Cyclosporine combined with Ursodiol

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Agranulocytosis Other Serious 7/27/2005 56 Female 109 lb 3/14/2006 Physician Germany
Primary
Secondary
Concomitant
Renal Failure Hospitalization 9/1/2005 54 Female 1/20/2006 Physician United States
Primary
Concomitant
Rhabdomyolysis Hospitalization 69 Male 9/27/2006 Physician United States
Primary
Secondary
Concomitant
Transplant Failure Hospitalization 9/9/2006 60 Male 191 lb 9/13/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Transaminases Increased Other Serious 69 Male 9/29/2006 United States
Primary
Secondary
Concomitant
Rhabdomyolysis Hospitalization 69 Male 10/3/2006 United States
Primary
Secondary
Concomitant
Agranulocytosis Other Serious 7/27/2005 56 Female 109 lb 1/25/2007 Physician Germany
Primary
Secondary
Concomitant
Skin Lesion Other Serious 0 Male 2/15/2007 Other Health Professional Turkey
Primary
Secondary
Concomitant
Pseudomembranous Colitis Other Serious 11/17/2006 45 Male 6/25/2007 Japan
Primary
Secondary
Concomitant
Bradycardia Required Intervention 2/24/2006 Female 213 lb 7/31/2007 Pharmacist United States
Primary
Concomitant
Seroma Hospitalization 1/9/2006 Female 150 lb 9/5/2007 Physician Switzerland
Primary
Concomitant
Seroma Hospitalization 4/20/2006 Female 152 lb 9/6/2007 Physician Switzerland
Primary
Concomitant
Somnolence Hospitalization 8/1/2007 8 Male 88 lb 9/11/2007 Pharmacist Canada
Primary
Secondary
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
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
Seroma Hospitalization 1/9/2006 Female 150 lb 12/3/2007 Physician Switzerland
Primary
Concomitant
Mental Status Changes Hospitalization 3/1/2008 Female 92 lb 3/31/2008 Physician United States
Primary
Secondary
Concomitant
Oral Intake Reduced Hospitalization 3/21/2008 51 Female 92 lb 4/3/2008 Physician United States
Primary
Secondary
Concomitant
Vision Blurred Other Serious 12/24/2007 41 Female 168 lb 3/12/2008 Pharmacist United States
Primary
Concomitant
Hepatocellular Injury Other Serious 68 Male 5/2/2008 Japan
Primary
Concomitant
Urinary Incontinence Death 45 Male 5/1/2008 Physician United States
Primary
Secondary
Concomitant
Weight Increased Hospitalization 5/16/2008 68 Female 144 lb 6/11/2008 Physician United States
Primary
Secondary
Concomitant
Hepatic Neoplasm Malignant Recurrent Hospitalization 3/13/2008 Male 159 lb 6/18/2008 Physician Germany
Primary
Concomitant
Weight Increased Hospitalization 5/16/2008 68 Female 144 lb 6/24/2008 Physician United States
Primary
Secondary
Concomitant
Diarrhoea Other Serious 6/1/2008 Female 106 lb 7/16/2008 Physician Denmark
Primary
Concomitant
Stem Cell Transplant Hospitalization 5/12/2008 60 Female 200 lb 7/14/2008 Physician United States
Primary
Secondary
Concomitant
Weight Increased Hospitalization 5/16/2008 68 Female 144 lb 7/16/2008 Physician United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 5/16/2008 68 Female 144 lb 7/30/2008 United States
Primary
Secondary
Concomitant
Vomiting Other Serious 5/19/2008 Male 52 lb 8/15/2008 Other Health Professional Brazil
Primary
Secondary
Concomitant
Pancytopenia Hospitalization 5/12/2008 Male 148 lb 8/19/2008 Physician Germany
Primary
Secondary
Concomitant
Weight Increased Hospitalization 5/16/2008 68 Female 144 lb 8/29/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 5/16/2008 68 Female 144 lb 9/26/2008 Physician United States
Primary
Secondary
Concomitant
Mucous Membrane Disorder Other Serious Male 10/3/2008 Other Health Professional Japan
Primary
Concomitant
Visual Impairment Required Intervention 1/9/2008 21 Female 106 lb 10/7/2008 Pharmacist United States
Primary
Secondary
Concomitant
Vomiting Other Serious 5/19/2008 Male 52 lb 10/16/2008 Other Health Professional Brazil
Primary
Secondary
Concomitant
Platelet Count Decreased Other Serious Male 10/17/2008 Other Health Professional Japan
Primary
Concomitant
