Tacrolimus combined with Ursodiol

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
International Normalised Ratio Increased 6/30/2004 53 9/12/2005 Pharmacist United States
Primary
Concomitant
Liver Function Test Abnormal 12/18/2004 38 9/12/2005 Pharmacist United States
Primary
Concomitant
Liver Function Test Abnormal 11/1/2004 61 9/12/2005 Pharmacist United States
Primary
Concomitant
International Normalised Ratio Increased 4/30/2004 60 9/12/2005 Physician United States
Primary
Concomitant
International Normalised Ratio Increased 7/22/2004 9/12/2005 Physician United States
Primary
Concomitant
Vomiting Hospitalization 8/3/2005 66 Male 11/16/2005 United States
Primary
Concomitant
Pancytopenia Hospitalization 5/24/2006 65 Male 6/14/2006 Other Health Professional United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 5/24/2006 65 Male 6/6/2006 Pharmacist United States
Primary
Secondary
Concomitant
Renal Failure Other Serious 11/4/2006 Male 220 lb 11/8/2006 Physician United States
Primary
Concomitant
Rhabdomyolysis Hospitalization 11/20/2006 69 Female 154 lb 1/25/2007 Physician United States
Primary
Concomitant
Pancytopenia Required Intervention 1/9/2007 46 Male 185 lb 2/6/2007 Pharmacist United States
Primary
Concomitant
Transplant Failure Life Threatening 1/1/2006 Male 159 lb 4/16/2007 Physician Germany
Primary
Concomitant
Transplant Failure Life Threatening 3/30/2006 Male 159 lb 6/26/2007 Physician Germany
Primary
Concomitant
Colitis Ulcerative Hospitalization 1/7/2007 21 Male 114 lb 2/1/2007 Pharmacist United States
Primary
Concomitant
Complications Of Transplanted Liver Hospitalization 1/17/2007 Male 9/13/2007 Physician United States
Primary
Secondary
Concomitant
Rash Erythematous Other Serious 8/15/2007 1 Female 26 lb 9/13/2007 Other Health Professional United Kingdom
Primary
Concomitant
Rhabdomyolysis Hospitalization 11/20/2006 68 Female 154 lb 9/13/2007 Pharmacist United States
Primary
Concomitant
Transplant Failure Life Threatening 3/30/2006 Male 159 lb 12/12/2007 Physician Germany
Primary
Concomitant
Hepatic Artery Thrombosis Hospitalization 1/17/2007 Male 1/7/2008 Physician United States
Primary
Secondary
Concomitant
Platelet Count Decreased Life Threatening 11/6/2007 Female 115 lb 11/15/2007 Pharmacist United States
Primary
Concomitant
Renal Failure Acute Hospitalization 8/14/2007 49 Male 1/18/2008 Other Health Professional France
Primary
Concomitant
Interacting
Flushing 1/15/2008 31 Male 315 lb 2/7/2008 United States
Primary
Concomitant
Transplant Failure Other Serious 5/12/2006 45 Female 159 lb 2/13/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Death Death 1/1/2008 73 Female 2/19/2008 Physician United States
Primary
Secondary
Concomitant
Death Death 1/1/2008 Female 2/22/2008 Physician United States
Primary
Secondary
Concomitant
Death Death 10/26/2007 73 Female 99 lb 2/25/2008 Physician United States
Primary
Secondary
Concomitant
Complications Of Transplanted Liver Death 10/26/2007 Female 2/26/2008 Physician United States
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 8/14/2007 49 Male 2/29/2008 Other Health Professional France
Primary
Concomitant
Interacting
Urinary Incontinence Death 45 Male 5/1/2008 Physician United States
Primary
Secondary
Concomitant
Pyrexia Life Threatening 6/1/2006 Male 5/8/2008 Physician United States
Primary
Concomitant
Dystonia Other Serious 55 Female 5/19/2008 Physician United States
Primary
Concomitant
Procedural Pain 12/21/2007 26 Female 6/10/2008 Physician United States
Primary
Concomitant
Spinal Osteoarthritis Hospitalization 5/12/2008 60 Female 200 lb 6/18/2008 Physician United States
Primary
Secondary
Concomitant
Pyrexia Life Threatening 1/1/2006 Male 7/9/2008 Physician United States
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 12/12/2007 66 Male 6/30/2008 Physician United States
Primary
Concomitant
