Cyclosporine combined with Sirolimus

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Urinary Tract Infection Hospitalization 8/5/2003 25 Female 123 lb 1/9/2006 Physician Germany
Primary
Secondary
Concomitant
Vascular Graft Complication Other Serious 59 Male 2/10/2006 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Stent Placement Other Serious 33 Female 2/11/2006 Other Health Professional Hong Kong
Primary
Secondary
Febrile Neutropenia Hospitalization 9/11/2005 25 Female 117 lb 2/15/2006 Physician France
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 9/11/2005 25 Female 117 lb 2/20/2006 Physician France
Primary
Secondary
Concomitant
Oxygen Saturation Decreased Other Serious 32 Female 132 lb 3/9/2006 United States
Primary
Concomitant
Pyrexia Hospitalization 9/11/2005 25 Female 117 lb 3/20/2006 Physician France
Primary
Secondary
Concomitant
Pyelonephritis Hospitalization 3/11/2006 36 Female 3/27/2006 Physician France
Primary
Secondary
White Blood Cell Count Decreased Other Serious 20 Male 4/3/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Staphylococcal Infection Hospitalization 4/5/2006 43 Female 167 lb 4/19/2006 Physician France
Primary
Secondary
Concomitant
Pyrexia Hospitalization 9/11/2005 25 Female 117 lb 4/21/2006 Physician France
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 3/11/2006 36 Female 4/24/2006 Physician France
Primary
Secondary
Urinary Tract Infection Hospitalization 3/11/2006 36 Female 90 lb 5/3/2006 Physician France
Primary
Secondary
White Blood Cell Count Decreased Hospitalization 65 Male 5/20/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Staphylococcal Infection Hospitalization 4/5/2006 43 Female 177 lb 6/1/2006 Physician France
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 3/11/2006 36 Female 90 lb 6/5/2006 Physician France
Primary
Secondary
Treatment Related Secondary Malignancy Other Serious 33 Female 6/6/2006 Other Health Professional China
Primary
Secondary
Skin Exfoliation Other Serious 2 Male 6/29/2006 United States
Primary
Concomitant
Renal Failure Other Serious 1/1/1996 43 Female 7/17/2006 Other Health Professional Italy
Primary
Secondary
Concomitant
Ventricular Dysfunction Other Serious 47 Male 7/17/2006 Other Health Professional Hong Kong
Primary
Secondary
Concomitant
Staphylococcal Abscess Hospitalization 4/5/2006 43 Female 177 lb 7/24/2006 Physician France
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 33 Female 8/4/2006 Hong Kong
Primary
Secondary
Fungal Sepsis Death 8/2/2006
Primary
Concomitant
Reversible Posterior Leukoencephalopathy Syndrome Other Serious 20 Male 8/15/2006 Austria
Primary
Concomitant
Pyrexia Hospitalization 9/11/2005 25 Female 121 lb 9/5/2006 Physician France
Primary
Secondary
Concomitant
Obliterative Bronchiolitis Other Serious 66 Male 10/4/2006 Other Health Professional Argentina
Primary
Secondary
Renal Tubular Atrophy Other Serious 18 Female 10/11/2006 Germany
Primary
Secondary
Concomitant
Viral Infection Hospitalization 7/2/2006 22 Male 114 lb 10/13/2006 Physician France
Primary
Secondary
Viral Infection Hospitalization 7/2/2006 22 Male 114 lb 10/24/2006 Physician France
Primary
Secondary
Concomitant
Staphylococcal Infection Hospitalization 4/5/2006 43 Female 167 lb 11/1/2006 Physician France
Primary
Secondary
Concomitant
Transaminases Increased Life Threatening 7/26/2006 58 Male 186 lb 8/9/2006 Pharmacist United States
Primary
Concomitant
Rash Pustular Hospitalization 8/1/2005 54 Male 2/20/2007 Other Health Professional Spain
Primary
Concomitant
Rash Pustular Hospitalization 8/1/2005 54 Male 2/20/2007 Other Health Professional Spain
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 11/1/2004 57 Male 2/24/2007 Other Health Professional France
Primary
Secondary
Concomitant
Rash Pustular Hospitalization 8/1/2005 54 Male 2/20/2007 Other Health Professional Spain
Primary
Concomitant
