Cytarabine combined with Itraconazole

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Venoocclusive Disease Life Threatening 11/23/2005 63 Female 121 lb 1/12/2006 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Rash Hospitalization 1/12/2006 Female 117 lb 2/15/2006 Physician Portugal
Primary
Concomitant
Platelet Count Decreased Life Threatening 10/10/2005 43 Female 2/27/2006 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 10/10/2005 43 Female 3/20/2006 Japan
Primary
Secondary
Concomitant
Weight Increased Other Serious 10/13/2005 Female 214 lb 3/27/2006 Physician Portugal
Primary
Concomitant
Skin Oedema Other Serious 1/17/2006 Female 282 lb 3/28/2006 Physician Portugal
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 20 Male 4/3/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Pulmonary Haemorrhage Death 83 Male 4/13/2006 Physician United States
Primary
Secondary
Concomitant
Renal Impairment Death 3/29/2006 64 Male 4/25/2006 Japan
Primary
Concomitant
Weight Increased Other Serious 10/13/2005 Female 214 lb 5/5/2006 Physician Portugal
Primary
Concomitant
Skin Oedema Other Serious 1/17/2006 Female 282 lb 5/5/2006 Physician Portugal
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 1/1/2005 57 Female 108 lb 5/5/2006 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 1/1/2005 57 Female 108 lb 6/1/2006 Physician Japan
Primary
Secondary
Concomitant
Skin Exfoliation Other Serious 46 Female 6/16/2006 Canada
Primary
Secondary
Concomitant
Pancytopenia Hospitalization 6/11/2006 Male 153 lb 6/16/2006 United States
Primary
Secondary
Concomitant
Vomiting Required Intervention 5/21/2005 74 Female 6/29/2006 Physician United States
Primary
Secondary
Concomitant
Tracheal Haemorrhage Hospitalization 5/31/2006 69 Male 6/28/2006 Physician United States
Primary
Secondary
Concomitant
Vomiting Required Intervention 5/21/2005 74 Female 6/27/2006 Physician United States
Primary
Secondary
Concomitant
Renal Impairment Death 3/29/2006 64 Male 6/30/2006 Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 7/27/2005 57 Female 108 lb 7/14/2006 Physician Japan
Primary
Secondary
Concomitant
Skin Exfoliation Other Serious 11/6/2005 46 Female 153 lb 7/25/2006 Canada
Primary
Secondary
Concomitant
Staphylococcal Infection Hospitalization 7/2/2006 31 Female 180 lb 7/27/2006 Physician United States
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 7/2/2006 31 Female 180 lb 9/7/2006 Physician United States
Primary
Concomitant
Febrile Neutropenia Other Serious 5/15/2006 83 Female 9/13/2006 United States
Primary
Secondary
Concomitant
Oedema Peripheral Other Serious 7/27/2005 57 Female 108 lb 10/12/2006 Physician Japan
Primary
Secondary
Concomitant
Skin Exfoliation Other Serious 11/6/2005 46 Female 11/8/2006 Pharmacist Canada
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Life Threatening 10/9/2006 68 Male 11/9/2006 United States
Primary
Concomitant
Stomatitis Hospitalization 6/10/2006 28 Male 11/15/2006 Japan
Primary
Secondary
Concomitant
Ventricular Flutter Life Threatening 2/27/2006 20 Female 11/21/2006 Japan
Primary
Concomitant
Stomatitis Hospitalization 6/10/2006 28 Male 1/2/2007 Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 8/28/2006 28 Male 1/8/2007 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 6/20/2006 58 Male 1/17/2007 Japan
Primary
Concomitant
Sepsis Other Serious 6/10/2006 Male 130 lb 1/30/2007 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Other Serious 8/28/2006 28 Male 2/5/2007 Japan
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Life Threatening 10/9/2006 68 Male 2/22/2007 Other Health Professional United States
Primary
Concomitant
Ventricular Flutter Other Serious 2/27/2006 Female 95 lb 3/5/2007 Physician Japan
Primary
Secondary
Concomitant
