Methotrexate combined with Pegaspargase

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Thrombosis 9/29/2006 Pharmacist United States
Primary
Concomitant
Renal Impairment Life Threatening 9/27/2007 Male 187 lb 10/9/2007 Pharmacist United States
Primary
Secondary
Concomitant
Systemic Candida Other Serious 26 Male 11/8/2007 Other Health Professional Germany
Primary
Secondary
Systemic Candida Hospitalization 26 Male 11/15/2007 Germany
Primary
Secondary
Concomitant
Systemic Candida Hospitalization 26 Male 11/21/2007 Germany
Primary
Secondary
Concomitant
Transient Ischaemic Attack Hospitalization 7/22/2008 9 Male 76 lb 8/8/2008 Physician United States
Primary
Secondary
Concomitant
Spinal Cord Disorder Hospitalization 3/25/2008 10 Male 84 lb 9/12/2008 Physician France
Primary
Concomitant
Vomiting Other Serious 10/23/2007 16 Female 156 lb 12/16/2008 Physician United States
Primary
Secondary
Nuclear Magnetic Resonance Imaging Brain Abnormal Other Serious 16 Male 2/17/2009 Physician United States
Primary
Concomitant
Lactobacillus Infection Hospitalization 5/3/2009 1 Male 20 lb 6/1/2009 Physician United States
Primary
Secondary
Concomitant
Stem Cell Transplant Life Threatening 9/16/2009 Male 120 lb 10/29/2009 Physician Netherlands
Primary
Concomitant
Somnolence Life Threatening 9/16/2009 Male 120 lb 11/2/2009 Physician Netherlands
Primary
Concomitant
Somnolence Life Threatening 9/15/2009 Male 120 lb 11/11/2009 Physician Netherlands
Primary
Concomitant
Tachypnoea Hospitalization 2 Male 3/9/2010 Australia
Primary
Secondary
Concomitant
Vocal Cord Paralysis Hospitalization 2 Male 3/24/2010 Physician Australia
Primary
Secondary
Concomitant
Neurotoxicity Other Serious 12 Male 5/13/2010
Primary
Secondary
Oesophageal Stenosis Hospitalization 1 Male 6/2/2010 Physician Ireland
Primary
Secondary
Oesophageal Stenosis Other Serious 2 Female 6/2/2010 Physician Ireland
Primary
Secondary
Oesophageal Stenosis Other Serious 11 Male 6/2/2010 Physician Ireland
Primary
Secondary
Oesophageal Stenosis Other Serious 11 Male 6/2/2010 Physician Ireland
Primary
Secondary
Oesophageal Stenosis Other Serious 4 Male 6/2/2010 Physician Ireland
Primary
Secondary
Leukoencephalopathy Other Serious 8 Male 8/24/2010 Physician United States
Primary
Secondary
Transient Ischaemic Attack Hospitalization 2/1/2008 8 Male 9/17/2010 Other Health Professional France
Primary
Secondary
Concomitant
Hyperglycaemia Hospitalization 8/7/2010 13 Male 130 lb 10/18/2010 United States
Primary
Secondary
Concomitant
Blood Bilirubin Abnormal 9/5/2010 13 Male 130 lb 10/22/2010 United States
Primary
Secondary
Concomitant
Oesophageal Pain Other Serious 5/12/2010 8 Female 60 lb 11/21/2010 Physician United States
Primary
Secondary
Anxiety Death 3/8/2011 15 Female 144 lb 3/23/2011 Physician United States
Primary
Secondary
Grand Mal Convulsion Hospitalization 4 Male 3/30/2011 Physician United States
Primary
Concomitant
Pleural Effusion Death 3/8/2011 15 Female 144 lb 5/24/2011 Physician United States
Primary
Secondary
Staphylococcal Abscess Other Serious 3/21/2011 10 Female 5/24/2011 Physician United States
Primary
