Busulfex combined with Tacrolimus

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Renal Impairment 11/15/2007 63 Female 4/2/2008 Japan
Primary
Concomitant
Ureteral Stent Insertion Hospitalization 7/9/2007 56 Male 4/2/2008 Japan
Primary
Secondary
Concomitant
Stomatitis Life Threatening 10/31/2007 50 Male 4/30/2008 Japan
Primary
Concomitant
Vomiting Hospitalization 10/26/2007 65 Female 4/30/2008 Japan
Primary
Concomitant
Thrombotic Microangiopathy Life Threatening 2/6/2007 23 Male 4/30/2008 Japan
Primary
Concomitant
Tumour Associated Fever Hospitalization 11/13/2006 58 Male 4/30/2008 Japan
Primary
Secondary
Concomitant
Sepsis Life Threatening 10/8/2007 57 Female 5/15/2008 Other Health Professional Japan
Primary
Concomitant
Pneumonia Aspiration Hospitalization 12/20/2007 1 Male 5/15/2008 Physician Japan
Primary
Concomitant
Vomiting Other Serious 9/30/2007 67 Female 5/15/2008 Physician Japan
Primary
Concomitant
Tumour Flare Life Threatening 10/30/2007 34 Male 5/15/2008 Physician Japan
Primary
Concomitant
Stomatitis Life Threatening 12/13/2006 30 Male 5/15/2008 Japan
Primary
Secondary
Concomitant
Vertigo Hospitalization 5/7/2007 60 Male 5/15/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Vomiting Life Threatening 2/6/2007 55 Female 5/15/2008 Japan
Primary
Concomitant
Stomatitis Hospitalization 10/12/2007 9 Female 6/6/2008 Japan
Primary
Secondary
Concomitant
Vomiting Life Threatening 10/21/2007 42 Male 6/6/2008 Japan
Primary
Concomitant
Tachycardia Life Threatening 12/13/2006 30 Male 6/11/2008 Japan
Primary
Secondary
Concomitant
Vomiting Life Threatening 5/1/2008 17 Male 6/18/2008 Japan
Primary
Concomitant
Vomiting Death 63 Male 6/19/2008 Japan
Primary
Concomitant
Weight Increased Life Threatening 11/4/2007 0 Male 9 lb 6/24/2008 Japan
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Recurrent Life Threatening 1/22/2008 26 Female 6/27/2008 Other Health Professional Japan
Primary
Concomitant
Bone Marrow Transplant Rejection Life Threatening 4/15/2008 2 Male 6/27/2008 Other Health Professional Japan
Primary
Concomitant
Pneumonia Disability 10/3/2007 37 Male 6/27/2008 Other Health Professional Japan
Primary
Concomitant
Oral Disorder Death 45 Female 6/27/2008 Other Health Professional Japan
Primary
Concomitant
Vomiting Hospitalization 3/22/2007 64 Male 6/30/2008 Physician Japan
Primary
Concomitant
Stomatitis Life Threatening 10/23/2007 50 Male 7/1/2008 Physician Japan
Primary
Concomitant
Vomiting 2/9/2008 16 Male 7/2/2008 Japan
Primary
Concomitant
Stenotrophomonas Sepsis Death 3/22/2007 65 Male 7/2/2008 Japan
Primary
Concomitant
Vomiting Life Threatening 2/29/2008 1 Female 7/2/2008 Japan
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 6/10/2008 Female 7/8/2008 Japan
Primary
Secondary
Concomitant
Stomatitis Hospitalization 12/28/2007 2 Female 7/11/2008 Japan
Primary
Concomitant
Stomatitis Hospitalization 8/31/2007 60 Male 7/10/2008 Japan
Primary
Concomitant
Streptococcal Sepsis Disability 7/12/2007 64 Male 7/16/2008 Japan
Primary
Concomitant
Stomatitis 2/3/2008 3 Female 7/16/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 11/30/2007 50 Male 7/16/2008 Japan
Primary
Concomitant
Vomiting 5/5/2008 12 Female 7/17/2008 Japan
Primary
Concomitant
Stomatitis Hospitalization 3/1/2007 42 Male 7/17/2008 Japan
Primary
Concomitant
