Funguard combined with Prograf

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
Tremor Life Threatening 11/22/2004 31 Female 6/6/2006 Physician Japan
Primary
Secondary
Concomitant
Tremor Life Threatening 11/22/2004 31 Female 9/29/2006 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Life Threatening 8/18/2006 6 Female 43 lb 10/2/2006 Physician Japan
Primary
Secondary
Concomitant
Urinary Retention Hospitalization 12/27/2005 58 Male 101 lb 11/9/2006 Physician Japan
Primary
Concomitant
Urinary Retention Hospitalization 12/24/2005 58 Male 101 lb 12/4/2006 Physician Japan
Primary
Concomitant
Sepsis Hospitalization 9/21/2006 Male 123 lb 11/9/2007 Physician Japan
Primary
Concomitant
Sepsis Hospitalization 9/21/2006 Male 123 lb 3/12/2008 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 6/15/2003 24 Female 3/19/2008 Physician Japan
Primary
Secondary
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
White Blood Cell Count Decreased Other Serious 6/15/2003 24 Female 7/7/2008 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 4/21/2007 69 Female 82 lb 7/11/2008 Physician Japan
Primary
Concomitant
Sepsis Hospitalization 9/21/2006 Male 123 lb 7/29/2008 Physician Japan
Primary
Concomitant
Vomiting Other Serious 4/21/2007 69 Female 82 lb 9/12/2008 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Death 8/1/2007 Female 112 lb 9/18/2008 Physician Japan
Primary
Concomitant
Tachycardia Other Serious 6/20/2008 49 10/8/2008 Pharmacist Japan
Primary
Concomitant
Vomiting Other Serious 4/21/2007 69 Female 82 lb 11/4/2008 Physician Japan
Primary
Secondary
Concomitant
Hepatic Failure Death 11/14/2006 Male 11/5/2008 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Alveolar Haemorrhage Hospitalization 9/4/2006 Male 117 lb 11/12/2008 Physician Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 9/21/2006 Male 123 lb 11/24/2008 Physician Japan
Primary
Concomitant
Pulmonary Alveolar Haemorrhage Hospitalization 9/4/2006 Male 117 lb 11/25/2008 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Alveolar Haemorrhage Hospitalization 9/4/2006 Male 117 lb 12/2/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Death 8/1/2007 Female 112 lb 12/10/2008 Physician Japan
Primary
Concomitant
Hepatic Failure Death 11/14/2006 Male 12/23/2008 Physician Japan
Primary
Secondary
Concomitant
Hepatic Failure Death 11/14/2006 Male 123 lb 2/2/2009 Physician Japan
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 4/18/2008 Female 43 lb 2/11/2009 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
Respiratory Failure Other Serious 4/18/2008 Female 43 lb 4/8/2009 Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 6/26/2008 57 Male 137 lb 4/14/2009 Physician Japan
Primary
Concomitant
Death Death 5/19/2006 Male 4/14/2009 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Death 6/2/2006 Male 4/14/2009 Physician Japan
Primary
Concomitant
Splenic Abscess Other Serious 11/16/2008 39 Female 126 lb 4/15/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Disorder Other Serious 8/14/2008 15 Female 110 lb 5/20/2009 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Death 6/2/2006 Male 106 lb 5/26/2009 Physician Japan
Primary
Concomitant
Graft Versus Host Disease Death 5/19/2006 Male 137 lb 5/26/2009 Physician Japan
Primary
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
Tachycardia Other Serious 6/20/2008 Male 8/7/2009 Pharmacist Japan
Primary
Concomitant
Sepsis Other Serious 6/26/2008 57 Male 137 lb 8/12/2009 Physician Japan
Primary
Concomitant
Sepsis Other Serious 6/26/2008 57 Male 137 lb 9/8/2009 Physician Japan
Primary
Concomitant
Stomatitis Life Threatening 9/28/2008 59 Female 123 lb 9/15/2009 Physician Japan
Primary
Secondary
Concomitant
Pseudomembranous Colitis Other Serious 8/25/2008 18 Male 128 lb 10/1/2009 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 9/2/2009 62 Female 2/17/2010 Physician Japan
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
White Blood Cell Count Decreased Hospitalization 9/2/2009 62 Female 5/27/2010 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Haemorrhage Hospitalization 2/26/2010 56 Male 10/7/2010 Physician Japan
Primary
Concomitant
Pulmonary Haemorrhage Hospitalization 2/26/2010 56 Male 11/10/2010 Physician Japan
Primary
Concomitant
Shock Life Threatening 11/11/2007 12 Female 80 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
Acute Respiratory Distress Syndrome Life Threatening 11/11/2007 12 Female 80 lb 1/6/2011 Physician Japan
Primary
Secondary
Concomitant
Histiocytosis Haematophagic Hospitalization 2/26/2010 56 Male 1/18/2011 Physician Japan
Primary
Concomitant
Oedema Peripheral Other Serious Male 117 lb 1/26/2011 Physician Japan
Primary
Secondary
Concomitant
Bronchopulmonary Aspergillosis Other Serious 12/1/2008 64 Female 1/28/2011 Physician Japan
Primary
Concomitant
Pneumonia Life Threatening 4/22/2007 41 Male 132 lb 2/4/2011 Physician Japan
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 12/1/2008 64 Female 2/8/2011 Physician Japan
Primary
Concomitant
Sepsis Hospitalization 2/2/2008 61 Female 117 lb 2/14/2011 Physician Japan
Primary
Secondary
Concomitant
Skin Exfoliation Death 5/23/2003 10 Female 44 lb 2/28/2011 Physician Japan
Primary
Concomitant
Disease Progression Death 8/15/2003 11 Female 44 lb 2/28/2011 Physician Japan
