Funguard combined with Prednisolone

Reports:


Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Weight Increased Other Serious 9/1/2004 43 Female 3/11/2006 Physician Japan
Primary
Concomitant
Weight Increased Other Serious 9/1/2004 43 Female 4/1/2006 Physician Japan
Primary
Concomitant
Tremor Life Threatening 11/22/2004 31 Female 6/6/2006 Physician Japan
Primary
Secondary
Concomitant
Leukaemia Death 10/17/2005 24 Female 88 lb 8/11/2006 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Haemorrhage Hospitalization 12/16/2005 45 Male 112 lb 9/11/2006 Physician Japan
Primary
Secondary
Concomitant
Tremor Life Threatening 11/22/2004 31 Female 9/29/2006 Physician Japan
Primary
Secondary
Concomitant
Speech Disorder Disability 11/2/2005 23 Male 11/1/2006 Physician Japan
Primary
Secondary
Concomitant
Toxic Skin Eruption Other Serious 12/15/2006 Female 139 lb 2/27/2007 Physician Japan
Primary
Secondary
Concomitant
Superinfection Life Threatening 1/23/2007 80 Female 3/15/2007 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 5/3/2007 58 Male 126 lb 5/22/2007 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 3/26/2007 59 Female 106 lb 5/23/2007 Pharmacist Japan
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 5/3/2007 58 Male 126 lb 6/4/2007 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 5/3/2007 58 Male 126 lb 6/9/2007 Physician Japan
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Life Threatening 10/27/2005 58 Male 146 lb 8/29/2007 Physician Japan
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Life Threatening 10/27/2005 58 Male 146 lb 8/30/2007 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 11/2/2005 23 Male 9/4/2007 Physician Japan
Primary
Secondary
Concomitant
Renal Tubular Acidosis Death 3/23/2006 73 Female 99 lb 9/12/2007 Physician Japan
Primary
Concomitant
Shock Death 3/23/2006 73 Female 99 lb 9/13/2007 Physician Japan
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Life Threatening 10/27/2005 58 Male 146 lb 9/25/2007 Physician Japan
Primary
Secondary
Concomitant
Shock Death 3/23/2006 73 Female 99 lb 9/26/2007 Physician Japan
Primary
Concomitant
Staphylococcal Infection Other Serious 3/26/2007 59 Female 106 lb 9/28/2007 Pharmacist Japan
Primary
Concomitant
Urinary Bladder Haemorrhage Life Threatening 1/23/2007 80 Female 90 lb 11/5/2007 Physician Japan
Primary
Concomitant
Pneumonia Cytomegaloviral Hospitalization 10/11/2007 Female 12/17/2007 Physician Japan
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Life Threatening 10/27/2005 58 Male 146 lb 2/5/2008 Physician Japan
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Life Threatening 10/27/2005 58 Male 146 lb 2/11/2008 Physician Japan
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Life Threatening 10/27/2005 58 Male 146 lb 2/15/2008 Physician Japan
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 1/1/2007 Female 108 lb 2/28/2008 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 6/15/2003 24 Female 3/19/2008 Physician Japan
Primary
Secondary
Concomitant
Tumour Invasion Other Serious 3/26/2007 59 Female 106 lb 4/11/2008 Pharmacist Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 6/15/2003 24 Female 7/7/2008 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
Thrombotic Microangiopathy Death 8/1/2007 Female 112 lb 9/18/2008 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Death 8/1/2007 Female 112 lb 12/10/2008 Physician Japan
Primary
Concomitant
