Daclizumab combined with Prednisone

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Sepsis Life Threatening 7/29/2004 43 Male 218 lb 1/12/2006 Physician Israel
Primary
Secondary
Concomitant
Pneumonia Klebsiella Hospitalization 7/21/2000 64 Male 150 lb 1/18/2006 Physician United States
Primary
Concomitant
Transplant Failure Life Threatening 7/26/2005 56 Male 1/18/2006 Physician Germany
Primary
Secondary
Concomitant
Ventricular Fibrillation Hospitalization 11/10/2001 60 Male 1/20/2006 Physician United States
Primary
Secondary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Life Threatening 11/26/2004 50 Male 99 lb 1/24/2006 Physician Czech Republic
Primary
Secondary
Concomitant
Urosepsis Hospitalization 10/10/2004 65 Female 159 lb 1/27/2006 Physician Israel
Primary
Secondary
Concomitant
Transaminases Increased Hospitalization 3/16/2005 57 Female 1/31/2006 Physician Spain
Primary
Secondary
Concomitant
Wound Infection Hospitalization 7/5/2005 65 Male 2/1/2006 Physician Spain
Primary
Secondary
Concomitant
Infection Hospitalization 11/4/2005 65 Male 2/2/2006 Physician Spain
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Hospitalization 1/8/2004 68 Male 176 lb 2/7/2006 Physician Spain
Primary
Secondary
Concomitant
Urosepsis Hospitalization 10/1/2004 65 Female 2/8/2006 Physician Israel
Primary
Secondary
Concomitant
Urosepsis Hospitalization 10/10/2004 65 Female 159 lb 2/13/2006 Physician Israel
Primary
Secondary
Concomitant
Post Procedural Haemorrhage Life Threatening 12/26/2004 41 Male 2/21/2006 Physician France
Primary
Secondary
Concomitant
Urosepsis Hospitalization 10/1/2004 65 Male 2/25/2006 Physician Israel
Primary
Secondary
Concomitant
Liver Abscess Hospitalization 8/22/2005 53 Male 2/27/2006 Physician France
Primary
Secondary
Concomitant
Respiratory Distress Life Threatening 8/19/2005 66 Male 3/1/2006 Physician Switzerland
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 3/16/2005 57 Female 3/22/2006 Physician Spain
Primary
Secondary
Concomitant
Cytomegalovirus Infection Hospitalization 5/10/2005 41 Male 3/23/2006 Physician France
Primary
Secondary
Concomitant
Thrombocytopenia Death 3/15/2005 62 Male 3/27/2006 Physician Canada
Primary
Secondary
Concomitant
Liver Abscess Hospitalization 8/22/2005 53 Male 10/3/2006 Physician France
Primary
Secondary
Concomitant
Staphylococcal Abscess Hospitalization 8/22/2005 53 Male 10/9/2006 Physician France
Primary
Secondary
Concomitant
Oedema Other Serious 12/1/2003 Male 5/3/2007 Physician Netherlands
Primary
Concomitant
Urinary Tract Infection Hospitalization 11/13/2004 53 Male 163 lb 4/5/2007 Physician Canada
Primary
Secondary
Concomitant
West Nile Viral Infection Hospitalization 10/7/2005 56 Male 8/31/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Lymphocele Other Serious 2/18/2003 28 Male 203 lb 9/14/2007 Physician Mexico
Primary
Secondary
Concomitant
Gastric Ulcer Hospitalization 7/11/2004 20 Female 157 lb 9/17/2007 Physician Mexico
Primary
Secondary
Concomitant
Escherichia Urinary Tract Infection Hospitalization 5 Male 40 lb 9/18/2007
Primary
Secondary
Large Intestinal Ulcer Other Serious 42 Female 146 lb 10/3/2007 Physician United States
Primary
Concomitant
Renal Failure Acute Other Serious 1/1/2004 Female 10/22/2007 Physician United States
Primary
Secondary
Splenomegaly Hospitalization 3/1/2003 24 Male 10/23/2007
Primary
Secondary
Concomitant
Pneumonia Bacterial Life Threatening 7/15/2003 61 Male 151 lb 11/6/2007 Physician Spain
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 3/15/2005 Male 183 lb 11/7/2007 Physician Canada
Primary
Secondary
Concomitant
Sinusitis Hospitalization 4/6/2005 Female 139 lb 12/20/2007 Physician Poland
Primary
Secondary
Human Polyomavirus Infection Other Serious 5/19/2004 55 Male 183 lb 12/20/2007 Physician Spain
Primary
Secondary
Concomitant
Nephropathy Toxic Hospitalization 7/18/2005 Male 12/26/2007 Physician Spain
Primary
Concomitant
Post Procedural Haemorrhage Other Serious 6/1/2004 53 Male 1/23/2008 Physician Spain
Primary
Secondary