Stomatitis Death 3/8/2007 67 Male 7/17/2008 Japan
Primary
Concomitant
Treatment Failure Life Threatening 10/17/2007 62 Male 7/17/2008 Other Health Professional Japan
Primary
Concomitant
Hypertrophic Cardiomyopathy 5/15/2008 1 Male 7/17/2008 Other Health Professional Japan
Primary
Concomitant
Nausea Death 6/27/2007 47 Female 7/17/2008 Other Health Professional Japan
Primary
Concomitant
Vomiting Hospitalization 5/27/2007 52 Male 7/16/2008 Japan
Primary
Concomitant
Stomatitis Death 9/29/2007 36 Female 7/16/2008 Japan
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 10/16/2007 13 Female 7/17/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 6/30/2007 46 Male 7/18/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 10/12/2007 9 Female 7/25/2008 Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 2/25/2007 22 Female 8/1/2008 Japan
Primary
Concomitant
Respiratory Failure Hospitalization 6/10/2008 15 Female 8/1/2008 Japan
Primary
Secondary
Concomitant
Stomatitis Life Threatening 7/30/2007 60 Male 8/5/2008 Japan
Primary
Concomitant
Vomiting 11/30/2007 9 Male 8/14/2008 Other Health Professional Japan
Primary
Concomitant
Stomatitis 5/23/2007 29 Female 8/14/2008 Japan
Primary
Concomitant
Vomiting Life Threatening 4/17/2007 40 Female 8/14/2008 Other Health Professional Japan
Primary
Concomitant
Stomatitis Life Threatening 10/10/2007 34 Male 8/18/2008 Japan
Primary
Concomitant
Vomiting Life Threatening 5/30/2007 32 Female 8/18/2008 Japan
Primary
Concomitant
Urine Output Decreased Life Threatening 8/13/2007 64 Female 8/19/2008 Japan
Primary
Concomitant
Stomatitis Hospitalization 5/27/2007 53 Female 8/22/2008 Japan
Primary
Concomitant
Stomatitis Disability 4/15/2008 Female 8/25/2008 Japan
Primary
Concomitant
Vomiting Hospitalization 46 Male 8/25/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 10/4/2007 66 Male 8/28/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 10/4/2007 66 Male 8/28/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 5/15/2007 62 Male 9/4/2008 Japan
Primary
Concomitant
Venoocclusive Liver Disease Hospitalization 2 Female 9/4/2008 Japan
Primary
Concomitant
Weight Increased Hospitalization 11/10/2007 55 Male 9/5/2008 Japan
Primary
Concomitant
Vomiting Life Threatening 10/1/2007 63 Male 9/5/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 6/25/2007 65 Male 9/5/2008 Japan
Primary
Concomitant
Vomiting Life Threatening 10/19/2007 44 Female 9/5/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 4/9/2007 43 Male 9/5/2008 Japan
Primary
Concomitant
Staphylococcal Sepsis Life Threatening 4/19/2007 17 Male 9/5/2008 Japan
Primary
Secondary
Concomitant
Vomiting Life Threatening 3/3/2006 9 Female 9/8/2008 Japan
Primary
Concomitant
Pneumonia Life Threatening 5/18/2007 65 Female 9/10/2008 Japan
Primary
Concomitant
Hepatic Function Abnormal Hospitalization 3/14/2007 35 Female 9/10/2008 Japan
Primary
Concomitant
Vomiting Life Threatening 12/16/2006 50 Male 9/9/2008 Japan
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 6/15/2007 52 Male 9/11/2008 Other Health Professional Japan
Primary
Concomitant
Thrombotic Microangiopathy Life Threatening 9/25/2007 48 Female 9/11/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Stomatitis Life Threatening 10/13/2007 53 Male 9/11/2008 Other Health Professional Japan
Primary
Concomitant