Stem Cell Transplant Hospitalization 5/12/2008 60 Female 200 lb 7/14/2008 Physician United States
Primary
Secondary
Concomitant
Pyrexia Life Threatening 6/19/2006 Male 7/24/2008 Physician United States
Primary
Concomitant
Eye Disorder Other Serious 34 Male 7/25/2008 Pharmacist United States
Primary
Concomitant
Weight Increased Other Serious 5/29/2008 Female 114 lb 8/13/2008 Other Health Professional Brazil
Primary
Concomitant
Gastrointestinal Neoplasm Other Serious 8/12/2008 Male 185 lb 8/22/2008 Physician Germany
Primary
Concomitant
Visual Impairment Required Intervention 1/9/2008 21 Female 106 lb 10/7/2008 Pharmacist United States
Primary
Secondary
Concomitant
Skin Ulcer Hospitalization 9/3/2008 Male 185 lb 10/10/2008 Physician Germany
Primary
Concomitant
Weight Increased Other Serious 5/29/2008 Female 114 lb 10/10/2008 Other Health Professional Brazil
Primary
Concomitant
Drug Level Increased Other Serious 9/21/2008 1 Female 22 lb 10/27/2008 Other Health Professional United Kingdom
Primary
Concomitant
Interacting
Vomiting Hospitalization 7/22/2007 Male 97 lb 11/4/2008 Other Health Professional Brazil
Primary
Concomitant
Hyperphosphatasaemia Other Serious 3 Male 11/4/2008
Primary
Secondary
Concomitant
Gastrointestinal Hypermotility Other Serious 9/21/2008 1 Female 11/3/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Immunosuppressant Drug Level Increased Other Serious 9/21/2008 1 Female 11/6/2008 United Kingdom
Primary
Secondary
Concomitant
Hypertrophic Cardiomyopathy Other Serious 0 Male 11/19/2008 Japan
Primary
Concomitant
Lethargy Hospitalization 10/20/2008 48 Female 10/20/2008 Pharmacist United States
Primary
Concomitant
Hypertrophic Cardiomyopathy Other Serious 0 Male 12/1/2008 Japan
Primary
Concomitant
Urinary Tract Infection Life Threatening 2/6/2008 14 Female 97 lb 12/19/2008 Physician United States
Primary
Secondary
Concomitant
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
Drug Level Increased Other Serious 9/21/2008 1 Female 1/19/2009 Other Health Professional United Kingdom
Primary
Concomitant
Interacting
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
Vomiting Hospitalization 6/1/2008 50 Female 104 lb 3/26/2009 Other Health Professional Germany
Primary
Secondary
Concomitant
Vanishing Bile Duct Syndrome Other Serious 26 Female 3/26/2009
Primary
Secondary
Concomitant
Splenic Infarction Hospitalization 5/12/2009 58 Male 148 lb 6/17/2009 Other Health Professional Taiwan, Province Of China
Primary
Concomitant
Splenic Infarction Hospitalization 5/12/2009 58 Male 148 lb 6/22/2009 Physician Taiwan, Province Of China
Primary
Concomitant
Oedema Peripheral Hospitalization 5/4/2009 Female 256 lb 8/14/2009 Physician Poland
Primary
Secondary
Concomitant
Stem Cell Transplant Hospitalization 7/27/2009 58 Female 182 lb 8/24/2009 Physician United States
Primary
Secondary
Concomitant
Obliterative Bronchiolitis Hospitalization 7/27/2009 58 Female 182 lb 8/24/2009 Physician United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 7/27/2009 58 Female 182 lb 9/4/2009 Physician United States
Primary
Secondary
Concomitant
Wound Infection Hospitalization 29 Female 276 lb 9/29/2009 United States
Primary
Concomitant
Transaminases Increased Other Serious 7/1/2006 57 Female 10/16/2009 Other Health Professional France
Primary
Concomitant
Red Blood Cell Count Decreased Hospitalization 7/27/2009 58 Female 182 lb 10/14/2009 Physician United States
Primary
Secondary
Concomitant
Pyrexia Hospitalization 10/26/2009 Male 11/12/2009 Physician
Primary
Secondary
Concomitant
Blood Creatine Phosphokinase Increased Hospitalization 1/8/2009 62 Female 117 lb 11/13/2009 Physician Japan
Primary
Secondary
Concomitant
Blood Creatine Phosphokinase Increased Hospitalization 1/8/2009 62 117 lb 12/2/2009 Physician Japan
Primary
Secondary
Concomitant
Rash Erythematous Hospitalization 1/1/2009 46 Female 108 lb 12/11/2009 Physician United States