Polyomavirus-associated Nephropathy Hospitalization 8/3/2005 Male 1/24/2008 Physician Germany
Primary
Concomitant
Transplant Rejection Other Serious 5/31/2007 Female 90 lb 4/11/2008 Physician Canada
Primary
Secondary
Concomitant
Human Polyomavirus Infection Other Serious 5/19/2004 Male 183 lb 4/17/2008 Physician Spain
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 1 Female 13 lb 9/26/2008
Primary
Secondary
Concomitant
Kidney Transplant Rejection Other Serious 10/7/2008 Male 260 lb 10/20/2008 Physician Canada
Primary
Secondary
Concomitant
Seroma Other Serious 9/29/2003 Female 4/3/2009 Physician Germany
Primary
Secondary
Pulmonary Embolism Death 4/23/2003 Female 141 lb 4/3/2009 Physician Mexico
Primary
Secondary
Concomitant
Transient Ischaemic Attack Hospitalization 11/28/2003 Male 168 lb 4/3/2009 Physician Spain
Primary
Secondary
Concomitant
Small Intestinal Obstruction Hospitalization 5/16/2004 Male 194 lb 4/3/2009 Physician Israel
Primary
Secondary
Concomitant
Vomiting Hospitalization 3/25/2004 Female 126 lb 4/3/2009 Physician Brazil
Primary
Secondary
Concomitant
Urinary Tract Infection Other Serious 8/5/2003 Female 123 lb 4/3/2009 Physician Germany
Primary
Secondary
Concomitant
Atrial Fibrillation Other Serious 5/28/2004 Male 201 lb 4/3/2009 Physician Israel
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Other Serious 6/11/2003 Male 4/10/2009 Physician Brazil
Primary
Secondary
Concomitant
Wound Dehiscence Hospitalization 4/14/2003 Male 261 lb 6/23/2009 Physician Sweden
Primary
Secondary
Concomitant
Vomiting Hospitalization 6/7/2003 Female 126 lb 6/23/2009 Physician Brazil
Primary
Secondary
Concomitant
Pancytopenia Hospitalization 6/21/2003 Female 155 lb 6/23/2009 Physician Brazil
Primary
Secondary
Concomitant
Respiratory Tract Infection Hospitalization 6/23/2003 Female 134 lb 6/23/2009 Physician Spain
Primary
Secondary
Concomitant
Hepatitis Hospitalization 3/22/2003 Male 96 lb 6/23/2009 Physician Brazil
Primary
Secondary
Concomitant
Wound Infection Other Serious 6/12/2003 Male 141 lb 6/23/2009 Physician Brazil
Primary
Secondary
Concomitant
Renal Cyst Infection Hospitalization 8/18/2003 Male 143 lb 6/23/2009 Physician Spain
Primary
Secondary
Concomitant
Bone Marrow Failure Hospitalization 8/11/2003 Male 146 lb 6/23/2009 Physician Brazil
Primary
Secondary
Concomitant
Varicella Life Threatening 7/25/2003 Female 118 lb 6/23/2009 Physician Spain
Primary
Secondary
Concomitant
Systemic Candida Hospitalization 8/20/2003 Male 6/23/2009 Physician Mexico
Primary
Secondary
Concomitant
Cytomegalovirus Infection Hospitalization 8/8/2003 Female 123 lb 6/23/2009 Physician Brazil
Primary
Secondary
Concomitant
Urinary Tract Infection Life Threatening 8/5/2003 Male 141 lb 6/23/2009 Physician Brazil
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 8/24/2003 Male 159 lb 6/23/2009 Physician Germany
Primary
Secondary
Concomitant
Herpes Zoster Other Serious 8/7/2003 Female 152 lb 6/23/2009 Physician Germany
Primary
Secondary
Concomitant
Pneumonia Bacterial Hospitalization 9/4/2003 Male 193 lb 6/23/2009 Physician Germany
Primary
Secondary
Concomitant
Hyperkalaemia Other Serious 11/5/2003 Male 265 lb 6/23/2009 Physician Israel
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 7/15/2003 Male 151 lb 6/23/2009 Physician Spain
Primary
Secondary
Concomitant
Ureteric Stenosis Hospitalization 11/4/2003 Female 83 lb 6/23/2009 Physician Brazil
Primary
Secondary
Concomitant
Lymphocele Life Threatening 11/28/2003 Male 160 lb 6/23/2009 Physician Spain
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 12/19/2003 Male 151 lb 6/23/2009 Physician Germany
Primary
Secondary
Concomitant
Transitional Cell Carcinoma Life Threatening 4/30/2004 Male 179 lb 6/23/2009 Physician Mexico
Primary
Secondary
Concomitant
Parvovirus Infection Other Serious 1/6/2004 Male 135 lb 6/23/2009 Physician Brazil
Primary
Secondary
Concomitant
Urosepsis Hospitalization 9/12/2003 Male 107 lb 6/23/2009 Physician Brazil
Primary
Secondary
Concomitant
Peritonitis Hospitalization 7/29/2003 Male 126 lb 6/23/2009 Physician Brazil
Primary
Secondary
