Onealfa combined with Prednisolone

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
White Blood Cell Count Increased Other Serious 2/5/2006 26 Female 115 lb 3/11/2006 Physician Japan
Primary
Secondary
Concomitant
Thoracic Vertebral Fracture Hospitalization 9/24/2004 Female 3/15/2006 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 2/5/2006 26 Female 115 lb 3/18/2006 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Pneumococcal Life Threatening 3/6/2006 Male 121 lb 4/12/2006 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Pneumococcal Life Threatening 3/6/2006 Male 121 lb 5/23/2006 Physician Japan
Primary
Secondary
Pneumocystis Jiroveci Pneumonia Hospitalization 2/29/2004 Female 121 lb 6/30/2006 Physician Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Hospitalization 11/4/2003 68 Male 101 lb 10/6/2006 Physician Japan
Primary
Concomitant
Pyrexia Hospitalization 7/31/2006 59 Female 152 lb 10/19/2006 Physician Japan
Primary
Concomitant
Platelet Count Decreased Hospitalization 11/4/2003 68 Male 101 lb 1/2/2007 Physician Japan
Primary
Concomitant
Restlessness Other Serious 1/2/2007 29 Female 93 lb 2/8/2007 Physician Japan
Primary
Concomitant
Pneumonia Hospitalization 3/1/2004 Female 121 lb 2/14/2007 Physician Japan
Primary
Secondary
Concomitant
Restlessness Hospitalization 1/2/2007 29 Female 93 lb 2/22/2007 Physician Japan
Primary
Concomitant
Pulmonary Congestion Hospitalization 5/2/2004 26 Female 119 lb 3/2/2007 Japan
Primary
Concomitant
Tachycardia Hospitalization 4/1/2004 26 Female 119 lb 3/14/2007 Japan
Primary
Concomitant
Appendicitis Hospitalization 2/15/2007 Female 99 lb 3/16/2007 Physician Japan
Primary
Secondary
Concomitant
Multiple Myeloma Life Threatening 12/21/2006 Male 82 lb 3/20/2007 Physician Japan
Primary
Secondary
Concomitant
Appendicitis Hospitalization 2/15/2007 Female 99 lb 3/23/2007 Physician Japan
Primary
Secondary
Concomitant
Multiple Myeloma Life Threatening 4/4/2004 Male 82 lb 5/3/2007 Physician Japan
Primary
Secondary
Concomitant
Vasculitis Other Serious 8/25/2006 Female 86 lb 5/7/2007 Physician Japan
Primary
Secondary
Concomitant
Appendicitis Hospitalization 2/15/2007 Female 99 lb 5/25/2007 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Death 3/3/2007 28 Female 127 lb 5/30/2007 Physician Japan
Primary
Concomitant
Appendicitis Hospitalization 2/15/2007 Female 99 lb 6/18/2007 Physician Japan
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Hospitalization 3/1/2004 Female 121 lb 7/5/2007 Physician Japan
Primary
Secondary
Concomitant
Ureteric Cancer Other Serious 3/7/2007 Female 95 lb 7/24/2007 Physician Japan
Primary
Concomitant
Ureteric Cancer Other Serious 3/7/2007 Female 95 lb 7/31/2007 Physician Japan
Primary
Concomitant
Pulmonary Alveolar Haemorrhage Death 3/3/2007 28 Female 127 lb 7/24/2007 Physician Japan
Primary
Concomitant
Gastroenteritis Hospitalization 10/23/2005 Female 97 lb 8/20/2007 Physician Japan
Primary
Secondary
Concomitant
Vasculitis Other Serious 8/25/2006 Female 86 lb 8/29/2007 Physician Japan
Primary
Secondary
Concomitant
Somnolence Disability 8/31/2006 76 Female 106 lb 9/17/2007 Physician Japan
Primary
Concomitant
Somnolence Disability 8/31/2006 76 Female 106 lb 10/2/2007 Physician Japan
Primary
Concomitant
Gastroenteritis Hospitalization 10/23/2005 Female 97 lb 10/8/2007 Physician Japan
Primary
Secondary
Concomitant
Somnolence Disability 8/31/2007 76 Female 106 lb 10/11/2007 Physician Japan
Primary
Concomitant
Histiocytosis Haematophagic Death 3/3/2007 Female 127 lb 10/26/2007 Physician Japan
Primary
Concomitant
Ileus Hospitalization 2/15/2007 Female 99 lb 1/14/2008 Physician Japan
Primary
Secondary
Concomitant
Stevens-johnson Syndrome Hospitalization 12/8/2007 66 Female 106 lb 1/29/2008 Physician Japan
Primary
Secondary
Concomitant
Gastroenteritis Hospitalization 10/23/2005 Female 97 lb 2/7/2008 Physician Japan