Kidney Transplant Rejection Other Serious 2/13/2007 20 Male 147 lb 3/7/2007 Physician Iran (Islamic Republic Of)
Primary
Concomitant
Thrombotic Microangiopathy Hospitalization 54 Male 3/28/2007 Physician France
Primary
Concomitant
Liver Function Test Abnormal Other Serious 3/29/2007 Male 190 lb 4/9/2007 Physician Spain
Primary
Concomitant
Liver Function Test Abnormal Other Serious 3/29/2007 Male 190 lb 4/17/2007 Physician Spain
Primary
Concomitant
Liver Function Test Abnormal Other Serious 3/29/2007 Male 192 lb 5/1/2007 Physician Spain
Primary
Concomitant
Renal Tubular Disorder Other Serious 23 Male 5/18/2007 Other Health Professional United States
Primary
Concomitant
Renal Tubular Disorder Hospitalization 26 Male 6/9/2007 Other Health Professional Canada
Primary
Concomitant
Liver Transplant Rejection Hospitalization 9/29/2006 Male 6/21/2007 Physician United States
Primary
Concomitant
Sepsis Life Threatening 1/1/2005 69 Male 7/4/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Lung Infiltration Hospitalization 4/17/2007 Male 185 lb 8/3/2007 Physician Austria
Primary
Concomitant
Diabetes Mellitus Inadequate Control Hospitalization 3/9/2007 Female 142 lb 8/9/2007 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Diabetes Mellitus Inadequate Control Hospitalization 3/9/2007 Female 142 lb 8/9/2007 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Lung Infiltration Other Serious 4/17/2007 Male 185 lb 8/17/2007 Physician Austria
Primary
Concomitant
Pleural Effusion Other Serious 8/23/2007 Italy
Primary
Concomitant
Thrombophlebitis Other Serious 8/23/2007 Italy
Primary
Concomitant
Myocardial Ischaemia Other Serious 8/23/2007 Italy
Primary
Concomitant
Sepsis Other Serious 8/23/2007 Italy
Primary
Concomitant
Peritoneal Haemorrhage Other Serious 8/23/2007 Italy
Primary
Concomitant
Lymphocele Other Serious 8/23/2007 Italy
Primary
Concomitant
Urinary Tract Infection Enterococcal Other Serious 7/11/2007 Female 159 lb 8/28/2007 Physician Korea, Republic Of
Primary
Concomitant
Lung Infiltration Other Serious 4/17/2007 Male 185 lb 8/30/2007 Physician Austria
Primary
Concomitant
Seroma Hospitalization 1/9/2006 Female 150 lb 9/5/2007 Physician Switzerland
Primary
Concomitant
Pneumonitis Life Threatening 7/20/2006 Male 9/5/2007 Other Health Professional Australia
Primary
Concomitant
Seroma Hospitalization 4/20/2006 Female 152 lb 9/6/2007 Physician Switzerland
Primary
Concomitant
Urinary Tract Infection Enterococcal Other Serious 7/11/2007 Female 137 lb 9/6/2007 Physician Korea, Republic Of
Primary
Concomitant
Somnolence Hospitalization 8/1/2007 8 Male 88 lb 9/11/2007 Pharmacist Canada
Primary
Secondary
Concomitant
Renal Impairment Other Serious 1/1/2006 54 Female 9/19/2007 Other Health Professional Italy
Primary
Concomitant
Interacting
Lung Infiltration Other Serious 4/17/2007 Male 185 lb 10/1/2007 Physician Austria
Primary
Concomitant
Somnolence Other Serious 8/1/2007 8 Male 88 lb 10/12/2007 Pharmacist Canada
Primary
Secondary
Concomitant
Somnolence Other Serious 1/1/2007 8 Male 88 lb 10/29/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Staphylococcal Infection Life Threatening 1/1/2007 8 Male 88 lb 10/31/2007 Physician United States
Primary
Secondary
Concomitant
Pneumonia Bacterial Life Threatening 7/15/2003 61 Male 151 lb 11/6/2007 Physician Spain
Primary
Secondary
Concomitant
Somnolence Other Serious 8/1/2007 8 Male 88 lb 11/8/2007 Physician Canada
Primary
Secondary
Concomitant
Staphylococcal Infection Life Threatening 8/18/2007 8 Male 88 lb 11/12/2007 Physician United States
Primary
Secondary
Concomitant
Obliterative Bronchiolitis Other Serious 11/21/2007 United States
Primary
Secondary
Concomitant
Urosepsis Hospitalization 5/26/2004 64 Female 134 lb 11/28/2007 Physician Germany
Primary
Secondary
Nephropathy Toxic Other Serious 26 Male 11/29/2007 Canada
Primary
Concomitant
Seroma Hospitalization 1/9/2006 Female 150 lb 12/3/2007 Physician Switzerland
Primary
