Busulfan combined with Prednisolone

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Visual Field Defect Other Serious 1/1/2005 49 Female 3/14/2006 Japan
Primary
Secondary
Concomitant
Visual Field Defect Other Serious 1/1/2005 49 Female 4/11/2006 Japan
Primary
Secondary
Concomitant
Viral Dna Test Positive Other Serious 1/1/2006 64 Female 10/17/2006 Japan
Primary
Concomitant
Viral Dna Test Positive Other Serious 1/1/2006 64 Female 11/1/2006 Japan
Primary
Concomitant
Thrombophlebitis Other Serious 1/1/2003 34 Female 11/21/2006 Japan
Primary
Concomitant
Weight Increased Hospitalization 56 Female 12/9/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombophlebitis Other Serious 1/1/2003 34 Female 1/5/2007 Japan
Primary
Secondary
Concomitant
Streptococcal Infection Other Serious 9/7/2005 5 Male 55 lb 12/29/2006 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 12/1/2004 49 Male 2/8/2007 Japan
Primary
Concomitant
Weight Decreased Other Serious 12/1/2004 49 Male 2/10/2007 Japan
Primary
Concomitant
Graft Versus Host Disease Other Serious 15 Male 5/29/2007 Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Other Serious 9 Female 5/29/2007 Japan
Primary
Secondary
Concomitant
Pain In Extremity Other Serious 9 Female 6/7/2007 Japan
Primary
Secondary
Concomitant
Pain In Extremity Other Serious 15 Male 6/7/2007 Japan
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 2/1/2005 15 Male 7/6/2007 Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 4/1/2005 9 Female 7/6/2007 Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 4/1/2005 9 Female 7/6/2007 Japan
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 2/1/2005 15 Male 7/6/2007 Japan
Primary
Secondary
Concomitant
Mental Status Changes Hospitalization 7/28/2007 Male 9/28/2007 Physician United States
Primary
Secondary
Concomitant
Renal Tubular Necrosis Other Serious 53 Male 12/6/2007 Other Health Professional Portugal
Primary
Secondary
Renal Tubular Necrosis Other Serious 53 Male 12/12/2007 Other Health Professional Portugal
Primary
Secondary
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
Progressive Multifocal Leukoencephalopathy Death Male 4/2/2008 Germany
Primary
Secondary
Venoocclusive Liver Disease Other Serious 4/4/2008 Physician Germany
Primary
Concomitant
Vertigo Death Male 5/2/2008 Germany
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Hospitalization 1/1/2004 Male 5/15/2008 Other Health Professional Germany
Primary
Secondary
Cytomegalovirus Colitis Other Serious 56 Male 6/6/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Psychotic Disorder Hospitalization 37 Male 6/20/2008 Korea, Republic Of
Primary
Concomitant
Sepsis Other Serious 8/1/2005 31 Male 1/18/2008 Other Health Professional Japan
Primary
Concomitant
Visual Acuity Reduced Other Serious 32 Female 11/17/2008 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Visual Acuity Reduced Other Serious 25 Female 11/18/2008 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Transplant Failure Other Serious 2 Female 12/17/2008 Other Health Professional United Kingdom
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 54 Male 1/15/2009 Physician Japan
Primary
Secondary
Thrombotic Microangiopathy Other Serious 11/1/2007 54 Male 1/20/2009 Physician Japan
Primary
Secondary
Thrombotic Microangiopathy Other Serious 11/17/2007 54 Male 2/2/2009 Physician Japan
Primary
Secondary
Concomitant
Respiratory Disorder Other Serious 8 Male 2/6/2009 Consumer Japan
Primary
Secondary
Concomitant
Respiratory Disorder Other Serious 8 Male 2/16/2009 Consumer Japan
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 38 Female 3/23/2009 Other Health Professional Tunisia