Stomatitis Life Threatening 11/20/2007 3 Male 9/11/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 3/1/2007 67 Male 9/11/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 9/18/2007 65 Male 9/12/2008 Other Health Professional Japan
Primary
Concomitant
Vomiting Life Threatening 5/23/2007 31 Male 9/16/2008 Japan
Primary
Secondary
Concomitant
Urine Output Decreased Life Threatening 8/13/2007 64 Female 9/15/2008 Japan
Primary
Secondary
Concomitant
Vomiting Life Threatening 12/8/2006 51 Female 9/17/2008 Japan
Primary
Concomitant
Stem Cell Transplant Life Threatening 7/26/2007 49 Male 9/17/2008 Japan
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 7/28/2007 13 Female 9/17/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 11/22/2007 50 Male 9/19/2008 Japan
Primary
Concomitant
Sepsis Death 57 Female 9/19/2008 Japan
Primary
Concomitant
Weight Increased Life Threatening 9/27/2007 67 Female 9/25/2008 Japan
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 8/8/2008 5 Male 9/25/2008 Japan
Primary
Secondary
Concomitant
Stomatitis Life Threatening 31 Female 9/25/2008 Japan
Primary
Concomitant
Vomiting Hospitalization 4/28/2008 16 Male 10/10/2008 Japan
Primary
Concomitant
T-cell Lymphoma Recurrent 1/21/2008 33 Male 10/16/2008 Japan
Primary
Concomitant
Vomiting Death 11/30/2006 11 Male 10/17/2008 Japan
Primary
Concomitant
Transplant Rejection Hospitalization 3/13/2007 33 Male 11/6/2008 Japan
Primary
Concomitant
Idiopathic Pneumonia Syndrome Hospitalization 3/24/2007 34 Female 11/10/2008 Japan
Primary
Concomitant
Vomiting Life Threatening 12/16/2006 50 Male 11/14/2008 Japan
Primary
Concomitant
Vomiting Life Threatening 4/25/2007 16 Male 11/14/2008 Japan
Primary
Secondary
Concomitant
Weight Increased Hospitalization 11/10/2007 55 Male 11/18/2008 Japan
Primary
Concomitant
Vomiting Life Threatening 9/6/2007 63 Male 11/21/2008 Japan
Primary
Concomitant
Vomiting Hospitalization 5/5/2007 50 Female 11/26/2008 Japan
Primary
Secondary
Concomitant
Vomiting Life Threatening 10/19/2007 44 Female 11/24/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 6/4/2007 44 Female 11/24/2008 Japan
Primary
Concomitant
Vomiting Hospitalization 9/28/2007 11 Male 11/25/2008 Japan
Primary
Concomitant
Nausea Death 6/27/2007 47 Female 11/25/2008 Japan
Primary
Concomitant
Vomiting Life Threatening 2/10/2007 0 Female 12/4/2008 Japan
Primary
Concomitant
White Blood Cell Count Increased Life Threatening 10/26/2007 64 Male 12/3/2008 Japan
Primary
Secondary
Concomitant
Vomiting Life Threatening 2/10/2007 0 Female 12/9/2008 Japan
Primary
Concomitant
Stomatitis Hospitalization 4/18/2007 64 Female 12/9/2008 Japan
Primary
Concomitant
Cytomegalovirus Chorioretinitis 32 Female 12/8/2008 Korea, Republic Of
Primary
Concomitant
Cytomegalovirus Chorioretinitis 25 Female 12/8/2008 Physician Korea, Republic Of
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 6/15/2007 52 Male 12/11/2008 Japan
Primary
Secondary
Concomitant
Vomiting Life Threatening 10/3/2007 34 Male 12/17/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Stomatitis Hospitalization 6/18/2007 27 Female 12/17/2008 Japan
Primary
Secondary
Concomitant
Stomatitis Hospitalization 3/1/2007 42 Male 12/16/2008 Japan
Primary
Concomitant
Vomiting Life Threatening 12/16/2006 50 Male 12/16/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 6/4/2007 44 Female 12/29/2008 Japan
