Busulfan combined with Mycophenolate Mofetil

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
Transaminases Increased Other Serious 9 Male 41 lb 5/8/2006 Other Health Professional Italy
Primary
Secondary
Concomitant
Skin Exfoliation Other Serious 31 Female 10/31/2006 Other Health Professional United States
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
Pharmaceutical Product Complaint Required Intervention 5/5/2007 Male 214 lb 5/17/2007 Physician United States
Primary
Concomitant
Neurotoxicity Other Serious 4 6/15/2007 Other Health Professional Italy
Primary
Secondary
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
Multi-organ Failure Other Serious 4 Female 2/26/2008 United States
Primary
Secondary
Concomitant
Graft Versus Host Disease Other Serious 39 Female 3/3/2008
Primary
Secondary
Nocardiosis Other Serious Female 3/13/2008 Physician United States
Primary
Concomitant
Drug Toxicity Death 4/1/2008 United States
Primary
Secondary
Concomitant
Therapeutic Agent Toxicity Death 4/2/2008 Germany
Primary
Secondary
Subcutaneous Nodule Other Serious 4 Female 4/3/2008 Japan
Primary
Secondary
Concomitant
Thrombosis Other Serious 53 Male 7/16/2008 Other Health Professional Portugal
Primary
Secondary
Concomitant
Tuberculosis Other Serious 31 Female 7/22/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vomiting Other Serious 31 Female 8/11/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Immune Reconstitution Syndrome Hospitalization 31 Female 8/13/2008 Consumer United States
Primary
Secondary
Concomitant
Vomiting Other Serious 31 Female 8/21/2008 United Kingdom
Primary
Secondary
Concomitant
Myelodysplastic Syndrome Other Serious 1/18/2008 66 Male 172 lb 8/28/2008 Physician United States
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 9/2/2008 France
Primary
Secondary
Concomitant
Vomiting Hospitalization 31 Female 9/2/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Sepsis Other Serious 8/1/2005 31 Male 1/18/2008 Other Health Professional Japan
Primary
Concomitant
Immune Reconstitution Syndrome Hospitalization 31 Female 10/14/2008 Consumer United States
Primary
Secondary
Concomitant
Hypertrophic Cardiomyopathy Other Serious 0 Male 11/19/2008 Japan
Primary
Concomitant
Uveitis Other Serious 18 Female 11/19/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Hypertrophic Cardiomyopathy Other Serious 0 Male 12/1/2008 Japan
Primary
Concomitant
Graft Versus Host Disease Other Serious 0 Male 12/15/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Respiratory Failure Death 59 Male 12/22/2008 Japan
Primary
Secondary
Concomitant
Paraesthesia Other Serious 39 Female 2/10/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 6/27/2008 44 Male 148 lb 3/20/2009 Physician Japan
Primary
Concomitant
Upper Respiratory Tract Infection Other Serious 16 Male 4/2/2009 Other Health Professional United Kingdom
Primary
Concomitant
Stomatitis Other Serious 4/8/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Viral Infection Other Serious 59 Male 4/30/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 6 Male 4/30/2009 Canada
Primary
Concomitant
Tremor Other Serious 16 5/18/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Systemic Mycosis Hospitalization 7/1/2006 50 Female 5/29/2009 Other Health Professional Italy
Primary
Secondary
Concomitant
Pain Other Serious 7 Male 6/12/2009 Canada
Primary
Concomitant
Suicidal Ideation Other Serious 17 Male 6/29/2009 Physician United States
Primary
Secondary
Concomitant
Suicidal Ideation Other Serious 17 Male 7/2/2009 Physician United States
Primary
Secondary
Concomitant
Suicidal Ideation Other Serious 17 Male 7/2/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Sudden Death Other Serious 7/6/2009 Other Health Professional United States
Primary
Concomitant
Weight Increased Other Serious 49 Female 110 lb 7/18/2009 Other Health Professional China
Primary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 6/27/2008 44 Male 148 lb 8/17/2009 Physician Japan
Primary
Concomitant
Transplant Rejection Other Serious 1/1/2007 30 Female 9/28/2009
Primary
Secondary
Concomitant
Systemic Mycosis Hospitalization 7/1/2006 50 Female 11/24/2009 Other Health Professional Italy
Primary
Secondary
Concomitant
Weight Increased Other Serious 1/1/2008 55 Female 12/3/2009 Physician Japan
Secondary
Concomitant
Transaminases Increased Other Serious 1/1/2008 31 Male 12/3/2009 Physician Japan
Secondary
Concomitant