Pyrexia Life Threatening 10/26/2008 34 Female 11/13/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Drug Exposure During Pregnancy Other Serious 29 Female 12/22/2008 Other Health Professional Brazil
Primary
Secondary
Venoocclusive Liver Disease Hospitalization 4/1/2008 60 Female 177 lb 12/19/2008 Physician United States
Primary
Secondary
Concomitant
Staphylococcal Infection Required Intervention 6/5/2008 63 Female 256 lb 12/26/2008 Physician United States
Primary
Secondary
Concomitant
Weight Increased Hospitalization 5/1/2008 68 Female 122 lb 12/26/2008 Physician United States
Primary
Secondary
Concomitant
Oesophagitis Hospitalization 6/9/2008 60 Male 249 lb 12/22/2008 Physician United States
Primary
Secondary
Concomitant
Cytomegalovirus Viraemia Hospitalization 10/22/2007 47 Female 114 lb 12/22/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Oesophagitis Hospitalization 6/9/2008 60 Male 249 lb 1/13/2009 Physician United States
Primary
Secondary
Concomitant
Pancytopenia Hospitalization 5/12/2008 Male 148 lb 2/17/2009 Physician Germany
Primary
Concomitant
Septic Shock Other Serious 8/18/2008 58 Male 132 lb 3/3/2009 Physician Spain
Primary
Secondary
Concomitant
Septic Shock Other Serious 8/18/2008 58 Male 132 lb 3/5/2009 Physician Spain
Primary
Secondary
Concomitant
Tachycardia Other Serious 8/18/2008 58 Male 3/6/2009 Other Health Professional Spain
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 8/12/2003 0 Male 13 lb 3/19/2009 France
Primary
Secondary
Concomitant
Viral Upper Respiratory Tract Infection Life Threatening 10/26/2008 34 Female 3/13/2009 Physician United States
Primary
Secondary
Concomitant
Interstitial Lung Disease Other Serious 3/21/2008 Male 4/16/2009 Physician United States
Primary
Concomitant
Hepatic Function Abnormal Other Serious 12/9/2007 4/17/2009 Physician Egypt
Primary
Concomitant
Viral Upper Respiratory Tract Infection Life Threatening 10/26/2008 34 Female 4/13/2009 Physician United States
Primary
Secondary
Concomitant
Hepatic Function Abnormal Other Serious 12/9/2007 5/4/2009 Physician Egypt
Primary
Concomitant
Transplant Rejection Hospitalization 4/9/2009 Male 56 lb 5/27/2009 United States
Primary
Concomitant
Oedema Other Serious 7/2/2008 14 Female 6/18/2009 Physician United States
Primary
Secondary
Concomitant
Drug Exposure During Pregnancy Other Serious 29 Female 7/9/2009 Other Health Professional Brazil
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 5/1/2009 61 Male 8/10/2009 Other Health Professional United States
Primary
Concomitant
Small Intestine Ulcer Other Serious 5/1/2009 61 Male 8/19/2009 Physician United States
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 48 Female 9/9/2009 Other Health Professional Japan
Primary
Concomitant
Sepsis Other Serious 5/1/2009 61 Male 9/14/2009 Physician United States
Primary
Concomitant
Systemic Lupus Erythematosus Rash Other Serious 51 Male 9/24/2009 Physician Italy
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 8/18/2009 23 Male 11/5/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 9/1/2009 5 Female 47 lb 10/29/2009 Other Health Professional United States
Primary
Concomitant
Respiratory Distress Other Serious 9/16/2009 22 Male 169 lb 11/4/2009 Physician United States
Primary
Secondary
Concomitant
Unresponsive To Stimuli Other Serious 9/16/2009 22 Male 169 lb 11/20/2009 Physician United States
Primary
Secondary
Concomitant
Tremor Hospitalization 8/16/2009 64 Male 11/23/2009 Other Health Professional United States
Primary
Concomitant
Multi-organ Failure Death 10/1/2009 52 Male 12/22/2009 Physician Japan
Primary
Concomitant
Tremor Hospitalization 8/16/2009 64 Male 12/21/2009 Physician United States
Primary
Concomitant
Shock Other Serious 9/16/2009 22 Male 169 lb 1/7/2010 Physician United States
Primary
Secondary
Concomitant
No Therapeutic Response Death 10/1/2009 52 Male 132 lb 1/29/2010 Physician Japan
Primary
Concomitant
Thrombocytopenia Hospitalization 4/6/2010 67 Male 176 lb 4/20/2010 Physician United States
Primary
Concomitant