Neutropenia Other Serious 5/15/2006 83 Female 2/26/2007 Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 1/1/2006 Male 130 lb 3/7/2007 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 6/20/2006 Male 117 lb 3/9/2007 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 8/11/2006 56 Male 3/9/2007 United States
Primary
Secondary
Concomitant
Stomatitis Other Serious 8/28/2006 28 Male 3/13/2007 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 3/16/2006 20 Female 3/13/2007 Japan
Primary
Secondary
Concomitant
Pneumonia Other Serious 5/15/2006 83 Female 3/19/2007 Japan
Primary
Secondary
Concomitant
Streptococcal Bacteraemia Death 12 Female 4/2/2007 Physician Japan
Primary
Concomitant
Streptococcal Bacteraemia Death 12 Female 4/6/2007 Physician Japan
Primary
Concomitant
Sepsis Other Serious 6/10/2006 Male 130 lb 4/17/2007 Physician Japan
Primary
Secondary
Concomitant
Pseudomembranous Colitis Other Serious 10/30/2006 Male 161 lb 4/17/2007 Physician Japan
Primary
Secondary
Concomitant
Nephrogenic Diabetes Insipidus Other Serious 12 Male 4/20/2007 Other Health Professional United States
Primary
Secondary
Pneumonia Other Serious 5/15/2006 83 Female 4/13/2007 Japan
Primary
Secondary
Concomitant
Stomatitis Other Serious 8/28/2006 28 Male 4/23/2007 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 8/11/2006 56 Male 4/19/2007 Japan
Primary
Secondary
Concomitant
Streptococcal Bacteraemia Death 12 Female 5/7/2007 Physician Japan
Primary
Concomitant
Pseudomembranous Colitis Other Serious 10/30/2006 Male 161 lb 6/15/2007 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Other Serious 5/15/2006 83 Female 6/21/2007 United States
Primary
Secondary
Concomitant
Pseudomembranous Colitis Other Serious 11/17/2006 45 Male 6/25/2007 Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 6/10/2006 Male 130 lb 7/10/2007 Physician Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 8/28/2006 28 Male 7/16/2007 United States
Primary
Secondary
Concomitant
Tachycardia Other Serious 9/20/2006 Male 7/30/2007 Physician Spain
Primary
Concomitant
Vision Blurred Hospitalization 11/11/2006 76 Male 7/25/2007 Physician United States
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 6/1/2007 Male 251 lb 9/4/2007 Australia
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 6/1/2007 Male 251 lb 9/4/2007 Australia
Primary
Secondary
Concomitant
Leukoencephalopathy Hospitalization 12/5/2006 70 Female 9/6/2007 Physician Japan
Primary
Secondary
Concomitant
Leukoencephalopathy Hospitalization 12/5/2006 70 Female 8/28/2007 Physician Japan
Primary
Secondary
Concomitant
Urinary Tract Infection Enterococcal Hospitalization 2/16/2007 76 Male 9/4/2007 Physician United States
Primary
Secondary
Concomitant
Hepatic Failure Death 11/13/2006 Male 168 lb 10/24/2007 Physician Italy
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Death 11/13/2006 70 Male 11/2/2007 Italy
Primary
Secondary
Concomitant
Multi-organ Failure Death 11/13/2006 Male 168 lb 12/26/2007 Physician Italy
Primary
Secondary
Concomitant
Multi-organ Failure Hospitalization 11/13/2006 70 Male 1/2/2008 Italy
Primary
Secondary
Concomitant
Nausea Life Threatening 1/16/2008 Male 192 lb 1/25/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Nausea Life Threatening 1/16/2008 Male 192 lb 2/23/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Pancytopenia Other Serious 24 Male 2/28/2008 Other Health Professional Italy
Primary
Secondary
Concomitant
Pancytopenia Other Serious 24 Male 2/29/2008 Other Health Professional Italy
Primary
Secondary
Concomitant
Neuropathy Peripheral Disability 34 Female 194 lb 4/25/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Neuropathy Peripheral Disability 34 Female 194 lb 4/30/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Neuropathy Peripheral Disability 34 Female 194 lb 5/23/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 9/21/2007 25 Male 112 lb 6/4/2008 Physician Japan