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Hospitalization 1/8/2008 Female 115 lb 4/2/2008 Physician Japan
Primary
Secondary
Concomitant
Femur Fracture Other Serious 10/23/2005 78 Female 4/11/2008 Physician Japan
Primary
Concomitant
Gastroenteritis Hospitalization 10/23/2005 Female 97 lb 4/14/2008 Physician Japan
Primary
Secondary
Concomitant
Femur Fracture Other Serious 10/23/2005 75 Female 4/21/2008 Physician Japan
Primary
Secondary
Concomitant
Femur Fracture Other Serious 10/23/2005 75 Female 4/24/2008 Physician Japan
Primary
Secondary
Concomitant
Femur Fracture Other Serious 10/23/2005 75 Female 5/16/2008 Physician Japan
Primary
Secondary
Concomitant
Mycobacterium Avium Complex Infection Hospitalization 6/21/2007 Female 90 lb 5/30/2008 Physician Japan
Primary
Secondary
Concomitant
Gastroenteritis Hospitalization 10/23/2005 Female 97 lb 6/4/2008 Physician Japan
Primary
Secondary
Concomitant
Femur Fracture Other Serious 10/23/2005 75 Female 6/4/2008 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Death 4/1/2008 51 Female 101 lb 6/18/2008 Physician Japan
Primary
Concomitant
Multiple Myeloma Life Threatening 4/4/2004 Male 82 lb 7/10/2008 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Death 4/1/2008 51 Female 101 lb 8/6/2008 Physician Japan
Primary
Concomitant
Oral Torus Other Serious 62 Female 9/5/2008 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 7/14/2008 Female 9/12/2008 Physician Japan
Primary
Concomitant
Oral Torus Other Serious 62 Female 9/12/2008 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 7/14/2008 Female 9/17/2008 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 7/14/2008 Female 9/26/2008 Physician Japan
Primary
Concomitant
Ileus Hospitalization 2/15/2007 Female 99 lb 10/3/2008 Physician Japan
Primary
Secondary
Concomitant
Femur Fracture Other Serious 10/23/2005 75 Female 10/8/2008 Physician Japan
Primary
Secondary
Concomitant
Femur Fracture Other Serious 10/23/2005 75 Female 10/15/2008 Physician Japan
Primary
Secondary
Concomitant
Cardio-respiratory Arrest Death 8/25/2008 Female 82 lb 10/22/2008 Physician Japan
Primary
Concomitant
Mycobacterium Avium Complex Infection Hospitalization 6/21/2007 Female 90 lb 11/14/2008 Physician Japan
Primary
Secondary
Concomitant
Femur Fracture Other Serious 10/23/2005 75 Female 11/17/2008 Physician Japan
Primary
Secondary
Concomitant
Cardio-respiratory Arrest Death 8/25/2008 Female 82 lb 12/2/2008 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 7/14/2008 Female 12/22/2008 Physician Japan
Primary
Concomitant
Vascular Injury Other Serious 11/29/2008 85 Female 88 lb 1/5/2009 Pharmacist Japan
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Hospitalization 8/2/2008 Male 143 lb 2/2/2009 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 9/19/2008 Male 48 lb 2/13/2009 Physician Japan
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Life Threatening 8/22/2008 Male 165 lb 2/24/2009 Physician Japan
Primary
Secondary
Concomitant
Mycobacterium Avium Complex Infection Hospitalization 6/21/2007 Female 90 lb 3/6/2009 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 2/16/2009 65 Female 4/13/2009 Physician
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 8/6/2008 Male 6/19/2009 Physician Japan
Primary
Secondary
Concomitant
Rhinitis Other Serious 11/1/2007 Male 143 lb 7/2/2009 Physician Japan
Primary
Concomitant
Haematoma Hospitalization 7/1/2009 60 Female 7/17/2009 Physician Japan
Primary
Secondary
Concomitant
Haematoma Hospitalization 7/1/2009 60 Female 7/24/2009 Physician Japan
Primary
Secondary
Concomitant
Rhinitis Other Serious 11/1/2007 Male 143 lb 8/4/2009 Physician Japan
Primary
Concomitant
Oesophageal Ulcer Hospitalization 7/1/2009 60 Female 8/6/2009 Physician Japan
Primary
Secondary
Concomitant
Respiratory Failure Life Threatening 8/1/2008 Male 165 lb 8/14/2009 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 9/19/2008 Male 48 lb 8/31/2009 Physician Japan
Primary
Secondary
Concomitant