Vomiting Hospitalization 31 Female 2/25/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vomiting Other Serious 31 Female 2/26/2010 United Kingdom
Primary
Secondary
Concomitant
Meningoencephalitis Herpetic Other Serious 55 Male 6/29/2010 Other Health Professional United States
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
Nephropathy Toxic Other Serious 55 Male 7/30/2010 Other Health Professional United States
Primary
Concomitant
Vasoplegia Syndrome Other Serious 36 Male 8/4/2010 Other Health Professional France
Primary
Secondary
Vasoplegia Syndrome Other Serious 51 Male 8/4/2010 Other Health Professional France
Primary
Secondary
Vasoplegia Syndrome Other Serious 51 Male 8/5/2010 Physician France
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
Herpes Zoster Other Serious 10/30/2009 31 Male 128 lb 8/16/2010 Physician Japan
Primary
Concomitant
Herpes Zoster Other Serious 10/30/2009 31 Male 8/24/2010 Physician Japan
Primary
Secondary
Concomitant
Transplant Failure Other Serious 7 Male 8/27/2010 Other Health Professional Jordan
Primary
Secondary
Concomitant
Weight Decreased Death 55 Male 9/15/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 21 Female 9/16/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Toxoplasmosis Other Serious 42 Female 9/17/2010 Other Health Professional Greece
Primary
Secondary
Concomitant
Toxoplasmosis Other Serious 42 Female 9/22/2010 Other Health Professional Greece
Primary
Secondary
Concomitant
Toxoplasmosis Death 42 Female 10/7/2010 Other Health Professional Germany
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
Sepsis Other Serious 10/1/2010 47 Male 11/2/2010 Other Health Professional Canada
Primary
Concomitant
Hypotension Hospitalization 10/22/2010 47 Male 11/5/2010 Physician Canada
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 11/8/2010 Other Health Professional China
Primary
Secondary
Concomitant
Pyrexia Other Serious 20 Female 11/9/2010 Other Health Professional Japan
Primary
Concomitant
Leukaemia Recurrent Other Serious 57 Male 11/11/2010 Other Health Professional Greece
Primary
Concomitant
Mucosal Inflammation Other Serious 1 Male 11/15/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Renal Failure Other Serious 6 Male 11/15/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 5 Male 11/15/2010 Physician United States
Primary
Secondary
Concomitant
Skin Toxicity Other Serious 14 Female 11/15/2010 Consumer Germany
Primary
Secondary
Concomitant
Renal Failure Other Serious 6 Female 11/15/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Mucosal Inflammation Other Serious 6 Female 11/15/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Staphylococcal Bacteraemia Other Serious 8/3/2009 62 Female 110 lb 11/24/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 18 Female 12/27/2010 Other Health Professional Japan
Primary
Concomitant
Respiratory Failure Death 1/5/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Viral Haemorrhagic Cystitis Life Threatening 11/7/2009 66 Male 128 lb 1/11/2011 Physician Japan
Primary
Secondary
Concomitant
Bk Virus Infection Death 20 Female 1/24/2011 Other Health Professional Singapore
Primary
Secondary
Chronic Graft Versus Host Disease Other Serious 1/26/2011 Physician Algeria
Primary
Secondary
Concomitant
Escherichia Sepsis Death 55 Male 1/27/2011 Physician Germany
Primary
Secondary
Concomitant
Pyrexia Other Serious 42 Male 1/27/2011 Physician Germany
Primary
Secondary
Concomitant
Cytomegalovirus Infection Death 48 Female 1/27/2011 Physician Germany
Primary
Secondary
Concomitant
Pneumonia Other Serious 68 Female 1/27/2011 Physician Germany
Primary
Secondary
Concomitant
Soft Tissue Infection Other Serious 39 Male 1/27/2011 Consumer Germany
Primary
Secondary
Concomitant
Pneumonia Other Serious 19 Male 1/27/2011 Physician Germany
Primary
Secondary
Concomitant
Cytomegalovirus Infection Other Serious 64 Male 1/27/2011 Physician Germany
Primary
Secondary
Concomitant
Pneumonia Other Serious 37 Male 1/27/2011 Physician Germany
Primary
Secondary
Concomitant
Organising Pneumonia Other Serious 53 Male 1/27/2011 Physician Germany
Primary
Secondary
Concomitant
Pneumonia Death 68 Female 1/27/2011 Physician Germany
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Other Serious 53 Male 1/27/2011 Physician Germany
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Intestine Death 17 Female 132 lb 1/28/2011 Other Health Professional France
Primary
Concomitant
Interacting
Acute Graft Versus Host Disease Other Serious 64 Male 1/28/2011 Physician Germany
