Cyclosporine combined with Thymoglobulin

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Urine Output Decreased Death 55 Female 1/25/2006 Other Health Professional Germany
Primary
Secondary
Concomitant
Multi-organ Failure Hospitalization 16 Male 1/17/2006 Physician Italy
Primary
Concomitant
Hepatotoxicity Hospitalization 10 Female 1/17/2006 Physician Italy
Primary
Concomitant
Vomiting Hospitalization 2/1/2006 Male 168 lb 3/28/2006 Physician Germany
Primary
Concomitant
Transaminases Increased Other Serious 9 Male 41 lb 5/8/2006 Other Health Professional Italy
Primary
Secondary
Concomitant
Skin Papilloma Hospitalization Female 6/2/2006 Ireland
Primary
Secondary
Concomitant
Venoocclusive Disease Hospitalization 10 Female 5/18/2006 Physician Italy
Primary
Concomitant
Renal Cell Carcinoma Stage Unspecified Other Serious 6 Female 7/13/2006 United States
Primary
Secondary
Fungal Sepsis Death 8/2/2006
Primary
Concomitant
Stem Cell Transplant Other Serious 1/26/2005 41 Female 132 lb 8/17/2006 Physician Canada
Primary
Concomitant
Vomiting Death 7/28/2006 4 Male 39 lb 8/22/2006 Physician China
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 1/26/2005 41 Female 132 lb 8/28/2006 Other Health Professional Canada
Primary
Concomitant
Soft Tissue Inflammation Hospitalization 7/1/2003 49 Female 10/4/2006 Physician United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 9/27/2005 61 Female 88 lb 11/14/2006 Physician France
Primary
Secondary
Respiratory Failure Other Serious 1/26/2005 41 Female 132 lb 12/4/2006 Other Health Professional Canada
Primary
Concomitant
Lymphocyte Count Decreased 12/5/2006 61 Female 192 lb 1/8/2007 Pharmacist United States
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 11/1/2004 57 Male 2/24/2007 Other Health Professional France
Primary
Secondary
Concomitant
Rhabdomyolysis Death 2/23/2007 64 Male 159 lb 3/20/2007 Physician Colombia
Primary
Concomitant
Blood Lactate Dehydrogenase Increased Other Serious 3/14/2007 31 Male 142 lb 3/20/2007 Pharmacist United States
Primary
Concomitant
Blood Lactate Dehydrogenase Increased Other Serious 3/14/2007 31 Male 142 lb 4/19/2007 Pharmacist United States
Primary
Concomitant
Pleural Effusion Life Threatening 1/1/2007 38 Female 117 lb 5/14/2007 Physician France
Primary
Concomitant
Rhabdomyolysis Death 2/23/2007 64 Male 159 lb 5/9/2007 Physician Colombia
Primary
Concomitant
Pleural Effusion Life Threatening 1/1/2007 38 Female 117 lb 8/10/2007 Physician France
Primary
Concomitant
Bradycardia Required Intervention 2/24/2006 Female 213 lb 7/31/2007 Pharmacist United States
Primary
Concomitant
Spinal Compression Fracture Hospitalization 1/5/2006 80 Female 134 lb 1/15/2007 Physician United States
Primary
Concomitant
Lymphoproliferative Disorder Death 5/6/2004 38 Female 128 lb 2/28/2005 Other Health Professional Poland
Primary
Concomitant
Chest Pain Hospitalization 4/6/2006 80 Female 137 lb 1/15/2007 Other Health Professional United States
Primary
Concomitant
Thrombocytopenia Hospitalization 8/6/2006 70 Male 190 lb 1/15/2007 Other Health Professional Canada
Primary
Concomitant
Renal Failure Acute Hospitalization 11/24/2005 62 Male 236 lb 1/15/2007 Physician France
Primary
Concomitant
Sepsis Hospitalization 9/7/2005 58 Female 132 lb 1/15/2007 Physician France
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 9/7/2005 58 Female 132 lb 1/15/2007 Other Health Professional France
Primary
Secondary
Concomitant
Staphylococcal Infection Death 12/1/2001 56 Female 168 lb 1/15/2007 Physician United States
Primary
Concomitant
Pleural Effusion Life Threatening 1/1/2007 38 Female 117 lb 10/11/2007 Physician France
Primary
Concomitant
Urinary Tract Infection Hospitalization 7/21/2007 57 Male 11/7/2007 Physician Germany
Primary
Concomitant
Urinary Tract Infection Hospitalization 7/21/2007 57 Male 11/29/2007 Physician Germany
Primary
Concomitant
Anaphylactic Shock Other Serious 16 Male 12/13/2007 Physician Spain
Primary