Secondary
Hypoalbuminaemia Other Serious 6/28/2011 15 Male 109 lb 7/11/2011 Consumer United States
Primary
Secondary
Hypotension Other Serious 3/8/2011 15 Female 144 lb 7/21/2011 Physician United States
Primary
Secondary
Blood Bilirubin Increased Other Serious 6/28/2011 15 Male 109 lb 7/27/2011 Consumer United States
Primary
Secondary
Hyperbilirubinaemia Death 5/31/2011 23 Male 306 lb 8/3/2011 Pharmacist United States
Primary
Concomitant
Anxiety Other Serious 3/8/2011 15 Female 144 lb 8/11/2011 Consumer United States
Primary
Secondary
Hypertension Other Serious 8/24/2011 17 Male 282 lb 9/19/2011 Physician United States
Primary
Secondary
Pyrexia Other Serious 8/13/2011 5 Male 9/21/2011 United States
Primary
Secondary
Pyrexia Other Serious 8/13/2011 5 Male 9/22/2011 Physician United States
Primary
Secondary
Memory Impairment Other Serious 9/14/2011 13 Male 87 lb 10/4/2011 Physician United States
Primary
Secondary
Concomitant
Akathisia Other Serious 9/14/2011 13 Male 87 lb 10/10/2011 Physician United States
Primary
Secondary
Flushing Other Serious 9/20/2011 13 Female 132 lb 10/13/2011 Consumer United States
Primary
Concomitant
Headache Hospitalization 6/1/2011 22 Female 11/10/2011 Physician United States
Primary
Secondary
Haemorrhage Hospitalization 10/21/2011 15 Male 77 lb 11/29/2011 Other Health Professional Austria
Primary
Concomitant
Hyperbilirubinaemia Other Serious 1/11/2012 42 Male 192 lb 1/20/2012 Consumer Germany
Primary
Secondary
Staphylococcal Infection Hospitalization 12/27/2011 11 Male 32 lb 1/20/2012 Physician United States
Primary
Secondary
Concomitant
Caecitis Hospitalization 12/18/2011 10 Female 46 lb 1/24/2012 Physician United States
Primary
Secondary
Tracheitis Hospitalization 1/17/2012 8 Female 92 lb 1/31/2012 Physician United States
Primary
Secondary
Wheezing Hospitalization 1/17/2012 8 Female 92 lb 2/10/2012 Consumer United States
Primary
Secondary
Cholestasis Other Serious 1/11/2012 42 Male 192 lb 2/14/2012 Consumer Germany
Primary
Secondary
Hyperbilirubinaemia Other Serious 1/11/2012 42 Male 192 lb 2/15/2012 Consumer Germany
Primary
Secondary
Oesophagitis Hospitalization 1/29/2012 20 Female 191 lb 2/20/2012 Consumer United States
Primary
Secondary
Pancreatitis Hospitalization 2/7/2012 6 Male 77 lb 2/21/2012 Physician United States
Primary
Secondary
Concomitant
Arthralgia Hospitalization 1/29/2012 20 Female 191 lb 2/29/2012 Physician United States
Primary
Secondary
Wheezing Hospitalization 1/17/2012 8 Female 92 lb 3/7/2012 Physician United States
Primary
Secondary
Vomiting Hospitalization 12/18/2011 10 Female 46 lb 3/8/2012 Consumer United States
Primary
Secondary
White Blood Cell Count Decreased Hospitalization 3/4/2012 18 Male 279 lb 3/13/2012 Consumer United States
Primary
Secondary
Caecitis Hospitalization 3/4/2012 19 Male 179 lb 3/15/2012 Consumer United States
Primary
Secondary
Joint Effusion Hospitalization 1/29/2012 20 Female 165 lb 3/16/2012 Consumer United States
Primary
Secondary
Decreased Appetite Hospitalization 1/29/2012 20 Female 165 lb 3/27/2012 Consumer United States
Primary
Secondary
