Fludarabine Phosphate combined with Mycophenolate Mofetil

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Rales Other Serious 55 Female 2/9/2006 Physician France
Primary
Concomitant
Squamous Cell Carcinoma Of Skin Other Serious 61 Male 7/15/2006 Physician United States
Primary
Secondary
Concomitant
Photosensitivity Reaction Other Serious 53 Male 7/15/2006 Physician United States
Primary
Secondary
Concomitant
Malignant Melanoma Other Serious 53 Male 10/12/2006 United States
Primary
Secondary
Concomitant
Soft Tissue Infection Required Intervention 8/1/2006 59 Male 11/3/2006 Physician United States
Primary
Secondary
Renal Impairment Death 56 Female 2/16/2007 Germany
Primary
Secondary
Concomitant
Somnolence Death 56 Female 2/16/2007 Germany
Primary
Secondary
Concomitant
Renal Impairment Other Serious 56 Female 2/28/2007 Physician Germany
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Of Skin Death 61 Male 5/15/2007 Physician United States
Primary
Secondary
Concomitant
Malignant Melanoma Other Serious 53 Male 5/29/2007 Physician United States
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Death 61 Male 5/29/2007 Physician United States
Primary
Secondary
Concomitant
Idiosyncratic Drug Reaction Other Serious 49 Female 6/20/2007 France
Primary
Concomitant
Reversible Posterior Leukoencephalopathy Syndrome Hospitalization 39 Female 7/10/2007 Other Health Professional United States
Primary
Concomitant
Viraemia Other Serious 12 Male 9/21/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Erythema Multiforme Death 8/15/2007 Male 292 lb 10/6/2007 Consumer United States
Primary
Concomitant
Erythema Multiforme Death 8/15/2007 Male 292 lb 10/16/2007 Consumer United States
Primary
Concomitant
Stem Cell Transplant Death 7/28/2007 65 Male 10/26/2007 Japan
Primary
Concomitant
Vasculitis Other Serious 15 Male 11/5/2007 Other Health Professional Canada
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Other Serious 65 Female 11/26/2007 Other Health Professional United States
Primary
Secondary
White Blood Cell Count Decreased Life Threatening 10/14/2007 43 Female 249 lb 11/19/2007 Other Health Professional Italy
Primary
Concomitant
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
Serratia Infection Life Threatening 10/14/2007 43 Female 249 lb 12/5/2007 Other Health Professional Italy
Primary
Concomitant
Ventricular Fibrillation Other Serious 10/14/2007 43 Female 249 lb 12/7/2007 Other Health Professional Italy
Primary
Concomitant
Ureteral Stent Insertion Hospitalization 7/9/2007 56 Male 4/2/2008 Japan
Primary
Secondary
Concomitant
Staphylococcal Bacteraemia Other Serious 44 Male 5/9/2008 United States
Primary
Secondary
Infection Death 6/26/2008 Spain
Primary
Secondary
Concomitant
Vitiligo Other Serious 41 Female 6/30/2008 Other Health Professional Turkey
Primary
Secondary
Lymphoproliferative Disorder Death 17 6/30/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Syncope Other Serious 21 Female 7/2/2008 Other Health Professional United States
Primary
Secondary
Retinal Haemorrhage Other Serious 26 Female 7/11/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombosis Other Serious 64 Female 7/16/2008 Other Health Professional France
Primary
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
Visual Acuity Reduced Other Serious 26 Female 7/22/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Streptococcal Sepsis Disability 7/12/2007 64 Male 7/16/2008 Japan
Primary
Concomitant
Vomiting Death 8/2/2007 28 Female 7/17/2008 Other Health Professional Japan
Primary
Concomitant
Treatment Failure Life Threatening 10/17/2007 62 Male 7/17/2008 Other Health Professional Japan
Primary
Concomitant
Vomiting Life Threatening 10/4/2007 66 Male 7/16/2008 Japan
Primary
Concomitant
Visual Impairment Other Serious Female 8/12/2008 Physician Austria
Primary
Secondary
Concomitant
Vomiting Life Threatening 5/30/2007 32 Female 8/18/2008 Japan
Primary
Concomitant
Vomiting Death 8/20/2007 28 Female 8/29/2008 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
Stomatitis Life Threatening 9/6/2007 59 Male 9/19/2008 Japan
Primary
Concomitant
Sepsis Other Serious 45 Male 9/26/2008 Other Health Professional United States
Primary
Concomitant
Sepsis Other Serious 8/1/2005 31 Male 1/18/2008 Other Health Professional Japan
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 8/8/2008 5 Male 9/25/2008 Japan
Primary
Secondary
Concomitant
Respiratory Failure Required Intervention 2 Male 10/1/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Immune Reconstitution Syndrome Hospitalization 31 Female 10/14/2008 Consumer United States
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 1/1/2007 37 Male 10/29/2008 Other Health Professional India
Primary
Secondary
Concomitant
