Busulfan combined with Tacrolimus

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
White Blood Cell Count Decreased Other Serious 20 Male 4/3/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 3/19/2006 Male 141 lb 4/11/2006 United States
Primary
Secondary
Granulocytopenia Required Intervention 59 Male 5/11/2006 Other Health Professional United States
Primary
Concomitant
Septic Shock Life Threatening 7/27/2006 51 Male 181 lb 8/16/2006 Physician United States
Primary
Concomitant
Stem Cell Transplant Hospitalization 8/25/2006 Male 138 lb 9/7/2006 United States
Primary
Secondary
Skin Exfoliation Other Serious 31 Female 10/31/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Pulmonary Fibrosis Hospitalization 8/25/2006 Male 138 lb 11/15/2006 United States
Primary
Secondary
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
Chronic Graft Versus Host Disease Other Serious 48 Male 3/3/2007 Japan
Primary
Concomitant
Weight Decreased Other Serious 48 Male 3/10/2007 Japan
Primary
Secondary
Concomitant
Ureteric Stenosis Other Serious 35 Male 3/14/2007 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 15 Female 3/15/2007 Japan
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 57 Male 3/20/2007 Consumer United States
Primary
Secondary
White Blood Cell Count Decreased Other Serious 15 Female 3/24/2007 Japan
Primary
Secondary
Concomitant
Ureteric Stenosis Other Serious 35 Male 3/28/2007 Japan
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 52 Male 4/4/2007 Other Health Professional United States
Primary
Secondary
Transfusion-transmitted Infectious Disease Required Intervention 5/10/2007 Female 161 lb 5/17/2007 Physician United States
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 10 Male 7/6/2007 Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 10 Male 7/6/2007 Japan
Primary
Secondary
Concomitant
Epstein-barr Virus Infection Hospitalization 5/2/2006 62 Male 218 lb 1/15/2007 Other Health Professional United States
Primary
Concomitant
Subdural Haemorrhage Life Threatening 6/24/2006 51 Female 124 lb 1/15/2007 United States
Primary
Concomitant
Cystitis Hospitalization 8/27/2006 44 Female 173 lb 1/15/2007 Other Health Professional United States
Primary
Concomitant
Stem Cell Transplant Hospitalization 7/28/2007 Male 9/20/2007 Physician United States
Primary
Secondary
Concomitant
Mental Status Changes Hospitalization 7/28/2007 Male 9/28/2007 Physician United States
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 1/1/2005 60 Male 10/16/2007 Physician Japan
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 1/1/2005 60 Male 11/5/2007 Japan
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 1/1/2005 60 Male 11/5/2007 Physician Japan
Primary
Secondary
Concomitant
Multi-organ Failure Other Serious 4 Female 2/26/2008 United States
Primary
Secondary
Concomitant
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
Progressive Multifocal Leukoencephalopathy Death Male 4/2/2008 Germany
Primary
Secondary
Venoocclusive Liver Disease Death 4/16/2008 United States
Primary
Secondary
Concomitant
Therapeutic Agent Toxicity Other Serious 5/12/2008 United States
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious Male 5/13/2008 Other Health Professional United States
Primary
Secondary
Vertigo Death Male 5/2/2008 Germany
Primary
Concomitant
Therapeutic Agent Toxicity Other Serious 5/16/2008 United States
Primary
Secondary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 4/25/2007 Physician United States
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 49 Male 5/19/2008 Other Health Professional United States
Primary
Secondary
Venoocclusive Liver Disease Other Serious 23 Male 5/20/2008 Other Health Professional United States
Primary
Secondary
Thrombotic Microangiopathy Other Serious 5/22/2008 Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 6/6/2008 United States
Primary
Secondary
Concomitant
Renal Impairment Other Serious 6/9/2008 United States
Primary
Secondary
Concomitant
Pulmonary Toxicity Other Serious 6/12/2008 United States
Primary
Secondary
Concomitant
Drug Rash With Eosinophilia And Systemic Symptoms Other Serious 9 Female 6/13/2008 Germany
Primary
Secondary
Pancytopenia Hospitalization 9 Female 6/25/2008 Other Health Professional Germany
Primary
Concomitant
Vomiting Hospitalization 23 Male 7/3/2008
Primary
Secondary
Concomitant
Subdural Haematoma Other Serious 7/17/2008 United States
Primary
Secondary
Concomitant
Therapeutic Agent Toxicity Death 8/7/2008 Germany
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 8/15/2008 Germany
Primary
Secondary
Concomitant
Myelodysplastic Syndrome Other Serious 1/18/2008 66 Male 172 lb 8/28/2008 Physician United States
Primary
Secondary
Concomitant
Hepatitis Hospitalization Female 9/12/2008 Other Health Professional
Primary
Concomitant
Staphylococcal Sepsis Other Serious 5 Male 10/1/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Streptococcal Sepsis Other Serious 12/19/2001 5 Male 10/1/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Other Serious 5 Male 10/28/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Transplant Failure Hospitalization 10/30/2008 Male 249 lb 11/5/2008 United States
Primary
Secondary
Visual Acuity Reduced Other Serious 36 Female 11/17/2008 Other Health Professional Korea, Republic Of
Primary
Secondary
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
Hypertrophic Cardiomyopathy Other Serious 0 Male 11/19/2008 Japan
Primary
Concomitant
Hypertrophic Cardiomyopathy Other Serious 0 Male 12/1/2008 Japan
Primary
Concomitant
Venoocclusive Liver Disease Hospitalization 3/31/2002 26 Female 123 lb 12/10/2008 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Infection Required Intervention 6/5/2008 63 Female 256 lb 12/26/2008 Physician United States
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 54 Male 1/15/2009 Physician Japan
Primary
Secondary
Ascites Other Serious 4/1/2009 Consumer United States
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 4/1/2009 Consumer United States