Concomitant
Pyrexia Hospitalization 2/20/2007 70 Male 12/13/2007 Physician Spain
Primary
Concomitant
Therapeutic Response Decreased Hospitalization 2/20/2007 70 Male 1/23/2008 Physician Spain
Primary
Concomitant
Somnolence Other Serious 4 Male 4/11/2008 Other Health Professional Germany
Primary
Secondary
Reversible Posterior Leukoencephalopathy Syndrome Other Serious 5 Male 4/14/2008 Other Health Professional Germany
Primary
Secondary
Somnolence Other Serious 4 Male 4/14/2008 Other Health Professional Germany
Primary
Secondary
Herpes Zoster Other Serious 11 Male 4/14/2008 Other Health Professional Germany
Primary
Secondary
Neutropenia Other Serious 4 Female 4/14/2008 Other Health Professional Germany
Primary
Secondary
Neutropenia Other Serious 11 Male 4/14/2008 Other Health Professional Germany
Primary
Secondary
Graft Versus Host Disease Hospitalization 4 Female 4/23/2008 Germany
Primary
Concomitant
Cold Agglutinins Positive Other Serious 33 Male 4/24/2008 Physician United States
Primary
Secondary
Capillary Leak Syndrome Death 11/6/2007 12 Male 4/25/2008 Physician Italy
Primary
Secondary
Concomitant
Cardiac Failure Death 3/8/2008 14 Female 4/25/2008 Physician Italy
Primary
Secondary
Concomitant
Vomiting 2/9/2007 57 Female 5/2/2008 Physician United States
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 11/1/2007 12 Male 5/6/2008 Physician Italy
Primary
Secondary
Concomitant
Cardiac Failure Death 3/8/2008 14 Female 5/6/2008 Physician Italy
Primary
Secondary
Concomitant
Cold Type Haemolytic Anaemia Other Serious 33 Male 5/22/2008 Physician United States
Primary
Secondary
Renal Failure Acute Other Serious 5/29/2008 Iceland
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 6/2/2008 Iceland
Primary
Secondary
Concomitant
Urinary Bladder Haemorrhage Other Serious 4/17/2008 81 Female 132 lb 5/23/2008 Physician Germany
Primary
Concomitant
Hypotension Other Serious 5/9/2008 65 Female 220 lb 5/27/2008 Physician United States
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 21 Male 6/24/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Thrombosis Other Serious 64 Female 7/16/2008 Other Health Professional France
Primary
Concomitant
Respiratory Failure Other Serious 31 Male 7/18/2008
Primary
Secondary
Concomitant
Vomiting Other Serious 7/23/2008 Poland
Primary
Secondary
Concomitant
Oliguria Other Serious 10/31/2007 16 Male 165 lb 7/10/2008 Physician Spain
Primary
Concomitant
Vomiting Hospitalization 39 Male 7/25/2008 Other Health Professional Germany
Primary
Secondary
Vomiting Hospitalization 39 Male 7/28/2008 Other Health Professional Germany
Primary
Secondary
Malignant Neoplasm Progression Other Serious 17 Male 8/5/2008 Other Health Professional United States
Primary
Secondary
Guillain-barre Syndrome Other Serious 23 Male 8/5/2008 Other Health Professional United States
Primary
Secondary
Parainfluenzae Virus Infection Other Serious 16 Male 8/5/2008 Other Health Professional United States
Primary
Secondary
Multi-organ Failure Other Serious 18 Male 8/5/2008 Other Health Professional United States
Primary
Secondary
Guillain-barre Syndrome Other Serious 23 Male 8/13/2008 Other Health Professional United States
Primary
Secondary
Venoocclusive Liver Disease Other Serious Male 8/20/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Renal Failure Other Serious 14 Male 8/22/2008 Other Health Professional Italy
Primary
Secondary
Venoocclusive Liver Disease Other Serious Male 8/22/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Systemic Mycosis Other Serious 5 Male 8/28/2008 Other Health Professional Israel
Primary
Secondary
Concomitant
Staphylococcal Sepsis Other Serious Male 8/29/2008 Other Health Professional Japan
Primary
Secondary
Respiratory Distress Other Serious 9/2/2008 Other Health Professional Iran (Islamic Republic Of)
Primary
Secondary
Human Herpesvirus 6 Infection Other Serious 7/9/2002 11 Female 9/2/2008 Other Health Professional Austria
Primary