Respiratory Distress Hospitalization 3/10/2012 12 Male 112 lb 3/28/2012 Consumer United States
Primary
Secondary
Depressed Level Of Consciousness Hospitalization 3/6/2012 13 Female 143 lb 3/29/2012 Consumer United States
Primary
Secondary
Fungaemia Hospitalization 12/18/2011 10 Female 46 lb 4/5/2012 Physician United States
Primary
Secondary
Platelet Count Decreased Hospitalization 3/4/2012 18 Male 279 lb 4/12/2012 Consumer United States
Primary
Secondary
Acidosis Life Threatening 3/10/2012 12 Male 112 lb 4/12/2012 Consumer United States
Primary
Secondary
Lung Infiltration Hospitalization 1/20/2012 8 Female 92 lb 5/2/2012 Physician United States
Primary
Secondary
White Blood Cell Count Decreased Death 3/4/2012 18 Male 279 lb 5/10/2012 Physician United States
Primary
Secondary
Encephalitic Infection Other Serious 3/9/2011 14 Female 143 lb 5/11/2012 Consumer United States
Primary
Secondary
Cerebrovascular Accident Hospitalization 3/9/2011 14 Female 143 lb 5/24/2012 Consumer United States
Primary
Secondary
Neutrophil Count Decreased Hospitalization Female 5/25/2012 Physician United States
Primary
Secondary
Concomitant
Staphylococcal Abscess Hospitalization 10 Female 5/25/2012 Physician United States
Primary
Secondary
Neutropenia Hospitalization 4/23/2012 3 Female 6/5/2012 Physician United States
Primary
Secondary
Concomitant
Neutropenia Hospitalization 4/23/2012 3 Female 6/15/2012 Physician United States
Primary
Secondary
Concomitant
Bacteraemia Hospitalization 6/1/2012 1 Female 21 lb 6/21/2012 Physician United States
Primary
Secondary
Concomitant
Acidosis Hospitalization 5/17/2012 14 Female 133 lb 6/27/2012 Physician United States
Primary
Secondary
Skin Infection Hospitalization 7/23/2012 1 Male 23 lb 8/11/2012 Physician United States
Primary
Secondary
Zygomycosis Hospitalization 10/23/2007 16 Female 156 lb 8/14/2012 Physician Us
Primary
Secondary
Neutropenia Hospitalization 4/23/2012 4 Female 11/12/2012 Physician Us
Primary
Secondary
Concomitant
Staphylococcal Infection Hospitalization 4/23/2012 4 Female 11/19/2012 Physician Us
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 8/9/2012 9/6/2012 Physician Us
Primary
Secondary
Hypoxia Other Serious 7/28/2012 4 Male 54 lb 9/6/2012 Other Health Professional Us
Primary
Secondary
Thrombocytopenia Other Serious 8/17/2012 23 Male 143 lb 10/29/2012 Physician Us
Primary
Secondary
Stomatitis Other Serious 8/10/2012 11 Male 1/18/2013 Physician Us
Primary
Secondary
Concomitant
Off Label Use Hospitalization 8/17/2012 9/21/2012 Other Health Professional Fr
Primary
Secondary
Concomitant
Stomatitis Hospitalization 8/10/2012 11 Male 2/4/2013 Physician Us
Primary
Secondary
Concomitant
Superior Vena Cava Syndrome Hospitalization 8/6/2012 24 Female 9/26/2012 Consumer Us
Primary
Secondary
Concomitant
Skin Infection Hospitalization 2012 10 Female 99 lb 12/20/2012 Consumer Us
Primary
Secondary
Concomitant
Transaminases Increased Other Serious 6/7/2012 20 Male 254 lb 10/9/2012 Consumer Us
Primary
Secondary
Tachycardia Hospitalization 8/28/2012 4 Male 54 lb 10/9/2012 Other Health Professional Us
Primary
Secondary
