2007 60 Male 143 lb 12/19/2008 Physician Spain
Primary
Secondary
Concomitant
Pneumonia Hospitalization 11/29/2008 Male 183 lb 12/19/2008 Physician Mexico
Primary
Secondary
Concomitant
Tachyarrhythmia Other Serious 57 Female 2/12/2009 Other Health Professional Germany
Primary
Concomitant
Aspartate Aminotransferase Increased Other Serious 1/15/2009 63 Female 143 lb 2/11/2009 United Kingdom
Primary
Concomitant
Renal Failure Other Serious 1/27/2009 59 Male 2/25/2009 Other Health Professional Spain
Primary
Concomitant
Mucosal Inflammation Other Serious 69 Male 3/10/2009 Italy
Primary
Secondary
Thrombocytopenia Other Serious 1/27/2009 60 Male 163 lb 3/18/2009 Physician Spain
Primary
Secondary
Concomitant
Mucosal Inflammation Other Serious 69 Male 3/20/2009 Other Health Professional Japan
Primary
Secondary
Staphylococcal Infection Other Serious 2/1/2009 59 Male 3/26/2009 Other Health Professional Spain
Primary
Concomitant
Multi-organ Failure Death 20 5/4/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Systemic Mycosis Death 17 5/7/2009 United Kingdom
Primary
Secondary
Concomitant
Drug Resistance Death 17 5/8/2009 United Kingdom
Primary
Secondary
Systemic Mycosis Death 17 5/12/2009 United Kingdom
Primary
Secondary
Concomitant
Pulmonary Oedema Death 17 5/7/2009 United Kingdom
Primary
Secondary
Concomitant
Systemic Mycosis Death 17 5/12/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Systemic Mycosis Death 17 6/4/2009 United Kingdom
Primary
Secondary
Concomitant
Systemic Mycosis Death 17 6/5/2009 United Kingdom
Primary
Secondary
Concomitant
Virus Serology Test Positive Death 4/17/2009 58 Female 97 lb 6/2/2009 Physician Japan
Primary
Concomitant
Systemic Mycosis Death 17 6/12/2009 United Kingdom
Primary
Secondary
Concomitant
Stem Cell Transplant 21 6/12/2009 United Kingdom
Primary
Secondary
Virus Serology Test Positive Death 4/17/2009 58 Female 97 lb 7/10/2009 Physician Japan
Primary
Concomitant
Graft Versus Host Disease Death 9/9/2008 Male 168 lb 9/9/2009 Physician United Kingdom
Primary
Concomitant
Renal Impairment Hospitalization 6/11/2008 22 Female 9/24/2009 Physician Japan
Primary
Secondary
Concomitant
Viral Infection Life Threatening 9/17/2008 70 Male 11/3/2009 Japan
Primary
Secondary
Concomitant
Neutrophil Count Decreased Other Serious 11/21/2008 77 Female 12/4/2009 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 59 Male 121 lb 12/31/2009 Physician Japan
Primary
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
Hepatic Function Abnormal Life Threatening 6/28/2009 Male 3/30/2010 Physician Japan
Primary
Concomitant
Respiratory Failure Hospitalization 12/16/2008 73 Male 117 lb 3/24/2010 Physician Japan
Primary
Concomitant
Tachycardia Life Threatening 3/3/2010 45 Female 240 lb 3/26/2010 Consumer United Kingdom
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 40 Female 4/2/2010 Physician Japan
Primary
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
Pyrexia Life Threatening 8/17/2009 59 Male 121 lb 4/2/2010 Physician Japan
Primary
Concomitant
Pancreatitis Acute Hospitalization 6/24/2009 15 Male 88 lb 5/3/2010 Other Health Professional Japan
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
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
Pyrexia Life Threatening 8/17/2009 59 Male 121 lb 6/8/2010 Physician 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
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
Pyrexia Other Serious 1/9/2009 58 Female 97 lb 7/28/2010 Physician Japan
Primary
Concomitant
Engraft Failure Hospitalization 9/2/2009 73 Female 126 lb 8/6/2010 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 3/11/2009 23 Female 97 lb 8/17/2010 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 3/11/2009 23 Female 97 lb 8/31/2010 Physician 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
Weight Increased Other Serious 1/17/2010 Male 168 lb 11/22/2010 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
Visual Impairment Other Serious 3/11/2009 48 Female 84 lb 11/8/2010 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