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 9/21/2007 25 Male 112 lb 6/19/2008 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 9/21/2007 25 Male 112 lb 6/27/2008 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 4/2/2008 19 Male 110 lb 7/16/2008 Physician Japan
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 9/21/2007 25 Male 112 lb 7/28/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Trichosporon Infection Death 4/15/2008 53 Male 123 lb 9/30/2008 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 2/9/2007 Male 11/3/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Pyrexia Other Serious 2/9/2007 Male 11/4/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Haemoptysis Life Threatening 9/1/2008 Female 12/24/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Haemoptysis Life Threatening 9/1/2008 Female 1/6/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 4/2/2008 19 Male 110 lb 3/20/2009 Physician Japan
Primary
Secondary
Concomitant
Septic Embolus Other Serious 3/1/2009 Female 112 lb 3/26/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Clostridial Infection Hospitalization 10/30/2008 Male 174 lb 5/26/2009 Other Health Professional Australia
Primary
Secondary
Pyrexia Hospitalization 10/30/2006 45 Male 6/12/2009 Japan
Primary
Secondary
Concomitant
Orthostatic Hypotension Other Serious 3 Male 7/9/2009 Physician Spain
Primary
Secondary
Concomitant
Pyrexia Required Intervention 16 Female 7/16/2009 Other Health Professional Turkey
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 4/8/2009 58 Female 106 lb 12/14/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Multi-organ Failure Death 11/13/2006 Male 168 lb 12/15/2009 Physician Italy
Primary
Secondary
Concomitant
Neutropenia Other Serious 17 Male 1/15/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Renal Impairment Other Serious 17 Male 2/1/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Renal Impairment Other Serious 17 Male 2/25/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Renal Impairment Other Serious 17 Male 2/22/2010 Physician United Kingdom
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 4/8/2009 58 Female 106 lb 3/25/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Hepatic Function Abnormal Life Threatening 6/28/2009 Male 3/30/2010 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 5/10/2010 64 Male 6/4/2010 Other Health Professional United Kingdom
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 10/19/2009 54 Male 132 lb 6/21/2010 Other Health Professional Japan
Primary
Concomitant
Cytarabine Syndrome Life Threatening 5/10/2010 64 Male 6/18/2010 Other Health Professional United Kingdom
Primary
Concomitant
Death Death 7/9/2010 Physician United States
Primary
Secondary
Concomitant
Syncope Death 63 Female 7/19/2010 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Pyrexia Other Serious 9/21/2009 37 Female 93 lb 8/9/2010 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Hospitalization 1/23/2010 66 Male 130 lb 8/13/2010 Consumer Japan
Primary
Concomitant
Septic Shock Other Serious 63 Female 8/17/2010 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 3/11/2009 23 Female 97 lb 8/17/2010 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 1/23/2010 67 Male 130 lb 8/19/2010 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 1/23/2010 67 Male 130 lb 8/24/2010 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 3/11/2009 23 Female 97 lb 8/31/2010 Physician Japan
Primary
Concomitant
Sebaceous Carcinoma Other Serious 10/1/2009 46 Male 203 lb 9/15/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Septic Shock Other Serious 5/21/2009 48 Female 132 lb 9/20/2010 Physician Italy