Sputum Culture Positive Life Threatening 8/1/2008 Male 165 lb 9/18/2009 Physician Japan
Primary
Secondary
Concomitant
Oesophageal Ulcer Hospitalization 7/1/2009 60 Female 10/2/2009 Physician Japan
Primary
Secondary
Concomitant
Histiocytosis Haematophagic Death 3/3/2007 Female 127 lb 11/30/2009 Physician Japan
Primary
Concomitant
Urinary Tract Infection Hospitalization 12/17/2009 Female 75 lb 1/5/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Pneumonia Bacterial Hospitalization 9/19/2009 Male 139 lb 1/12/2010 Physician Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/17/2009 Female 75 lb 1/15/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Upper Respiratory Tract Inflammation Other Serious 7/15/2008 Male 73 lb 1/27/2010 Physician Japan
Primary
Secondary
Concomitant
Rash Life Threatening 11/2/2009 64 Male 1/26/2010 Physician Japan
Primary
Concomitant
Shock Haemorrhagic Hospitalization 3/7/2009 Male 112 lb 2/9/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/17/2009 Female 75 lb 2/17/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Pneumonia Staphylococcal Hospitalization 9/19/2009 Male 139 lb 2/19/2010 Physician Japan
Primary
Secondary
Concomitant
Lymphocyte Count Decreased Other Serious 10/7/2008 Female 117 lb 3/4/2010 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 3/5/2009 Male 108 lb 3/26/2010 Physician Japan
Primary
Secondary
Concomitant
Shock Haemorrhagic Hospitalization 3/7/2009 Male 112 lb 3/29/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Muscular Weakness Other Serious 12/13/2009 Female 121 lb 3/30/2010 Physician Japan
Primary
Concomitant
Anal Cancer Hospitalization Female 3/30/2010 Physician Japan
Primary
Concomitant
Sepsis Hospitalization 12/17/2009 Female 75 lb 3/31/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Subcutaneous Abscess Hospitalization 10/16/2009 67 Female 4/5/2010 Other Health Professional Japan
Primary
Concomitant
Glomerulonephritis Acute Other Serious 3/16/2010 61 Female 126 lb 4/6/2010 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 7/21/2009 71 Female 126 lb 4/7/2010 Physician Switzerland
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 8/11/2009 58 Female 4/9/2010 Physician Japan
Primary
Concomitant
Sepsis Hospitalization 12/17/2009 66 Female 75 lb 4/9/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Hospitalization 8/6/2009 66 Male 154 lb 4/14/2010 Physician Japan
Primary
Concomitant
Rash Hospitalization 5/15/2009 58 Female 4/15/2010 Physician Japan
Primary
Concomitant
Nocardiosis Other Serious 11/12/2009 66 Female 88 lb 4/16/2010 Physician Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 7/21/2009 71 Female 126 lb 4/21/2010 Physician Switzerland
Primary
Concomitant
Rash Hospitalization 5/15/2009 58 Female 4/23/2010 Physician Japan
Primary
Concomitant
Sepsis Hospitalization 12/17/2009 66 Female 75 lb 4/23/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Femur Fracture Other Serious 10/23/2005 75 Female 4/23/2010 Physician Japan
Primary
Secondary
Concomitant
Muscular Weakness Other Serious 12/13/2009 68 Female 121 lb 4/27/2010 Physician Japan
Primary
Concomitant
Dyspnoea Exertional Hospitalization 1/13/2010 67 Female 98 lb 4/27/2010 Physician Japan
Primary
Concomitant
Sepsis Hospitalization 12/17/2009 66 Female 75 lb 4/30/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Rash Hospitalization 5/15/2009 58 Female 106 lb 5/6/2010 Physician Japan
Primary
Concomitant
Sepsis Hospitalization 12/17/2009 66 Female 75 lb 5/7/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/17/2009 66 Female 75 lb 5/21/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Nocardiosis Other Serious 11/12/2009 66 Female 88 lb 5/28/2010 Physician Japan
Primary
Secondary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Hospitalization 8/20/2009 46 Female 157 lb 6/4/2010 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 7/21/2009 71 Female 126 lb 6/7/2010 Physician Switzerland
