Ambisome combined with Funguard

Reports:


Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Leukoencephalopathy Other Serious 12/5/2006 70 Female 9/3/2007 Pharmacist Japan
Primary
Secondary
Sepsis Hospitalization 9/21/2006 Male 123 lb 11/9/2007 Physician Japan
Primary
Concomitant
Renal Impairment Life Threatening 1/1/2007 Female 12/17/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 12/16/2006 Male 146 lb 12/18/2007 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Life Threatening 1/1/2007 Female 12/28/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 2/12/2007 Male 1/8/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Impairment Life Threatening 1/1/2007 Female 1/17/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 5/9/2007 59 Male 130 lb 1/18/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 2/12/2007 Male 2/28/2008 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 2/12/2007 Male 3/3/2008 Physician Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 9/21/2006 Male 123 lb 3/12/2008 Physician Japan
Primary
Concomitant
Liver Disorder Other Serious 7/2/2007 Female 112 lb 3/14/2008 Physician Japan
Primary
Concomitant
Respiratory Failure Other Serious 4/11/2008 Female 43 lb 6/10/2008 Japan
Primary
Secondary
Concomitant
Viral Infection Other Serious 4/11/2008 Female 43 lb 6/17/2008 Japan
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 4/11/2008 Female 43 lb 6/27/2008 Japan
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 9/21/2007 25 Male 7/3/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 12/5/2007 25 Male 7/10/2008 Physician Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 9/21/2006 Male 123 lb 7/29/2008 Physician Japan
Primary
Concomitant
Respiratory Failure Other Serious 8/24/2007 77 Male 8/8/2008 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Life Threatening 1/1/2007 Female 9/10/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Shock Life Threatening 8/8/2007 Female 9/12/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Transfusion Death 8/3/2007 9/18/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Neutrophil Count Decreased Other Serious 5/2/2008 61 Male 120 lb 11/4/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Neutrophil Count Decreased Other Serious 5/2/2008 61 Male 120 lb 11/6/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Blood Creatinine Increased Other Serious 5/9/2008 61 Male 142 lb 11/14/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 9/21/2006 Male 123 lb 11/24/2008 Physician Japan
Primary
Concomitant
Blood Creatinine Increased Other Serious 5/9/2008 61 Male 142 lb 12/11/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Impairment Life Threatening 8/12/2007 Female 12/30/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Visual Acuity Reduced Other Serious 11/27/2008 73 Male 1/5/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Visual Acuity Reduced Other Serious 11/27/2008 73 Male 1/12/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Visual Acuity Reduced Other Serious 11/27/2008 Male 115 lb 1/19/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 10/20/2008 49 Male 1/19/2009 Physician Japan
Primary
Secondary
Concomitant
Visual Acuity Reduced Other Serious 11/28/2008 Male 115 lb 1/27/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Pancreatitis Acute Life Threatening 11/28/2008 14 Male 2/4/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Life Threatening 8/12/2007 Female 2/5/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 4/18/2008 Female 43 lb 2/11/2009 Japan
Primary
Secondary
Concomitant
Pancreatitis Acute Other Serious 10/20/2008 14 Male 2/16/2009 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 11/1/2008 14 Male 3/2/2009 Physician United Kingdom
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 12/16/2006 Male 146 lb 3/5/2009 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 10/20/2008 14 Male 3/10/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 4/18/2008 Female 43 lb 4/8/2009 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 Hospitalization 7/1/2007 16 Male 4/24/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Renal Impairment Other Serious 10/20/2008 Male 154 lb 5/14/2009 Physician Japan
Primary
Secondary
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
Renal Impairment Hospitalization 10/6/2008 66 Female 8/28/2009 Physician Japan
Primary
Concomitant