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection Other Serious 16 Male 4/2/2009 Other Health Professional United Kingdom
Primary
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 5/11/2009 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
Sepsis Other Serious 1/30/2009 40 Male 110 lb 5/14/2009 Japan
Primary
Concomitant
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
Non-hodgkin's Lymphoma Recurrent Other Serious 5/26/2009 Physician United Kingdom
Primary
Secondary
Upper Respiratory Tract Infection Other Serious 16 6/12/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Pain Other Serious 7 Male 6/12/2009 Canada
Primary
Concomitant
Polyomavirus-associated Nephropathy Hospitalization 50 Male 6/15/2009 Other Health Professional United States
Primary
Secondary
Sudden Death Other Serious 7/6/2009 Other Health Professional United States
Primary
Concomitant
Upper Respiratory Tract Infection Other Serious 16 8/10/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Tenderness Other Serious 63 Male 8/13/2009 Physician United States
Primary
Secondary
Viral Haemorrhagic Cystitis Other Serious 6/27/2008 44 Male 148 lb 8/17/2009 Physician Japan
Primary
Concomitant
Sepsis Other Serious 1/30/2009 40 Male 110 lb 8/27/2009 Japan
Primary
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
Transplant Rejection Other Serious 1/1/2007 30 Female 9/28/2009
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Death 12/1/2009 Other Health Professional Japan
Primary
Concomitant
Haemorrhage Intracranial Death 2/5/2010 United States
Primary
Secondary
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
Staphylococcus Test Positive 6/6/2010 67 Female 203 lb 7/2/2010 United States
Primary
Secondary
Pyrexia Hospitalization 3/12/2010 59 Male 132 lb 7/16/2010 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 3/12/2010 59 Male 132 lb 7/19/2010 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Disease Hospitalization 4/30/2010 31 Female 7/19/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 4/30/2010 31 Female 176 lb 7/21/2010 Other Health Professional United States
Primary
Concomitant
Venoocclusive Disease Hospitalization 4/30/2010 31 Female 7/21/2010 Other Health Professional United States
Primary
Concomitant
Pyrexia Other Serious 3/12/2010 59 Male 7/21/2010 Physician Japan
Primary
Secondary
Concomitant
Graft Versus Host Disease Other Serious 7/23/2010 Other Health Professional United States
Primary
Concomitant
Graft Versus Host Disease Death 7/23/2010 Other Health Professional United States
Primary
Concomitant
Neurotoxicity Death 7/23/2010 Other Health Professional United States
Primary
Concomitant
Neurotoxicity Death 7/23/2010 Other Health Professional United States
Primary
Concomitant
Venoocclusive Disease Other Serious 4/30/2010 31 Female 7/27/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 10/20/2009 50 Female 97 lb 8/3/2010 Physician Japan
Primary
Concomitant
Transplant Failure Other Serious 12/1/2009 60 Male 126 lb 8/4/2010 Physician Japan
Primary
Concomitant
Bacterial Sepsis Other Serious 33 Male 8/13/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 31 Female 8/13/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Mycobacterium Kansasii Pneumonia Death 53 Male 8/13/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 28 Female 8/13/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Nephrotic Syndrome Other Serious 9/19/2009 69 Female 86 lb 8/13/2010 Physician Japan
Primary
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
Cardiac Arrest Death 8/31/2010 Physician United States
Primary
Secondary
Concomitant
Death Death 8/31/2010 Physician United States
Primary
Secondary
Concomitant
Disease Progression Death 8/31/2010 Physician United States
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Death 8/31/2010 Physician United States
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Death 9/2/2010 Other Health Professional Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 4/30/2010 32 Female 9/7/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Death 9/8/2010 Other Health Professional 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
Thrombotic Microangiopathy Other Serious 70 Male 10/4/2010 Physician Japan
Primary
Concomitant
Disease Recurrence Death 7/18/2008 60 Male 231 lb 10/5/2010 Other Health Professional United States
Primary
Secondary
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
Respiratory Failure Other Serious 41 Female 10/14/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Herpes Zoster Other Serious 10/30/2009 31 Male 128 lb 10/20/2010 Physician Japan
Primary
Concomitant
Encephalopathy Other Serious 4/10/2010 35 Male 139 lb 10/20/2010 Physician Japan
Primary
Concomitant
Stenotrophomonas Infection Hospitalization 5/17/2010 59 Male 126 lb 10/21/2010 Physician Japan
Primary
Concomitant
Staphylococcal Sepsis Life Threatening 1/14/2009 67 Male 99 lb 10/26/2010 Consumer Japan
Primary
Concomitant
Stenotrophomonas Infection Hospitalization 5/17/2010 59 Male 126 lb 10/27/2010 Physician Japan
Primary
Concomitant
Transplant Failure Other Serious 12/27/2008 52 Male 152 lb 10/28/2010 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Death 9/21/2009 62 Female 126 lb 11/3/2010 Physician Japan
Primary
Concomitant
Febrile Neutropenia Other Serious 10/23/2009 41 Male 132 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
Thyroid Disorder Other Serious 7/17/2009 28 Male 110 lb 11/23/2010 Physician Japan
Primary
Concomitant
Cytomegalovirus Infection Other Serious 7/17/2009 28 Male 110 lb 11/24/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Life Threatening Male 112 lb 11/24/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Life Threatening Male 112 lb 11/24/2010 Physician Japan
Primary
Concomitant
Chronic Lymphocytic Leukaemia Death 7/18/2008 60 Male 231 lb 12/3/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Overdose Other Serious 52 Female 12/21/2010 Other Health Professional United States
Primary
Concomitant

Drug Data