Fludarabine Phosphate combined with Mitoxantrone

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Paralysis Other Serious 10/1/2005 66 Male 168 lb 1/13/2006 Physician Germany
Primary
Concomitant
Transplant Life Threatening 7/2/2005 59 Male 139 lb 2/22/2006 Physician France
Primary
Secondary
Concomitant
Peritoneal Carcinoma Life Threatening 7/2/2005 59 Male 139 lb 3/6/2006 Physician France
Primary
Secondary
Concomitant
Metastases To Peritoneum Life Threatening 7/2/2005 59 Male 139 lb 3/16/2006 Physician France
Primary
Secondary
Concomitant
Ventricular Arrhythmia Hospitalization 10/8/2003 76 Male 225 lb 4/17/2006 Other Health Professional Germany
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious Unknown 5/1/2006 United States
Primary
Secondary
Thrombocytopenia Other Serious Unknown 5/1/2006 Physician United States
Primary
Secondary
Thrombocytopenia Other Serious Unknown 5/1/2006 Physician United States
Primary
Secondary
Thrombocytopenia Other Serious Unknown 5/1/2006 Physician United States
Primary
Secondary
Neutropenia Other Serious Unknown 5/1/2006 United States
Primary
Secondary
Neutropenia Other Serious Unknown 5/1/2006 United States
Primary
Secondary
Neutropenia Other Serious Unknown 5/1/2006 United States
Primary
Secondary
Neutropenia Other Serious Unknown 5/1/2006 United States
Primary
Secondary
Neutropenia Other Serious Unknown 5/1/2006 United States
Primary
Secondary
Neutropenia Other Serious Unknown 5/1/2006 United States
Primary
Secondary
Neutropenia Other Serious Unknown 5/1/2006 United States
Primary
Secondary
Neutropenia Other Serious Unknown 5/1/2006 United States
Primary
Secondary
Neutropenia Other Serious 5/1/2006 United States
Primary
Secondary
Neutropenia Other Serious Unknown 5/1/2006 United States
Primary
Secondary
Myelodysplastic Syndrome Other Serious 2/1/1999 53 Male 8/14/2006 Other Health Professional Hong Kong
Primary
Secondary
Myelodysplastic Syndrome Death 6/1/2002 65 Male 8/14/2006 Other Health Professional Hong Kong
Primary
Secondary
Septic Shock Death 7/24/2006 58 Male 126 lb 8/18/2006 Other Health Professional Spain
Primary
Concomitant
Febrile Neutropenia Hospitalization 8/1/2006 56 Male 173 lb 8/22/2006 Physician United Kingdom
Primary
Secondary
Concomitant
Transplant Failure Death 48 Male 9/1/2006 Germany
Primary
Secondary
Concomitant
Neutropenia Other Serious 7/25/2005 72 Female 168 lb 9/12/2006 Other Health Professional Italy
Primary
Secondary
Concomitant
Myelodysplastic Syndrome Death 12/1/2000 71 Male 9/8/2006
Primary
Secondary
Myelodysplastic Syndrome Other Serious 2/1/1999 53 Male 9/8/2006
Primary
Secondary
Myelodysplastic Syndrome Death 6/1/2002 65 Male 9/8/2006
Primary
Secondary
Myelodysplastic Syndrome Other Serious 1/1/2005 45 Female 9/8/2006
Primary
Secondary
Pancytopenia Other Serious 66 Female 11/22/2006 Physician Australia
Primary
Secondary
Malignant Neoplasm Progression Other Serious 53 Male 11/22/2006 Physician Australia
Primary
Secondary
Pulmonary Fibrosis Other Serious 6/1/2006 77 Male 181 lb 2/22/2007 Physician Germany
Primary
Concomitant
Pulmonary Fibrosis Other Serious 6/1/2006 77 Male 181 lb 3/22/2007 Physician Germany
Primary
Secondary
Concomitant
Myelodysplastic Syndrome Death 52 Female 4/12/2007 Other Health Professional United Kingdom
Primary
Secondary
Diplopia Hospitalization 5/15/2006 73 Male 5/17/2007 Consumer United States
Primary
Secondary
Tumour Lysis Syndrome Other Serious 4/13/2007 Female 174 lb 5/30/2007 Physician United States
Primary
Secondary
Concomitant
Pulmonary Tuberculosis Hospitalization 8/14/2006 Female 185 lb 6/21/2007 Physician France
Primary
Secondary
Pulmonary Tuberculosis Hospitalization 8/14/2006 Female 185 lb 6/22/2007 Physician France
Primary
Secondary