Weight Increased Other Serious 12/9/2008 25 Female 99 lb 9/8/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 4/4/2007 61 Male 130 lb 9/9/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 5/9/2007 61 Male 130 lb 9/21/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Weight Increased Other Serious 12/9/2008 25 Female 99 lb 9/24/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Life Threatening Male 2 lb 9/30/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Failure Death Male 2 lb 10/26/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Failure Life Threatening Male 17 lb 11/6/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Failure Life Threatening Male 17 lb 11/30/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Failure Death 9/20/2009 0 Male 2 lb 12/14/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Transfusion Death 8/3/2007 2/23/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Platelet Count Increased Other Serious 7/21/2008 Female 104 lb 3/10/2010 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Death 3/1/2007 22 Female 99 lb 12/29/2010 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Death 3/1/2007 22 Female 99 lb 1/17/2011 Physician Japan
Primary
Secondary
Concomitant
Respiratory Distress Life Threatening 8/16/2009 2 Male 23 lb 1/31/2011 Physician Japan
Primary
Secondary
Concomitant
Sepsis Death 11/8/2007 56 Male 88 lb 1/31/2011 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
Circulatory Collapse Death 3/1/2007 22 Female 99 lb 2/16/2011 Physician Japan
Primary
Secondary
Concomitant
Atrioventricular Block Second Degree Other Serious 10/23/2010 56 Female 2/25/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Blood Alkaline Phosphatase Increased Death 3/12/2009 16 Male 82 lb 3/2/2011 Physician Japan
Primary
Secondary
Concomitant
Disseminated Intravascular Coagulation Hospitalization 5/3/2008 66 Male 99 lb 3/7/2011 Physician Japan
Primary
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
Atrioventricular Block Second Degree Other Serious 10/23/2010 54 Female 3/18/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Pseudomonas Infection Death 11/8/2007 56 Male 88 lb 4/6/2011 Physician Japan
Primary
Secondary
Concomitant
Sepsis Death 8/19/2009 55 Female 121 lb 4/13/2011 Physician Japan
Primary
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
Cardiac Failure Death 9/1/2010 56 Male 159 lb 4/25/2011 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Death 3/1/2007 22 Female 99 lb 4/28/2011 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Toxoplasmal Death 10/6/2009 22 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
Respiratory Distress Life Threatening 8/16/2009 2 Male 23 lb 5/19/2011 Physician Japan
Primary
Secondary
Concomitant
Renal Disorder Life Threatening 7/25/2010 60 Female 93 lb 5/24/2011 Physician Japan
Primary
Secondary
Concomitant
Off Label Use Other Serious 4/4/2011 60 Male 5/25/2011 Pharmacist Japan
Primary
Secondary
Concomitant
Hepatic Function Abnormal Death 8/31/2010 56 Male 159 lb 5/27/2011 Physician Japan
Primary
Concomitant
Convulsion Death 5/3/2008 66 Male 99 lb 5/31/2011 Physician Japan
Primary
Concomitant
Renal Disorder Life Threatening 4/8/2011 62 Male 5/31/2011 Other Health Professional Japan
Primary
Secondary
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
Hyperglycaemia Life Threatening 3/30/2011 72 Female 6/15/2011 Other Health Professional Japan
Primary
Concomitant
Fluid Retention Life Threatening 3/30/2011 72 Female 6/27/2011 Physician Japan
Primary
Concomitant
Pneumonia Death 3/18/2011 71 Male 6/28/2011 Physician Japan
Primary
Concomitant
Hypertransaminasaemia Other Serious 5/2/2011 36 Male 6/28/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Off Label Use Other Serious 4/4/2011 60 Male 7/5/2011 Pharmacist Japan
Primary
Concomitant
Interacting
Hypokalaemia Other Serious 3/30/2011 72 Female 7/8/2011 Physician Japan
Primary
Concomitant
Pneumonia Life Threatening 3/18/2011 71 Male 7/12/2011 Physician Japan
Primary
Concomitant
Pancytopenia Other Serious 4/8/2011 62 Male 7/19/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Impairment Death 3/18/2011 71 Male 7/21/2011 Physician Japan
Primary
Concomitant
Renal Impairment Death 10/6/2009 22 Male 119 lb 7/27/2011 Physician Japan
Primary
Secondary
Concomitant
Hypotension Other Serious 3/31/2011 60 Male 7/29/2011 Pharmacist Japan
Primary
Concomitant
Interacting
Multi-organ Failure Death 3/1/2007 22 Female 99 lb 8/18/2011 Physician Japan
Primary
Secondary
Concomitant
Hypernatraemia Life Threatening 3/30/2011 72 Female 8/18/2011 Physician Japan
Primary
Concomitant
Agranulocytosis Other Serious 7/1/2011 71 Male 119 lb 9/19/2011 Other Health Professional Japan
