Fludarabine combined with Tacrolimus

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Granulocytopenia Required Intervention 59 Male 5/11/2006 Other Health Professional United States
Primary
Concomitant
Streptococcal Infection Hospitalization 6/7/2006 Male 135 lb 6/8/2006 United States
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Other Serious 7/3/2006 Consumer United States
Primary
Secondary
Concomitant
Septic Shock Life Threatening 7/27/2006 51 Male 181 lb 8/16/2006 Physician United States
Primary
Concomitant
Sputum Culture Positive Life Threatening 10/19/2006 35 Female 294 lb 11/9/2006 Other Health Professional United States
Primary
Concomitant
Sputum Culture Positive Life Threatening 10/19/2006 35 Female 294 lb 12/6/2006 Other Health Professional United States
Primary
Concomitant
Tachypnoea Life Threatening 10/25/2006 63 Male 12/13/2006 Other Health Professional United States
Primary
Concomitant
Restlessness Life Threatening 10/25/2006 63 Male 1/18/2007 Physician United States
Primary
Concomitant
Viral Dna Test Positive Other Serious 7/11/2004 15 Male 73 lb 1/30/2007 Japan
Primary
Concomitant
Viral Dna Test Positive Other Serious 7/11/2004 15 Male 73 lb 2/8/2007 Japan
Primary
Concomitant
Viral Dna Test Positive Other Serious 7/11/2004 15 Male 73 lb 2/8/2007 Japan
Primary
Concomitant
Viral Myocarditis Other Serious 56 Male 2/22/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Ventricular Tachycardia Hospitalization 56 Male 2/26/2007
Primary
Secondary
Systemic Candida Other Serious 45 Female 3/5/2007 Japan
Primary
Concomitant
Urticaria Other Serious 1/23/2007 24 Female 106 lb 1/29/2007 Physician United States
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 15 Female 3/15/2007 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 15 Female 3/24/2007 Japan
Primary
Secondary
Concomitant
Encephalitis Herpes Other Serious 58 Female 4/27/2007 Physician United States
Primary
Concomitant
Viral Dna Test Positive Other Serious 7/11/2004 15 Male 73 lb 6/22/2007 Japan
Primary
Secondary
Concomitant
Pancreatitis Other Serious 5/30/2007 Female 31 lb 9/17/2007 Pharmacist
Primary
Concomitant
Renal Failure Other Serious 2/22/2008 Other Health Professional United States
Primary
Secondary
Multi-organ Failure Other Serious 7 Male 2/26/2008 United States
Primary
Secondary
Concomitant
Multi-organ Failure Other Serious 4 Female 2/26/2008 United States
Primary
Secondary
Concomitant
Renal Disorder Other Serious 2/29/2008 Other Health Professional United States
Primary
Secondary
Nocardiosis Other Serious Female 3/13/2008 Physician United States
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Other Serious Male 3/27/2008 Other Health Professional Germany
Primary
Secondary
Progressive Multifocal Leukoencephalopathy Other Serious Male 3/31/2008 Other Health Professional Germany
Primary
Secondary
Drug Toxicity Death 4/1/2008 United States
Primary
Secondary
Concomitant
Therapeutic Agent Toxicity Death 4/2/2008 Germany
Primary
Secondary
Multi-organ Failure Other Serious 4/2/2008 United States
Primary
Secondary
Concomitant
Progressive Multifocal Leukoencephalopathy Death Male 4/2/2008 Germany
Primary
Secondary
Venoocclusive Liver Disease Other Serious 4/7/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Death 4/16/2008 United States
Primary
Secondary
Concomitant
Therapeutic Agent Toxicity Other Serious 5/16/2008 United States
Primary
Secondary
Concomitant
Weight Increased Other Serious 5/29/2008 Female 114 lb 8/13/2008 Other Health Professional Brazil
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 8/15/2008 Germany
Primary
Secondary
Concomitant
Stomatitis Other Serious 8/20/2008 Japan
Primary
Secondary
