Funguard combined with Methotrexate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Venoocclusive Liver Disease Life Threatening 6/6/2005 2 Male 26 lb 1/3/2006 Physician Japan
Primary
Secondary
Concomitant
Vomiting Disability 11/4/2005 9 Male 53 lb 3/29/2006 Physician Japan
Primary
Concomitant
Renal Tubular Acidosis Other Serious 5/5/2005 20 Male 8/3/2006 Consumer United States
Primary
Secondary
Concomitant
Renal Tubular Acidosis Other Serious 5/5/2005 20 Male 8/30/2006 Consumer United States
Primary
Secondary
Concomitant
Pancytopenia Hospitalization 1/1/2005 72 Male 11/1/2006 Other Health Professional Japan
Primary
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 6/20/2006 Male 117 lb 3/22/2007 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 6/27/2006 30 Female 90 lb 7/3/2007 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 6/27/2006 30 Female 90 lb 7/3/2007 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 6/27/2006 30 Female 90 lb 7/12/2007 Japan
Primary
Secondary
Concomitant
Leukoencephalopathy Other Serious 12/5/2006 70 Female 9/3/2007 Pharmacist Japan
Primary
Secondary
Thrombocytopenia Other Serious 9/21/2007 25 Male 7/3/2008 Other Health Professional United Kingdom
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
Transfusion Death 8/3/2007 9/18/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Renal Impairment Other Serious 8/3/2007 24 Male 126 lb 10/20/2008 Consumer Japan
Primary
Secondary
Concomitant
Liver Disorder Other Serious 8/25/2008 18 Male 128 lb 2/18/2009 Physician Japan
Primary
Secondary
Concomitant
Nausea Life Threatening 9/28/2008 59 Female 123 lb 3/16/2009 Physician Japan
Primary
Secondary
Concomitant
Rhabdomyolysis Other Serious 10/24/2008 2 Male 27 lb 3/18/2009 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 4/2/2008 19 Male 110 lb 3/20/2009 Physician Japan
Primary
Secondary
Concomitant
Splenic Abscess Other Serious 11/16/2008 39 Female 126 lb 4/15/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 10/20/2008 Male 154 lb 5/14/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Disorder Other Serious 8/14/2008 15 Female 110 lb 5/20/2009 Physician Japan
Primary
Secondary
Concomitant
Sepsis Death 9/18/2008 64 Male 117 lb 5/26/2009 Physician Japan
Primary
Concomitant
Systemic Mycosis Other Serious 12/9/2008 25 Female 99 lb 6/9/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 10/20/2008 Male 154 lb 6/29/2009 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Death 3/12/2008 Male 126 lb 7/31/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Disorder Other Serious 8/14/2008 15 Female 110 lb 8/4/2009 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Life Threatening 9/23/2008 59 Female 123 lb 8/6/2009 Physician Japan
Primary
Secondary
Concomitant
Weight Increased Other Serious 12/9/2008 25 Female 99 lb 9/8/2009 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Life Threatening 9/28/2008 59 Female 123 lb 9/15/2009 Physician Japan
Primary
Secondary
Concomitant
Weight Increased Other Serious 12/9/2008 25 Female 99 lb 9/24/2009 Physician Japan
Primary
Secondary
Concomitant
Pseudomembranous Colitis Other Serious 8/25/2008 18 Male 128 lb 10/1/2009 Physician Japan
Primary
Secondary
Concomitant
Sepsis Life Threatening 9/18/2008 64 Male 117 lb 11/2/2009 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 2/11/2009 24 Female 12/4/2009 Japan
Primary
Secondary
Concomitant
Transfusion Death 8/3/2007 2/23/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Renal Impairment Other Serious 8/3/2007 Male 126 lb 2/24/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Stomatitis Other Serious 9/25/2008 39 Male 157 lb 3/3/2010 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Death 3/12/2008 Male 126 lb 3/9/2010 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Other Serious 9/25/2008 39 Male 157 lb 3/22/2010 Physician Japan
Primary
Secondary