Primary
Concomitant
Bronchopulmonary Aspergillosis Death 5/15/2011 66 Female 9/21/2011 Physician United States
Primary
Concomitant
Drug Ineffective Death 73 Male 10/26/2011 Physician Japan
Primary
Concomitant
Sepsis Death 8/10/2011 68 Male 150 lb 11/18/2011 Other Health Professional Japan
Primary
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
Renal Impairment Life Threatening 4/8/2011 62 Male 112 lb 2/20/2012 Other Health Professional Japan
Primary
Secondary
Concomitant
Pneumonia Other Serious 9/19/2011 74 Male 141 lb 2/27/2012 Other Health Professional Japan
Primary
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
Hepatic Function Abnormal Disability 11/25/2010 61 Male 112 lb 3/30/2012 Other Health Professional Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Death 11/14/2011 61 Female 108 lb 4/3/2012 Other Health Professional Japan
Primary
Concomitant
Pneumonia Other Serious 9/19/2011 74 Male 141 lb 4/5/2012 Other Health Professional Japan
Primary
Concomitant
Sepsis Other Serious 8/10/2011 68 Male 150 lb 4/19/2012 Other Health Professional 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
Hepatic Function Abnormal Death 4/6/2012 25 Male 88 lb 6/13/2012 Other Health Professional Japan
Primary
Concomitant
Tubulointerstitial Nephritis Life Threatening 11/3/2011 35 Female 165 lb 7/3/2012 Physician Japan
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Death 7/29/2011 68 Male 150 lb 7/5/2012 Other Health Professional Japan
Primary
Concomitant
Clostridium Colitis Life Threatening 6/16/2011 1 Male 40 lb 7/13/2012 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Failure Death Male 7/23/2012 Other Health Professional Japan
Primary
Concomitant
Gastric Ulcer Other Serious 6/16/2011 1 Male 40 lb 7/25/2012 Other Health Professional Japan
Primary
Secondary
Concomitant
Hypertension Other Serious 10/7/2011 3 Male 26 lb 7/27/2012 Physician Japan
Primary
Concomitant
Condition Aggravated Death 7/27/2012 8/14/2012 Other Health Professional Japan
Primary
Concomitant
Diarrhoea Hospitalization 2/14/2012 56 Female 95 lb 8/16/2012 Physician Japan
Primary
Concomitant
Pulmonary Oedema Other Serious 3/9/2011 65 Male 150 lb 9/25/2012 Country Not Specified
Primary
Secondary
Concomitant
Lung Infection Death 11/14/2011 61 Female 108 lb 11/27/2012 Physician Jp
Primary
Concomitant
Off Label Use Death 2/25/2010 63 Male 139 lb 12/27/2012 Physician Jp
Primary
Concomitant
Sepsis Hospitalization 4/4/2012 75 Male 123 lb 10/15/2012 Physician Jp
Primary
Concomitant
Hepatic Function Abnormal Other Serious 5/15/2012 57 Male 103 lb 11/23/2012 Physician Jp
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Death 2011 Male 141 lb 11/26/2012 Other Health Professional Jp
Primary
Concomitant
Pulmonary Haemorrhage Death 9/25/2012 65 Male 11/27/2012 Other Health Professional Jp
Primary
Concomitant
Renal Impairment Death 5/5/2012 57 Male 103 lb 12/21/2012 Consumer Jp
Primary
Secondary
Concomitant
Interstitial Lung Disease Hospitalization 11/15/2012 57 Male 159 lb 12/19/2012 Other Health Professional Jp
Primary
Concomitant
Depressed Level Of Consciousness Death 1/5/2013 62 Male 112 lb 1/28/2013 Pharmacist Jp
Primary
Concomitant
Sick Sinus Syndrome Other Serious 3/25/2013 74 Male 6/7/2013 Other Health Professional Jp
Primary
Concomitant
White Blood Cell Count Increased Death 10/9/2012 70 Male 128 lb 5/29/2013 Physician Jp
Primary
Concomitant
Sudden Death Death 4/13/2013 82 Male 7/31/2013 Other Health Professional Jp
Primary
Secondary
Concomitant
Death Death 4/23/2013 75 Male 5/7/2013 Other Health Professional Jp
Primary
Concomitant
Renal Impairment Hospitalization 1/27/2012 7 Male 57 lb 5/16/2013 Physician Jp
Primary
Secondary
Concomitant
Ventricular Fibrillation Death 4/19/2013 82 Male 6/25/2013 Other Health Professional Jp
Primary
Concomitant
Pneumonia Death 4/17/2012 70 Male 126 lb 7/16/2013 Other Health Professional Jp
Primary
Concomitant
Renal Failure Death 21 Male 6/13/2013 Other Health Professional Jp
Primary
Concomitant
Acute Myeloid Leukaemia Death Male 6/19/2013 Other Health Professional Jp
Primary
Concomitant
Septic Shock Life Threatening 8/8/2011 83 Male 126 lb 8/5/2013 Other Health Professional Jp
Primary
Concomitant
Sepsis Life Threatening 11/22/2012 76 Male 141 lb 8/16/2013 Physician Jp
Primary
Concomitant
Sepsis Other Serious 10/10/2012 16 Female 90 lb 8/26/2013 Physician Jp
Primary
Secondary
Concomitant
Platelet Count Decreased Life Threatening 9/18/2012 61 Male 8/29/2013 Physician Jp
Primary
Secondary
Concomitant