Pancytopenia Hospitalization 8/11/2010 77 Male 110 lb 12/29/2010 Physician Italy
Primary
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
Bacterial Infection Death 8/20/2009 46 Male 161 lb 1/3/2011 Other Health Professional Japan
Primary
Concomitant
Interstitial Lung Disease Death 10/23/2009 62 Male 130 lb 1/6/2011 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
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
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
Diarrhoea Hospitalization 3/15/2011 68 Male 128 lb 5/19/2011 Consumer United Kingdom
Primary
Secondary
Concomitant
Petechiae Other Serious 1/29/2010 49 Male 110 lb 5/20/2011 Physician Japan
Primary
Concomitant
Disease Progression Hospitalization 2/21/2011 58 Female 5/24/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Weight Increased Hospitalization 1/17/2010 55 Male 168 lb 6/7/2011 Physician Japan
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 2/28/2009 59 Male 141 lb 6/10/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Face Oedema Other Serious 6/27/2011 31 Male 146 lb 7/18/2011 Physician Spain
Primary
Concomitant
Escherichia Sepsis Death 2/24/2010 57 Female 119 lb 8/18/2011 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
Thrombocytopenia Other Serious 3/11/2009 23 Female 97 lb 9/29/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Death 1/1/2005 59 Male 126 lb 11/4/2011 Physician Japan
Primary
Secondary
Concomitant
Hepatomegaly Hospitalization 5/10/2010 56 Male 132 lb 11/22/2011 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
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
Renal Failure Disability 4/18/2008 70 Female 12/9/2011 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
Escherichia Sepsis Death 2/24/2010 57 Female 119 lb 12/15/2011 Physician Japan
Primary
Concomitant
Acute Myeloid Leukaemia Recurrent Other Serious 2/26/2010 56 Male 134 lb 12/19/2011 Physician Japan
Primary
Concomitant
Cytomegalovirus Chorioretinitis Hospitalization 8/24/2009 21 Male 104 lb 12/20/2011 Physician Japan
Primary
Concomitant
Cytomegalovirus Test Positive Other Serious 6/6/2011 72 Male 128 lb 12/20/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 3/17/2010 46 Male 159 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
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
Cytomegalovirus Test Positive Death 1/23/2010 66 Male 130 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
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
Venoocclusive Liver Disease Death 2/7/2009 57 Male 139 lb 2/7/2012 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
Acute Graft Versus Host Disease In Skin Other Serious 8/24/2009 21 Male 104 lb 2/22/2012 Physician Japan
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Other Serious 8/17/2011 48 Female 84 lb 2/24/2012 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease In Skin Death 3/6/2009 9 Male 49 lb 3/9/2012 Physician Japan
Primary
Concomitant
Idiopathic Thrombocytopenic Purpura Other Serious 6/8/2009 6 Male 33 lb 3/9/2012 Physician Japan
Primary
Concomitant
Hypomagnesaemia Hospitalization 1/17/2010 55 Male 168 lb 3/12/2012 Physician Japan
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection Hospitalization 1/2/2012 55 Female 125 lb 3/20/2012 Physician United Kingdom
Primary
Secondary
Concomitant
Skin Infection Other Serious 4/2/2011 27 Female 112 lb 4/9/2012 Physician Japan
Primary
Concomitant
Drug Interaction Other Serious 67 Male 110 lb 4/12/2012 Other Health Professional Japan
Primary
Secondary
Concomitant
Interacting
Acute Graft Versus Host Disease Other Serious 1/1/2010 36 Male 128 lb 4/19/2012 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Other Serious 9/9/2011 52 Female 110 lb 4/30/2012 Physician Japan
Primary
Concomitant
Neutropenia Other Serious 2/25/2011 2 Male 33 lb 5/21/2012 Physician Japan
Primary
Concomitant
Decreased Appetite Hospitalization 4/2/2011 27 Female 112 lb 5/30/2012 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Hospitalization 5/24/2010 Male 18 lb 6/7/2012 Physician Japan
Primary
Concomitant

Drug Data