Concomitant
Pancreatitis Acute Other Serious 3/10/2010 13 Female 88 lb 4/23/2010 Physician Japan
Primary
Secondary
Concomitant
Pancreatitis Acute Other Serious 3/10/2010 13 Female 88 lb 5/6/2010 Physician Japan
Primary
Secondary
Concomitant
Respiratory Disorder Life Threatening 10/8/2009 12 Male 92 lb 11/11/2010 Physician Japan
Primary
Concomitant
Shock Life Threatening 11/11/2007 12 Female 80 lb 11/15/2010 Physician Japan
Primary
Secondary
Concomitant
Encephalitis Fungal Death Male 139 lb 11/15/2010 Physician Japan
Primary
Secondary
Concomitant
Shock Life Threatening 11/11/2007 12 Female 80 lb 12/6/2010 Physician Japan
Primary
Secondary
Concomitant
Respiratory Disorder Life Threatening 10/10/2009 12 Male 92 lb 12/6/2010 Physician Japan
Primary
Concomitant
Pancytopenia Hospitalization 10/28/2009 7 Male 49 lb 12/7/2010 Physician Japan
Primary
Secondary
Concomitant
Mouth Haemorrhage Death 4/25/2009 4 Female 32 lb 12/8/2010 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Hospitalization 9/18/2010 5 Female 53 lb 12/21/2010 Physician Japan
Primary
Concomitant
Acute Respiratory Distress Syndrome Life Threatening 11/11/2007 12 Female 80 lb 1/6/2011 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 9/13/2010 58 Male 121 lb 1/6/2011 Physician Japan
Primary
Secondary
Concomitant
Glossitis Hospitalization 9/13/2010 58 Male 121 lb 1/7/2011 Physician Japan
Primary
Secondary
Concomitant
Infection Death 4/25/2009 4 Female 32 lb 1/24/2011 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Life Threatening 4/22/2007 41 Male 132 lb 2/4/2011 Physician Japan
Primary
Secondary
Concomitant
Cardiac Failure Life Threatening 2/14/2008 17 Female 134 lb 2/9/2011 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Death 7/18/2010 29 Female 82 lb 2/9/2011 Physician Japan
Primary
Secondary
Concomitant
Hepatic Function Abnormal Death 9/18/2010 56 Male 159 lb 2/14/2011 Physician Japan
Primary
Concomitant
Cardiac Failure Death 7/25/2010 60 Female 93 lb 2/14/2011 Physician Japan
Primary
Secondary
Concomitant
Human Herpesvirus 6 Infection Hospitalization 3/27/2010 23 Male 117 lb 2/14/2011 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Hospitalization 9/18/2010 5 Female 53 lb 2/23/2011 Physician Japan
Primary
Concomitant
Candida Test Positive Other Serious 61 Male 2/23/2011 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 8/3/2010 1 Male 24 lb 2/28/2011 Physician Japan
Primary
Secondary
Concomitant
Systemic Mycosis Hospitalization 4/22/2007 41 Male 132 lb 3/2/2011 Physician Japan
Primary
Secondary
Concomitant
Blood Alkaline Phosphatase Increased Death 3/12/2009 16 Male 82 lb 3/2/2011 Physician Japan
Primary
Secondary
Concomitant
Enterococcal Sepsis Life Threatening 3/9/2009 16 Male 82 lb 3/14/2011 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Life Threatening 3/9/2009 16 Male 82 lb 3/14/2011 Physician Japan
Primary
Secondary
Concomitant
Cardiac Disorder Disability 1/19/2010 2 Female 22 lb 3/24/2011 Physician Japan
Primary
Secondary
Concomitant
Diffuse Large B-cell Lymphoma Other Serious 55 Male 3/18/2011 Physician Japan
Primary
Concomitant
Pseudomonas Infection Hospitalization 8/4/2006 48 Male 165 lb 4/12/2011 Physician Japan
Primary
Concomitant
Renal Failure Acute Death 2/14/2011 62 Female 110 lb 4/8/2011 Physician Japan
Primary
Concomitant
Mucous Membrane Disorder Disability 8/1/2009 20 Male 110 lb 4/13/2011 Physician Japan
Primary
Secondary
Concomitant
Sepsis Death 8/19/2009 55 Female 121 lb 4/13/2011 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Life Threatening 12/7/2009 1 Female 22 lb 4/19/2011 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Life Threatening 12/7/2009 1 Female 22 lb 4/19/2011 Physician Japan
Primary
Secondary
Concomitant
Renal Disorder Hospitalization 7/25/2010 60 Female 93 lb 4/20/2011 Physician Japan
Primary
Secondary
Concomitant
