Busulfan combined with Cyclosporine

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Weight Increased Required Intervention 12/15/2005 Female 117 lb 12/28/2005 United States
Primary
Secondary
Pneumonia Hospitalization 7/5/2005 58 Male 1/20/2006 Physician Japan
Primary
Secondary
Concomitant
Stem Cell Transplant Hospitalization 1/26/2006 47 Male 198 lb 1/31/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Other Serious 45 Male 2/25/2006 Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 28 Male 3/4/2006 Physician United States
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 46 Female 3/4/2006 Physician United States
Primary
Concomitant
Neurotoxicity Other Serious 25 Female 3/4/2006 Physician United States
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 43 Male 3/4/2006 Physician United States
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 38 Female 3/4/2006 Physician United States
Primary
Concomitant
Toxic Epidermal Necrolysis Other Serious 45 Male 3/9/2006 Japan
Primary
Concomitant
Visual Field Defect Other Serious 1/1/2005 49 Female 3/14/2006 Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 14 Male 3/14/2006 Japan
Primary
Secondary
Transplant Rejection Other Serious 1 Male 3/15/2006 Japan
Primary
Secondary
Concomitant
Spinal Myelogram Abnormal Other Serious 34 Female 3/21/2006 Physician Japan
Primary
Concomitant
Cytomegalovirus Viraemia Life Threatening 4/21/2004 1 Male 18 lb 3/23/2006 Physician Japan
Primary
Secondary
Concomitant
Stem Cell Transplant Hospitalization 53 Male 3/20/2006
Primary
Secondary
Shoulder Pain Hospitalization 53 Male 3/20/2006
Primary
Secondary
Vomiting Disability 11/4/2005 9 Male 53 lb 3/29/2006 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 53 Male 3/20/2006
Primary
Secondary
Shoulder Pain Hospitalization 53 Male 3/20/2006
Primary
Secondary
White Blood Cell Count Decreased Other Serious 20 Male 4/3/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Visual Field Defect Other Serious 1/1/2005 49 Female 4/11/2006 Japan
Primary
Secondary
Concomitant
Graft Versus Host Disease Other Serious 40 Male 5/5/2006 Other Health Professional Switzerland
Primary
Concomitant
Transaminases Increased Other Serious 9 Male 41 lb 5/8/2006 Other Health Professional Italy
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Other Serious 1/1/2004 45 Male 5/24/2006 Physician Japan
Primary
Concomitant
Thrombotic Thrombocytopenic Purpura Other Serious Female 6/14/2006 Consumer Germany
Primary
Secondary
Concomitant
Urinary Bladder Haemorrhage Other Serious 14 Male 8/24/2006 Other Health Professional France
Primary
Concomitant
Status Epilepticus Other Serious 10 Female 9/1/2006 Spain
Primary
Concomitant
Status Epilepticus Other Serious 5 Male 9/1/2006 Spain
Primary
Concomitant
Histiocytosis Haematophagic Other Serious 4 Female 10/9/2006 Japan
Primary
Concomitant
Serum Ferritin Increased Other Serious 4 Female 10/17/2006 Japan
Primary
Secondary
Concomitant
Viral Dna Test Positive Other Serious 1/1/2006 64 Female 10/17/2006 Japan
Primary
Concomitant
Skin Exfoliation Other Serious 31 Female 10/31/2006 Other Health Professional United States
Primary
Secondary
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
Pyrexia Other Serious 12/1/2004 49 Male 2/8/2007 Japan
Primary
Concomitant
Venoocclusive Disease Hospitalization Female 2/10/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Venoocclusive Disease Hospitalization Female 2/10/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Pyrexia Other Serious 22 Male 2/22/2007 Consumer United Kingdom
Primary
Secondary
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
Thrombotic Microangiopathy Other Serious 44 Male 3/14/2007 Japan
Primary
Concomitant
Ureteric Stenosis Other Serious 35 Male 3/14/2007 Japan
Primary
Secondary
Concomitant
Cerebral Toxoplasmosis Death 22 Male 3/15/2007 Consumer United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 15 Female 3/15/2007 Japan
Primary
Secondary
Concomitant
Pneumonia Other Serious 32 Female 3/17/2007 Japan
Primary
Secondary
Ureteric Stenosis Other Serious 35 Male 3/28/2007 Japan
Primary
Secondary
Concomitant
Weight Increased Life Threatening 1/7/2007 1 Female 4/13/2007 Consumer France
Primary
Secondary
Concomitant
Thrombocytopenia Death 13 Female 4/16/2007 Other Health Professional India
Primary
Secondary
