Ara-C combined with Methotrexate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Ventricular Hypertrophy Life Threatening 3/27/2006 Female 116 lb 5/3/2006 Physician United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 3/20/2006 70 Female 117 lb 5/11/2006 Physician United States
Primary
Secondary
Concomitant
Pulmonary Oedema Life Threatening 3/27/2006 Female 116 lb 5/26/2006 Physician United States
Primary
Secondary
Concomitant
Pulmonary Oedema Life Threatening 3/27/2006 Female 116 lb 6/9/2006 Physician United States
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 16 Male 6/6/2006 Physician United States
Primary
Concomitant
Tongue Disorder Hospitalization 6/1/2006 Male 212 lb 7/18/2006 Physician Germany
Primary
Secondary
Concomitant
Pulmonary Oedema Life Threatening 4/7/2006 Female 116 lb 8/10/2006 Physician United States
Primary
Secondary
Concomitant
Vomiting Life Threatening 8/15/2006 18 Female 124 lb 8/16/2006 Other Health Professional United States
Primary
Concomitant
Pyrexia Hospitalization 9/4/2006 24 Male 176 lb 9/5/2006 Other Health Professional United States
Primary
Secondary
Vertigo Hospitalization 7/16/2006 57 Male 198 lb 9/5/2006 United Kingdom
Primary
Concomitant
Pyrexia Other Serious 9/11/2006 35 Male 154 lb 9/19/2006 Physician France
Primary
Secondary
Pyrexia Other Serious 9/11/2006 35 Male 154 lb 9/19/2006 Physician France
Primary
Secondary
Somnolence Other Serious 6/1/2006 60 Female 9/18/2006 Physician United Kingdom
Primary
Concomitant
Fungal Infection Death 10/2/2006 Physician United States
Primary
Concomitant
Mucormycosis Death 10/2/2006 Physician United States
Primary
Concomitant
Mucormycosis Death 10/13/2006 Physician United States
Primary
Concomitant
Weight Increased Required Intervention 9/18/2006 Male 36 lb 9/29/2006 Pharmacist United States
Primary
Concomitant
Hyponatraemia Required Intervention 9/5/2006 8 Male 61 lb 10/4/2006 Pharmacist United States
Primary
Concomitant
Hospitalisation Other Serious 1/19/2006 Female 179 lb 11/20/2006 Other Health Professional United States
Primary
Concomitant
Thrombocytopenia Other Serious 11/1/2005 Female 179 lb 12/12/2006 Other Health Professional United States
Primary
Concomitant
Pyrexia Other Serious 12/1/2004 49 Male 2/8/2007 Japan
Primary
Concomitant
Weight Decreased Other Serious 12/1/2004 49 Male 2/10/2007 Japan
Primary
Concomitant
Wheelchair User Other Serious 14 Female 2/21/2007
Primary
Secondary
Malignant Neoplasm Progression Other Serious 5/13/2005 63 Female 3/13/2007 Consumer United States
Primary
Secondary
Acute Myeloid Leukaemia Other Serious 1/23/2006 64 Male 3/13/2007 Other Health Professional United States
Primary
Secondary
Malignant Neoplasm Progression Other Serious 5/13/2005 63 Female 3/16/2007 Consumer United States
Primary
Secondary
Acute Myeloid Leukaemia Other Serious 1/23/2006 64 Male 3/19/2007 Other Health Professional United States
Primary
Secondary
Pruritus Hospitalization 10/1/2005 Female 183 lb 3/19/2007 Netherlands
Primary
Secondary
Concomitant
Urinary Retention Death 40 Male 3/22/2007 Malaysia
Primary
Secondary
Inappropriate Antidiuretic Hormone Secretion Other Serious 66 Female 4/10/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Somnolence Other Serious 6/6/2005 40 Male 4/18/2007 Other Health Professional Malaysia
Primary
Secondary
Tachycardia Other Serious 2/16/2005 17 Male 5/3/2007
Primary
Secondary
Urinary Retention Other Serious 6/6/2005 40 Male 5/3/2007
Primary
Secondary
Tumour Lysis Syndrome Other Serious 21 Male 5/22/2007 Other Health Professional Japan
Primary
Secondary
Spinal Cord Disorder Other Serious 11/1/2004 28 Female 6/13/2007 Other Health Professional Taiwan, Province Of China
Primary
Secondary
Musculoskeletal Disorder Hospitalization 6/16/2008 7/28/2008 Physician Italy
Primary
Secondary
Sepsis Other Serious 1/1/2008 Male 7/30/2008 Physician United Kingdom