Primary
Concomitant
Weight Increased Hospitalization 11/10/2007 55 Male 12/29/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 9/18/2007 65 Male 1/5/2009 Japan
Primary
Concomitant
Vomiting 10/27/2007 64 Female 1/22/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Life Threatening 6/8/2006 60 Male 1/29/2009 Japan
Primary
Concomitant
Weight Increased Hospitalization 11/10/2007 55 Male 2/3/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 6/15/2007 52 Male 2/3/2009 Japan
Primary
Secondary
Concomitant
Toxic Encephalopathy Life Threatening 7/4/2007 51 Male 2/3/2009 Japan
Primary
Secondary
Concomitant
Stomatitis Disability 10/11/2007 58 Female 2/6/2009 Japan
Primary
Concomitant
Nausea Life Threatening 6/27/2007 47 Female 2/6/2009 Japan
Primary
Concomitant
Human Herpes Virus 6 Serology Positive Hospitalization 2 Male 5/8/2009 Physician Japan
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection 16 5/21/2009 United Kingdom
Primary
Secondary
Concomitant
Tubulointerstitial Nephritis Hospitalization 50 Male 6/18/2009 Greece
Primary
Secondary
Concomitant
Venoocclusive Liver Disease 1 Female 12/1/2009 Japan
Primary
Concomitant
Venoocclusive Liver Disease 1 Female 12/14/2009 Japan
Primary
Concomitant
Overdose Other Serious 52 Female 3/19/2010 Other Health Professional United States
Primary
Concomitant
Sepsis 64 Male 3/18/2010 Japan
Primary
Concomitant
Influenza Other Serious 52 Female 3/8/2010 United States
Primary
Concomitant
Tonsillar Inflammation Other Serious 41 Male 3/8/2010 United States
Primary
Concomitant
Overdose 41 Male 3/26/2010 Other Health Professional United States
Primary
Concomitant
Hepatic Function Abnormal Life Threatening 6/28/2009 Male 3/30/2010 Physician Japan
Primary
Concomitant
Renal Failure Acute Other Serious 52 Male 4/1/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Influenza Other Serious 52 Female 3/30/2010 United States
Primary
Concomitant
Renal Failure Acute Other Serious 52 Male 4/5/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Tumour Lysis Syndrome Other Serious 52 Male 4/2/2010 Physician United States
Primary
Concomitant
Sepsis 64 Male 4/1/2010 Japan
Primary
Concomitant
Renal Failure Acute Other Serious 52 Male 4/16/2010 Physician United States
Primary
Concomitant
T-lymphocyte Count Decreased Other Serious 1 Female 4/23/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Pleural Effusion Other Serious 64 Male 4/26/2010 Physician Japan
Primary
Concomitant
Fluid Retention Other Serious 64 Male 4/26/2010 Physician Japan
Primary
Concomitant
Pseudomonas Infection Other Serious 8 Female 13 lb 4/26/2010 Other Health Professional United States
Primary
Concomitant
Pseudomonas Infection Other Serious 1 Female 4/30/2010 Other Health Professional United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 1 Female 13 lb 4/29/2010 United States
Primary
Concomitant
Neoplasm Progression Other Serious 56 Female 4/29/2010 Physician Japan
Primary
Concomitant
Pleural Effusion Other Serious 64 Male 5/3/2010 Japan
Primary
Concomitant
Fluid Retention Other Serious 64 Male 5/3/2010 Japan
Primary
Concomitant
Staphylococcal Infection Life Threatening 5/1/2007 65 Male 99 lb 5/26/2010 Consumer Japan
Primary
Concomitant
Stem Cell Transplant Death 3/10/2008 59 Male 5/24/2010 Japan
Primary
Secondary
Concomitant

Drug Data