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection Other Serious 16 Male 4/2/2009 Other Health Professional United Kingdom
Primary
Concomitant
Respiratory Failure Hospitalization 38 Female 4/7/2009 Other Health Professional Tunisia
Primary
Secondary
Concomitant
Respiratory Distress Other Serious 58 Male 4/20/2009 Japan
Primary
Secondary
Concomitant
Venoocclusive Disease Death 1 4/21/2009 United Kingdom
Primary
Secondary
Respiratory Distress Other Serious 58 Male 5/4/2009 Japan
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection Other Serious 16 5/8/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection Other Serious 16 5/11/2009 United Kingdom
Primary
Secondary
Upper Respiratory Tract Infection Other Serious 16 5/11/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection Other Serious 16 5/13/2009 Other Health Professional United Kingdom
Primary
Secondary
Tremor Other Serious 16 5/18/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection Other Serious 16 5/15/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Monocytosis Other Serious 12 Female 68 lb 6/12/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Monocytosis Other Serious 12 Female 68 lb 6/19/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Intracranial Venous Sinus Thrombosis Other Serious 8/1/2008 42 Female 7/9/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 7/1/2008 Female 93 lb 7/22/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection Other Serious 16 8/10/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Electrolyte Imbalance Hospitalization 3/15/2008 Female 10/2/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Electrolyte Imbalance Hospitalization 3/15/2008 Female 11/5/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Other Serious 59 Female 11/23/2009 Other Health Professional Sweden
Primary
Secondary
Concomitant
Anaemia Haemolytic Autoimmune Other Serious 10 Male 8/2/2010 Physician United States
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Hospitalization 1/23/2010 66 Male 130 lb 8/13/2010 Consumer Japan
Primary
Concomitant
Herpes Zoster Other Serious 10/30/2009 31 Male 128 lb 8/16/2010 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 1/23/2010 67 Male 130 lb 8/19/2010 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 1/23/2010 67 Male 130 lb 8/24/2010 Physician Japan
Primary
Secondary
Concomitant
Herpes Zoster Other Serious 10/30/2009 31 Male 8/24/2010 Physician Japan
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 21 Female 9/16/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 5/11/2009 70 Female 86 lb 10/15/2010 Physician Japan
Primary
Concomitant
Herpes Zoster Other Serious 10/30/2009 31 Male 128 lb 10/20/2010 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 20 Female 11/9/2010 Other Health Professional Japan
Primary
Concomitant
Thyroid Disorder Other Serious 7/17/2009 28 Male 110 lb 11/23/2010 Physician Japan
Primary
Concomitant
Staphylococcal Bacteraemia Other Serious 8/3/2009 62 Female 110 lb 11/24/2010 Physician Japan
Primary
Secondary
Concomitant
Cytomegalovirus Infection Other Serious 7/17/2009 28 Male 110 lb 11/24/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 18 Female 12/27/2010 Other Health Professional Japan
Primary
Concomitant
Bacterial Infection Death 8/20/2009 46 Male 161 lb 1/3/2011 Other Health Professional Japan
Primary
Concomitant
Staphylococcal Infection Death 4/14/2010 60 Male 110 lb 1/20/2011 Physician Japan
Primary
Concomitant
Bronchopulmonary Aspergillosis Other Serious 12/1/2008 64 Female 1/28/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 12/1/2008 64 Female 2/8/2011 Physician Japan
Primary
Concomitant