Concomitant
Stomatitis Other Serious 8/21/2008 Japan
Primary
Secondary
Concomitant
Myelodysplastic Syndrome Other Serious 1/18/2008 66 Male 172 lb 8/28/2008 Physician United States
Primary
Secondary
Concomitant
Pneumonitis Other Serious 8/29/2008 United States
Primary
Concomitant
Staphylococcal Sepsis Other Serious 5 Male 10/28/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Influenza Other Serious 3/1/2007 39 Male 1/23/2009 Other Health Professional Japan
Primary
Concomitant
Transplant Rejection Other Serious 1/1/2007 30 Female 9/28/2009
Primary
Secondary
Concomitant
Cholelithiasis Hospitalization 12/25/2007 30 Male 145 lb 10/12/2009 Physician Japan
Primary
Secondary
Concomitant
Subarachnoid Haemorrhage Other Serious 38 Female 10/15/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Weight Increased Other Serious 44 Female 10/20/2009 Other Health Professional Japan
Primary
Concomitant
Post Transplant Distal Limb Syndrome Other Serious 10 10/21/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Other Serious 9/23/2009 Male 255 lb 10/28/2009 United States
Primary
Secondary
Concomitant
Post Transplant Distal Limb Syndrome Other Serious 10 Male 11/2/2009 Physician Japan
Primary
Secondary
Concomitant
Syncope Other Serious 9/18/2009 56 Male 11/24/2009 United States
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 9/23/2009 Male 255 lb 12/2/2009 United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 9/23/2009 Male 255 lb 12/2/2009 United States
Primary
Secondary
Concomitant
Syncope Other Serious 9/18/2009 56 Male 12/4/2009 United States
Primary
Concomitant
Septic Shock Life Threatening 4/6/2009 Male 12/3/2009 Physician Germany
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Intestine Hospitalization 7/25/2009 32 Male 12/1/2009 Other Health Professional Spain
Primary
Concomitant
Haemorrhage Intracranial Death 2/5/2010 United States
Primary
Secondary
White Blood Cell Count Increased Other Serious 12/1/2008 50 Male 2/10/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Haemorrhage Intracranial Death 2/12/2010 United States
Primary
Secondary
Hypersensitivity Hospitalization 1/24/2010 Male 200 lb 2/12/2010 Other Health Professional United States
Primary
Concomitant
Therapeutic Response Decreased Other Serious 64 Female 2/24/2010 Other Health Professional Sweden
Primary
Secondary
Concomitant
Pulmonary Alveolar Haemorrhage Death 3/4/2010 United States
Primary
Secondary
Concomitant
Pulmonary Alveolar Haemorrhage Death 3/8/2010 United States
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 12/1/2008 50 Male 3/14/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Diabetes Mellitus Other Serious 61 Male 3/18/2010 Other Health Professional Belgium
Primary
Secondary
Concomitant
Overdose Other Serious 52 Female 3/19/2010 Other Health Professional United States
Primary
Concomitant
T-lymphocyte Count Decreased Other Serious 1 Female 4/23/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 50 Male 4/23/2010 Australia
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 50 Male 4/26/2010 Australia
Primary
Secondary
Concomitant
Pseudomonas Infection Other Serious 1 Female 4/30/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Respiratory Syncytial Virus Infection Other Serious 44 Female 5/28/2010 United States
Primary
Secondary
Concomitant
Serum Sickness Other Serious 63 Female 6/1/2010 United States
Primary
Secondary
Concomitant
Stem Cell Transplant Hospitalization 5/12/2010 64 Male 5/25/2010 Other Health Professional Canada
Primary
Concomitant
Septic Shock Other Serious 50 Female 6/4/2010 United States
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Other Serious 50 Male 6/4/2010 United States