Diplopia Hospitalization 5/15/2006 73 Male 8/1/2007 United Kingdom
Primary
Secondary
Pulmonary Fibrosis Other Serious 6/1/2006 Male 181 lb 8/24/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Medication Error 8/30/2007 8/31/2007 Pharmacist United States
Primary
Secondary
Febrile Neutropenia Life Threatening 9/26/2007 Male 10/3/2007 Physician United Kingdom
Primary
Secondary
Febrile Neutropenia Life Threatening 9/26/2007 Male 154 lb 10/5/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Pneumonia Hospitalization 1/25/2006 Male 130 lb 10/17/2007 Consumer France
Primary
Secondary
Rash Hospitalization 2/20/2002 Female 128 lb 11/9/2007 Consumer Japan
Primary
Concomitant
Pneumonia Bacterial Death 6/20/2007 Male 11/10/2007 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 1/2/2006 Male 194 lb 11/12/2007 Consumer France
Primary
Secondary
Renal Failure Other Serious 1/1/2006 Female 11/16/2007 Consumer United Kingdom
Primary
Concomitant
Pharmaceutical Product Complaint 8/31/2007 Pharmacist United States
Primary
Secondary
Febrile Neutropenia Hospitalization 8/2/2007 Female 123 lb 11/28/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Pneumonia Bacterial Death 6/20/2007 Male 12/7/2007 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 5/25/2007 Male 141 lb 12/13/2007 Consumer United Kingdom
Primary
Secondary
Acute Respiratory Failure Hospitalization 12/5/2007 Male 12/22/2007 Consumer United Kingdom
Primary
Secondary
Concomitant
Acute Respiratory Failure Hospitalization 12/5/2007 Male 1/2/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 9/27/2007 60 Female 1/16/2008 Other Health Professional United States
Primary
Secondary
Neurological Symptom Life Threatening 12/24/2007 Male 154 lb 1/22/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Trichosporon Infection Death 9/13/2006 77 Male 3/19/2008 Physician Japan
Primary
Secondary
Platelet Count Decreased Other Serious 3/10/2008 71 Male 163 lb 4/18/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Tremor Other Serious 3/10/2008 71 Male 165 lb 4/18/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Pyrexia Hospitalization 12/13/2007 Female 143 lb 4/19/2008 Consumer United Kingdom
Primary
Secondary
Sinusitis Fungal Hospitalization 52 Female 4/23/2008 United Kingdom
Primary
Secondary
Concomitant
Stomatitis Life Threatening 6/12/2007 52 Female 4/30/2008 Japan
Primary
Concomitant
Petit Mal Epilepsy Disability 2/3/2008 22 Female 99 lb 5/12/2008 Physician Poland
Primary
Concomitant
Colon Cancer Other Serious 2/12/2008 66 Male 6/9/2008 Consumer United Kingdom
Primary
Secondary
Refractory Anaemia With Ringed Sideroblasts Other Serious 10/1/2007 54 Male 6/3/2008 Other Health Professional United States
Primary
Concomitant
Pulmonary Toxicity Other Serious 6/13/2008 Italy
Primary
Secondary
Pulmonary Toxicity Other Serious 6/13/2008 Italy
Primary
Secondary
Febrile Neutropenia Hospitalization 7/23/2007 Male 172 lb 6/26/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 5/7/2006 Female 132 lb 7/2/2008 Physician France
Primary
Secondary
Sepsis Other Serious 7/7/2008 Japan
Primary
Secondary
Colon Cancer Other Serious 2/12/2008 7/10/2008 Consumer United Kingdom
Primary
Secondary
Pneumonia Hospitalization 1/2/2006 Male 130 lb 7/22/2008 Consumer France
Primary
Secondary
Pneumonia Other Serious Female 9/11/2008 Physician Hungary
Primary
Secondary
Pneumonia Other Serious Female 9/11/2008 Physician Hungary
Primary
Secondary
Pneumonia Death 49 Male 9/18/2008 Physician Hungary
Primary
Secondary
Pneumonia Death 66 Female 9/19/2008 Physician Hungary
Primary
Secondary
Progressive Multifocal Leukoencephalopathy Hospitalization 4/1/2000 64 Male 10/10/2008 Physician Australia
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Other Serious 75 Male 11/7/2008 Italy