Dehydration Other Serious 10/1/2010 47 Male 2/11/2011 Other Health Professional Canada
Primary
Concomitant
Chronic Graft Versus Host Disease Other Serious 7 3/1/2011 Other Health Professional Poland
Primary
Concomitant
Chronic Graft Versus Host Disease Death 20 Female 3/2/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Histiocytosis Haematophagic Death 1/1/2009 48 Male 3/22/2011 Other Health Professional Japan
Primary
Concomitant
Hyperbilirubinaemia Hospitalization 10/4/2010 47 Male 295 lb 3/24/2011 Other Health Professional Canada
Primary
Concomitant
Stem Cell Transplant Death 9/8/2009 64 Male 217 lb 3/17/2011 Physician United States
Primary
Concomitant
Bronchiectasis Hospitalization 35 Male 3/30/2011 Other Health Professional Japan
Primary
Concomitant
Delirium Other Serious 6/16/2010 53 Male 154 lb 4/8/2011 Physician Japan
Primary
Concomitant
Engraftment Syndrome Other Serious 1/3/2010 20 Male 4/20/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Hyperbilirubinaemia Hospitalization 10/4/2010 47 Male 295 lb 4/21/2011 Other Health Professional Canada
Primary
Concomitant
Cytomegalovirus Viraemia Hospitalization 4/28/2010 56 Male 139 lb 5/5/2011 Physician Japan
Primary
Concomitant
Pneumonia Life Threatening 4/28/2010 56 Male 139 lb 5/23/2011 Physician Japan
Primary
Concomitant
Bk Virus Infection Other Serious 10/4/2010 47 Male 295 lb 5/25/2011 Other Health Professional Canada
Primary
Concomitant
Extradural Haematoma Death 63 Male 5/26/2011 Physician Germany
Primary
Secondary
Delirium Other Serious 10 Male 6/8/2011 Other Health Professional Thailand
Primary
Concomitant
Escherichia Infection Other Serious 54 Female 6/15/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Pseudomonal Sepsis Death 1/1/2005 6 Male 6/17/2011 Consumer United Kingdom
Primary
Concomitant
Fungal Infection Death 1/1/2008 5 Male 6/17/2011 Consumer United Kingdom
Primary
Concomitant
Escherichia Sepsis Other Serious 54 Female 6/22/2011 Physician Japan
Primary
Concomitant
Cytomegalovirus Infection Other Serious 54 Female 6/27/2011 Other Health Professional Japan
Primary
Concomitant
Anaemia Haemolytic Autoimmune Other Serious 54 Female 6/27/2011 Other Health Professional Japan
Primary
Concomitant
Blood Creatinine Increased Hospitalization 9/22/2007 Male 19 lb 6/28/2011 Physician Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 10/4/2010 47 Male 295 lb 6/29/2011 Other Health Professional Canada
Primary
Concomitant
Encephalitis Viral Other Serious 4/15/2008 7 Female 50 lb 7/1/2011 Physician Japan
Primary
Secondary
Concomitant
Respiratory Failure Death 10/4/2010 47 Male 295 lb 7/1/2011 Other Health Professional Canada
Primary
Concomitant
Hypertension Life Threatening 4/22/2010 13 Male 90 lb 7/5/2011 Physician Japan
Primary
Concomitant
Lung Disorder Life Threatening 4/28/2010 56 Male 139 lb 7/8/2011 Physician Japan
Primary
Concomitant
Gastrointestinal Disorder Other Serious 1 Female 6/23/2011 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Extradural Haematoma Hospitalization 63 Male 7/27/2011 Other Health Professional Germany
Primary
Secondary
Chronic Graft Versus Host Disease Other Serious 20 Female 8/8/2011 Physician Japan
Primary
Secondary
Concomitant
Graft Versus Host Disease Disability 4/20/2011 58 Male 119 lb 8/11/2011 Physician Japan
Primary
Concomitant
Febrile Neutropenia Hospitalization 9/14/2010 49 Female 115 lb 8/25/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease In Skin Life Threatening 10/21/2009 22 Female 104 lb 9/26/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 10/21/2009 22 Female 104 lb 9/26/2011 Physician Japan
Primary
Secondary
Concomitant
Hypertension Other Serious 6/12/2010 53 Male 154 lb 10/5/2011 Physician Japan
Primary
Concomitant