Thrombocytopenia Hospitalization 4/6/2010 67 Male 176 lb 5/5/2010 Physician United States
Primary
Concomitant
Pancytopenia Other Serious 43 Female 5/20/2010 Physician Japan
Primary
Concomitant
Hypoxia Hospitalization 6/7/2010 64 Male 6/23/2010 Physician United States
Primary
Concomitant
Hypoxia Hospitalization 6/7/2010 64 Male 6/25/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Alopecia 1/1/2008 70 Female 6/29/2010 Other Health Professional United States
Primary
Concomitant
Sepsis Hospitalization 6/22/2010 55 Male 189 lb 8/10/2010 Other Health Professional United States
Primary
Concomitant
Hypoxia Hospitalization 6/7/2010 64 Male 8/13/2010 Physician United States
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 3/11/2009 23 Female 97 lb 8/17/2010 Physician Japan
Primary
Concomitant
Respiratory Distress Hospitalization 5/3/2010 2 Male 8/16/2010 Physician United States
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 3/11/2009 23 Female 97 lb 8/31/2010 Physician Japan
Primary
Concomitant
Multi-organ Failure Other Serious 6/7/2010 64 Male 9/8/2010 Physician United States
Primary
Concomitant
Unresponsive To Stimuli Other Serious 9/16/2009 22 Male 169 lb 9/28/2010 Physician United States
Primary
Secondary
Concomitant
Pulmonary Haemorrhage Life Threatening 2/8/2010 15 Female 110 lb 10/15/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Splenomegaly Other Serious 43 Female 10/27/2010 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Hospitalization 5/26/2010 Male 18 lb 11/24/2010 Physician Japan
Primary
Concomitant
Therapeutic Agent Toxicity Other Serious 6/24/2009 49 Female 237 lb 10/26/2010 Other Health Professional Australia
Primary
Concomitant
Vomiting Other Serious 6/12/2010 12/1/2010 Consumer Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 1/29/2010 49 Male 110 lb 12/13/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 1/29/2010 49 Male 110 lb 12/13/2010 Physician Japan
Primary
Concomitant
Therapeutic Response Decreased Other Serious 7/1/2009 48 Female 115 lb 1/6/2011 Physician Japan
Primary
Concomitant
Staphylococcal Sepsis Other Serious 7/12/2010 52 Male 115 lb 1/10/2011 Physician Japan
Primary
Concomitant
Blood Pressure Increased Other Serious 8/9/2009 48 Female 115 lb 1/10/2011 Physician Japan
Primary
Secondary
Concomitant
Multi-organ Failure Death 10/22/2010 54 Male 176 lb 1/21/2011 Physician Japan
Primary
Concomitant
No Therapeutic Response Other Serious 1/1/2010 74 Male 2/8/2011 Other Health Professional United States
Primary
Concomitant
Hypoxia Life Threatening 6/7/2010 64 Male 2/8/2011 Consumer United States
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 2/3/2011 49 Female 2/21/2011 Consumer United States
Primary
Secondary
Concomitant
Delirium Other Serious 6/16/2010 53 Male 154 lb 4/8/2011 Physician Japan
Primary
Concomitant
No Therapeutic Response Hospitalization 1/1/2010 74 Male 133 lb 4/11/2011 Physician United States
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 4/15/2011 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Septic Shock Death 4/15/2011 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Pneumonia Cytomegaloviral Death 4/15/2011 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Pneumonia Cytomegaloviral Death 4/15/2011 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Intestine Hospitalization 4/9/2011 42 Female 197 lb 4/28/2011 Consumer United States
Primary
Secondary
Concomitant
Pneumonia Life Threatening 9/5/2010 69 Male 5/5/2011 Other Health Professional United States
Primary
Concomitant
Acute Graft Versus Host Disease In Intestine Hospitalization 4/9/2011 42 Female 197 lb 5/15/2011 Physician United States
Primary
Secondary
Concomitant
Microangiopathy Hospitalization 5/1/2011 46 Female 162 lb 5/17/2011 Consumer United States
Primary
Secondary
Concomitant
Occult Blood Positive Other Serious 1/1/2010 74 Male 133 lb 5/20/2011 Physician United States
Primary
Secondary
Concomitant
Disseminated Intravascular Coagulation Death 7/30/2010 49 Male 110 lb 5/20/2011 Physician Japan