Primary
Secondary
Drug Ineffective Other Serious 75 Male 11/17/2008 United Kingdom
Primary
Concomitant
Pneumonia Bacterial Hospitalization 1/2/2006 Male 130 lb 11/17/2008 Consumer France
Primary
Secondary
Gastrointestinal Inflammation Other Serious 1/1/2007 Male 11/19/2008 Consumer United Kingdom
Primary
Concomitant
Leukaemia Other Serious 5/10/2008 69 Male 11/25/2008 Physician Japan
Primary
Concomitant
Toxic Encephalopathy Other Serious 3/1/2006 13 Female 11/24/2008 Other Health Professional Japan
Primary
Concomitant
Toxic Encephalopathy Other Serious 3/1/2006 13 Female 11/26/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Toxic Encephalopathy Other Serious 3/1/2006 13 Female 11/26/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Colon Cancer Life Threatening 9/23/2008 12/18/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Progressive Multifocal Leukoencephalopathy Other Serious 6/1/2008 Female 12/24/2008 Physician Germany
Primary
Secondary
Concomitant
Progressive Multifocal Leukoencephalopathy Other Serious 10/8/2008 Male 12/24/2008 Other Health Professional United Kingdom
Primary
Concomitant
Myelodysplastic Syndrome Other Serious 1/19/2009 United States
Primary
Secondary
Colon Cancer Other Serious 2/11/2008 1/21/2009 Consumer United Kingdom
Primary
Secondary
Gastrointestinal Disorder Hospitalization 12/13/2008 Male 2/26/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 10/21/2008 Female 4/9/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Ventricular Septal Defect Other Serious Male 4 lb 4/9/2009 Germany
Primary
Secondary
Progressive Multifocal Leukoencephalopathy Other Serious 59 Female 4/22/2009 Other Health Professional United States
Primary
Concomitant
Pleural Effusion Hospitalization 3/31/2009 72 Female 120 lb 4/24/2009 Consumer United States
Primary
Secondary
Concomitant
Hip Arthroplasty Hospitalization 9/19/2007 Male 4/24/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 54 Male 5/11/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
Progressive Multifocal Leukoencephalopathy Other Serious Female 105 lb 5/15/2009 Other Health Professional United States
Primary
Concomitant
Septic Shock Other Serious 21 Male 5/19/2009 Other Health Professional Hong Kong
Primary
Secondary
Concomitant
Rhabdomyolysis Hospitalization 54 Male 5/18/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
Progressive Multifocal Leukoencephalopathy Death 64 Female 6/26/2009 Austria
Primary
Secondary
Hip Arthroplasty Hospitalization 4/16/2008 Male 6/26/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Non-hodgkin's Lymphoma Unspecified Histology Aggressive Death Male 6/29/2009 Physician United Kingdom
Primary
Concomitant
Staphylococcal Infection Other Serious 1/1/2008 43 Male 6/29/2009 Physician United Kingdom
Primary
Secondary
Pruritus Other Serious 6/3/2009 78 Male 7/1/2009 Consumer United Kingdom
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Death 8/1/2008 64 Female 7/7/2009 Consumer United Kingdom
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Death 59 Female 9/14/2009 Other Health Professional United States
Primary
Secondary
Supraventricular Extrasystoles Required Intervention Male 4 lb 11/16/2009 Physician Germany
Primary
Concomitant
Stevens-johnson Syndrome Death 3/9/2010 Physician Italy
Primary
Secondary
Transplant Rejection Other Serious 2/1/2009 56 Male 3/25/2010 Other Health Professional Japan
Primary
Concomitant
Transplant Rejection Other Serious 2/1/2009 56 Male 3/31/2010 Other Health Professional Japan
Primary
Concomitant
Paresis Life Threatening 4/10/2010 56 Male 5/7/2010 Physician Austria
Primary
Secondary
Neurological Symptom Hospitalization 5/4/2009 65 Male 7/12/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Leukaemia Recurrent Death 57 Female 9/30/2010 Turkey