Visual Acuity Reduced Other Serious 6/1/2007 26 Female 11/18/2008 Other Health Professional Japan
Primary
Concomitant
Visual Acuity Reduced Other Serious 6/1/2007 26 Female 11/18/2008 Other Health Professional Japan
Primary
Concomitant
Uveitis Other Serious 18 Female 11/19/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Splenectomy Hospitalization 7 Female 11/24/2008
Primary
Secondary
Concomitant
Skin Nodule Other Serious 1/1/2006 36 Female 12/1/2008 Other Health Professional Germany
Primary
Concomitant
Vision Blurred Other Serious 28 Female 12/1/2008 Other Health Professional Italy
Primary
Secondary
Concomitant
Respiratory Disorder Death 43 Female 12/2/2008 Japan
Primary
Concomitant
White Blood Cell Count Increased Life Threatening 10/26/2007 64 Male 12/3/2008 Japan
Primary
Secondary
Concomitant
Graft Versus Host Disease Other Serious 0 Male 12/15/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 2 Female 12/18/2008 Other Health Professional United Kingdom
Primary
Concomitant
Respiratory Failure Death 59 Male 12/22/2008 Japan
Primary
Secondary
Concomitant
Rheumatoid Factor Positive Other Serious 1/1/2005 36 Female 1/8/2009 Consumer United Kingdom
Primary
Secondary
Thrombotic Thrombocytopenic Purpura Other Serious 12/27/2008 Male 150 lb 1/13/2009 United States
Primary
Concomitant
Wheezing Other Serious 4/9/2008 Male 162 lb 1/13/2009 Other Health Professional United States
Primary
Concomitant
Graft Complication Death 33 137 lb 2/6/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Haemorrhage Other Serious 41 152 lb 2/6/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Fungal Infection Other Serious 41 159 lb 2/6/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Cytomegalovirus Infection Other Serious 32 203 lb 2/6/2009 United States
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 23 123 lb 2/6/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 1/1/2005 36 Female 2/27/2009 Consumer United Kingdom
Primary
Secondary
Renal Failure Other Serious 1/27/2009 59 Male 2/25/2009 Other Health Professional Spain
Primary
Concomitant
Immune System Disorder Other Serious 1/1/2008 43 Female 3/6/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Weight Increased Death 43 Female 3/3/2009 Japan
Primary
Secondary
Concomitant
Infection Other Serious 3/17/2009 Other Health Professional Italy
Primary
Secondary
Concomitant
Infection Other Serious 3/17/2009 Other Health Professional Italy
Primary
Secondary
Concomitant
Pyrexia Other Serious 61 Female 3/26/2009 Other Health Professional Japan
Primary
Concomitant
Staphylococcal Infection Other Serious 2/1/2009 59 Male 3/26/2009 Other Health Professional Spain
Primary
Concomitant
Weight Increased Other Serious 64 Female 4/2/2009 Other Health Professional Germany
Primary
Concomitant
Immune System Disorder Other Serious 1/1/2008 43 Female 101 lb 4/3/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Drug Toxicity Other Serious 17 Female 3/31/2009 Sweden
Primary
Secondary
Concomitant
Epstein-barr Virus Infection Other Serious 10 Male 3/31/2009 Sweden
Primary
Secondary
Concomitant
Pyrexia Other Serious 61 Female 4/7/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Immune System Disorder Other Serious 1/1/2008 43 Female 101 lb 4/8/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 59 Male 4/8/2009 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 61 Female 4/17/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Immune System Disorder Death 1/15/2008 43 Female 101 lb 4/22/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Graft Versus Host Disease Other Serious 2 4/28/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Viral Infection Other Serious 59 Male 4/30/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Respiratory Failure Death 4/30/2009 Other Health Professional Switzerland
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 6 Male 4/30/2009 Canada
Primary
Concomitant
Sicca Syndrome Other Serious 33 Female 5/12/2009 Other Health Professional Germany
Primary
Secondary
Concomitant
Sicca Syndrome Other Serious 33 Female 5/14/2009 Other Health Professional Germany
Primary
Secondary
Concomitant
Systemic Mycosis Hospitalization 7/1/2006 50 Female 5/29/2009 Other Health Professional Italy
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 6/1/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 6/1/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 6/1/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Pseudomonal Sepsis Other Serious 3/28/2009 60 Male 150 lb 5/26/2009 Physician Japan
Primary
Concomitant
Pain Other Serious 7 Male 6/12/2009 Canada
Primary
Concomitant
Cytomegalovirus Infection Other Serious 4 6/22/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Hypotension Hospitalization 5/11/2009 55 Male 207 lb 6/22/2009 Physician United States
Primary