Septic Shock Life Threatening 2012 16 Male 215 lb 11/7/2012 Consumer Us
Primary
Secondary
Weight Decreased Other Serious 8/26/2012 15 Male 94 lb 11/20/2012 Physician Us
Primary
Secondary
Concomitant
Osteonecrosis Other Serious 12 Female 10/15/2012 Physician Us
Primary
Secondary
Trendelenburg's Symptom Required Intervention 12 Female 10/18/2012 Other Health Professional Us
Primary
Secondary
Tachypnoea Hospitalization 10/19/2012 Male 25 lb 11/7/2012 Physician Us
Primary
Secondary
Concomitant
Neutropenia Hospitalization 4/23/2012 4 Female 11/20/2012 Consumer Us
Primary
Secondary
Concomitant
Vomiting Hospitalization 10/9/2012 9 Female 9/6/2013 Other Health Professional Us
Primary
Secondary
Concomitant
Mucosal Inflammation Other Serious 8/19/2012 4 Female 11/16/2012 Other Health Professional Us
Primary
Secondary
Concomitant
Ventricular Tachycardia Hospitalization 4/22/2012 10 Male 77 lb 1/28/2013 Consumer Us
Primary
Secondary
Concomitant
Viith Nerve Paralysis Hospitalization 15 Male 12/19/2012 Physician Us
Primary
Concomitant
Thrombocytopenia Other Serious 12/8/2012 9 Female 4/11/2013 Other Health Professional Us
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 10/22/2012 13 Male 12/21/2012 Physician Us
Primary
Secondary
Concomitant
Intracranial Hypotension Hospitalization 7/7/2012 19 Male 119 lb 2/4/2013 Other Health Professional Nl
Primary
Secondary
Urinary Tract Infection Hospitalization 10/28/2012 4 Female 1/3/2013 Physician Us
Primary
Secondary
Urinary Tract Infection Hospitalization 10/24/2012 4 Female 5/1/2013 Consumer Us
Primary
Secondary
Escherichia Bacteraemia Hospitalization 9/19/2012 1 Male 19 lb 1/4/2013 Physician Us
Primary
Secondary
Urinary Tract Infection Life Threatening 10/28/2012 4 Female 1/7/2013 Physician Us
Primary
Secondary
Urinary Tract Infection Hospitalization 12/26/2012 1 Female 16 lb 1/15/2013 Physician Us
Primary
Secondary
Thrombocytopenia Other Serious 12/8/2012 Female 2/22/2013 Physician Us
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 12/8/2012 9 Female 2/24/2013 Physician Us
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 15 Male 1/3/2013 Physician Us
Primary
Concomitant
Aphasia Hospitalization 1/29/2013 15 Male 148 lb 2/6/2013 Physician Us
Primary
Secondary
Concomitant
Vomiting Hospitalization 1/28/2013 Male 190 lb 1/30/2013 Physician Us
Primary
Secondary
Pulmonary Embolism Hospitalization 1/30/2013 Male 151 lb 2/4/2013 Us
Primary
Secondary
Glaucoma Other Serious 3 Male 3/22/2013 Physician Us
Primary
Secondary
Thrombocytopenia Hospitalization 12/8/2012 9 Female 2/20/2013 Other Health Professional Us
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection Hospitalization 12/30/2012 4 Male 2/24/2013 Physician Us
Primary
Secondary
Concomitant
Tumour Lysis Syndrome Hospitalization 12/18/2012 Male 166 lb 2/25/2013 Country Not Specified
Primary
Secondary
Convulsion Hospitalization 12/3/2012 2 Male 26 lb 12/19/2012 Pharmacist Sa
Primary
Concomitant
Rhabdomyolysis Other Serious 3/11/2013 11 Male 91 lb 4/26/2013 Physician Us
Primary
Secondary
Concomitant
Infective Myositis Hospitalization 2/13/2013 6 Female 52 lb 7/8/2013 Consumer Us