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 4/8/2009 58 Female 106 lb 10/28/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 4/8/2009 58 Female 106 lb 11/2/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
No Adverse Event Death 11/10/2010 Physician United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 1/29/2010 49 Male 110 lb 12/13/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 1/29/2010 49 Male 110 lb 12/13/2010 Physician Japan
Primary
Concomitant
Skin Nodule Hospitalization 4/1/2007 8 Male 12/15/2010 Physician Korea, Republic Of
Primary
Secondary
Hiccups Death 7/30/2010 49 Male 110 lb 12/17/2010 Physician Japan
Primary
Secondary
Concomitant
Sepsis Life Threatening 11/2/2010 45 Male 265 lb 12/27/2010 Physician Switzerland
Primary
Secondary
Concomitant
Febrile Neutropenia Death 8/11/2010 24 Male 141 lb 1/7/2011 Physician Japan
Primary
Concomitant
Acute Myeloid Leukaemia Recurrent Other Serious 2/26/2010 56 Male 134 lb 1/10/2011 Physician Japan
Primary
Concomitant
Pneumonia Death 10/26/2009 59 Male 121 lb 1/11/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Skin Hospitalization 2/26/2010 56 Male 134 lb 1/11/2011 Physician Japan
Primary
Secondary
Concomitant
Disorientation Death 4/13/2009 52 Male 117 lb 1/10/2011 Physician Japan
Primary
Concomitant
Neutropenia Hospitalization 10/18/2010 35 Female 1/25/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 8/26/2010 63 Female 1/28/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Visual Impairment Hospitalization 72 Male 207 lb 1/28/2011 Other Health Professional United Kingdom
Primary
Concomitant
Multi-organ Failure Death 11/13/2006 70 Male 168 lb 2/2/2011 Physician Italy
Primary
Secondary
Concomitant
Bone Marrow Failure Other Serious 8/26/2010 63 Female 2/10/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Drug Ineffective For Unapproved Indication Other Serious 67 Male 2/10/2011 Other Health Professional Spain
Primary
Secondary
Trichosporon Infection Other Serious 26 Male 2/10/2011 Other Health Professional Spain
Primary
Secondary
Coma Death 60 Male 2/10/2011 Other Health Professional Spain
Primary
Secondary
Trichosporon Infection Other Serious 65 Female 2/10/2011 Other Health Professional Spain
Primary
Secondary
Trichosporon Infection Other Serious 65 Female 2/10/2011 Other Health Professional Spain
Primary
Secondary
Fungal Infection Hospitalization 6/24/2009 15 Male 126 lb 2/14/2011 Consumer Japan
Primary
Concomitant
Infusion Related Reaction Life Threatening 8/18/2010 46 Female 2/18/2011 Physician Czech Republic
Primary
Concomitant
Pneumonia Bacterial Other Serious 7/19/2010 32 Female 108 lb 2/18/2011 Physician Japan
Primary
Secondary
Concomitant
Chills Death 1/21/2011 62 Female 110 lb 3/4/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 29 Male 3/18/2011 Physician Japan
Primary
Concomitant
Dysphagia Other Serious 2/3/2007 76 Male 3/2/2011 Physician United States
Primary
Secondary
Concomitant
Circulatory Collapse Hospitalization 1/21/2011 62 Female 110 lb 3/27/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Bronchiectasis Hospitalization 35 Male 3/30/2011 Other Health Professional Japan
Primary
Concomitant
Neutropenic Sepsis Hospitalization 2/21/2011 58 Female 4/1/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Drug Ineffective Hospitalization 65 Male 4/6/2011 Physician Italy
Primary
Secondary
Eosinophilic Pneumonia Hospitalization 9/9/2009 36 Female 115 lb 4/6/2011 Physician Japan
Primary
Secondary
Concomitant
Disease Progression Hospitalization 2/21/2011 58 Female 4/8/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Hepatic Failure Death 4/2/2010 65 Male 141 lb 4/13/2011 Physician Spain
Primary
Secondary
Concomitant
Toothache Hospitalization 9/21/2009 37 Female 93 lb 4/14/2011 Physician Japan
Primary
Concomitant

Drug Data