Secondary
Concomitant
Staphylococcal Sepsis Other Serious Male 9/5/2008 Other Health Professional Japan
Primary
Secondary
Fungal Rhinitis Other Serious 41 Male 7/8/2008 Other Health Professional Italy
Primary
Secondary
Concomitant
Transplant Rejection Death 48 Male 9/29/2008 Physician Thailand
Primary
Secondary
Pancytopenia Other Serious 0 Female 10/3/2008 Other Health Professional United States
Primary
Secondary
Concomitant
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
Oliguria Other Serious 10/31/2007 16 Male 165 lb 9/24/2008 Physician Spain
Primary
Concomitant
Oliguria Other Serious 10/31/2007 16 Male 165 lb 10/14/2008 Physician Spain
Primary
Concomitant
Miller Fisher Syndrome Other Serious 9 Female 10/24/2008 Physician Italy
Primary
Secondary
Urinoma Other Serious 1/1/2007 55 Male 10/29/2008 Physician Portugal
Primary
Concomitant
Vomiting Life Threatening 3/6/2007 57 Female 11/10/2008 Japan
Primary
Concomitant
Staphylococcal Infection Other Serious 5 Male 11/25/2008 Other Health Professional Israel
Primary
Secondary
Concomitant
Pyrexia Life Threatening 10/26/2008 34 Female 11/13/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Evans Syndrome Death 2 11/24/2008 Consumer United Kingdom
Primary
Secondary
Insomnia Required Intervention 8/23/2008 42 Male 370 lb 11/24/2008 Physician United Kingdom
Primary
Concomitant
Epstein-barr Virus Infection Other Serious 6 11/24/2008 Consumer United Kingdom
Primary
Secondary
Hypertension Other Serious 0 11/25/2008 Other Health Professional United Kingdom
Primary
Secondary
Toxic Encephalopathy Other Serious 1 11/25/2008 Other Health Professional United Kingdom
Primary
Secondary
Toxic Encephalopathy Other Serious 9 11/26/2008 Other Health Professional United Kingdom
Primary
Secondary
Rash Generalised Hospitalization 10/18/2008 55 Female 137 lb 11/20/2008 Other Health Professional United Kingdom
Primary
Concomitant
Pneumonia Bacterial Hospitalization 53 Male 12/4/2008 Other Health Professional France
Primary
Secondary
Concomitant
Insomnia Required Intervention 8/23/2008 42 Male 370 lb 12/2/2008 Physician United Kingdom
Primary
Concomitant
Rash Hospitalization 10/18/2008 55 Female 137 lb 12/2/2008 Other Health Professional United Kingdom
Primary
Concomitant
Staphylococcal Infection Death 12/1/2001 56 Female 168 lb 1/15/2007 Other Health Professional United States
Primary
Concomitant
Visual Impairment Hospitalization 46 Male 12/12/2008 Other Health Professional Turkey
Primary
Secondary
Concomitant
Evans Syndrome Death 2 12/17/2008 Other Health Professional United Kingdom
Primary
Secondary
Transaminases Increased Life Threatening 11/22/2008 49 Female 143 lb 12/17/2008 Physician Poland
Primary
Concomitant
Shock Life Threatening 11/4/2008 41 Male 203 lb 12/17/2008 Physician Poland
Primary
Concomitant
Urinoma Other Serious 1/1/2007 55 Male 12/24/2008 Physician Portugal
Primary
Concomitant
Febrile Neutropenia Other Serious 12/31/2008 55 Male 178 lb 1/14/2009 Other Health Professional United Kingdom
Primary
Concomitant
Toxic Epidermal Necrolysis Death 11/25/2008 62 Female 163 lb 1/23/2009 Consumer France
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Death 11/25/2008 62 Female 163 lb 1/27/2009 Consumer France
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Death 11/25/2008 Female 163 lb 1/28/2009 Other Health Professional France
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Hospitalization 11/1/2008 Female 163 lb 1/28/2009 Other Health Professional France
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Hospitalization 11/25/2008 62 Female 163 lb 1/28/2009 Other Health Professional France
Primary
Concomitant
Evans Syndrome Death 2 1/23/2009 Other Health Professional United Kingdom
Primary
Secondary
Liver Transplant Rejection Other Serious 1/12/2009 51 Male 176 lb 2/5/2009 Physician Canada
Primary
Concomitant
Multi-organ Failure Other Serious 12/26/2008 24 Male 2/10/2009 Physician Japan
Primary
Concomitant