Pneumonia Cytomegaloviral Hospitalization 1/1/2007 Female 108 lb 2/24/2009 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
Sepsis Other Serious 6/26/2008 57 Male 137 lb 4/14/2009 Physician Japan
Primary
Concomitant
Pulmonary Alveolar Haemorrhage Death 60 Male 4/17/2009 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Death 8/28/2008 66 Male 145 lb 4/21/2009 Japan
Primary
Secondary
Concomitant
Pulmonary Alveolar Haemorrhage Death 60 Male 4/22/2009 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Other Serious 10/6/2008 Female 165 lb 6/25/2009 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Hospitalization 4/28/2008 54 Male 161 lb 7/10/2009 Physician Japan
Primary
Concomitant
Stomatitis Death 3/12/2008 Male 126 lb 7/31/2009 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Death 8/28/2008 66 Male 145 lb 10/13/2009 Japan
Primary
Secondary
Concomitant
Stomatitis Death 3/12/2008 Male 126 lb 3/9/2010 Physician Japan
Primary
Secondary
Concomitant
Shock Haemorrhagic Other Serious 9/1/2008 64 Female 146 lb 3/31/2010 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
Thrombocytopenia Other Serious 10/7/2010 64 Male 119 lb 11/22/2010 Physician Japan
Primary
Concomitant
Thrombocytopenia Other Serious 10/7/2010 64 Male 119 lb 11/24/2010 Physician Japan
Primary
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
Infection Death 4/25/2009 4 Female 32 lb 1/24/2011 Physician Japan
Primary
Secondary
Concomitant
Bronchopulmonary Aspergillosis Other Serious 12/1/2008 64 Female 1/28/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 12/1/2008 64 Female 2/8/2011 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Hospitalization 9/18/2010 5 Female 53 lb 2/23/2011 Physician Japan
Primary
Concomitant
Oculomucocutaneous Syndrome Hospitalization 52 Male 3/9/2011 Other Health Professional Japan
Primary
Concomitant
Pneumonia Staphylococcal Life Threatening 6/15/2003 24 Female 108 lb 4/4/2011 Physician Japan
Primary
Secondary
Concomitant
Cytomegalovirus Viraemia Hospitalization 4/28/2010 56 Male 139 lb 5/5/2011 Physician Japan
Primary
Concomitant
Renal Failure Disability 5/25/2008 4 Male 37 lb 5/19/2011 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Life Threatening 4/28/2010 56 Male 139 lb 5/23/2011 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Hospitalization 4/26/2010 24 Female 90 lb 5/26/2011 Physician Japan
Primary
Secondary
Concomitant
Dehydration Other Serious 10/7/2010 64 Male 119 lb 6/2/2011 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
Blood Lactate Dehydrogenase Increased Hospitalization 10/20/2010 65 Female 108 lb 6/7/2011 Physician Japan
Primary
Secondary
Concomitant
C-reactive Protein Increased Hospitalization 12/1/2010 90 Male 6/7/2011 Physician Japan
Primary
Secondary
Concomitant
Anaemia Other Serious 12/28/2009 62 Female 51 lb 6/10/2011 Physician Japan
Primary
Concomitant
Sensory Disturbance Other Serious 5/21/2008 15 Male 106 lb 6/13/2011 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 12/1/2010 90 Male 6/28/2011 Japan
Primary
Secondary
Concomitant
Graft Versus Host Disease Disability 1/16/2008 4 Female 34 lb 6/28/2011 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
Interstitial Lung Disease Hospitalization 12/28/2009 62 Female 51 lb 7/14/2011 Physician Japan
Primary
Concomitant
Histiocytosis Haematophagic Death 4/25/2009 4 Female 32 lb 7/18/2011 Physician Japan
Primary
Secondary
Concomitant
Diarrhoea Hospitalization 6/8/2010 57 Male 126 lb 7/27/2011 Physician Japan
Primary
Secondary