Primary
Secondary
Concomitant
Systemic Candida Death 20 Female 1/31/2011 Other Health Professional United Kingdom
Primary
Secondary
Infection Other Serious 2/4/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Candidiasis Other Serious 27 Male 2/7/2011 Physician France
Primary
Secondary
Concomitant
Stevens-johnson Syndrome Hospitalization 20 Female 2/8/2011 Other Health Professional Singapore
Primary
Secondary
Concomitant
Posterior Reversible Encephalopathy Syndrome Hospitalization 20 Female 2/8/2011 Other Health Professional Singapore
Primary
Secondary
Concomitant
Central Nervous System Lymphoma Hospitalization 20 Female 2/8/2011 Other Health Professional Singapore
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 20 Female 2/8/2011 Other Health Professional Singapore
Primary
Secondary
Concomitant
Sepsis Death 20 Female 2/8/2011 Other Health Professional Singapore
Primary
Secondary
Hypertension Hospitalization 10/22/2010 47 Male 2/9/2011 Other Health Professional Canada
Primary
Secondary
Concomitant
Hypoxia Death 2 Male 2/11/2011 Other Health Professional United States
Primary
Concomitant
Dehydration Other Serious 10/1/2010 47 Male 2/11/2011 Other Health Professional Canada
Primary
Concomitant
Haematuria Other Serious 20 Female 2/11/2011 Other Health Professional Singapore
Primary
Secondary
Stevens-johnson Syndrome Other Serious 20 Female 2/16/2011 Other Health Professional Singapore
Primary
Secondary
Concomitant
Cytomegalovirus Test Positive Hospitalization Female 66 lb 2/18/2011 Physician Japan
Primary
Secondary
Concomitant
Biliary Tract Infection Other Serious 15 Female 2/22/2011 Physician Japan
Primary
Concomitant
Ileus Other Serious 3/1/2011 Physician United States
Primary
Secondary
Concomitant
Sepsis Hospitalization 20 Female 2/15/2011
Primary
Secondary
Chronic Graft Versus Host Disease Death 20 Female 3/2/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 3/4/2011 Physician Lebanon
Primary
Secondary
Concomitant
Endothelial Dysfunction Other Serious 2 Male 2/25/2011 Physician United States
Primary
Secondary
Concomitant
Microangiopathy Death 2 Male 4/1/2011 Other Health Professional United States
Primary
Concomitant
Cardiac Tamponade Other Serious 1 Male 4/6/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Hypersensitivity Other Serious 4/8/2011 Other Health Professional United States
Primary
Secondary
Venoocclusive Liver Disease Other Serious 4/15/2011 Physician United States
Primary
Secondary
Cardiac Tamponade Other Serious 1 Male 4/25/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 16 Female 4/25/2011 Physician Russian Federation
Primary
Secondary
Concomitant
Death Other Serious 4/26/2011 Other Health Professional Italy
Primary
Secondary
Concomitant
Fungal Infection Death 42 Male 5/18/2011 Physician China
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 24 Male 5/18/2011 Physician China
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 30 Male 5/19/2011 Physician China
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 20 Male 5/19/2011 Physician China
Primary
Secondary
Concomitant
Cytomegalovirus Infection Other Serious 9 Male 5/10/2011 Other Health Professional United States
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 31 Female 5/19/2011 Physician China
Primary
Secondary
Concomitant
Multi-organ Failure Death 5/25/2011 Physician United States
Primary
Secondary
Concomitant
Myelodysplastic Syndrome Other Serious 5/25/2011 Physician United States
Primary
Secondary
Concomitant
Disease Recurrence Death 5/25/2011 Physician United States
Primary
Secondary
Concomitant
Bacterial Infection Death 5/25/2011 Physician United States
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Death 5/25/2011 Physician United States
Primary
Secondary
Concomitant
Myelodysplastic Syndrome Death 5/25/2011 Physician United States
Primary
Secondary
Concomitant
Myelodysplastic Syndrome Other Serious 5/25/2011 Physician United States
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 55 Male 5/25/2011 Physician China
Primary
Secondary
Concomitant
Transplant Failure Other Serious 7/19/2011 Physician United States
Primary
Secondary
Concomitant
Adenovirus Infection Other Serious 7/19/2011 Physician United States
Primary
Secondary
Concomitant
Transplant Failure Other Serious 7/19/2011 Physician United States
Primary
Secondary
Concomitant
Fungal Sepsis Other Serious 7/19/2011 Physician United States
Primary
Secondary
Concomitant

Drug Data