Prednisolone combined with Ursodiol

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Sialoadenitis Hospitalization 12/19/2005 68 Female 1/16/2006 Physician Japan
Primary
Concomitant
Pancytopenia Hospitalization 5/24/2006 65 Male 6/14/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Rheumatoid Arthritis Other Serious 9/15/2005 81 Female 8/10/2006 Japan
Primary
Concomitant
Drug Ineffective Hospitalization 9/29/2004 35 Female 8/21/2006 Japan
Primary
Concomitant
Rhabdomyolysis Hospitalization 69 Male 10/3/2006 United States
Primary
Secondary
Concomitant
Trigeminal Nerve Disorder Life Threatening 83 Female 10/20/2006 Other Health Professional United Kingdom
Primary
Concomitant
Weight Gain Poor Other Serious 10/28/2003 14 Female 100 lb 2/23/2007 Consumer United Kingdom
Primary
Concomitant
Multi-organ Failure Other Serious 1/1/2004 75 Male 3/19/2007 Japan
Primary
Secondary
Concomitant
Sinusitis Aspergillus Life Threatening 83 Female 3/20/2007 Other Health Professional United Kingdom
Primary
Concomitant
Multi-organ Failure Other Serious 1/1/2004 75 Male 3/30/2007 Japan
Primary
Secondary
Concomitant
Multi-organ Failure Other Serious 1/1/2004 75 Male 4/6/2007 Japan
Primary
Secondary
Concomitant
Cytomegalovirus Enterocolitis Other Serious 52 Female 5/8/2007 Japan
Primary
Concomitant
Anaphylactic Reaction Other Serious 5/29/2007 17 Female 99 lb 6/13/2007 Other Health Professional United Kingdom
Primary
Concomitant
Red Blood Cell Count Decreased Other Serious 6/1/2006 86 Male 131 lb 10/6/2007 Japan
Primary
Concomitant
Lethargy 7/4/2007 Male 43 lb 1/16/2008 Physician United States
Primary
Secondary
Concomitant
Jaundice Hospitalization 86 Male 3/7/2008 Pharmacist United Kingdom
Primary
Secondary
Jaundice Hospitalization 86 Male 3/7/2008 Pharmacist United Kingdom
Primary
Secondary
Protein Total Decreased Other Serious 1/24/2008 86 Male 3/26/2008 Pharmacist United Kingdom
Primary
Concomitant
Jaundice Hospitalization 86 Male 3/26/2008 Consumer United Kingdom
Primary
Secondary
Jaundice Hospitalization 86 Male 3/28/2008 Other Health Professional United Kingdom
Primary
Secondary
Jaundice Hospitalization 86 Male 3/31/2008 Other Health Professional United Kingdom
Primary
Secondary
Jaundice Hospitalization 86 Male 3/31/2008 Other Health Professional United Kingdom
Primary
Secondary
Jaundice Hospitalization 86 Male 3/31/2008 Consumer United Kingdom
Primary
Secondary
Jaundice Hospitalization 86 Male 3/28/2008 Pharmacist United Kingdom
Primary
Secondary
Jaundice Hospitalization 86 Male 4/2/2008 Other Health Professional United Kingdom
Primary
Secondary
Jaundice Hospitalization 86 Male 3/28/2008 Pharmacist United Kingdom
Primary
Secondary
Jaundice Hospitalization 86 Male 4/8/2008 United Kingdom
Primary
Secondary
Jaundice Hospitalization 86 Male 4/10/2008 Other Health Professional United Kingdom
Primary
Secondary
Jaundice Hospitalization 86 Male 4/10/2008 Other Health Professional United Kingdom
Primary
Secondary
Jaundice Hospitalization 86 Male 3/28/2008 United Kingdom
Primary
Secondary
Concomitant
Jaundice Hospitalization 86 Male 4/7/2008 United Kingdom
Primary
Secondary
Concomitant
Jaundice Other Serious 1/24/2008 86 Male 5/12/2008 Consumer United Kingdom
Primary
Concomitant
Jaundice Hospitalization 86 Male 6/4/2008 Other Health Professional United Kingdom
Primary
Secondary
Jaundice Hospitalization 86 Male 6/4/2008 Other Health Professional United Kingdom
Primary
Secondary
Jaundice Hospitalization 86 Male 6/10/2008 Other Health Professional Sweden
Primary
Secondary
Jaundice Hospitalization 86 Male 6/11/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Jaundice Hospitalization 86 Male 6/16/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Jaundice Hospitalization 86 Male 6/12/2008 United Kingdom
Primary
Secondary
Concomitant
Jaundice Hospitalization 86 Male 6/16/2008 United Kingdom