Primary
Secondary
Musculoskeletal Disorder Hospitalization 6/16/2008 8/4/2008 Physician Italy
Primary
Secondary
Peripheral Sensory Neuropathy Hospitalization 6/1/2008 61 Female 8/8/2008 Physician Italy
Primary
Secondary
Vomiting Other Serious 9/10/2006 Male 174 lb 8/7/2008 Physician United States
Primary
Secondary
Transient Ischaemic Attack Hospitalization 7/22/2008 9 Male 76 lb 8/8/2008 Physician United States
Primary
Secondary
Concomitant
Crystal Urine Present Hospitalization 4/1/2008 23 Male 154 lb 7/7/2008 Pharmacist United States
Primary
Concomitant
Stomatitis Other Serious 8/21/2008 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 3/20/2007 Male 117 lb 8/28/2008 Physician Japan
Primary
Secondary
Concomitant
Septic Shock Hospitalization 8/26/2008 9/3/2008 Physician Italy
Primary
Secondary
Peripheral Sensory Neuropathy Hospitalization 6/16/2008 61 Female 9/8/2008 Physician Italy
Primary
Secondary
Neutropenia Hospitalization 1/1/2008 11 Female 9/24/2008 Other Health Professional Switzerland
Primary
Secondary
Tumour Lysis Syndrome Other Serious 64 Female 10/23/2008 Other Health Professional Japan
Primary
Concomitant
Thrombotic Thrombocytopenic Purpura Life Threatening 10/6/2008 55 Male 10/24/2008 Physician Italy
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Life Threatening 10/6/2008 55 Male 11/3/2008 Physician Italy
Primary
Secondary
Concomitant
Vomiting Other Serious 10/1/2004 64 Female 11/3/2008 Physician Japan
Primary
Concomitant
Pneumonia Other Serious 45 Male 12/2/2008
Primary
Secondary
Orchidectomy Hospitalization 1 Male 12/4/2008 Other Health Professional Japan
Primary
Concomitant
Thrombotic Thrombocytopenic Purpura Life Threatening 10/6/2008 55 Male 12/8/2008 Physician Italy
Primary
Secondary
Concomitant
Mucosal Inflammation Other Serious 1/1/2004 69 Female 12/12/2008 Physician Taiwan, Province Of China
Primary
Secondary
Mucosal Inflammation Other Serious 10/1/2004 69 Female 12/16/2008 Consumer United Kingdom
Primary
Secondary
Sepsis Hospitalization 1/1/2007 53 Female 12/24/2008
Primary
Secondary
Pseudomembranous Colitis Other Serious 43 Male 12/30/2008 Other Health Professional Japan
Primary
Secondary
Gamma-glutamyltransferase Increased Hospitalization 12/21/2008 4 Male 44 lb 1/7/2009 Physician Germany
Primary
Secondary
Concomitant
Tuberculosis Other Serious 32 Male 1/16/2009 Other Health Professional China
Primary
Secondary
Concomitant
Puncture Site Infection Hospitalization 12/21/2008 4 Male 44 lb 1/22/2009 Physician Germany
Primary
Secondary
Concomitant
Transaminases Increased Hospitalization 12/21/2008 4 Male 44 lb 2/2/2009 Physician Germany
Primary
Secondary
Concomitant
Myeloblast Count Increased Other Serious 5/1/2007 Male 3/6/2009 Physician Japan
Primary
Concomitant
Myeloblast Count Increased Other Serious 5/10/2007 Male 155 lb 3/23/2009 Physician Japan
Primary
Concomitant
Respiratory Failure Other Serious 10/1/2007 Female 3/24/2009 Physician United States
Primary
Secondary
Concomitant
Peripheral Sensory Neuropathy Other Serious 3/4/2009 23 Male 116 lb 3/24/2009 Physician United States
Primary
Secondary
Concomitant
Pyrexia Hospitalization 10/1/2008 75 Female 4/3/2009 Physician Italy
Primary
Secondary
Graft Versus Host Disease Other Serious 17 Male 4/15/2009 Other Health Professional India
Primary
Secondary
Concomitant
Salivary Gland Mass Other Serious 1/1/2008 38 Female 6/17/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Transaminases Increased Hospitalization 12/21/2008 4 Male 44 lb 6/26/2009 Physician Germany
Primary
Secondary
Concomitant
Neutropenia Other Serious 57 Male 8/6/2009
Primary
Secondary
Concomitant
Hepatotoxicity Other Serious 5/1/2009 24 Female 203 lb 8/6/2009 Pharmacist United States
Primary
Concomitant
Sepsis Hospitalization 4/1/2006 63 Female 351 lb 9/4/2009 Germany
Primary
Concomitant