Primary
Secondary
Concomitant
Oxygen Saturation Decreased Hospitalization 12/14/2009 Male 101 lb 12/24/2009 Physician United States
Primary
Secondary
Concomitant
Methaemoglobinaemia Hospitalization 12/14/2009 Male 101 lb 1/5/2010 Physician United States
Primary
Secondary
Concomitant
Traumatic Fracture Hospitalization 12/11/2007 41 Female 12/30/2009 Physician Japan
Primary
Secondary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 1/1/2009 41 Male 158 lb 12/16/2009 Physician United States
Primary
Concomitant
Methaemoglobinaemia Hospitalization 12/14/2009 Male 101 lb 1/11/2010 Physician United States
Primary
Secondary
Concomitant
Viral Haemorrhagic Cystitis Required Intervention 6/8/2009 41 Male 158 lb 1/4/2010 Physician United States
Primary
Concomitant
Weight Decreased Hospitalization 6/18/2009 57 Male 1/12/2010 Other Health Professional France
Primary
Concomitant
Drug Interaction Hospitalization 1/8/2009 62 Female 117 lb 1/29/2010 Physician Japan
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 6/18/2009 57 Male 2/3/2010 Physician France
Primary
Concomitant
Drug Interaction Hospitalization 1/8/2009 62 Female 117 lb 2/12/2010 Physician Japan
Primary
Secondary
Concomitant
Vomiting Life Threatening 12/14/2007 69 Male 3/4/2010 Lawyer United States
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 6/18/2009 57 Male 3/29/2010 Other Health Professional France
Primary
Concomitant
Vomiting Required Intervention 6/8/2009 41 Male 158 lb 3/31/2010 Physician United States
Primary
Concomitant
Weight Increased Hospitalization 1/1/2002 Female 4/22/2010 Physician Japan
Primary
Concomitant
Blood Bilirubin Increased 1/1/2008 70 Male 5/19/2010 Pharmacist United States
Primary
Secondary
Vomiting Other Serious 9/1/2009 20 Female 5/20/2010 United States
Primary
Concomitant
Vomiting Other Serious 1/2/2007 69 Male 187 lb 6/7/2010 Lawyer United States
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 5/13/2010 31 Female 176 lb 6/16/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Shock Other Serious 1/6/2010 67 Female 115 lb 6/17/2010 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 5/13/2010 31 Female 6/17/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Neoplasm Progression Other Serious 5/7/2010 28 Male 6/18/2010 Physician United States
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 10/19/2009 54 Male 132 lb 6/21/2010 Other Health Professional Japan
Primary
Concomitant
Varicella Virus Test Positive Other Serious 9 Male 6/23/2010 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Vomiting Other Serious 9/1/2009 20 Female 7/1/2010 United States
Primary
Concomitant
Depressed Level Of Consciousness Other Serious 5/29/2010 7 Male 54 lb 7/2/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Pyrexia Other Serious 1/1/2009 49 Male 7/15/2010 Physician United States
Primary
Secondary
Concomitant
Incisional Hernia Hospitalization 4/13/2010 46 Male 185 lb 7/16/2010 Physician Germany
Primary
Concomitant
Venoocclusive Disease Hospitalization 4/30/2010 31 Female 7/19/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 4/30/2010 31 Female 176 lb 7/21/2010 Other Health Professional United States
Primary
Concomitant
Venoocclusive Disease Hospitalization 4/30/2010 31 Female 7/21/2010 Other Health Professional United States
Primary
Concomitant
Hepatorenal Syndrome 62 7/15/2010 Other Health Professional France
Primary
Concomitant
Staphylococcal Skin Infection Hospitalization 8 Male 7/28/2010 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 4/30/2010 31 Female 7/27/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Depressed Level Of Consciousness Other Serious 5/29/2010 7 Male 54 lb 8/9/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Pyrexia Other Serious 9/21/2009 37 Female 93 lb 8/9/2010 Physician Japan
Primary
Concomitant
Sepsis Hospitalization 6/22/2010 55 Male 189 lb 8/10/2010 Other Health Professional United States