Thyroid Cancer Other Serious 48 Male 2/19/2009 Other Health Professional Korea, Republic Of
Primary
Secondary
Blood Bilirubin Increased Other Serious 1/21/2009 71 Female 128 lb 2/12/2009 Physician Canada
Primary
Concomitant
Red Blood Cell Count Decreased Other Serious 12/30/2008 55 Male 178 lb 2/13/2009 Other Health Professional United Kingdom
Primary
Concomitant
Thyroid Cancer Other Serious 23 Male 2/19/2009 Other Health Professional Korea, Republic Of
Primary
Secondary
Thyroid Cancer Other Serious 39 Male 2/19/2009 Other Health Professional Korea, Republic Of
Primary
Secondary
Thyroid Cancer Other Serious 40 Female 2/19/2009 Other Health Professional Korea, Republic Of
Primary
Secondary
Myalgia Hospitalization 2/13/2009 67 Male 160 lb 2/23/2009 Physician United States
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 2/18/2009 12 Female 110 lb 3/3/2009 Physician Japan
Primary
Concomitant
Transplant Rejection Other Serious Male 3/16/2009 Physician Brazil
Primary
Secondary
Tachycardia Other Serious 2/18/2009 12 Female 110 lb 3/11/2009 Physician Japan
Primary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Death 37 Male 3/11/2009 Consumer United Kingdom
Primary
Secondary
Therapeutic Response Decreased Hospitalization 1/9/2009 51 Male 174 lb 3/9/2009 Physician Canada
Primary
Concomitant
Viral Upper Respiratory Tract Infection Life Threatening 10/26/2008 34 Female 3/13/2009 Physician United States
Primary
Secondary
Concomitant
Liver Disorder Other Serious 3/2/2009 68 Female 121 lb 3/19/2009 Physician Japan
Primary
Concomitant
Urine Output Decreased Death 12/26/2008 25 Male 134 lb 3/19/2009 Physician Japan
Primary
Concomitant
White Blood Cell Count Increased Other Serious 12/26/2008 25 Male 3/12/2009 Physician Japan
Primary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Death 37 Male 3/20/2009 Consumer United Kingdom
Primary
Secondary
Liver Disorder Other Serious 3/2/2009 68 Female 121 lb 3/24/2009 Physician Japan
Primary
Concomitant
Renal Failure Death 2/18/2009 68 Female 121 lb 4/6/2009 Physician Japan
Primary
Concomitant
Serum Sickness Life Threatening 2/21/2009 20 Female 4/8/2009 Physician United Kingdom
Primary
Concomitant
Viral Upper Respiratory Tract Infection Life Threatening 10/26/2008 34 Female 4/13/2009 Physician United States
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 6 Male 4/30/2009 Canada
Primary
Concomitant
Myalgia Hospitalization 2/13/2009 67 Male 160 lb 4/17/2009 Physician United States
Primary
Concomitant
Serum Sickness Life Threatening 2/21/2009 20 Female 189 lb 5/4/2009 Physician United Kingdom
Primary
Concomitant
Serum Sickness Hospitalization 2/25/2009 66 Female 5/6/2009 Other Health Professional France
Primary
Secondary
Concomitant
Red Blood Cell Count Decreased Other Serious 12/30/2008 55 Male 178 lb 5/8/2009 Physician United Kingdom
Primary
Concomitant
Sepsis Other Serious 3/7/2009 60 Male 128 lb 5/11/2009 Physician Japan
Primary
Secondary
Concomitant
Lower Respiratory Tract Infection Fungal Hospitalization 3/26/2009 27 Male 136 lb 5/11/2009 Physician United Kingdom
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 5/7/2009 62 128 lb 5/14/2009 Physician Japan
Primary
Concomitant
Myalgia Hospitalization 2/13/2009 67 Male 160 lb 6/2/2009 Physician United States
Primary
Concomitant
Virus Serology Test Positive Death 4/17/2009 58 Female 97 lb 6/2/2009 Physician Japan
Primary
Concomitant
Visual Impairment Disability 4/8/2009 48 Female 84 lb 6/2/2009 Physician Japan
Primary
Concomitant
Infection Other Serious 1 5/28/2009 United Kingdom
Primary
Secondary
Pyrexia Other Serious 5/7/2009 62 Male 128 lb 5/22/2009 Physician Japan
Primary
Concomitant
Thrombocytopenia Other Serious 23 Female 5/28/2009 United States
Primary
Concomitant
Pain Other Serious 7 Male 6/12/2009 Canada
Primary
Concomitant
Stenotrophomonas Infection Other Serious 59 Male 6/16/2009 Other Health Professional Italy
Primary
Secondary
Concomitant

Drug Data