Concomitant
Vesical Fistula Hospitalization 1/25/2004 Female 126 lb 6/23/2009 Physician Spain
Primary
Secondary
Concomitant
Cytomegalovirus Infection Hospitalization 11/6/2003 Male 121 lb 6/23/2009 Physician Brazil
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 6/15/2003 Male 185 lb 6/23/2009 Physician Brazil
Primary
Secondary
Concomitant
Vomiting Hospitalization 6/6/2003 Male 132 lb 6/23/2009 Physician Germany
Primary
Secondary
Concomitant
Lymphocele Other Serious 2/18/2003 Male 203 lb 6/23/2009 Physician Mexico
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 9/9/2004 Female 6/23/2009 Physician Germany
Primary
Secondary
Concomitant
Urinoma Hospitalization 2/20/2004 Male 6/23/2009 Physician Spain
Primary
Secondary
Concomitant
Human Polyomavirus Infection Other Serious 5/19/2004 Male 183 lb 6/23/2009 Physician Spain
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 9/21/2004 Male 187 lb 6/23/2009 Physician Spain
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Hospitalization 1/8/2004 Male 176 lb 6/23/2009 Physician Spain
Primary
Secondary
Concomitant
Gastric Ulcer Hospitalization 7/11/2004 Female 157 lb 6/23/2009 Physician Mexico
Primary
Secondary
Concomitant
Ureteric Obstruction Other Serious 9/1/2004 Female 6/23/2009 Physician Australia
Primary
Secondary
Concomitant
Human Polyomavirus Infection Other Serious 5/5/2004 Female 132 lb 6/23/2009 Physician Poland
Primary
Secondary
Concomitant
Urosepsis Hospitalization 11/4/2004 Female 119 lb 6/23/2009 Physician Spain
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 10/18/2004 Male 146 lb 6/23/2009 Physician Spain
Primary
Secondary
Concomitant
Pyrexia Life Threatening 7/29/2004 Male 218 lb 6/23/2009 Physician Israel
Primary
Secondary
Concomitant
Urinary Tract Infection Other Serious 8/23/2004 Male 189 lb 6/23/2009 Physician Israel
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 11/16/2004 Female 164 lb 6/23/2009 Physician Spain
Primary
Secondary
Concomitant
Ureteric Stenosis Hospitalization 11/29/2004 Male 187 lb 6/23/2009 Physician Canada
Primary
Secondary
Concomitant
Urosepsis Life Threatening 9/6/2004 Male 159 lb 6/23/2009 Physician Israel
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 10/8/2004 Male 185 lb 6/23/2009 Physician Spain
Primary
Secondary
Concomitant
Cerebrovascular Accident Death 3/20/2005 Male 6/23/2009 Physician Brazil
Primary
Secondary
Concomitant
Pancreatitis Acute Hospitalization 9/16/2004 Male 198 lb 6/23/2009 Physician Czech Republic
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection Hospitalization 12/4/2004 Male 119 lb 6/23/2009 Physician Spain
Primary
Secondary
Concomitant
Sepsis Life Threatening 6/11/2004 Male 170 lb 6/23/2009 Physician Czech Republic
Primary
Secondary
Concomitant
Urinary Tract Infection Life Threatening 1/16/2006 Female 6/23/2009 Physician Czech Republic
Primary
Secondary
Concomitant
Cytomegalovirus Enteritis Hospitalization 6/29/2004 Male 148 lb 6/23/2009 Physician Spain
Primary
Secondary
Concomitant
Graft Loss Hospitalization 9/11/2004 Male 99 lb 6/23/2009 Physician Brazil
Primary
Secondary
Concomitant
Cytomegalovirus Gastrointestinal Infection Hospitalization 9/1/2003 Male 134 lb 6/23/2009 Physician Brazil
Primary
Secondary
Concomitant
Bronchopneumonia Hospitalization 11/26/2003 Female 133 lb 6/23/2009 Physician Czech Republic
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 6/30/2004 Male 220 lb 6/23/2009 Physician Spain
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 2/23/2004 Male 6/23/2009 Physician Brazil
Primary
Secondary
Concomitant
Gastroenteritis Other Serious 9/1/2006 Male 6/23/2009 Physician Australia
Primary
Secondary
Concomitant
Varicella Hospitalization 8/29/2005 Male 6/23/2009 Physician Mexico
Primary
Secondary
Concomitant
Death Death 6/1/2005 Female 161 lb 6/23/2009 Physician Mexico
Primary
Secondary
Concomitant
Cerebrovascular Accident Death 3/20/2005 Male 6/24/2009 Physician Brazil
Primary
Secondary
Concomitant
Post Herpetic Neuralgia Life Threatening 5/10/2004 Female 6/24/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Wound Dehiscence Other Serious 7/10/2003 Male 6/25/2009 Physician Germany