Concomitant
Adenovirus Infection Hospitalization 8/26/2008 50 Male 141 lb 7/27/2011 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Death 10/6/2009 22 Male 119 lb 7/27/2011 Physician Japan
Primary
Secondary
Concomitant
Agranulocytosis Other Serious 8/13/2007 56 Male 137 lb 8/8/2011 Physician Japan
Primary
Secondary
Concomitant
Cardiac Failure Life Threatening 2/14/2008 17 Female 134 lb 8/10/2011 Physician Japan
Primary
Secondary
Concomitant
Cytomegalovirus Viraemia Hospitalization 10/16/2010 63 Female 8/22/2011 Physician Japan
Primary
Concomitant
Congestive Cardiomyopathy Disability 5/25/2008 4 Male 37 lb 8/26/2011 Physician Japan
Primary
Secondary
Concomitant
Cytomegalovirus Viraemia Life Threatening 11/22/2004 31 Female 8/26/2011 Physician Japan
Primary
Secondary
Concomitant
Hyperbilirubinaemia Death 12/15/2004 31 Female 8/31/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Bronchopulmonary Aspergillosis Death 63 Female 9/2/2011 Physician Japan
Primary
Concomitant
Engraftment Syndrome Other Serious 3/15/2011 49 Male 9/6/2011 Physician Japan
Primary
Secondary
Concomitant
Agranulocytosis Other Serious 7/1/2011 71 Male 119 lb 9/19/2011 Other Health Professional Japan
Primary
Concomitant
Graft Versus Host Disease Disability 6/6/2011 13 Female 88 lb 9/20/2011 Physician Japan
Primary
Concomitant
Somnolence Hospitalization 3/30/2009 59 Male 9/27/2011 Physician Japan
Primary
Concomitant
Septic Shock Hospitalization 9/12/2011 55 Female 95 lb 10/3/2011 Physician Japan
Primary
Secondary
Concomitant
Hyperglycaemia Life Threatening 10/3/2011 Male 10/13/2011 Physician Japan
Primary
Concomitant
Death Death 10/3/2011 Male 10/18/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Death 60 Male 86 lb 10/28/2011 Physician Japan
Primary
Concomitant
Trichosporon Infection Death 75 Male 11/1/2011 Physician Japan
Primary
Concomitant
Metabolic Acidosis Other Serious 10/4/2011 43 Male 11/3/2011 Physician Japan
Primary
Concomitant
Visual Impairment Death 6/6/2011 13 Female 88 lb 11/8/2011 Physician Japan
Primary
Concomitant
Cytomegalovirus Viraemia Hospitalization 12/15/2004 31 Female 11/14/2011 Japan
Primary
Secondary
Concomitant
Diarrhoea Life Threatening 8/5/2011 63 Male 11/24/2011 Consumer Japan
Primary
Concomitant
Soft Tissue Infection Death 15 Female 11/25/2011 Physician Japan
Primary
Concomitant
Trichosporon Infection Death 6/17/2009 75 Male 11/22/2011 Physician Japan
Primary
Secondary
Concomitant
Lymphocyte Count Decreased Hospitalization 8/4/2011 70 Female 11/29/2011 Other Health Professional Japan
Primary
Concomitant
Soft Tissue Infection Death 10/17/2011 15 Female 86 lb 12/1/2011 Other Health Professional Japan
Primary
Concomitant
Tumour Lysis Syndrome Other Serious 10/4/2011 43 Male 12/1/2011 Physician Japan
Primary
Concomitant
Pneumonia Life Threatening 9/20/2011 77 Female 106 lb 12/6/2011 Other Health Professional Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 12/1/2010 90 Male 12/21/2011 Japan
Primary
Secondary
Concomitant
Abdominal Pain Upper Other Serious 10/4/2011 43 Male 12/28/2011 Physician Japan
Primary
Concomitant
Abdominal Pain Upper Death 10/4/2011 43 Male 1/17/2012 Physician Japan
Primary
Concomitant
Hepatic Failure Disability 6/3/2005 61 Male 1/24/2012 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Death 12/21/2005 61 Female 136 lb 1/26/2012 Japan
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 6/13/2011 3 Male 29 lb 2/7/2012 Physician Japan
Primary
Concomitant