Ulcer Haemorrhage Other Serious 29 Male 10/14/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 1/1/2005 47 Male 10/30/2009 Japan
Primary
Concomitant
Neutropenia Other Serious 17 Male 12/24/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Neutropenia Other Serious 17 Male 1/4/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Subdural Haematoma Other Serious 1/1/2009 42 Female 1/7/2010 Other Health Professional Japan
Primary
Secondary
Respiratory Failure Death 12/8/2009 29 Female 1/13/2010 Physician Italy
Primary
Secondary
Renal Impairment Other Serious 17 Male 1/22/2010 Other Health Professional United Kingdom
Primary
Secondary
Renal Impairment Other Serious 17 Male 1/26/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Renal Impairment Other Serious 17 Male 1/28/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Subdural Haematoma Other Serious 1/1/2009 43 Female 1/29/2010 Other Health Professional Japan
Primary
Secondary
Septic Shock Hospitalization 1/10/2010 Male 157 lb 1/29/2010 Physician Brazil
Primary
Secondary
Renal Failure Life Threatening 10/7/2009 Female 126 lb 2/1/2010 Physician France
Primary
Secondary
Concomitant
Subdural Haematoma Other Serious 1/1/2009 43 Female 2/16/2010 Other Health Professional Japan
Primary
Secondary
Renal Impairment Other Serious 17 Male 2/22/2010 Other Health Professional United Kingdom
Primary
Secondary
Renal Impairment Other Serious 17 Male 2/25/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Renal Impairment Other Serious 17 Male 2/25/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Renal Impairment Other Serious 17 Male 2/26/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Renal Impairment Other Serious 17 Male 3/10/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Renal Impairment Other Serious 17 Male 3/12/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Renal Impairment Other Serious 17 Male 3/16/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Intracranial Hypotension Hospitalization 2/23/2010 51 Male 3/17/2010 Physician Italy
Primary
Secondary
Concomitant
Intracranial Hypotension Hospitalization 2/23/2010 51 Male 3/19/2010 Physician Italy
Primary
Secondary
Concomitant
Renal Impairment Other Serious 17 Male 3/29/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Renal Impairment Other Serious Male 3/19/2010 United Kingdom
Primary
Concomitant
Renal Impairment Other Serious 17 Male 3/31/2010 Other Health Professional United Kingdom
Primary
Secondary
Renal Impairment Other Serious 17 Male 4/1/2010 Other Health Professional United Kingdom
Primary
Secondary
Hypertension Hospitalization 10/4/2008 67 Female 4/13/2010 Physician United States
Primary
Secondary
Wernicke's Encephalopathy Disability 5/9/2008 4/13/2010 Physician United States
Primary
Secondary
Mesenteric Vein Thrombosis Other Serious 4/10/2008 4/13/2010 Physician United States
Primary
Secondary
Concomitant
Peripheral Sensory Neuropathy Hospitalization 6/16/2008 61 Female 4/13/2010 Physician United States
Primary
Secondary
Intestinal Haemorrhage Hospitalization 3/14/2008 4/13/2010 Physician United States
Primary
Secondary
T-cell Lymphoma Hospitalization 11/30/2008 70 Male 4/13/2010 Physician United States
Primary
Secondary
Concomitant
Septic Shock Hospitalization 8/26/2008 4/20/2010 Physician United States
Primary
Secondary
Wernicke's Encephalopathy Disability 5/9/2008 4/20/2010 Physician United States
Primary
Secondary
Intestinal Haemorrhage Hospitalization 3/14/2008 4/20/2010 Physician United States
Primary
Secondary
T-cell Lymphoma Hospitalization 11/30/2008 70 Male 4/20/2010 Physician United States
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Life Threatening 10/6/2008 55 Male 4/27/2010 Physician United States
Primary
Secondary
Concomitant
Drug Toxicity Death 4/23/2010 United States
Primary
Secondary
Drug Toxicity Other Serious 4/23/2010 United States
Primary