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 3/11/2009 23 Female 97 lb 8/17/2010 Physician Japan
Primary
Concomitant
Shock Other Serious 1/6/2010 67 Female 115 lb 8/17/2010 Physician Japan
Primary
Secondary
Concomitant
Oedema Peripheral Hospitalization 5/4/2009 58 Female 256 lb 8/20/2010 Physician Poland
Primary
Secondary
Concomitant
Orthostatic Hypotension Other Serious 1/1/2010 50 Male 166 lb 8/24/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Sinus Tachycardia Other Serious 11/25/2008 36 Female 105 lb 8/10/2010 United States
Primary
Concomitant
Oedema Peripheral Hospitalization 5/4/2009 58 Female 256 lb 8/30/2010 Physician Poland
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 3/11/2009 23 Female 97 lb 8/31/2010 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 4/30/2010 32 Female 9/7/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Depressed Level Of Consciousness Other Serious 5/29/2010 7 Male 54 lb 9/8/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Venoocclusive Disease Hospitalization 4/30/2010 31 Female 9/8/2010 Other Health Professional United States
Primary
Concomitant
Venoocclusive Disease Other Serious 4/30/2010 31 Female 176 lb 9/9/2010 Other Health Professional United States
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 4/13/2009 4 Female 31 lb 9/9/2010 Physician Japan
Primary
Concomitant
Vomiting Other Serious 9/1/2009 20 Female 9/13/2010 United States
Primary
Concomitant
Febrile Neutropenia Other Serious 8/11/2009 10 Male 86 lb 9/20/2010 Physician Japan
Primary
Concomitant
Multi-organ Failure Hospitalization 6/24/2009 15 Male 126 lb 9/23/2010 Physician Japan
Primary
Concomitant
Venoocclusive Disease Other Serious 9/24/2010 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
White Blood Cell Count Decreased Other Serious 4/10/2009 4 Female 31 lb 10/8/2010 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 12/14/2007 69 Male 187 lb 10/11/2010 Other Health Professional United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 4/10/2009 4 Female 31 lb 10/11/2010 Physician Japan
Primary
Secondary
Concomitant
Pruritus Hospitalization 9/30/2009 18 Female 137 lb 10/18/2010 Physician Japan
Primary
Concomitant
Liver Transplant Rejection Hospitalization 57 Female 10/1/2010 Physician France
Primary
Concomitant
Vomiting Other Serious 9/1/2009 20 Female 223 lb 10/28/2010 United States
Primary
Concomitant
Vomiting Other Serious 5/1/2010 48 Male 181 lb 11/2/2010 Physician Germany
Primary
Secondary
Concomitant
Tachycardia Hospitalization 4/28/2010 19 Female 115 lb 11/8/2010 Physician Japan
Primary
Concomitant
Vomiting Life Threatening 5/1/2010 48 Male 181 lb 11/19/2010 Physician Germany
Primary
Secondary
Concomitant
Weight Increased Other Serious 1/17/2010 Male 168 lb 11/22/2010 Physician Japan
Primary
Concomitant
Multi-organ Failure Hospitalization 6/24/2009 15 Male 126 lb 11/23/2010 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Hospitalization 5/26/2010 Male 18 lb 11/24/2010 Physician Japan
Primary
Concomitant
Wheezing Other Serious 1/1/2010 12/2/2010 Other Health Professional United States
Primary
Concomitant
Vomiting Hospitalization 4/1/2010 17 Female 83 lb 10/4/2010 Pharmacist United States
Primary
Concomitant
Vomiting Other Serious 9/1/2009 20 Female 223 lb 12/29/2010 United States
Primary
Concomitant
Sepsis Life Threatening 7/28/2010 30 Female 99 lb 1/6/2011 Physician Japan
Primary
Concomitant
Haemorrhage Death 4/13/2009 4 Female 31 lb 1/7/2011 Physician Japan
Primary
Concomitant
Acute Myeloid Leukaemia Recurrent Death 8/6/2010 67 Female 110 lb 1/7/2011 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Other Serious 7/12/2010 52 Male 115 lb 1/10/2011 Physician Japan
Primary
Concomitant
Hyperkalaemia Other Serious 2/9/2010 66 Male 12/22/2010 Belgium
Primary
Secondary
Concomitant

Drug Data