Busulfex combined with Cyclosporine

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Venoocclusive Liver Disease Life Threatening 2 Female 17 lb 12/11/2006 Physician Israel
Primary
Concomitant
Skin Lesion Other Serious 0 Male 2/15/2007 Other Health Professional Turkey
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Life Threatening 11/25/2006 1 Female 17 lb 2/16/2007 Physician Israel
Primary
Concomitant
Nephrogenic Fibrosing Dermopathy Other Serious 8/1/2005 36 Male 6/13/2007 Physician United States
Primary
Concomitant
Nephrogenic Systemic Fibrosis Other Serious 8/1/2005 36 Male 7/27/2007 Physician United States
Primary
Secondary
Concomitant
Vomiting Death 2/25/2007 13 Female 8/1/2007 Japan
Primary
Concomitant
Staphylococcal Infection Life Threatening 1/1/2007 8 Male 88 lb 10/31/2007 Physician United States
Primary
Secondary
Concomitant
Staphylococcal Infection Life Threatening 8/18/2007 8 Male 88 lb 11/12/2007 Physician United States
Primary
Secondary
Concomitant
Weight Increased Life Threatening 5/7/2007 30 Male 4/2/2008 Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease 10/23/2007 29 Female 4/2/2008 Japan
Primary
Concomitant
Septic Embolus Other Serious 7/17/2007 49 Male 4/2/2008 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased 8/29/2007 3 Male 4/30/2008 Japan
Primary
Secondary
Concomitant
Ventricular Extrasystoles Life Threatening 10/7/2007 57 Male 4/30/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 7/3/2007 51 Female 4/30/2008 Japan
Primary
Concomitant
Mucosal Inflammation 11/9/2007 1 Male 4/30/2008 Japan
Primary
Secondary
Concomitant
Stem Cell Transplant Life Threatening 7/27/2007 43 Female 4/30/2008 Japan
Primary
Concomitant
Vomiting Life Threatening 5/28/2007 25 Male 4/30/2008 Japan
Primary
Concomitant
Weight Increased Death 9/13/2007 13 Male 4/30/2008 Japan
Primary
Concomitant
White Blood Cell Count Increased Life Threatening 10/21/2007 46 Male 5/15/2008 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Death 50 Female 6/6/2008 Israel
Primary
Concomitant
Thrombotic Microangiopathy Death 51 Male 6/6/2008 France
Primary
Concomitant
Vertigo Death 67 Male 6/6/2008 Germany
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Death 40 Male 6/6/2008 France
Primary
Concomitant
Visual Disturbance Hospitalization 30 Female 6/6/2008 Other Health Professional France
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Death 44 Female 6/6/2008 France
Primary
Concomitant
Thrombotic Microangiopathy Hospitalization 44 Male 6/6/2008 Argentina
Primary
Concomitant
Thrombotic Microangiopathy Hospitalization 44 Male 6/6/2008 Korea, Republic Of
Primary
Concomitant
Thrombotic Microangiopathy Hospitalization 37 Male 6/6/2008 Israel
Primary
Concomitant
Stomatitis Hospitalization 3/1/2007 62 Female 6/9/2008 Physician Japan
Primary
Concomitant
Vomiting 9/1/2007 18 Female 6/9/2008 Other Health Professional Japan
Primary
Concomitant
Venoocclusive Liver Disease Hospitalization 7/1/2007 50 Male 6/19/2008 Japan
Primary
Concomitant
Vomiting Life Threatening 7/9/2007 50 Female 6/27/2008 Other Health Professional Japan
Primary
Concomitant
Vomiting Life Threatening 9/24/2007 58 Male 6/27/2008 Other Health Professional Japan
Primary
Concomitant
Vomiting Life Threatening 5/3/2007 2 Female 6/30/2008 Japan
Primary
Concomitant