Concomitant
Thrombocytopenia Hospitalization 11/16/2007 Female 132 lb 1/18/2008 Physician Korea, Republic Of
Primary
Concomitant
Thrombocytopenia Hospitalization 11/10/2007 Female 132 lb 1/31/2008 Physician Korea, Republic Of
Primary
Concomitant
Herpes Zoster Other Serious 10/6/2004 62 Female 149 lb 2/4/2008 Physician Spain
Primary
Secondary
Concomitant
Renal Transplant Other Serious 12 Female 2/21/2008 Other Health Professional Turkey
Primary
Concomitant
Lymphoedema Hospitalization 1/1/2005 56 Female 4/16/2008 Physician Italy
Primary
Concomitant
Squamous Cell Carcinoma Of Skin Other Serious 1/1/1990 46 Male 4/21/2008 Other Health Professional Denmark
Primary
Secondary
Concomitant
Lymphoedema Hospitalization 1/1/2005 56 Female 4/22/2008 Physician Italy
Primary
Concomitant
Pleural Effusion Other Serious 4/18/2005 Female 141 lb 4/22/2008 Physician Italy
Primary
Concomitant
Renal Mass Other Serious 1/1/2003 60 Female 5/1/2008 Other Health Professional Hungary
Primary
Secondary
Thrombotic Microangiopathy Hospitalization 44 Female 5/2/2008 United States
Primary
Concomitant
Thrombotic Microangiopathy Hospitalization 26 Male 5/2/2008 United States
Primary
Secondary
Concomitant
Normal Newborn Other Serious 30 Female 9/24/2008 Taiwan, Province Of China
Primary
Concomitant
Ureteric Cancer Other Serious 12/1/2003 53 Female 9/25/2008 Other Health Professional Taiwan, Province Of China
Primary
Secondary
Concomitant
Sudden Death Other Serious 70 Male 10/2/2008 Other Health Professional Spain
Primary
Secondary
Wound Other Serious 2/1/2007 65 Female 10/6/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 65 Female 10/7/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Systemic Inflammatory Response Syndrome Life Threatening Male 10/13/2008 Physician Germany
Primary
Concomitant
Transitional Cell Carcinoma Other Serious 9/1/2004 40 Male 10/24/2008 Physician Taiwan, Province Of China
Primary
Concomitant
Transitional Cell Carcinoma Other Serious 3/1/2004 53 Female 10/24/2008 Physician Taiwan, Province Of China
Primary
Concomitant
Kaposi's Sarcoma Other Serious 44 Male 11/5/2008 Italy
Primary
Concomitant
Squamous Cell Carcinoma Of Skin Hospitalization 62 Male 11/7/2008 Other Health Professional France
Primary
Secondary
Kaposi's Sarcoma Other Serious 44 Male 11/10/2008 Italy
Primary
Concomitant
Nausea Required Intervention 6/9/2008 39 Male 163 lb 7/8/2008 United States
Primary
Concomitant
Enterocolitis Other Serious 1/1/2003 57 Female 12/9/2008
Primary
Secondary
Concomitant
Sputum Abnormal Other Serious 53 Male 12/11/2008 Other Health Professional Germany
Primary
Secondary
Thrombotic Microangiopathy Other Serious 26 Female 1/14/2009 United Kingdom
Primary
Secondary
Renal Failure Other Serious 2/2/2009 United States
Primary
Concomitant
Zygomycosis Other Serious 40 Male 2/11/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Zygomycosis Other Serious 40 Male 2/17/2009 Physician United States
Primary
Secondary
Concomitant
Trichostasis Spinulosa Other Serious 37 Female 2/17/2009
Primary
Secondary
Concomitant
Zygomycosis Other Serious 40 Male 2/20/2009 United States
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 26 Female 3/5/2009 United Kingdom
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 3/16/2009 Physician Brazil
Primary
Secondary
Transplant Rejection Other Serious 3/16/2009 Physician Brazil
Primary
Secondary
Vesicoureteric Reflux Hospitalization 3/2/2004 Female 4/2/2009 Physician Turkey
Primary
Concomitant
Tendonitis Hospitalization 10/18/2004 Male 4/3/2009 Physician Spain
Primary
Secondary
Concomitant
Urinary Tract Infection Other Serious 8/5/2003 Female 123 lb 4/3/2009 Physician Germany
Primary
Secondary
Concomitant
Zygomycosis Other Serious 40 Male 4/16/2009 Physician United States
Primary
Secondary
Thrombotic Microangiopathy Other Serious 9 Female 5/8/2009 Other Health Professional Switzerland
Primary
Concomitant