Primary
Secondary
Pyrexia Life Threatening 1/1/2006 Male 7/9/2008 Physician United States
Primary
Concomitant
Small For Dates Baby Other Serious 7/11/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Small For Dates Baby Other Serious 7/14/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Drug Level Increased Other Serious 9/21/2008 1 Female 22 lb 10/27/2008 Other Health Professional United Kingdom
Primary
Concomitant
Interacting
White Blood Cell Count Increased Other Serious 7/9/2008 Male 10/27/2008 Consumer United States
Primary
Secondary
Concomitant
Gastrointestinal Hypermotility Other Serious 9/21/2008 1 Female 11/3/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 3/5/2008 11/14/2008 Consumer Germany
Primary
Secondary
Concomitant
Portal Vein Thrombosis Hospitalization 8/14/2008 12/24/2008 Japan
Primary
Secondary
Concomitant
Drug Level Increased Other Serious 9/21/2008 1 Female 1/19/2009 Other Health Professional United Kingdom
Primary
Concomitant
Interacting
Jaundice 86 Male 5/8/2008 Other Health Professional United Kingdom
Primary
Secondary
Portal Vein Thrombosis Hospitalization 8/14/2008 2/3/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Vanishing Bile Duct Syndrome Other Serious 26 Female 3/5/2009 Other Health Professional Turkey
Primary
Secondary
Concomitant
Vanishing Bile Duct Syndrome Other Serious 26 Female 3/6/2009 Other Health Professional Turkey
Primary
Secondary
Concomitant
Pulmonary Tuberculosis Other Serious 7/4/2007 55 Female 189 lb 5/27/2009 Other Health Professional Russian Federation
Primary
Concomitant
Lethargy 7/4/2007 4 Male 43 lb 6/4/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Muscular Weakness Hospitalization 12/11/2008 54 Female 6/10/2009 Japan
Primary
Secondary
Concomitant
Urinary Retention Other Serious 8/15/2008 81 Male 115 lb 6/19/2009 Physician Japan
Primary
Concomitant
Drug Exposure During Pregnancy Other Serious 29 Female 7/9/2009 Other Health Professional Brazil
Primary
Secondary
Concomitant
Lymphoedema Other Serious 62 Male 7/7/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Sinus Bradycardia Hospitalization 6/1/2009 1 Male 26 lb 7/21/2009 Other Health Professional
Primary
Concomitant
Toxic Skin Eruption Hospitalization 4/29/2009 68 Female 110 lb 7/27/2009 Physician Japan
Primary
Secondary
Concomitant
Septic Shock Other Serious 6/30/2009 79 Male 7/31/2009 Physician United States
Primary
Concomitant
Septic Shock Other Serious 6/30/2009 79 Male 8/11/2009 Physician United States
Primary
Concomitant
Sepsis Other Serious 8/5/2009 Female 9/1/2009 Japan
Primary
Concomitant
Sepsis Other Serious 8/5/2009 Female 9/11/2009 Japan
Primary
Concomitant
Vocal Cord Polyp Other Serious 2/17/2004 57 Female 192 lb 9/16/2009 United States
Primary
Concomitant
Sepsis Hospitalization 5/1/2009 71 Male 9/15/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Escherichia Sepsis Hospitalization 5/1/2009 71 Male 10/13/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Corneal Erosion Other Serious 9/25/2009 57 10/22/2009 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 9/1/2009 5 Female 47 lb 10/29/2009 Other Health Professional United States
Primary
Concomitant
Urinary Tract Infection Death Female 163 lb 11/9/2009 United Kingdom
Primary
Concomitant
Hepatitis C Rna Increased 1/24/2009 62 Female 11/5/2009 Other Health Professional Japan
Primary
Concomitant
Non-small Cell Lung Cancer Life Threatening 9/21/2009 62 Male 11/10/2009 Other Health Professional Japan
Primary
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
Malignant Neoplasm Progression Life Threatening 9/21/2009 62 Male 12/4/2009 Physician Japan
Primary
Concomitant
Traumatic Fracture Hospitalization 12/11/2007 41 Female 12/30/2009 Physician Japan
Primary
Secondary
Concomitant
Biliary Tract Infection Other Serious 76 Male 1/11/2010 Physician Japan
