Fludarabine Phosphate combined with Tacrolimus

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Pneumonia Death Unknown 12/21/2005 Physician United States
Primary
Secondary
Concomitant
Cardiomyopathy Death Unknown 12/21/2005 Physician United States
Primary
Secondary
Concomitant
Sepsis Death 12/21/2005 Physician United States
Primary
Secondary
Concomitant
Pneumonia Cytomegaloviral Death 12/21/2005 Physician United States
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Death 12/21/2005 Physician United States
Primary
Secondary
Concomitant
Dementia Death 12/21/2005 Physician United States
Primary
Secondary
Concomitant
Sudden Cardiac Death Death 12/21/2005 Physician United States
Primary
Secondary
Concomitant
Venoocclusive Disease Death 12/21/2005 Physician United States
Primary
Secondary
Concomitant
Complications Of Transplant Surgery Death 12/21/2005 Physician United States
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Death 12/21/2005 Physician United States
Primary
Secondary
Concomitant
Pneumonia Death Unknown 12/21/2005 Physician United States
Primary
Secondary
Concomitant
Stem Cell Transplant Death Unknown 12/21/2005 Physician United States
Primary
Secondary
Concomitant
Respiratory Syncytial Virus Infection Other Serious 12/16/2005 Male 160 lb 1/13/2006 United States
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 3/19/2006 Male 141 lb 4/11/2006 United States
Primary
Secondary
Troponin I Increased Hospitalization 8/1/2006 Male 181 lb 8/1/2006 United States
Primary
Secondary
Stem Cell Transplant Hospitalization 8/25/2006 Male 138 lb 9/7/2006 United States
Primary
Secondary
Pulmonary Fibrosis Hospitalization 8/25/2006 Male 138 lb 11/15/2006 United States
Primary
Secondary
Graft Versus Host Disease Death 57 Male 3/20/2007 Consumer United States
Primary
Secondary
Mucous Membrane Disorder Other Serious 57 Female 6/13/2007 Japan
Primary
Secondary
Concomitant
Viral Dna Test Positive Other Serious 7/11/2004 15 Male 73 lb 6/22/2007 Japan
Primary
Secondary
Concomitant
Wrong Technique In Drug Usage Process Other Serious 5/30/2007 Female 31 lb 6/28/2007 Pharmacist United States
Primary
Concomitant
Vomiting Life Threatening 1/28/2007 34 Female 7/16/2007 Japan
Primary
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
Pneumonia Parainfluenzae Viral Hospitalization 5/30/2007 45 Male 9/18/2007 Japan
Primary
Concomitant
Stomatitis Life Threatening 5/6/2007 56 Female 9/18/2007 Japan
Primary
Secondary
Concomitant
Transplant Failure Death 3/24/2007 34 Female 9/18/2007 Japan
Primary
Concomitant
Stenotrophomonas Infection Death 4/12/2007 33 Male 9/18/2007 Japan
Primary
Concomitant
Stem Cell Transplant Hospitalization 7/28/2007 Male 9/20/2007 Physician United States
Primary
Secondary
Concomitant
Transplant Rejection Life Threatening 5/23/2007 60 Male 9/20/2007 Other Health Professional Japan
Primary
Concomitant
Stem Cell Transplant Life Threatening 4/9/2007 43 Male 9/20/2007 Other Health Professional Japan
Primary
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
Vomiting Life Threatening 1/28/2007 34 Female 10/22/2007 Japan
Primary
Concomitant
Sepsis Other Serious 58 Female 10/30/2007 Physician United States
Primary
Concomitant
Vomiting Life Threatening 1/1/2007 15 Male 10/26/2007 Japan
Primary
Concomitant
Stomatitis 6/10/2007 21 Female 10/26/2007 Japan
Primary
Concomitant
Stem Cell Transplant Death 7/28/2007 65 Male 10/26/2007 Japan
Primary
Concomitant
Thrombocytopenia Other Serious 1/1/2005 60 Male 11/5/2007 Physician Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 6/3/2007 60 Male 11/16/2007 Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Life Threatening 6/24/2007 14 Female 11/16/2007 Japan