Secondary
Concomitant
Suicidal Ideation Other Serious 17 Male 6/29/2009 Physician United States
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 6 Male 6/26/2009 Canada
Primary
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
Stem Cell Transplant Hospitalization 6 Male 6/30/2009 Other Health Professional Canada
Primary
Concomitant
Tuberculosis Other Serious 12/1/2007 19 Male 7/3/2009 Other Health Professional Brazil
Primary
Secondary
Concomitant
Sudden Death Other Serious 7/6/2009 Other Health Professional United States
Primary
Concomitant
Sepsis Hospitalization 6/22/2008 58 7/6/2009 Other Health Professional Germany
Primary
Secondary
Concomitant
Renal Tubular Necrosis Other Serious 10/27/2007 57 Male 7/6/2009 Other Health Professional Netherlands
Primary
Concomitant
Tuberculosis Other Serious 12/1/2007 19 Male 7/7/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Pseudomonal Sepsis Other Serious 3/4/2009 60 Male 150 lb 6/15/2009 Physician Japan
Primary
Concomitant
Toxoplasmosis Other Serious 40 Male 7/28/2009 Other Health Professional France
Primary
Secondary
Concomitant
Strongyloidiasis Other Serious 63 Male 8/14/2009 Physician United States
Primary
Secondary
Weight Increased Other Serious 44 Female 9/11/2009 Other Health Professional Japan
Primary
Concomitant
Thrombotic Microangiopathy Death Unknown 9/9/2009 Germany
Primary
Secondary
Concomitant
Vomiting Other Serious 7/1/2007 56 Female 9/24/2009 United Kingdom
Primary
Secondary
Concomitant
Graft Versus Host Disease In Lung Other Serious 2/1/2006 45 Female 9/24/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 9/1/2006 52 Male 9/24/2009 United Kingdom
Primary
Secondary
Concomitant
Graft Versus Host Disease Other Serious 2/1/2006 45 Female 9/24/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Graft Versus Host Disease In Lung Other Serious 2/1/2006 45 Female 10/10/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Nausea Other Serious 7/1/2007 56 Female 10/10/2009 United Kingdom
Primary
Secondary
Concomitant
Oral Disorder Other Serious 9/1/2006 52 Male 10/10/2009 United Kingdom
Primary
Secondary
Concomitant
Ultrasound Kidney Abnormal Other Serious 10/8/2009 50 Female 164 lb 10/29/2009 Physician United States
Primary
Secondary
Renal Atrophy Other Serious 10/8/2009 50 Female 164 lb 11/8/2009 Physician United States
Primary
Secondary
Viral Infection Hospitalization 11/5/2009 50 Female 163 lb 11/17/2009 Physician United States
Primary
Secondary
Pseudomonal Sepsis Other Serious 3/4/2009 60 Male 150 lb 11/24/2009 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 64 Male 12/7/2009 Physician Germany
Primary
Secondary
Concomitant
Toxoplasmosis Hospitalization 12/21/2009 Male 121 lb 12/23/2009 Consumer United States
Primary
Secondary
Concomitant
Transaminases Increased Hospitalization 1/5/2010 55 Male 151 lb 1/13/2010 Consumer United States
Primary
Secondary
Concomitant
Tremor Other Serious 39 Female 3/11/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Adenovirus Infection Death 51 Female 3/15/2010 Physician United Kingdom
Primary
Concomitant
Type 1 Diabetes Mellitus Other Serious 61 Male 3/22/2010 Other Health Professional Belgium
Primary
Secondary
Concomitant
Refractoriness To Platelet Transfusion Other Serious 51 Female 3/25/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Pneumonia Toxoplasmal Other Serious 40 Male 3/31/2010 Other Health Professional France
Primary
Secondary
Concomitant
Vitritis Other Serious 0 Female 3/26/2010 Austria
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 64 Female 4/1/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 51 Female 4/1/2010 Consumer United Kingdom
Primary
Concomitant
Fungal Infection Death 3/29/2010 United States
Primary
Secondary
Venoocclusive Liver Disease Other Serious 64 Female 4/5/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Pneumonia Toxoplasmal Other Serious 40 Male 4/5/2010 Other Health Professional France
Primary
Secondary
Concomitant
Vomiting Hospitalization 31 Female 4/6/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Interacting
Sepsis Other Serious 2 Male 5/6/2010 Other Health Professional United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 24 Male 5/6/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Off Label Use Other Serious 5 Male 5/14/2010 Other Health Professional China
Primary
Secondary
Concomitant
Weight Increased Required Intervention 44 Female 5/14/2010 Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Required Intervention 44 Female 5/25/2010 Physician Japan
Primary
Concomitant
Weight Increased Required Intervention 45 Female 5/25/2010 Physician Japan
Primary
Concomitant
Relapsing-remitting Multiple Sclerosis Other Serious 39 Female 6/21/2010 Other Health Professional Canada
Primary
Secondary
Concomitant

Drug Data