Cystitis Haemorrhagic Other Serious 1/19/2010 48 Male 146 lb 10/6/2011 Physician Japan
Primary
Concomitant
Pseudomonal Sepsis Other Serious 10/21/2009 22 Female 104 lb 10/11/2011 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 3/24/2011 74 Female 101 lb 10/28/2011 Physician Japan
Primary
Concomitant
Chronic Graft Versus Host Disease Other Serious 7 12/5/2011 Other Health Professional Poland
Primary
Concomitant
Hypoalbuminaemia Other Serious 5/24/2011 50 Male 128 lb 12/7/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Death 19 Male 12/9/2011 Physician Japan
Primary
Concomitant
Acute Myeloid Leukaemia Death 10/19/2011 55 Female 115 lb 12/13/2011 Consumer Germany
Primary
Secondary
Concomitant
Cytomegalovirus Viraemia Other Serious 7 Female 12/13/2011 Physician Japan
Primary
Concomitant
Febrile Neutropenia Hospitalization 9/14/2010 49 Female 115 lb 12/14/2011 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
Non-hodgkin's Lymphoma Recurrent Death 4/20/2011 58 Male 119 lb 12/30/2011 Physician Japan
Primary
Concomitant
Graft Versus Host Disease In Skin Other Serious 4/22/2010 13 Male 90 lb 1/9/2012 Physician Japan
Primary
Concomitant
Hepatitis B Hospitalization 47 Female 1/6/2012 Other Health Professional France
Primary
Concomitant
Pseudomonal Sepsis Death 10/21/2009 22 Female 104 lb 2/21/2012 Physician Japan
Primary
Secondary
Concomitant
Dysphagia Disability 3/23/2009 62 Female 2/27/2012 Other Health Professional France
Primary
Secondary
Concomitant
Convulsion Life Threatening 5/22/2011 6 Male 40 lb 3/12/2012 Physician Japan
Primary
Concomitant
Nausea Other Serious 6/12/2010 53 Male 154 lb 3/15/2012 Physician Japan
Primary
Concomitant
Lethargy Hospitalization 55 Male 3/21/2012 Other Health Professional United Kingdom
Primary
Concomitant
Graft Versus Host Disease In Skin Death 4/20/2010 13 Male 90 lb 3/26/2012 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 15 Male 3/28/2012 Physician Japan
Primary
Concomitant
Chromosome Analysis Abnormal Other Serious 36 Male 4/2/2012 Other Health Professional
Primary
Secondary
Diarrhoea Disability 8/18/2011 64 Male 99 lb 4/3/2012 Physician Japan
Primary
Concomitant
Neurological Decompensation Death 5/1/2010 45 Male 4/13/2012 Other Health Professional Spain
Primary
Secondary
Concomitant
Pyrexia Other Serious 9/14/2010 49 Female 115 lb 4/20/2012 Physician Japan
Primary
Concomitant
Chronic Graft Versus Host Disease Hospitalization 6 Male 5/1/2012 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 19 Female 5/14/2012 Physician Japan
Primary
Concomitant
Post Transplant Distal Limb Syndrome Life Threatening 51 Male 5/11/2012 Physician Japan
Primary
Concomitant
Anaphylactic Reaction Other Serious 2/1/2012 5/29/2012 Physician Germany
Primary
Secondary
Concomitant
Dry Eye Other Serious 6/12/2010 53 Male 154 lb 5/30/2012 Physician Japan
Primary
Concomitant
Graft Versus Host Disease In Skin Death 4/20/2010 13 Male 90 lb 6/1/2012 Physician Japan
Primary
Secondary
Concomitant
T-lymphocyte Count Decreased Other Serious 2/9/2012 6/4/2012 Physician Germany
Primary
Secondary
Concomitant
Hepatitis B Other Serious 47 Female 6/22/2012 Other Health Professional Italy
Primary
Secondary
Helicobacter Sepsis Other Serious 9/14/2010 49 Female 115 lb 7/10/2012 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 15 Male 7/25/2012 Physician Japan
Primary
Concomitant
Viral Haemorrhagic Cystitis Hospitalization 6 Male 9/19/2012 Physician Jp
Primary
Concomitant
Post Transplant Lymphoproliferative Disorder Death 1/12/2007 49 Male 187 lb 11/2/2012 Other Health Professional Es
Primary
Concomitant
Stenotrophomonas Infection Other Serious 11/27/2012 Physician No
Primary
Secondary

Drug Data