Primary
Secondary
Concomitant
Viral Upper Respiratory Tract Infection Other Serious 31 Female 6/4/2010 United States
Primary
Secondary
Concomitant
Pneumothorax Other Serious 3/24/2010 56 Male 190 lb 6/4/2010 Physician United States
Primary
Secondary
Concomitant
Pneumothorax Other Serious 3/23/2010 56 Male 190 lb 6/7/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Serum Sickness Other Serious 63 Female 6/8/2010 United States
Primary
Secondary
Concomitant
Respiratory Syncytial Virus Infection Other Serious 44 Female 6/8/2010 United States
Primary
Secondary
Concomitant
Viral Upper Respiratory Tract Infection Other Serious 31 Female 6/8/2010 United States
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Other Serious 50 Male 6/8/2010 United States
Primary
Secondary
Concomitant
Septic Shock Other Serious 50 Female 6/8/2010 United States
Primary
Secondary
Concomitant
Renal Failure Other Serious 8/19/2009 63 Male 188 lb 4/16/2010 Other Health Professional United States
Primary
Concomitant
Sepsis Other Serious 6/9/2010 United States
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 4/1/2010 38 Female 6/15/2010 Other Health Professional United States
Primary
Concomitant
Thrombocytopenia Other Serious 4/1/2010 38 Female 6/16/2010 Other Health Professional United States
Primary
Concomitant
Venoocclusive Disease Other Serious 5/13/2010 31 Female 176 lb 6/16/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 5/13/2010 31 Female 6/17/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Varicella Virus Test Positive Other Serious 9 Male 6/23/2010 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Syncope Other Serious 6/9/2010 61 Female 185 lb 7/7/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 1/23/2010 67 Male 130 lb 8/19/2010 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Skin Infection Other Serious 9 Male 8/20/2010 Other Health Professional Netherlands
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 1/23/2010 67 Male 130 lb 8/24/2010 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Disease Hospitalization 4/30/2010 31 Female 9/8/2010 Other Health Professional United States
Primary
Concomitant
Venoocclusive Disease Other Serious 4/30/2010 31 Female 176 lb 9/9/2010 Other Health Professional United States
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 70 Male 9/20/2010 Physician Japan
Primary
Concomitant
Multi-organ Failure Hospitalization 6/24/2009 15 Male 126 lb 9/23/2010 Physician Japan
Primary
Concomitant
Venoocclusive Disease Other Serious 9/24/2010 Physician United States
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 70 Male 10/4/2010 Physician Japan
Primary
Concomitant
Pneumothorax Other Serious 3/23/2010 56 Male 190 lb 10/6/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Pneumothorax Other Serious 3/23/2010 56 Male 190 lb 10/6/2010 Physician United States
Primary
Secondary
Concomitant
Febrile Neutropenia Other Serious 10/23/2009 41 Male 132 lb 11/3/2010 Physician Japan
Primary
Concomitant
Multi-organ Failure Hospitalization 6/24/2009 15 Male 126 lb 11/23/2010 Physician Japan
Primary
Concomitant
Weight Decreased Other Serious 64 Male 12/26/2010 Physician United States
Primary
Concomitant
Pyrexia Other Serious 26 Male 1/27/2011 Physician Germany
Primary
Secondary
Concomitant
Pleural Effusion Death 5 Male 3/18/2011 Other Health Professional Japan
Primary
Secondary
Skin Erosion Death 12 Male 3/23/2011 Physician Japan
Primary
Secondary
Concomitant
Skin Erosion Death 12 Male 3/23/2011 Physician Japan
Primary
Secondary
Concomitant
Cardio-respiratory Arrest Death 12 Male 3/23/2011 Physician Japan
Primary
Secondary
Concomitant