Zygomycosis Other Serious 48 Female 6/4/2009 Other Health Professional India
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 1/1/2003 59 Female 6/11/2009
Primary
Secondary
Renal Disorder Other Serious 7/1/2002 61 Female 6/11/2009
Primary
Secondary
Renal Tubular Necrosis Other Serious 55 Male 6/11/2009
Primary
Secondary
Concomitant
Proteinuria Other Serious 38 Female 6/11/2009
Primary
Secondary
Proteinuria Other Serious 11/1/2002 44 Female 6/11/2009
Primary
Secondary
Transplant Rejection Other Serious 1/1/2003 59 Female 6/15/2009 Physician United States
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 7/1/2002 61 Female 6/15/2009 Physician United States
Primary
Secondary
Transplant Rejection Other Serious 55 Male 6/15/2009 Physician United States
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 7/1/2000 38 Female 6/15/2009 Physician United States
Primary
Secondary
Urine Protein/creatinine Ratio Increased Other Serious 41 Female 6/16/2009 Other Health Professional United States
Primary
Secondary
Urine Protein/creatinine Ratio Increased Other Serious 31 Female 6/16/2009 Other Health Professional United States
Primary
Secondary
Urine Protein/creatinine Ratio Increased Other Serious 38 Female 6/16/2009 Other Health Professional United States
Primary
Secondary
Urine Protein/creatinine Ratio Increased 44 Female 6/16/2009 Other Health Professional United States
Primary
Secondary
Urine Protein/creatinine Ratio Increased Other Serious 61 Female 6/18/2009 Other Health Professional United States
Primary
Secondary
Urine Protein/creatinine Ratio Increased Other Serious 55 Male 6/18/2009 Other Health Professional United States
Primary
Secondary
Urine Protein/creatinine Ratio Increased Other Serious 59 Female 6/18/2009 Other Health Professional United States
Primary
Secondary
Bone Marrow Failure Hospitalization 8/11/2003 Male 146 lb 6/23/2009 Physician Brazil
Primary
Secondary
Concomitant
Post Procedural Haemorrhage Hospitalization 8/22/2003 Male 205 lb 6/23/2009 Physician Germany
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 7/15/2003 Male 151 lb 6/23/2009 Physician Spain
Primary
Secondary
Concomitant
Gastritis Hospitalization 2/1/2004 Male 6/23/2009 Physician Germany
Primary
Secondary
Concomitant
Cytomegalovirus Infection Hospitalization 4/19/2004 Male 6/23/2009 Physician Germany
Primary
Secondary
Concomitant
Urosepsis Hospitalization 5/26/2004 Female 134 lb 6/23/2009 Physician Germany
Primary
Secondary
Concomitant
Pneumonia Hospitalization 10/6/2003 Male 137 lb 6/23/2009 Physician Turkey
Primary
Secondary
Concomitant
Gastroenteritis Hospitalization 5/20/2003 Male 6/23/2009 Physician Germany
Primary
Secondary
Concomitant
Encephalitis Other Serious 11/21/2003 Male 121 lb 6/23/2009 Physician Turkey
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 9/9/2004 Female 6/23/2009 Physician Germany
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
Ureteric Obstruction Other Serious 9/1/2004 Female 6/23/2009 Physician Australia
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 11/27/2004 Male 183 lb 6/23/2009 Physician Germany
Primary
Secondary
Concomitant
Subcutaneous Abscess Hospitalization 10/29/2004 Male 176 lb 6/23/2009 Physician Germany
Primary
Secondary
Concomitant
Ureteric Stenosis Hospitalization 11/29/2004 Male 187 lb 6/23/2009 Physician Canada
Primary
Secondary
Concomitant
Urinary Tract Infection Life Threatening 1/16/2006 Female 6/23/2009 Physician Czech Republic
Primary
Secondary
Concomitant
Graft Loss Hospitalization 9/11/2004 Male 99 lb 6/23/2009 Physician Brazil
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 6/30/2004 Male 220 lb 6/23/2009 Physician Spain
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/2/2004 Female 190 lb 6/23/2009 Physician Czech Republic
Primary
Secondary
Concomitant
Gastroenteritis Other Serious 9/1/2006 Male 6/23/2009 Physician Australia
Primary
Secondary
Concomitant

Drug Data