Vomiting Hospitalization 3/22/2007 64 Male 6/30/2008 Physician Japan
Primary
Concomitant
Vomiting Life Threatening 2/6/2008 1 Female 7/2/2008 Japan
Primary
Concomitant
Enterobacter Sepsis Hospitalization 8/21/2007 29 Male 7/8/2008 Japan
Primary
Concomitant
Staphylococcal Sepsis Hospitalization 10/22/2007 32 Female 7/8/2008 Japan
Primary
Concomitant
Vomiting Hospitalization 7/24/2007 58 Male 7/8/2008 Japan
Primary
Concomitant
Pneumonia Hospitalization 7/28/2007 47 Male 7/8/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 8/1/2007 53 Male 7/1/2008 Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease 7/1/2007 18 Female 7/10/2008 Japan
Primary
Concomitant
Stomatitis 11/4/2007 53 Male 7/10/2008 Japan
Primary
Concomitant
Staphylococcal Sepsis 12/2/2006 67 Male 7/10/2008 Japan
Primary
Concomitant
Grand Mal Convulsion Life Threatening 2/17/2007 5 Female 7/16/2008 Japan
Primary
Concomitant
Stomatitis Hospitalization 11/26/2007 54 Female 7/17/2008 Japan
Primary
Concomitant
Vomiting Death 8/2/2007 28 Female 7/17/2008 Other Health Professional Japan
Primary
Concomitant
Stomatitis Hospitalization 4/15/2008 16 Male 7/17/2008 Other Health Professional Japan
Primary
Concomitant
Viral Haemorrhagic Cystitis Life Threatening 9/10/2007 51 Male 7/16/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 6/29/2007 49 Male 7/16/2008 Japan
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 10/16/2007 13 Female 7/17/2008 Japan
Primary
Concomitant
Vomiting Hospitalization 6/12/2007 51 Male 7/17/2008 Other Health Professional Japan
Primary
Concomitant
Transplant Rejection 12/27/2006 13 Female 7/18/2008 Japan
Primary
Concomitant
Stomatitis 2/21/2008 6 Female 7/18/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 12/5/2007 42 Male 7/25/2008 Japan
Primary
Concomitant
Stomatitis Hospitalization 5/30/2007 58 Male 8/1/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 4/5/2007 42 Male 8/5/2008 Japan
Primary
Concomitant
Febrile Neutropenia Life Threatening 4/5/2007 28 Male 8/5/2008 Japan
Primary
Concomitant
Liver Disorder Disability 7/11/2008 31 Male 8/7/2008 Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 5/20/2007 59 Female 8/14/2008 Japan
Primary
Concomitant
Viral Haemorrhagic Cystitis Death 9/22/2007 63 Male 8/18/2008 Japan
Primary
Secondary
Concomitant
Pyrexia Life Threatening 7/11/2008 31 Male 8/18/2008 Japan
Primary
Secondary
Concomitant
Urine Output Decreased Life Threatening 8/13/2007 64 Female 8/19/2008 Japan
Primary
Concomitant
Vomiting Life Threatening 5/3/2007 2 Female 8/27/2008 Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 1/3/2008 7 Male 8/29/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 10/22/2007 57 Female 8/29/2008 Japan
Primary
Concomitant
Vomiting Hospitalization 3/6/2008 16 Male 9/3/2008 Japan
Primary
Concomitant
Ventricular Fibrillation Life Threatening 5/11/2007 35 Male 9/8/2008 Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Hospitalization 2 Female 9/4/2008 Japan
Primary
Concomitant
Transplant Failure Life Threatening 5/23/2007 55 Female 9/8/2008 Japan
Primary
Concomitant
Vomiting Hospitalization 1/11/2007 8 Male 9/8/2008 Japan
Primary
Concomitant
Vomiting Life Threatening 7/9/2007 12 Female 9/8/2008 Japan
Primary
Concomitant
Vomiting Life Threatening 12/23/2007 48 Male 9/9/2008 Japan
Primary
Concomitant
Mallory-weiss Syndrome Death 4/27/2007 47 Male 9/16/2008 Japan