Primary
Secondary
Concomitant
Neutropenia Other Serious 14 Female 10/5/2010 Japan
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 11/4/2010 Consumer United Kingdom
Primary
Secondary
Conus Medullaris Syndrome Other Serious 74 Female 11/17/2010 Physician Spain
Primary
Concomitant
Red Blood Cell Count Decreased Other Serious 12/12/2009 57 Female 11/30/2010 Other Health Professional Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 9 Female 12/28/2010 Physician Japan
Primary
Concomitant
Acute Myeloid Leukaemia Death 53 Female 2/16/2011 Australia
Primary
Secondary
Concomitant
Neutropenia Other Serious 5/2/2011 Physician China
Primary
Secondary
Refractory Cytopenia With Multilineage Dysplasia Other Serious 53 Female 4/27/2011 Other Health Professional Australia
Primary
Concomitant
Refractory Anaemia With An Excess Of Blasts Death 62 Female 4/27/2011 Other Health Professional Australia
Primary
Concomitant
Myelodysplastic Syndrome Other Serious 53 Male 4/27/2011 Other Health Professional Australia
Primary
Concomitant
Myelodysplastic Syndrome Other Serious 54 Male 4/27/2011 Other Health Professional Australia
Primary
Concomitant
Weight Increased Other Serious 68 Male 5/18/2011 Other Health Professional Japan
Primary
Secondary
Staphylococcal Abscess Hospitalization 42 Male 5/24/2011 Other Health Professional Poland
Primary
Concomitant
Herpes Zoster Hospitalization 2/28/2009 59 Male 141 lb 6/10/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Death 62 Female 2/21/2011 Australia
Primary
Secondary
Concomitant
Hip Arthroplasty Hospitalization 4/16/2008 67 Male 187 lb 7/12/2011 Consumer United Kingdom
Primary
Secondary
Concomitant
Dermatitis Exfoliative Hospitalization 4/1/2011 69 Male 7/29/2011 Consumer United Kingdom
Primary
Secondary
Concomitant
Cauda Equina Syndrome Other Serious 74 Female 8/12/2011 Other Health Professional Spain
Primary
Secondary
Concomitant
Pulmonary Tuberculosis Hospitalization 6/26/2011 9/15/2011 Consumer United Kingdom
Primary
Secondary
Condition Aggravated Hospitalization 5/25/2010 70 Female 176 lb 9/22/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Viith Nerve Paralysis Disability 49 Male 11/23/2011 Other Health Professional Switzerland
Primary
Secondary
Interstitial Lung Disease Hospitalization 12/16/2011 Physician Germany
Primary
Concomitant
Guillain-barre Syndrome Life Threatening 49 Male 12/19/2011 Other Health Professional Austria
Primary
Secondary
Cardiac Failure Hospitalization 3/11/2012 2 Male 35 lb 3/12/2012 United States
Primary
Secondary
Concomitant
Clumsiness Death 50 Male 3/15/2012 Other Health Professional Latvia
Primary
Concomitant
General Physical Health Deterioration Death 65 Male 3/21/2012 Other Health Professional United Kingdom
Primary
Concomitant
Acute Myeloid Leukaemia Other Serious 54 Male 4/4/2012 Other Health Professional Serbia
Primary
Secondary
Myelodysplastic Syndrome Other Serious 54 Male 4/4/2012 Other Health Professional Serbia
Primary
Secondary
Acute Myeloid Leukaemia Other Serious 54 Male 4/13/2012 Other Health Professional Serbia
Primary
Secondary
Acute Myeloid Leukaemia Other Serious 54 Male 4/10/2012 Other Health Professional Serbia
Primary
Secondary
Cns Ventriculitis Death 65 Male 4/16/2012 Physician United States
Primary
Secondary
Acute Myeloid Leukaemia Death 54 Male 4/24/2012 Other Health Professional Serbia
Primary
Secondary
Tumour Flare Hospitalization 2/24/2011 58 Male 236 lb 11/8/2011 Physician United States
Primary
Concomitant
Febrile Neutropenia Death Female 6/13/2012 Physician Argentina
Primary
Concomitant
Arrhythmia Death 6/21/2012 Physician Germany
Primary
Secondary
Immunosuppression Death Female 6/21/2012 Physician Argentina
Primary
Secondary
Concomitant

Drug Data