Primary
Concomitant
Streptococcal Sepsis Other Serious 5/3/2007 54 Female 11/16/2007 Japan
Primary
Concomitant
Squamous Cell Carcinoma Other Serious 65 Female 11/26/2007 Other Health Professional United States
Primary
Secondary
Virus Serology Test Positive Other Serious 56 Male 11/20/2007 Japan
Primary
Secondary
Stem Cell Transplant Other Serious 1/1/2005 65 Female 11/20/2007 Consumer United States
Primary
Secondary
Oral Herpes Other Serious 1/1/2005 65 Female 11/29/2007 Consumer
Primary
Secondary
Thrombotic Thrombocytopenic Purpura Other Serious 2/1/2001 52 Male 12/10/2007 Japan
Primary
Concomitant
Cytomegalovirus Viraemia Hospitalization 6/11/2007 60 Male 12/10/2007 Japan
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Other Serious 2/1/2001 52 Male 12/21/2007 Japan
Primary
Concomitant
Vomiting Hospitalization 12/28/2007 Female 197 lb 1/8/2008 United States
Primary
Secondary
Squamous Cell Carcinoma Other Serious 1/1/2005 65 Female 1/15/2008 Consumer United States
Primary
Secondary
Hepatitis Other Serious 1/15/2008 53 Female 126 lb 1/24/2008 Physician United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 10/31/2007 65 Female 3/6/2008 Japan
Primary
Concomitant
Stem Cell Transplant Life Threatening Male 3/6/2008 Japan
Primary
Concomitant
Vertigo Death 58 Male 3/29/2008 Physician Germany
Primary
Secondary
Ureteral Stent Insertion Hospitalization 7/9/2007 56 Male 4/2/2008 Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 10/26/2007 65 Female 4/30/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 6/12/2007 52 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
Therapeutic Agent Toxicity Other Serious 5/12/2008 United States
Primary
Secondary
Concomitant
Vertigo Death Male 5/2/2008 Germany
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
Vertigo Hospitalization 5/7/2007 60 Male 5/15/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Vulval Cancer Other Serious 5/20/2008 United States
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 5/22/2008 Japan
Primary
Secondary
Concomitant
Vulval Cancer Other Serious 5/22/2008 United States
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
Vomiting Life Threatening 5/1/2008 17 Male 6/18/2008 Japan
Primary
Concomitant
Weight Increased Life Threatening 11/4/2007 0 Male 9 lb 6/24/2008 Japan
Primary
Secondary
Concomitant
Pancytopenia Hospitalization 9 Female 6/25/2008 Other Health Professional Germany
Primary
Concomitant
Transplant Failure Other Serious 63 Male 7/1/2008 Japan
Primary
Secondary
Concomitant
Staphylococcal Bacteraemia Other Serious 63 Female 7/1/2008 Japan
Primary
Secondary
Concomitant
Transplant Failure Other Serious 61 Male 7/1/2008 Japan
Primary
Secondary
Concomitant
Transplant Failure Other Serious 59 Female 7/1/2008 Japan
Primary
Secondary
Concomitant
Multi-organ Failure Other Serious 57 Female 7/1/2008 Japan
Primary
Secondary
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
Vomiting 2/9/2008 16 Male 7/2/2008 Japan
Primary
Concomitant
Stomatitis Hospitalization 12/28/2007 2 Female 7/11/2008 Japan
Primary
Concomitant
Subdural Haematoma Other Serious 7/17/2008 United States
Primary
Secondary
Concomitant
Streptococcal Sepsis Disability 7/12/2007 64 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
Treatment Failure Life Threatening 10/17/2007 62 Male 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
Stomatitis Life Threatening 6/30/2007 46 Male 7/18/2008 Japan
Primary
Concomitant
Vomiting Hospitalization 2/25/2007 22 Female 8/1/2008 Japan
Primary
Concomitant