Primary
Secondary
Drug Interaction Hospitalization 1/8/2009 62 Female 117 lb 1/29/2010 Physician Japan
Primary
Secondary
Concomitant
Drug Interaction Hospitalization 1/8/2009 62 Female 117 lb 2/12/2010 Physician Japan
Primary
Secondary
Concomitant
Biliary Tract Infection Hospitalization 76 Male 3/2/2010 Japan
Primary
Secondary
Death Death 3/26/2010 58 Male 4/15/2010 United States
Primary
Concomitant
Vocal Cord Polyp Other Serious 2/17/2004 57 Female 192 lb 4/23/2010 United States
Primary
Concomitant
Weight Increased Hospitalization 1/1/2002 Female 4/22/2010 Physician Japan
Primary
Concomitant
Deafness Unilateral Other Serious 81 Female 5/10/2010 Other Health Professional United Kingdom
Primary
Concomitant
Deafness Unilateral Other Serious 81 Female 5/21/2010 Other Health Professional United Kingdom
Primary
Concomitant
Pancytopenia Other Serious 43 Female 5/20/2010 Physician Japan
Primary
Concomitant
Postoperative Fever Hospitalization 1/28/2010 70 Female 89 lb 6/2/2010 Physician Japan
Primary
Concomitant
Staphylococcal Sepsis Hospitalization 12/14/2009 72 Male 132 lb 6/4/2010 Physician Japan
Primary
Secondary
Concomitant
Lower Respiratory Tract Infection Other Serious 5/14/2010 78 Male 165 lb 6/14/2010 Other Health Professional United Kingdom
Primary
Concomitant
Staphylococcal Sepsis Hospitalization 12/14/2009 72 Male 132 lb 6/14/2010 Physician Japan
Primary
Secondary
Concomitant
Lower Respiratory Tract Infection Hospitalization 5/14/2010 78 Male 165 lb 6/15/2010 Other Health Professional United Kingdom
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 10/19/2009 54 Male 132 lb 6/21/2010 Other Health Professional Japan
Primary
Concomitant
Lower Respiratory Tract Infection Other Serious 5/14/2010 78 Male 165 lb 6/21/2010 Other Health Professional United Kingdom
Primary
Concomitant
Pyrexia Hospitalization 5/13/2010 64 Female 95 lb 6/17/2010 Japan
Primary
Concomitant
Lower Respiratory Tract Infection Other Serious 5/14/2010 78 Male 165 lb 6/24/2010 Other Health Professional United Kingdom
Primary
Concomitant
Lower Respiratory Tract Infection Other Serious 78 Male 6/24/2010 Consumer United Kingdom
Primary
Concomitant
Rash Hospitalization 5/6/2010 62 Female 119 lb 7/12/2010 Physician Japan
Primary
Concomitant
Rash Hospitalization 5/6/2010 62 Female 119 lb 7/15/2010 Physician Japan
Primary
Concomitant
Postoperative Fever Hospitalization 1/28/2010 70 Female 89 lb 7/19/2010 Physician Japan
Primary
Concomitant
Hepatorenal Syndrome 62 7/15/2010 Other Health Professional France
Primary
Concomitant
Pharyngeal Oedema Hospitalization 3/19/2010 27 Male 7/23/2010 Physician Japan
Primary
Concomitant
Death Death 8/5/2008 74 Male 150 lb 7/27/2010 Physician India
Primary
Secondary
Concomitant
Weight Increased Other Serious 1/1/2008 75 Female 106 lb 7/26/2010 Japan
Primary
Secondary
Grand Mal Convulsion Life Threatening 7/24/2010 16 Female 8/5/2010 Other Health Professional United Kingdom
Primary
Concomitant
Renal Impairment Other Serious 12/1/2007 75 Female 106 lb 8/5/2010 Japan
Primary
Secondary
Grand Mal Convulsion Life Threatening 7/24/2010 16 Female 8/11/2010 Other Health Professional United Kingdom
Primary
Concomitant
Pharyngeal Oedema Hospitalization 3/18/2010 27 Male 8/20/2010 Physician Japan
Primary
Concomitant
Pyrexia Hospitalization 5/13/2010 64 Female 95 lb 8/24/2010 Japan
Primary
Concomitant
Pharyngeal Oedema Hospitalization 3/18/2010 27 Male 9/8/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 4/13/2009 4 Female 31 lb 9/9/2010 Physician Japan
Primary
Concomitant
Rash Hospitalization 5/6/2010 62 Female 119 lb 9/14/2010 Physician Japan
Primary
Concomitant
Pyrexia Hospitalization 5/13/2010 64 Female 95 lb 9/20/2010 Japan
Primary
Concomitant
Weight Decreased Life Threatening 8/9/2009 13 Female 9/23/2010 Japan
Primary