Primary
Secondary
Concomitant
Petechiae Other Serious 1/29/2010 49 Male 110 lb 5/20/2011 Physician Japan
Primary
Concomitant
Venoocclusive Disease Other Serious 22 Male 4/1/2011 Physician United States
Primary
Concomitant
Disseminated Intravascular Coagulation Death 7/30/2010 49 Male 110 lb 6/16/2011 Physician Japan
Primary
Secondary
Concomitant
Hallucination Other Serious 6/19/2011 17 Female 184 lb 6/23/2011 Physician United States
Primary
Concomitant
Extremity Contracture Other Serious 6/20/2006 69 Female 120 lb 7/20/2011 Consumer United States
Primary
Secondary
Concomitant
Gastric Antral Vascular Ectasia Hospitalization 1/1/2010 74 Male 133 lb 7/27/2011 Physician United States
Primary
Secondary
Concomitant
Joint Range Of Motion Decreased Other Serious 6/6/2011 36 Male 145 lb 6/13/2011 Other Health Professional United States
Primary
Concomitant
Dizziness Hospitalization 9/27/2010 8/22/2011 Physician Japan
Primary
Concomitant
Pneumonia Cytomegaloviral Death 8/31/2011 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Septic Shock Death 8/31/2011 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Cytomegalovirus Test Positive Other Serious 8/31/2011 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Pneumonia Cytomegaloviral Death 8/31/2011 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Dyspnoea Death 22 Male 9/8/2011 Physician United Kingdom
Primary
Concomitant
Cough Hospitalization 1/1/2010 55 Female 134 lb 9/22/2011 Physician Australia
Primary
Concomitant
Haematuria Other Serious 1/1/2011 21 Female 119 lb 9/23/2011 Pharmacist Brazil
Primary
Concomitant
Thrombocytopenia Other Serious 3/11/2009 23 Female 97 lb 9/29/2011 Physician Japan
Primary
Concomitant
Enterocolitis Bacterial Death 4/27/2009 70 Female 75 lb 10/3/2011 Physician Japan
Primary
Concomitant
Hypertension Other Serious 6/12/2010 53 Male 154 lb 10/5/2011 Physician Japan
Primary
Concomitant
Pneumonia Death 6/24/2009 49 Female 237 lb 9/19/2011 Other Health Professional Australia
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 1/1/2011 4 Male 37 lb 10/11/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Haematemesis Other Serious 4 Male 38 lb 10/14/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Urinary Tract Infection Pseudomonal Life Threatening 6/9/2010 73 Female 128 lb 11/9/2011 Physician Japan
Primary
Concomitant
Aspergillus Test Positive Hospitalization 1/1/2010 55 Female 134 lb 11/14/2011 Physician Australia
Primary
Concomitant
Hemianopia Life Threatening 5/1/2010 48 Male 181 lb 11/21/2011 Physician Germany
Primary
Secondary
Concomitant
Fall Other Serious 6/12/2010 70 Male 154 lb 11/23/2011 Physician Japan
Primary
Concomitant
Thyroid Cancer Other Serious 3/8/2010 74 Female 99 lb 11/25/2011 Physician Japan
Primary
Concomitant
Aggression Life Threatening 5/1/2010 48 Male 181 lb 11/30/2011 Physician Germany
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 3/8/2010 74 Female 99 lb 12/1/2011 Physician Japan
Primary
Concomitant
Chronic Graft Versus Host Disease Other Serious 8/18/2009 18 Female 108 lb 12/9/2011 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Death 2/7/2009 57 Male 139 lb 12/14/2011 Physician Japan
Primary
Concomitant
Graft Versus Host Disease In Skin Life Threatening 5/31/2011 9 Male 79 lb 12/19/2011 Physician Japan
Primary
Concomitant
Cytomegalovirus Chorioretinitis Hospitalization 8/24/2009 21 Male 104 lb 12/20/2011 Physician Japan
Primary
Concomitant
Shock Hospitalization 11/8/2010 75 Female 121 lb 12/22/2011 Physician Japan
Primary
Concomitant
Blood Potassium Increased Death 6/25/2009 35 Male 130 lb 12/16/2011 Physician Japan
Primary
Concomitant
Autoimmune Hepatitis Other Serious 61 Female 115 lb 1/3/2012 Consumer United States
Primary
Concomitant
Herpes Simplex Hospitalization 12/30/2011 46 Female 126 lb 1/10/2012 Physician Canada
Primary
Concomitant
Rash Hospitalization 12/30/2011 46 Female 126 lb 1/13/2012 Physician Canada
Primary
Concomitant

Drug Data