Concomitant
Reticulocyte Count Increased Hospitalization 0 Female 4/28/2007 Other Health Professional United States
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 10 Male 5/29/2007 Japan
Primary
Secondary
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
Thrombotic Microangiopathy Other Serious 10 Male 6/7/2007 Japan
Primary
Secondary
Concomitant
Pain In Extremity Other Serious 15 Male 6/7/2007 Japan
Primary
Secondary
Concomitant
Neurotoxicity Other Serious 4 6/15/2007 Other Health Professional Italy
Primary
Secondary
Concomitant
Pleural Effusion Other Serious 46 Male 6/24/2007 Japan
Primary
Concomitant
Pneumoperitoneum Other Serious 4 Male 6/29/2007 Belgium
Primary
Secondary
Pleural Effusion Other Serious 46 Male 7/6/2007 Japan
Primary
Concomitant
Weight Increased Life Threatening 4/5/2007 51 Female 7/16/2007 Other Health Professional Japan
Primary
Concomitant
Respiratory Failure Death 5/8/2003 13 Female 8/20/2007 Other Health Professional Japan
Primary
Concomitant
Stomatitis Hospitalization 4/8/2007 55 Male 9/4/2007 Other Health Professional Japan
Primary
Concomitant
Somnolence Hospitalization 8/1/2007 8 Male 88 lb 9/11/2007 Pharmacist Canada
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 9/27/2007 Physician Russian Federation
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Death Female 9/27/2007 Physician Russian Federation
Primary
Secondary
Concomitant
Scleroderma Other Serious 9/27/2007 Physician Russian Federation
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Other Serious 9/27/2007 Physician Russian Federation
Primary
Secondary
Concomitant
Sepsis Other Serious 9/27/2007 Physician Russian Federation
Primary
Secondary
Concomitant
Somnolence Other Serious 8/1/2007 8 Male 88 lb 10/12/2007 Pharmacist Canada
Primary
Secondary
Concomitant
Reticulocyte Count Decreased Other Serious 54 Male 10/25/2007 Physician Japan
Primary
Secondary
Concomitant
Somnolence Other Serious 1/1/2007 8 Male 88 lb 10/29/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Somnolence Other Serious 8/1/2007 8 Male 88 lb 11/8/2007 Physician Canada
Primary
Secondary
Concomitant
Urine Analysis Abnormal Other Serious 53 Male 11/13/2007 Other Health Professional Portugal
Primary
Secondary
Concomitant
Reticulocyte Count Decreased Hospitalization 2/16/2004 54 Male 11/21/2007 Physician Japan
Primary
Secondary
Concomitant
Subdural Haematoma Other Serious 7 Female 11/23/2007 Other Health Professional Turkey
Primary
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
Vaginal Disorder Other Serious 28 Female 12/13/2007 Other Health Professional Greece
Primary
Secondary
White Blood Cell Count Decreased Other Serious 10/1/2005 26 Female 12/14/2007 Other Health Professional Spain
Primary
Concomitant
Reticulocyte Count Decreased Hospitalization 2/16/2004 54 Male 12/18/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Oesophagitis Other Serious 26 Female 1/23/2008 Other Health Professional Spain
Primary
Secondary
Oesophagitis Other Serious 26 Female 1/29/2008 Other Health Professional Spain
Primary
Secondary
Thrombocytopenic Purpura Other Serious 1 Female 2/7/2008 Japan
Primary
Concomitant
Sepsis Other Serious 1 Male 2/7/2008 Japan
Primary
Concomitant
Vulvovaginal Dryness Other Serious 2/1/2001 28 Female 2/12/2008
Primary
Secondary
Concomitant
Infection Death 2/19/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Subarachnoid Haemorrhage Disability 6/10/2006 52 Female 132 lb 2/19/2008 Physician Slovakia (Slovak Republic)
Primary
Secondary
Concomitant
Infection Death 2/21/2008 Germany
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 2/21/2008 Germany
Primary
Secondary
Concomitant
Adenocarcinoma Death 2/21/2008 Canada
Primary
Secondary
Concomitant
Sepsis Other Serious 2/21/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Sepsis Other Serious 2/21/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Sepsis Other Serious 2/21/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Infection Other Serious 2/21/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Infection Other Serious 2/21/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Infection Other Serious 2/21/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 2/21/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 2/21/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 2/21/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Infection Death 2/21/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Infection Death 2/21/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Drug Toxicity Death 2/22/2008 France