Therapeutic Agent Toxicity Death 8/7/2008 Germany
Primary
Secondary
Concomitant
Multi-organ Failure Other Serious 57 Female 8/7/2008 Japan
Primary
Secondary
Concomitant
Staphylococcal Bacteraemia Other Serious 63 Female 8/7/2008 Japan
Primary
Secondary
Concomitant
Transplant Failure Other Serious 59 Female 8/7/2008 Japan
Primary
Secondary
Concomitant
Transplant Failure Other Serious 63 Male 8/7/2008 Japan
Primary
Secondary
Concomitant
Transplant Failure Other Serious 61 Male 8/7/2008 Japan
Primary
Secondary
Concomitant
Pulmonary Toxicity Other Serious 8/7/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Bone Pain Other Serious 8/7/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Subdural Haematoma Other Serious 8/7/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Stomatitis Life Threatening 7/30/2007 60 Male 8/5/2008 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
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
Vomiting Hospitalization 9/25/2007 48 Female 9/4/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 5/15/2007 62 Male 9/4/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 4/9/2007 43 Male 9/5/2008 Japan
Primary
Concomitant
Pneumonia Life Threatening 5/18/2007 65 Female 9/10/2008 Japan
Primary
Concomitant
Infection Other Serious 44 Male 181 lb 9/15/2008 United States
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 9/18/2007 65 Male 9/12/2008 Other Health Professional Japan
Primary
Concomitant
Hepatitis Hospitalization Female 9/12/2008 Other Health Professional
Primary
Concomitant
Urine Output Decreased Life Threatening 8/13/2007 64 Female 9/15/2008 Japan
Primary
Secondary
Concomitant
Weight Increased Life Threatening 9/27/2007 67 Female 9/25/2008 Japan
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
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
Weight Increased Other Serious 5/29/2008 Female 114 lb 10/10/2008 Other Health Professional Brazil
Primary
Concomitant
Septic Shock Other Serious 8/1/2008 58 Male 123 lb 10/16/2008 Physician Spain
Primary
Secondary
Concomitant
Septic Shock Other Serious 8/1/2008 58 Male 123 lb 10/17/2008 Physician Spain
Primary
Secondary
Concomitant
T-cell Lymphoma Recurrent 1/21/2008 33 Male 10/16/2008 Japan
Primary
Concomitant
Tachycardia Other Serious 8/1/2008 Male 10/22/2008 Other Health Professional Spain
Primary
Concomitant
Transplant Rejection Hospitalization 3/13/2007 33 Male 11/6/2008 Japan
Primary
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
Idiopathic Pneumonia Syndrome Hospitalization 3/24/2007 34 Female 11/10/2008 Japan
Primary
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
Skin Nodule Other Serious 1/1/2006 36 Female 12/1/2008 Other Health Professional Germany
Primary
Concomitant
Stomatitis Hospitalization 10/26/2007 10 Male 12/8/2008 Physician Japan
Primary
Secondary
Venoocclusive Liver Disease Hospitalization 9/30/2007 14 Female 12/9/2008 Physician Japan
Primary
Secondary
Sepsis Life Threatening 9/27/2004 70 Female 117 lb 12/10/2008 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Life Threatening 10/26/2007 64 Male 12/3/2008 Japan
Primary
Secondary
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
Systemic Candida Death 45 Male 12/12/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 1/29/2005 49 Male 366 lb 12/12/2008 Physician Japan
Primary
Concomitant
Stomatitis Hospitalization 3/1/2007 42 Male 12/16/2008 Japan
Primary
Concomitant
Thrombotic Microangiopathy Hospitalization 70 Male 12/30/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Stomatitis Life Threatening 9/18/2007 65 Male 1/5/2009 Japan
Primary
Concomitant

Drug Data