Primary
Secondary
Concomitant
Ureteric Fistula Hospitalization 7/6/2004 Male 6/25/2009 Physician Brazil
Primary
Secondary
Concomitant
Bone Marrow Failure Hospitalization 8/11/2003 Male 6/25/2009 Physician Brazil
Primary
Secondary
Concomitant
Pyrexia Life Threatening 10/8/2003 Female 6/25/2009 Physician Brazil
Primary
Secondary
Concomitant
Seroma Hospitalization 9/20/2004 Male 6/25/2009 Physician Germany
Primary
Concomitant
Renal Impairment Other Serious 1/19/2004 Female 6/25/2009 Physician Spain
Primary
Secondary
Concomitant
Vascular Calcification Hospitalization 12/21/2004 Female 6/25/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Weight Decreased Other Serious 3/1/2004 Female 6/25/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Urine Output Decreased Hospitalization 8/12/2004 Female 6/25/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Ureteric Stenosis Hospitalization 11/4/2003 Female 7/1/2009 Physician Brazil
Primary
Secondary
Concomitant
Hepatitis Hospitalization 3/16/2003 Male 7/1/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Vomiting Hospitalization 9/11/2004 Male 7/1/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Hospitalization 1/9/2004 Male 7/2/2009 Physician Spain
Primary
Secondary
Concomitant
Osteoma Hospitalization 3/8/2004 Male 7/9/2009 Physician Spain
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 8/23/2004 Male 7/29/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Retroperitoneal Haematoma Other Serious 7/20/2009 Male 154 lb 7/23/2009 Physician United States
Primary
Concomitant
Retroperitoneal Haematoma Other Serious 7/17/2009 Male 154 lb 10/16/2009 Physician United States
Primary
Secondary
Concomitant
Juvenile Arthritis Disability 6 Male 11/13/2009 Other Health Professional United States
Primary
Secondary
Hepatic Cirrhosis Other Serious 1/1/2006 45 Male 11/23/2009 Other Health Professional United States
Primary
Secondary
Squamous Cell Carcinoma Other Serious 11 Male 11/25/2009 Physician United States
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Other Serious 9 Male 11/25/2009 Physician United States
Primary
Concomitant
Hepatitis B Death 45 Male 2/8/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Transplant Other Serious 35 Male 3/12/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 47 Female 3/12/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Other Serious 11 Male 3/18/2010 Physician United States
Primary
Secondary
Ileus Other Serious 22 Male 11/29/2010 Other Health Professional United States
Primary
Secondary
Pseudomonal Sepsis Other Serious 1/1/2009 12/21/2010 United States
Primary
Secondary
Eschar Death 63 Male 1/20/2011 Physician United States
Primary
Secondary
Concomitant
Mantle Cell Lymphoma Stage Iv Hospitalization 3/4/2009 42 Female 119 lb 2/4/2011 Other Health Professional United States
Primary
Concomitant
Death Death 62 Male 3/10/2011 Other Health Professional United States
Primary
Secondary
Urinary Tract Infection Death 3/29/2011 Other Health Professional China
Primary
Secondary
Leukopenia Hospitalization 63 Male 6/22/2011 Physician United States
Primary
Secondary
Concomitant
Leukopenia Hospitalization 63 Male 6/22/2011 Physician United States
Primary
Secondary
Concomitant
Weight Decreased Other Serious 3/1/2004 66 Female 220 lb 12/10/2012 Physician Es
Primary
Secondary
Concomitant
Skin Papilloma Other Serious 18 Female 10/18/2012 Other Health Professional Us
Primary
Concomitant
Renal Failure Chronic Other Serious 18 Female 11/29/2012 Physician Us
Primary
Secondary
Ureteric Obstruction Life Threatening 9/1/2004 55 Female 12/12/2012 Physician Au
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 1/16/2006 66 Female 12/13/2012 Physician Cz
Primary
Secondary
Concomitant
Renal Vessel Disorder Disability 7/15/2003 61 Male 12/17/2012 Physician Es
Primary
Secondary
Concomitant
Ureteric Stenosis Hospitalization 11/29/2004 46 Male 187 lb 12/14/2012 Physician Ca
Primary
Secondary
Concomitant

Drug Data