Primary
Secondary
Concomitant
Lymphoproliferative Disorder Death 2/22/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Infection Death 2/22/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Arrhythmia Death 2/22/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Lymphoproliferative Disorder Death 2/22/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Encephalopathy Death 2/22/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Interstitial Lung Disease Death 2/22/2008 Canada
Primary
Secondary
Concomitant
Cerebral Haemorrhage Death 2/22/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Subarachnoid Haemorrhage Disability 6/10/2006 52 Female 2/26/2008 Consumer United States
Primary
Secondary
Concomitant
Speech Rehabilitation Other Serious 1 Female 2/25/2008 Other Health Professional Japan
Primary
Concomitant
Vaginal Inflammation Hospitalization 21 Female 2/25/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Inflammation Other Serious 12 2/25/2008 Other Health Professional United States
Primary
Concomitant
Weight Decreased Hospitalization 42 Male 2/26/2008 Other Health Professional Spain
Primary
Concomitant
Rash Papular Hospitalization 10/1/2005 26 Female 2/27/2008
Primary
Secondary
Concomitant
Swelling Other Serious 22 Male 3/21/2008 Other Health Professional Pakistan
Primary
Secondary
Concomitant
Progressive Multifocal Leukoencephalopathy Other Serious Male 3/27/2008 Other Health Professional Germany
Primary
Secondary
Drug Toxicity Death 3/28/2008 Russian Federation
Primary
Secondary
Concomitant
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
Subcutaneous Nodule Other Serious 4 Female 4/3/2008 Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 4/4/2008 Physician Germany
Primary
Concomitant
Graft Versus Host Disease Other Serious 14 Male 4/14/2008 Other Health Professional Germany
Primary
Secondary
Neutropenia Other Serious 4 Female 4/14/2008 Other Health Professional Germany
Primary
Secondary
Toxoplasmosis Hospitalization 14 Male 4/23/2008 Germany
Primary
Concomitant
Graft Versus Host Disease Other Serious 14 Female 4/23/2008 Germany
Primary
Concomitant
Graft Versus Host Disease Hospitalization 4 Female 4/23/2008 Germany
Primary
Concomitant
Toxoplasmosis Hospitalization 14 Male 5/5/2008 Germany
Primary
Concomitant
Graft Versus Host Disease Other Serious 14 Female 5/5/2008 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
Thrombotic Microangiopathy Other Serious 5/22/2008 Japan
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 5/29/2008 Iceland
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 6/2/2008 Iceland
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 42 Male 6/4/2008 Other Health Professional Spain
Primary
Secondary
Venoocclusive Disease Other Serious 42 Male 6/9/2008 Other Health Professional Spain
Primary
Secondary
Metabolic Encephalopathy Other Serious 23 Female 6/10/2008 Other Health Professional United States
Primary
Concomitant
Drug Rash With Eosinophilia And Systemic Symptoms Other Serious 9 Female 6/13/2008 Germany
Primary
Secondary
Renal Failure Chronic Other Serious 5/1/2006 43 Male 6/18/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 48 Male 6/20/2008 Other Health Professional Spain
Primary
Secondary
Concomitant
Psychotic Disorder Hospitalization 37 Male 6/20/2008 Korea, Republic Of
Primary
Concomitant
Vomiting Other Serious 1 Male 6/26/2008 United States
Primary
Secondary
Pancytopenia Hospitalization 9 Female 6/25/2008 Other Health Professional Germany
Primary
Concomitant
Thrombosis Other Serious 53 Male 7/16/2008 Other Health Professional Portugal
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 7/21/2008 Other Health Professional Japan
Primary
Concomitant
Leukaemia Recurrent Death 47 Female 7/21/2008 Other Health Professional Japan
Primary
Concomitant
Tuberculosis Other Serious 31 Female 7/22/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Cystitis Haemorrhagic Other Serious 7/25/2008 Other Health Professional Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 50 Female 8/1/2008 Consumer Japan
Primary
Secondary
Concomitant

Drug Data