Primary
Concomitant
Vomiting Life Threatening 3/16/2007 51 Female 9/16/2008 Japan
Primary
Concomitant
Stomatitis Hospitalization 10/15/2006 55 Female 9/16/2008 Japan
Primary
Secondary
Concomitant
Stomatitis Death 1/15/2008 47 Male 9/15/2008 Japan
Primary
Concomitant
Urine Output Decreased Life Threatening 8/13/2007 64 Female 9/15/2008 Japan
Primary
Secondary
Concomitant
Vomiting Life Threatening 10/18/2007 53 Female 9/17/2008 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 7/28/2007 13 Female 9/17/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 5/1/2007 57 Female 9/17/2008 Japan
Primary
Concomitant
Vomiting Life Threatening 3/6/2007 57 Female 9/17/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 9/6/2007 59 Male 9/19/2008 Japan
Primary
Concomitant
Swelling Other Serious 8/1/2005 37 Male 9/27/2008 Physician United States
Primary
Secondary
Concomitant
Stomatitis Life Threatening 12/27/2006 13 Female 9/23/2008 Japan
Primary
Concomitant
Thrombocytopenia Hospitalization 19 Male 9/26/2008 Germany
Primary
Concomitant
Stomatitis Life Threatening 8/3/2007 57 Male 10/3/2008 Japan
Primary
Concomitant
Vomiting Death 8/30/2006 46 Male 10/13/2008 Japan
Primary
Concomitant
Stomatitis Death 5/30/2007 41 Female 10/13/2008 Japan
Primary
Concomitant
Venoocclusive Liver Disease Life Threatening 4/13/2007 43 Male 10/13/2008 Japan
Primary
Concomitant
Tubulointerstitial Nephritis 8/9/2007 11 Male 10/16/2008 Germany
Primary
Concomitant
Liver Function Test Abnormal Death 8/30/2006 46 Male 10/20/2008 Japan
Primary
Concomitant
Venoocclusive Liver Disease Life Threatening 8/13/2007 43 Male 10/17/2008 Japan
Primary
Concomitant
Vomiting Life Threatening 5/3/2007 2 Female 10/23/2008 Japan
Primary
Secondary
Concomitant
Multi-organ Failure Death 8/17/2007 44 Female 10/28/2008 Japan
Primary
Concomitant
Vomiting Life Threatening 3/6/2007 57 Female 11/10/2008 Japan
Primary
Concomitant
Stomatitis Hospitalization 12/25/2007 53 Male 11/11/2008 Japan
Primary
Concomitant
Venoocclusive Liver Disease Life Threatening 8/13/2007 43 Male 11/26/2008 Japan
Primary
Concomitant
Ventricular Fibrillation Life Threatening 5/11/2007 35 Male 11/25/2008 Japan
Primary
Secondary
Concomitant
Graft Versus Host Disease Other Serious 4/5/2007 Female 12/8/2008 Physician France
Primary
Concomitant
Interacting
Stomatitis Hospitalization 11/26/2007 54 Female 12/1/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 6/1/2007 61 Male 12/4/2008 Japan
Primary
Concomitant
Vomiting Life Threatening 7/24/2007 58 Male 12/3/2008 Japan
Primary
Secondary
Concomitant
Stomatitis Hospitalization 11/5/2007 53 Male 12/3/2008 Japan
Primary
Concomitant
Vomiting Life Threatening 9/24/2007 58 Male 12/9/2008 Japan
Primary
Secondary
Concomitant
Vomiting 12/6/2006 39 Male 12/18/2008 Japan
Primary
Secondary
Concomitant
Graft Versus Host Disease Other Serious 4/5/2007 Female 12/23/2008 Physician France
Primary
Concomitant
Interacting
Renal Failure Hospitalization 9/3/2007 29 Female 12/23/2008 Japan
Primary
Concomitant
Ventricular Fibrillation Life Threatening 5/11/2007 35 Male 12/23/2008 Japan
Primary
Secondary
Concomitant
Gamma-glutamyltransferase Increased Life Threatening 10/5/2007 Female 12/29/2008 Japan
Primary
Concomitant
Venoocclusive Liver Disease Life Threatening 8/13/2007 43 Male 1/5/2009 Japan
Primary
Concomitant