Primary
Secondary
Off Label Use Other Serious NotSpecified 3/22/2013 Other Health Professional Gb
Primary
Secondary
T-cell Lymphoma Other Serious NotSpecified 3/22/2013 Other Health Professional Gb
Primary
Secondary
Off Label Use Other Serious NotSpecified 3/22/2013 Other Health Professional Gb
Primary
Secondary
Off Label Use Other Serious NotSpecified 3/22/2013 Other Health Professional Gb
Primary
Secondary
Off Label Use Other Serious NotSpecified 3/22/2013 Other Health Professional Gb
Primary
Secondary
Off Label Use Other Serious NotSpecified 3/22/2013 Other Health Professional Gb
Primary
Secondary
Off Label Use Death NotSpecified 3/25/2013 Other Health Professional Gb
Primary
Secondary
Off Label Use Death NotSpecified 3/25/2013 Other Health Professional Gb
Primary
Secondary
Pneumonia Respiratory Syncytial Viral Death NotSpecified 3/25/2013 Other Health Professional Gb
Primary
Secondary
Venoocclusive Disease Death NotSpecified 3/25/2013 Other Health Professional Gb
Primary
Secondary
T-cell Lymphoma Death NotSpecified 3/25/2013 Other Health Professional Gb
Primary
Secondary
White Blood Cell Count Decreased Hospitalization 3/21/2013 Male 194 lb 3/21/2013 Physician Us
Primary
Secondary
Death Death NotSpecified 3/29/2013 Physician Us
Primary
Secondary
Concomitant
Speech Disorder Other Serious 14 Male 3/29/2013 Other Health Professional Ca
Primary
Secondary
Concomitant
White Blood Cell Count Decreased 3/21/2013 34 Male 194 lb 3/29/2013 Physician Us
Primary
Secondary
Micrococcal Sepsis Hospitalization 11/4/2012 1 Female 12 lb 4/3/2013 Physician Us
Primary
Secondary
Pancreatitis Acute Life Threatening 3/29/2013 48 Male 159 lb 5/20/2013 Consumer Nl
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 3/8/2013 1 Female 16 lb 4/17/2013 Physician Us
Primary
Secondary
Hypercholesterolaemia Hospitalization 4/15/2013 34 Male 203 lb 4/29/2013 Physician Nl
Primary
Secondary
Stomatitis Hospitalization 4/15/2013 1 Female 17 lb 6/11/2013 Physician Us
Primary
Secondary
Guillain-barre Syndrome Hospitalization 4/10/2013 23 Female 148 lb 5/6/2013 Physician Us
Primary
Secondary
Concomitant
Tremor Hospitalization 5/4/2013 27 Female 152 lb 5/7/2013 Physician Country Not Specified
Primary
Secondary
Sinus Tachycardia Hospitalization 5/5/2013 1 Female 17 lb 6/18/2013 Physician Us
Primary
Secondary
Sinusitis 3/8/2010 10 Male 9/5/2011 Physician Us
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 5/17/2013 30 Male 169 lb 5/29/2013 Physician Country Not Specified
Primary
Secondary
Concomitant
Sepsis Hospitalization 5/27/2013 2 Male 24 lb 6/12/2013 Physician Us
Primary
Secondary
Concomitant
Sepsis Life Threatening 12/8/2012 15 Male 137 lb 6/24/2013 Physician Us
Primary
Secondary
Concomitant
Convulsion Hospitalization 6/18/2013 9 Male 66 lb 7/1/2013 Physician Us
Primary
Secondary
Concomitant
Neurotoxicity Other Serious 13 Female 7/11/2013 Physician Us
Primary
Secondary
Transverse Sinus Thrombosis Other Serious 13 Female 7/18/2013 Other Health Professional Us
Primary
Secondary
Wheezing Disability NotSpecified 5/29/2013 Physician Gb
Primary
Secondary

Drug Data