Renal Disorder Death 7/17/2010 29 Female 82 lb 4/20/2011 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Other Serious 11/27/2010 Male 32 lb 4/20/2011 Pharmacist Japan
Primary
Secondary
Concomitant
Cytomegalovirus Gastroenteritis Death 55 Male 4/20/2011 Physician Japan
Primary
Concomitant
Pulmonary Alveolar Haemorrhage Death 1/26/2011 81 Female 129 lb 4/21/2011 Physician Japan
Primary
Concomitant
Glucose Tolerance Impaired Disability 6/5/2009 59 Male 146 lb 4/22/2011 Physician Japan
Primary
Secondary
Concomitant
Influenza Life Threatening 2/14/2011 62 Female 110 lb 4/22/2011 Physician Japan
Primary
Concomitant
Sepsis Hospitalization 9/13/2010 58 Male 121 lb 4/25/2011 Physician Japan
Primary
Secondary
Concomitant
Cardiac Failure Death 9/1/2010 56 Male 159 lb 4/25/2011 Physician Japan
Primary
Concomitant
Febrile Neutropenia Hospitalization 3/20/2008 58 Male 119 lb 4/29/2011 Physician Japan
Primary
Secondary
Concomitant
Sepsis Death 8/19/2009 55 Female 121 lb 5/2/2011 Physician Japan
Primary
Concomitant
Renal Impairment Hospitalization 5/2/2007 56 Female 95 lb 5/2/2011 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 8/9/2008 7 Female 33 lb 5/4/2011 Physician Japan
Primary
Secondary
Concomitant
Cytomegalovirus Viraemia Hospitalization 4/28/2010 56 Male 139 lb 5/5/2011 Physician Japan
Primary
Concomitant
Staphylococcal Sepsis Hospitalization 4/22/2007 41 Male 132 lb 5/6/2011 Physician Japan
Primary
Secondary
Concomitant
Systemic Candida Death 8/7/2009 12 Male 95 lb 5/6/2011 Physician Japan
Primary
Secondary
Concomitant
Histiocytosis Haematophagic Death 2/25/2009 16 Female 115 lb 5/13/2011 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Life Threatening 4/28/2010 56 Male 139 lb 5/23/2011 Physician Japan
Primary
Concomitant
Aspergillosis Other Serious 49 Male 5/23/2011 Physician Japan
Primary
Concomitant
Renal Disorder Life Threatening 7/25/2010 60 Female 93 lb 5/24/2011 Physician Japan
Primary
Secondary
Concomitant
Hepatic Function Abnormal Death 8/31/2010 56 Male 159 lb 5/27/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Death 11/6/2008 49 Male 134 lb 6/3/2011 Physician Japan
Primary
Concomitant
Fungal Infection Other Serious 11/6/2008 49 Male 134 lb 6/3/2011 Physician Japan
Primary
Concomitant
Hepatic Function Abnormal Death 8/31/2010 56 Male 159 lb 6/7/2011 Physician Japan
Primary
Concomitant
Sensory Disturbance Other Serious 5/21/2008 15 Male 106 lb 6/13/2011 Physician Japan
Primary
Concomitant
Abdominal Pain Hospitalization 10/21/2007 16 Male 99 lb 6/14/2011 Physician Japan
Primary
Secondary
Concomitant
Sepsis Life Threatening 11/19/2008 55 Female 99 lb 6/30/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Respiratory Distress Syndrome Life Threatening 11/11/2007 12 Female 80 lb 7/5/2011 Physician Japan
Primary
Secondary
Concomitant
Arrhythmia Life Threatening 2/14/2008 17 Female 134 lb 7/5/2011 Physician Japan
Primary
Secondary
Concomitant
Pericardial Effusion Life Threatening 10/10/2009 12 Male 92 lb 7/5/2011 Physician Japan
Primary
Concomitant
Mucous Membrane Disorder Disability 8/1/2009 20 Male 110 lb 7/5/2011 Physician Japan
Primary
Secondary
Concomitant
Lung Disorder Life Threatening 4/28/2010 56 Male 139 lb 7/8/2011 Physician Japan
Primary
Concomitant
Human Herpesvirus 6 Infection Hospitalization 3/27/2010 23 Male 117 lb 7/14/2011 Physician Japan
Primary
Secondary
Concomitant
Systemic Candida Death 8/7/2009 12 Male 95 lb 7/14/2011 Physician Japan
Primary
Secondary
Concomitant
Histiocytosis Haematophagic Death 4/25/2009 4 Female 32 lb 7/18/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Skin Death 12/10/2009 7 Male 53 lb 7/19/2011 Physician Japan
Primary
Concomitant
Pneumonia Bacterial Death 10/1/2010 60 Male 183 lb 7/19/2011 Physician Japan
Primary
Concomitant
Febrile Neutropenia Hospitalization 5/2/2007 56 Female 95 lb 7/21/2011 Physician Japan
Primary
Secondary
Concomitant
Encephalitis Fungal Death Male 139 lb 8/1/2011 Physician Japan