Primary
Concomitant
Sepsis Hospitalization 12/17/2009 66 Female 75 lb 6/15/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Muscular Weakness Other Serious 12/13/2009 68 Female 121 lb 6/21/2010 Physician Japan
Primary
Concomitant
Thermal Burn Other Serious 8/17/2009 14 Female 160 lb 6/29/2010 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 6/8/2010 71 Female 6/28/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Upper Respiratory Tract Inflammation Hospitalization 9/12/2005 34 Female 104 lb 6/30/2010 Physician Japan
Primary
Concomitant
Urticaria Hospitalization 5/10/2010 29 Female 130 lb 7/20/2010 Physician Japan
Primary
Concomitant
Volvulus Hospitalization 6/12/2009 80 Female 7/22/2010 Physician Japan
Primary
Secondary
Concomitant
Upper Respiratory Tract Inflammation Life Threatening 9/12/2005 34 Female 104 lb 7/23/2010 Physician Japan
Primary
Concomitant
Muscular Weakness Other Serious 12/13/2009 68 Female 121 lb 7/27/2010 Physician Japan
Primary
Concomitant
Fasciitis Hospitalization 7/9/2010 10 Male 79 lb 7/27/2010 Physician Japan
Primary
Concomitant
Chest X-ray Abnormal Hospitalization 7/1/2010 79 Female 8/13/2010 Physician Japan
Primary
Secondary
Concomitant
Fasciitis Hospitalization 6/25/2010 10 Male 79 lb 9/4/2010 Physician Japan
Primary
Concomitant
Renal Impairment Other Serious 7/1/2010 79 Female 9/8/2010 Physician Japan
Primary
Secondary
Concomitant
Glomerulonephritis Acute Other Serious 3/16/2010 61 Female 126 lb 9/23/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 8/11/2009 58 Female 9/24/2010 Physician Japan
Primary
Secondary
Concomitant
Thermal Burn Hospitalization 8/17/2009 14 Female 160 lb 9/24/2010 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Other Serious 8/1/2010 79 Female 9/30/2010 Physician Japan
Primary
Secondary
Concomitant
Fasciitis Hospitalization 6/25/2010 10 Male 79 lb 10/1/2010 Physician Japan
Primary
Concomitant
Rash Life Threatening 11/2/2009 64 Male 10/6/2010 Other Health Professional Japan
Primary
Concomitant
Renal Disorder Hospitalization 3/1/2010 61 Female 134 lb 11/15/2010 Physician Japan
Primary
Concomitant
Thermal Burn Hospitalization 8/17/2009 14 Female 160 lb 11/22/2010 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 11/22/2010 57 Female 90 lb 12/27/2010 Physician Japan
Primary
Concomitant
Back Pain 12/2/2010 75 Female 12/28/2010 Physician Japan
Primary
Concomitant
Diarrhoea Hospitalization 11/22/2010 57 Female 90 lb 1/5/2011 Physician Japan
Primary
Secondary
Concomitant
Gastrointestinal Amyloidosis Hospitalization 11/22/2010 57 Female 90 lb 1/11/2011 Physician Japan
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Death 10/16/2009 80 Female 93 lb 1/18/2011 Physician Japan
Primary
Secondary
Concomitant
Gastrointestinal Amyloidosis Death 11/22/2010 57 Female 90 lb 1/21/2011 Physician Japan
Primary
Secondary
Concomitant
Ascites Death 1/1/2009 42 Male 161 lb 1/21/2011 Physician Japan
Primary
Concomitant
Hypertrophy Other Serious 1/1/2009 42 Male 161 lb 1/21/2011 Physician Japan
Primary
Concomitant
Gastrointestinal Tube Insertion Life Threatening 1/1/2009 42 Male 161 lb 1/25/2011 Physician Japan
Primary
Concomitant
Gastrointestinal Amyloidosis Hospitalization 11/22/2010 57 Female 90 lb 1/28/2011 Physician Japan
Primary
Secondary
Concomitant
Cytomegalovirus Infection Hospitalization 3/3/2010 61 Female 134 lb 1/31/2011 Other Health Professional Japan
Primary
Concomitant
C-reactive Protein Increased Hospitalization 12/17/2010 63 Male 143 lb 1/31/2011 Physician Japan
Primary
Concomitant
Pneumonia Death 11/22/2010 57 Female 90 lb 2/3/2011 Physician Japan
Primary
Secondary
Concomitant
Amyloidosis Death 11/22/2010 57 Female 90 lb 2/4/2011 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 11/22/2010 57 Female 90 lb 2/17/2011 Physician Japan
Primary
Secondary
Concomitant
Retinal Haemorrhage Other Serious 1/14/2011 61 Female 2/17/2011 Physician Japan
Primary
Secondary

Drug Data