Nervous System Disorder Death 4/21/2011 16 Male 95 lb 2/17/2012 Physician Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Hospitalization 12/8/2011 78 Male 110 lb 2/29/2012 Other Health Professional Japan
Primary
Concomitant
Respiratory Failure Death 7/21/2004 55 Female 3/2/2012 Japan
Primary
Secondary
Concomitant
Hepatic Neoplasm Malignant Recurrent Death 8/30/2004 55 Male 3/7/2012 Physician Japan
Primary
Secondary
Concomitant
Intra-abdominal Haemorrhage Other Serious 3/6/2006 56 Male 3/9/2012 Japan
Primary
Secondary
Concomitant
Hepatic Failure Other Serious 6/27/2011 71 Male 119 lb 3/14/2012 Physician Japan
Primary
Concomitant
Nervous System Disorder Death 4/21/2011 16 Male 95 lb 3/15/2012 Physician Japan
Primary
Secondary
Concomitant
Alanine Aminotransferase Increased Life Threatening 11/30/2011 58 Female 3/26/2012 Other Health Professional Japan
Primary
Secondary
Concomitant
Tremor Other Serious 2/16/2012 63 Male 112 lb 4/2/2012 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Death 11/14/2011 61 Female 108 lb 4/3/2012 Other Health Professional Japan
Primary
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
Shock Life Threatening 11/30/2011 58 Female 4/9/2012 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 7/23/2011 58 Male 4/10/2012 Other Health Professional Japan
Primary
Concomitant
Urine Output Decreased Life Threatening 10/4/2011 43 Male 4/11/2012 Other Health Professional Japan
Primary
Concomitant
Bilirubin Conjugated Increased Death 12/5/2011 68 Female 84 lb 4/12/2012 Physician Japan
Primary
Concomitant
Hypertension Hospitalization 10/18/2010 10 Male 83 lb 4/17/2012 Physician Japan
Primary
Concomitant
Tumour Lysis Syndrome Life Threatening 10/4/2011 43 Male 5/1/2012 Other Health Professional Japan
Primary
Concomitant
Pain In Extremity Disability 10/29/2008 13 Male 78 lb 5/16/2012 Physician Japan
Primary
Secondary
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
Renal Failure Acute Hospitalization 7/23/2011 58 Male 132 lb 6/6/2012 Other Health Professional Japan
Primary
Concomitant
Bilirubin Conjugated Increased Other Serious 1/1/2011 67 Female 84 lb 6/11/2012 Physician Japan
Primary
Concomitant
Renal Impairment Hospitalization 1/1/2011 67 Female 84 lb 6/18/2012 Physician Japan
Primary
Concomitant
Palpitations Life Threatening 6/15/2011 58 Male 132 lb 6/20/2012 Other Health Professional Japan
Primary
Concomitant
Haemorrhoids Other Serious 3/23/2011 75 Female 84 lb 6/27/2012 Other Health Professional Japan
Primary
Concomitant
Psychiatric Symptom Other Serious 12/18/2008 22 Male 152 lb 6/28/2012 Physician Japan
Primary
Secondary
Concomitant
Clostridium Colitis Life Threatening 6/16/2011 1 Male 40 lb 7/13/2012 Other Health Professional Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Death 5/22/2011 67 Male 130 lb 7/23/2012 Physician Japan
Primary
Concomitant
Zygomycosis Death 63 Male 7/23/2012 Physician Japan
Primary
Concomitant
Gastric Ulcer Other Serious 6/16/2011 1 Male 40 lb 7/25/2012 Other Health Professional Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Death 2/2/2012 67 Male 7/26/2012 Physician Japan
Primary
Concomitant
Hypertension Other Serious 10/7/2011 3 Male 26 lb 7/27/2012 Physician Japan
Primary
Concomitant
Haemoptysis Death 3/14/2012 125 lb 8/13/2012 Physician Japan
Primary
Concomitant
Diarrhoea Hospitalization 2/14/2012 56 Female 95 lb 8/16/2012 Physician Japan
Primary
Concomitant
Eye Infection Fungal Other Serious 81 Female 8/16/2012 Physician Japan
Primary
Concomitant