Cardio-respiratory Arrest Death 12 Male 3/23/2011 Physician Japan
Primary
Secondary
Concomitant
Ileus Paralytic Death 12 Male 3/23/2011 Physician Japan
Primary
Secondary
Concomitant
Graft Versus Host Disease Other Serious 16 Female 3/30/2011 Other Health Professional Japan
Primary
Concomitant
Skin Erosion Death Male 4/1/2011 Other Health Professional Japan
Primary
Secondary
Precursor T-lymphoblastic Lymphoma/leukaemia Death 11 Male 4/26/2011 Other Health Professional Japan
Primary
Secondary
Enterococcal Bacteraemia Hospitalization 12/1/2011 65 Female 260 lb 2/7/2012 Physician United States
Primary
Concomitant
Pyrexia Life Threatening 5/12/2011 6 Female 31 lb 9/28/2012 Physician Jp
Primary
Concomitant
Viral Infection Death 4/1/2009 7 Female 9/5/2012 Physician Jp
Primary
Concomitant
Death Death 8/28/2012 Physician Us
Primary
Secondary
Concomitant
Death Death 8/28/2012 Physician Us
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 8/28/2012 Physician Us
Primary
Secondary
Concomitant
Death Death 8/28/2012 Physician Us
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 8/30/2012 Physician Us
Primary
Secondary
Concomitant
Encephalitis Cytomegalovirus Other Serious 11 Female 9/4/2012 Other Health Professional Country Not Specified
Primary
Secondary
Concomitant
Rash Death 8/8/2012 Male 177 lb Us
Primary
Secondary
Vomiting Other Serious 7 Female 9/27/2012 Other Health Professional Gb
Primary
Secondary
Concomitant
Venoocclusive Disease Death 9/2012 Female 10/2/2012 Other Health Professional Kr
Primary
Concomitant
Cystitis Haemorrhagic Other Serious 54 Female 11/18/2012 Physician Jp
Primary
Secondary
Concomitant
Viral Infection Other Serious 11/28/2012 Physician Country Not Specified
Primary
Secondary
Concomitant
Bacteraemia Other Serious 12/10/2012 Country Not Specified
Primary
Secondary
Concomitant
Bacteraemia Other Serious 12/11/2012 Country Not Specified
Primary
Secondary
Concomitant
Bacteraemia Other Serious 12/11/2012 Country Not Specified
Primary
Secondary
Concomitant
Bacteraemia Other Serious 12/11/2012 Country Not Specified
Primary
Secondary
Concomitant
Bacteraemia Other Serious 12/11/2012 Country Not Specified
Primary
Secondary
Concomitant
Pneumonia Death 12/11/2012 Country Not Specified
Primary
Secondary
Concomitant
Pneumonia Death 12/11/2012 Country Not Specified
Primary
Secondary
Concomitant
Microangiopathy Life Threatening 12/5/2012 NotSpecified 2/11/2013 Physician Es
Primary
Secondary
Concomitant
Recurrent Cancer Death 12/27/2012 Us
Primary
Concomitant
Graft Versus Host Disease Other Serious 54 Male 1/23/2013 Other Health Professional Country Not Specified
Primary
Secondary
Graft Versus Host Disease Other Serious 67 Male 1/23/2013 Other Health Professional Country Not Specified
Primary
Secondary
Renal Failure Acute Other Serious 54 Female 1/25/2013 Other Health Professional Us
Primary
Secondary
Concomitant
Sudden Death Death NotSpecified 4/9/2013 Physician De
Primary
Secondary
Infection Death NotSpecified 4/9/2013 Physician De
Primary
Secondary
Toxicity To Various Agents Death NotSpecified 4/9/2013 Physician De
Primary
Secondary
Infection Death NotSpecified 4/9/2013 Physician De
Primary
Secondary
Infection Death NotSpecified 4/10/2013 Physician De
Primary
Secondary
Zygomycosis Death 62 Female 4/15/2013 Physician Jp
Primary
Concomitant
Suicidal Ideation Hospitalization 40 Male 5/1/2013 Physician Kr
Primary
Concomitant
Renal Impairment Other Serious 61 Female 5/16/2013 Other Health Professional Country Not Specified
Primary
Secondary
Concomitant
Drug Ineffective Death 62 Female 6/19/2013 Other Health Professional Jp
Primary
Concomitant
Wheezing Disability NotSpecified 5/29/2013 Physician Gb
Primary
Secondary

Drug Data