Secondary
Concomitant
Encephalitis Herpes Hospitalization 9/27/2009 74 Male 10/4/2010 Physician Japan
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
White Blood Cell Count Decreased Other Serious 4/10/2009 4 Female 31 lb 10/11/2010 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Haemorrhage Life Threatening 2/8/2010 15 Female 110 lb 10/15/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Pruritus Hospitalization 9/30/2009 18 Female 137 lb 10/18/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 8/12/2010 63 Male 126 lb 10/29/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 8/12/2010 10/29/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Tachycardia Hospitalization 4/28/2010 19 Female 115 lb 11/8/2010 Physician Japan
Primary
Concomitant
Splenomegaly Other Serious 43 Female 10/27/2010 Physician Japan
Primary
Concomitant
Staphylococcal Bacteraemia Other Serious 8/3/2009 62 Female 110 lb 11/24/2010 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Hospitalization 5/26/2010 Male 18 lb 11/24/2010 Physician Japan
Primary
Concomitant
Treatment Noncompliance Life Threatening 8/9/2009 13 Female 11/8/2010 Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 6/12/2010 12/1/2010 Consumer Japan
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 8/12/2010 12/8/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Pneumonia Life Threatening 11/4/2009 72 Male 101 lb 12/20/2010 Other Health Professional Japan
Primary
Concomitant
Haemorrhage Death 4/13/2009 4 Female 31 lb 1/7/2011 Physician Japan
Primary
Concomitant
Staphylococcal Sepsis Other Serious 7/12/2010 52 Male 115 lb 1/10/2011 Physician Japan
Primary
Concomitant
Multi-organ Failure Death 10/22/2010 54 Male 176 lb 1/21/2011 Physician Japan
Primary
Concomitant
Hepatic Function Abnormal Hospitalization 5/6/2010 62 Female 119 lb 2/4/2011 Physician Japan
Primary
Concomitant
Device Related Infection Death Female 89 lb 3/25/2011 Physician Japan
Primary
Concomitant
Delirium Other Serious 6/16/2010 53 Male 154 lb 4/8/2011 Physician Japan
Primary
Concomitant
Infection Hospitalization 10/25/2010 56 Male 243 lb 4/19/2011 Other Health Professional Australia
Primary
Concomitant
Rash Hospitalization 3/15/2010 54 Female 95 lb 4/20/2011 Physician Japan
Primary
Secondary
Concomitant
Liver Disorder Hospitalization 4/25/2011 66 Male 381 lb 5/2/2011 Physician Japan
Primary
Secondary
Concomitant
Pruritus Hospitalization 3/12/2010 54 Female 95 lb 5/20/2011 Physician Japan
Primary
Secondary
Concomitant
Candida Test Positive Hospitalization 3/12/2010 54 Female 95 lb 5/25/2011 Physician Japan
Primary
Secondary
Concomitant
Gram Stain Positive Other Serious 2/8/2010 70 Female 89 lb 5/25/2011 Physician Japan
Primary
Concomitant
Haematemesis Other Serious 10/3/2010 71 Female 89 lb 5/27/2011 Physician Japan
Primary
Concomitant
Liver Disorder Hospitalization 3/26/2010 54 Female 95 lb 6/3/2011 Physician Japan
Primary
Secondary
Concomitant
Malaise Other Serious 10/3/2010 71 Female 89 lb 6/14/2011 Physician Japan
Primary
Concomitant
Cytomegalovirus Infection Other Serious 4/18/2011 58 Male 6/22/2011 Physician Japan
Primary
Secondary
Concomitant
Pancreatitis Other Serious 2/10/2010 23 Male 117 lb 6/30/2011 Physician Japan
Primary
Secondary
Concomitant
B-cell Lymphoma Other Serious 4/14/2011 58 Male 143 lb 7/5/2011 Physician Japan
Primary
Secondary
Concomitant
Hypertension Life Threatening 4/22/2010 13 Male 90 lb 7/5/2011 Physician Japan
Primary
Concomitant
Memory Impairment Hospitalization 2/10/2010 23 Male 117 lb 7/6/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Lymphocyte Count Decreased Life Threatening 4/14/2011 58 Male 143 lb 7/20/2011 Physician Japan
Primary
Secondary
Concomitant
Gastric Cancer Other Serious 6/24/2011 72 Male 116 lb 7/27/2011 Physician Japan
Primary
Secondary
Concomitant

Drug Data