Primary
Secondary
Concomitant
Agranulocytosis Other Serious 8/13/2007 56 Male 137 lb 8/8/2011 Physician Japan
Primary
Secondary
Concomitant
Sepsis Death 5/17/2006 57 Male 123 lb 8/9/2011 Physician Japan
Primary
Secondary
Concomitant
Cardiac Failure Life Threatening 2/14/2008 17 Female 134 lb 8/10/2011 Physician Japan
Primary
Secondary
Concomitant
Graft Versus Host Disease Disability 6/6/2011 13 Female 88 lb 9/20/2011 Physician Japan
Primary
Concomitant
Visual Impairment Death 6/6/2011 13 Female 88 lb 11/8/2011 Physician Japan
Primary
Concomitant
Neutrophil Count Increased Death 7/23/2010 58 Male 143 lb 11/18/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Weight Increased Death 7/23/2010 58 Male 143 lb 11/18/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Recurrent Death 12/10/2009 7 Male 53 lb 12/30/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 6/13/2011 3 Male 29 lb 2/7/2012 Physician Japan
Primary
Concomitant
Disorientation Hospitalization 11/13/2011 68 Male 142 lb 2/14/2012 Pharmacist Japan
Primary
Secondary
Concomitant
Nervous System Disorder Death 4/21/2011 16 Male 95 lb 2/17/2012 Physician Japan
Primary
Secondary
Concomitant
Enterococcus Test Positive Other Serious 9/1/2011 79 Female 3/12/2012 Physician Japan
Primary
Secondary
Concomitant
Trichosporon Infection Other Serious Female 3/13/2012 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 51 Male 3/14/2012 Physician Japan
Primary
Secondary
Concomitant
Nervous System Disorder Death 4/21/2011 16 Male 95 lb 3/15/2012 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Hospitalization 51 Male 3/19/2012 Physician Japan
Primary
Secondary
Concomitant
Hypertension Hospitalization 10/18/2010 10 Male 83 lb 4/3/2012 Physician Japan
Primary
Concomitant
Memory Impairment Other Serious 10/18/2010 10 Male 83 lb 4/3/2012 Physician Japan
Primary
Concomitant
Cerebral Infarction Hospitalization 11/12/2011 68 Male 142 lb 4/4/2012 Pharmacist Japan
Primary
Secondary
Concomitant
Hypertension Hospitalization 10/18/2010 10 Male 83 lb 4/17/2012 Physician Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 10/7/2011 3 Male 26 lb 5/25/2012 Physician Japan
Primary
Concomitant
Infection Life Threatening 10/7/2011 3 Male 26 lb 5/30/2012 Physician Japan
Primary
Concomitant
Hypertension Other Serious 10/7/2011 3 Male 26 lb 7/27/2012 Physician Japan
Primary
Concomitant
Pneumatosis Intestinalis Hospitalization 10/28/2011 10 Male 64 lb 12/17/2012 Physician Jp
Primary
Secondary
Concomitant
Pneumatosis Intestinalis Other Serious 10/28/2011 10 Male 64 lb 10/10/2012 Physician Jp
Primary
Secondary
Concomitant
Vomiting Other Serious 4/25/2012 4 Female 22 lb 11/1/2012 Physician Jp
Primary
Concomitant
Gastritis Other Serious 5/24/2012 27 Male 183 lb 8/27/2013 Physician Jp
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 18 Male 10/9/2012 Physician Jp
Primary
Concomitant
Ventricular Arrhythmia Other Serious 5/14/2008 Male 61 lb 1/30/2013 Physician Jp
Primary
Concomitant
Drug Ineffective Other Serious 11 Female 70 lb 3/6/2013 Physician Jp
Primary
Concomitant
Pancytopenia Hospitalization 10/28/2009 7 Male 49 lb 3/8/2013 Physician Jp
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 4/2/2008 20 Male 110 lb 3/22/2013 Physician Jp
Primary
Secondary
Concomitant
Streptococcal Sepsis Other Serious 1/9/2011 54 Male 131 lb 4/17/2013 Country Not Specified
Primary
Secondary
Concomitant
Respiratory Arrest Death 11/19/2011 38 Female 99 lb 4/17/2013 Physician Jp
Primary
Secondary
Concomitant
Posterior Reversible Encephalopathy Syndrome Life Threatening 11/10/2011 37 Female 5/25/2013 Physician Jp
Primary
Secondary
Concomitant
Varicella Virus Test Positive Life Threatening 11/10/2011 37 Female 5/22/2013 Jp
Primary
Secondary
Concomitant
Off Label Use Other Serious 8/5/2011 11 Male 99 lb 5/31/2013 Physician Jp
Primary
Secondary
Concomitant

Drug Data