Secondary
Drug Toxicity Death 4/23/2010 United States
Primary
Secondary
T-cell Lymphoma Hospitalization 5/9/2008 4/30/2010 Physician United States
Primary
Secondary
Intracranial Hypotension Hospitalization 2/23/2010 51 Male 5/12/2010 Physician United States
Primary
Secondary
Concomitant
Pyrexia Hospitalization 5/10/2010 34 Female 6/4/2010 Physician United Kingdom
Primary
Secondary
Pyrexia Hospitalization 5/10/2010 34 Female 6/8/2010 Physician United Kingdom
Primary
Secondary
Pyrexia Hospitalization 5/10/2010 34 Female 6/15/2010 Physician Italy
Primary
Secondary
Concomitant
Subcutaneous Nodule Other Serious 54 Male 7/2/2010 Other Health Professional Hungary
Primary
Concomitant
Zygomycosis Other Serious 10/23/2007 16 Female 156 lb 7/30/2010 Physician United States
Primary
Secondary
Urinary Bladder Haemorrhage Hospitalization 4/30/2009 55 Male 8/6/2010 Physician Italy
Primary
Secondary
Concomitant
Urinary Bladder Haemorrhage Hospitalization 4/30/2009 55 Male 8/18/2010 Physician Italy
Primary
Secondary
Concomitant
Urinary Incontinence Other Serious 1/1/2009 59 Female 132 lb 8/23/2010 Consumer United States
Primary
Secondary
Concomitant
Toothache Hospitalization 3/23/2008 19 Female 143 lb 9/28/2010 Consumer
Primary
Secondary
Concomitant
Zygomycosis Other Serious 10/23/2007 16 Female 156 lb 10/5/2010 Physician United States
Primary
Secondary
Urinary Retention Other Serious 1/29/2009 65 Female 119 lb 9/28/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Renal Failure Life Threatening 9/29/2010 58 Female 10/8/2010 Physician France
Primary
Concomitant
Vomiting Hospitalization 10/24/2009 53 Male 190 lb 10/13/2010 Physician United States
Primary
Secondary
Concomitant
Somnolence Hospitalization 6/16/2010 61 Male 10/21/2010 Physician Germany
Primary
Secondary
Concomitant
Toxic Skin Eruption Other Serious 9/21/2010 58 Female 10/27/2010 Physician France
Primary
Secondary
Urinary Incontinence Hospitalization 12/12/2006 64 Female 154 lb 11/9/2010 Physician Germany
Primary
Concomitant
Neurotoxicity Hospitalization 7/1/2007 70 Female 150 lb 11/9/2010 Physician Germany
Primary
Concomitant
Therapeutic Response Decreased Hospitalization 5/1/2008 27 Male 11/30/2010
Primary
Secondary
Post Lumbar Puncture Syndrome Other Serious 11/29/2007 13 Male 121 lb 11/15/2010 Physician France
Primary
Concomitant
Cerebral Venous Thrombosis Other Serious 8/26/2005 10 Male 79 lb 11/15/2010 Physician France
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 9 Female 12/28/2010 Physician Japan
Primary
Concomitant
Transplant Failure Other Serious 9 Female 2/10/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious Female 2/11/2011 Physician Japan
Primary
Secondary
Concomitant
Precursor T-lymphoblastic Lymphoma/leukaemia Other Serious 12 2/15/2011 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 17 Male 2/17/2011 Physician United Kingdom
Primary
Secondary
Renal Impairment Other Serious 17 Male 2/17/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Renal Impairment Other Serious 17 Male 2/25/2011 Consumer United Kingdom
Primary
Secondary
Cytomegalovirus Infection Hospitalization 4/30/2009 55 Male 3/1/2011 Physician Germany
Primary
Secondary
Concomitant
Neutropenia Other Serious 17 Male 3/3/2011 Consumer United Kingdom
Primary
Secondary
Concomitant
Renal Impairment Other Serious 17 Male 3/7/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Neutropenia Other Serious 17 Male 3/7/2011 Consumer United Kingdom
Primary
Secondary
Renal Impairment Other Serious 17 Male 3/9/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Lymphoproliferative Disorder Other Serious 17 Male 3/14/2011 Consumer United Kingdom
Primary
Secondary
Concomitant
Weight Decreased Other Serious 17 Male 3/14/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Dyspnoea Other Serious 4/14/2011 Physician United Kingdom
Primary
Secondary

Drug Data