Primary
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
Hepatic Failure Life Threatening 12/8/2010 66 Female 163 lb 3/8/2011 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
Diffuse Large B-cell Lymphoma Other Serious 55 Male 3/18/2011 Physician Japan
Primary
Concomitant
Septic Shock Death 12/8/2010 66 Female 163 lb 3/29/2011 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Staphylococcal Life Threatening 6/15/2003 24 Female 108 lb 4/4/2011 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Haemorrhage Death 2/2/2008 61 Female 117 lb 4/7/2011 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Acute Death 2/14/2011 62 Female 110 lb 4/8/2011 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
Cytomegalovirus Gastroenteritis Death 55 Male 4/20/2011 Physician Japan
Primary
Concomitant
Influenza Life Threatening 2/14/2011 62 Female 110 lb 4/22/2011 Physician Japan
Primary
Concomitant
Pneumonia Toxoplasmal Death 10/6/2009 22 Male 119 lb 4/29/2011 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Cytomegaloviral Death 6/9/2009 10 Male 63 lb 5/5/2011 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Hospitalization 4/22/2007 41 Male 132 lb 5/6/2011 Physician Japan
Primary
Secondary
Concomitant
Aspergillosis Other Serious 49 Male 5/23/2011 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
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
Systemic Candida Death 8/7/2009 12 Male 95 lb 7/14/2011 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Cytomegaloviral Death 6/9/2009 10 Male 64 lb 7/15/2011 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Death 10/6/2009 22 Male 119 lb 7/27/2011 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 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
Engraftment Syndrome Other Serious 3/15/2011 49 Male 9/6/2011 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
Hypertension Other Serious 4/23/2007 60 Female 122 lb 1/24/2012 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
Hepatic Neoplasm Malignant Recurrent Death 8/30/2004 55 Male 3/7/2012 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
Acute Graft Versus Host Disease Hospitalization 51 Male 3/19/2012 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
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
Shock Life Threatening 11/30/2011 58 Female 4/9/2012 Other Health Professional Japan
Primary
Secondary
Concomitant
Convulsion Hospitalization 3/7/2012 60 Female 4/11/2012 Physician Japan
Primary
Secondary
Concomitant
Hypertension Hospitalization 10/18/2010 10 Male 83 lb 4/17/2012 Physician Japan
Primary
Concomitant
Convulsion Hospitalization 3/7/2012 60 Female 4/27/2012 Physician Japan
Primary
Secondary
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
Convulsion Hospitalization 3/7/2012 60 Female 5/29/2012 Physician Japan
Primary
Secondary
Concomitant
Infection Life Threatening 10/7/2011 3 Male 26 lb 5/30/2012 Physician Japan
Primary
Concomitant
Convulsion Hospitalization 3/7/2012 60 Female 6/5/2012 Physician Japan
Primary
Secondary
Concomitant
Bronchopulmonary Aspergillosis Death 52 Female 6/8/2012 Physician Japan
Primary
Secondary
Concomitant
Bronchopulmonary Aspergillosis Death 52 Female 6/8/2012 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Staphylococcal Death 52 Female 6/8/2012 Physician Japan
Primary
Concomitant
Pneumonia Staphylococcal Hospitalization 1/3/2009 52 Female 6/18/2012 Physician Japan
Primary
Concomitant
Pneumonia Staphylococcal Death 52 Female 6/18/2012 Physician Japan
Primary
Concomitant
Drug Ineffective Death 52 Female 6/19/2012 Physician Japan
Primary
Secondary
Concomitant
Drug Ineffective Death 52 Female 6/18/2012 Physician Japan
Primary
Secondary
Concomitant
Convulsion Hospitalization 3/7/2012 60 Female 6/29/2012 Physician Japan
Primary
Secondary
Concomitant
Psychiatric Symptom Other Serious 12/18/2008 22 Male 152 lb 6/28/2012 Physician Japan
Primary
Secondary
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
Drug Ineffective Other Serious 15 Male 12/12/2012 Physician Jp
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 6/4/2009 35 Male 12/26/2012 Physician Jp
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 2011 51 Female 101 lb 8/2/2013 Physician Jp
Primary
Concomitant
Urticaria Other Serious 9/29/2006 6 Male 44 lb 4/26/2013 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
Renal Impairment Hospitalization 1/27/2012 7 Male 57 lb 5/16/2013 Physician Jp
Primary
Secondary
Concomitant
Zygomycosis Other Serious 28 Male 7/1/2013 Physician Jp
Primary
Secondary
Concomitant
Off Label Use Other Serious 8/5/2011 11 Male 99 lb 5/31/2013 Physician Jp
Primary
Secondary
Concomitant
Neutropenia Other Serious 4/14/2012 64 Female 79 lb 7/5/2013 Physician Jp
Primary
Secondary
Concomitant
Oral Infection Other Serious 4/20/2012 19 Male 123 lb 8/2/2013 Physician Jp
Primary
Secondary
Concomitant
Sepsis Other Serious 4/5/2012 4 Male 44 lb 8/5/2013 Physician Jp
Primary
Secondary
Concomitant
Sepsis Other Serious 2011 17 Male 90 lb 8/29/2013 Physician Jp
Primary
Concomitant
Supraventricular Tachycardia Hospitalization 1/28/2013 17 Female 130 lb 8/14/2013 Physician Jp
Primary
Secondary
Concomitant
Sepsis Other Serious 10/10/2012 16 Female 90 lb 8/26/2013 Physician Jp
Primary
Secondary
Concomitant

Drug Data