Vomiting Death 24 Male 1/22/2009 Japan
Primary
Concomitant
Stomatitis Hospitalization 5/30/2007 41 Female 1/27/2009 Japan
Primary
Concomitant
Vomiting Life Threatening 9/15/2007 58 Male 1/27/2009 Japan
Primary
Secondary
Concomitant
Renal Failure Life Threatening 8/2/2007 29 Female 2/3/2009 Japan
Primary
Concomitant
Toxic Encephalopathy Life Threatening 7/4/2007 51 Male 2/3/2009 Japan
Primary
Secondary
Concomitant
Transplant Rejection 12 Male 2/6/2009 Turkey
Primary
Concomitant
Stomatitis Hospitalization 4/28/2007 17 Female 2/26/2009 Japan
Primary
Concomitant
Multi-organ Failure Death 8/17/2007 44 Female 3/19/2009 Japan
Primary
Concomitant
Vascular Injury Hospitalization 19 5/21/2009 United Kingdom
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection 16 5/21/2009 United Kingdom
Primary
Secondary
Concomitant
Thrombocytopenia 8 Male 5/21/2009 United Kingdom
Primary
Concomitant
Procedural Complication 5 5/21/2009 France
Primary
Concomitant
Obliterative Bronchiolitis 4 6/3/2009 France
Primary
Concomitant
Anti-thyroid Antibody Positive 3 6/18/2009 France
Primary
Concomitant
Intracranial Venous Sinus Thrombosis 42 Female 6/30/2009 Japan
Primary
Concomitant
Stomatitis 42 Female 7/10/2009 Japan
Primary
Concomitant
Pneumonia Life Threatening 10/8/2008 65 Male 132 lb 8/6/2009 Physician Japan
Primary
Secondary
Concomitant
Nausea Other Serious 10/29/2008 58 Female 106 lb 9/8/2009 Physician Japan
Primary
Secondary
Concomitant
Nausea Other Serious 10/29/2008 58 Female 106 lb 9/15/2009 Physician Japan
Primary
Secondary
Concomitant
Mucosal Inflammation 5 Male 10/1/2009 Italy
Primary
Concomitant
Drug Interaction 2 Unknown 11/12/2009 France
Primary
Secondary
Mucous Membrane Disorder 9 Male 12/2/2009 Japan
Primary
Concomitant
Mucous Membrane Disorder 12 Female 12/2/2009 Japan
Primary
Concomitant
Respiratory Syncytial Virus Bronchiolitis Other Serious 1 Male 12/9/2009 Other Health Professional United States
Primary
Concomitant
Red Blood Cell Count Decreased Hospitalization 35 Female 99 lb 12/14/2009 Physician Japan
Primary
Concomitant
Red Blood Cell Count Decreased Hospitalization 35 Female 99 lb 12/23/2009 Japan
Primary
Concomitant
Weight Decreased 51 Male 2/12/2010 United Kingdom
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 51 Female 3/4/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Failure Life Threatening 2/3/2010 70 Male 192 lb 2/26/2010 Germany
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 51 Female 3/9/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy 49 Male 3/3/2010 Japan
Primary
Concomitant
Thrombotic Microangiopathy Death 12/10/2008 51 Female 3/3/2010 Japan
Primary
Secondary
Concomitant
Weight Decreased Other Serious 55 Male 3/12/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Scleroderma Other Serious 61 Female 3/19/2010 Other Health Professional Turkey
Primary
Secondary
Concomitant
Pleural Effusion Death 11 Female 3/15/2010 Turkey
Primary
Concomitant
Vomiting 42 Female 3/15/2010 Physician Japan
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 2/1/2009 56 Male 3/25/2010 Other Health Professional Japan
Primary
Concomitant
Thrombocytopenia Other Serious 1 Female 3/26/2010 Other Health Professional India
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 49 Male 4/1/2010 Other Health Professional Japan
Primary
Concomitant

Drug Data