Acetaminophen 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 11/1/2004 61 9/12/2005 Pharmacist United States
Primary
Concomitant
Venoocclusive Disease Other Serious 10/14/2006 11 Female 60 lb 11/30/2006 Physician Canada
Primary
Concomitant
Tumour Lysis Syndrome Other Serious 10/14/2006 11 Female 60 lb 1/4/2007 Physician Canada
Primary
Concomitant
Transfusion-related Acute Lung Injury Other Serious 10/15/2006 0 Female 15 lb 1/11/2007 Other Health Professional Canada
Primary
Concomitant
Transplant Rejection Hospitalization 12/28/2006 50 Female 110 lb 2/8/2007 Physician United States
Primary
Secondary
Concomitant
Urticaria Hospitalization 5/23/2007 7 Female 47 lb 7/18/2007 Other Health Professional United States
Primary
Concomitant
Urticaria Hospitalization 5/23/2007 7 Female 47 lb 8/6/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Seroma Hospitalization 4/20/2006 Female 152 lb 9/6/2007 Physician Switzerland
Primary
Concomitant
Vomiting Hospitalization 5/23/2007 7 Female 47 lb 9/17/2007 United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 10/28/2007 14 Female 126 lb 11/12/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 10/14/2006 11 Female 60 lb 11/8/2007 Physician Canada
Primary
Secondary
Concomitant
Vomiting Life Threatening 10/28/2007 14 Female 126 lb 11/21/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Urinary Retention Hospitalization 10/5/2007 6 Female 12/5/2007 Other Health Professional France
Primary
Secondary
Stomatitis Other Serious 7/24/2007 51 Male 12/13/2007 United States
Primary
Secondary
Concomitant
Pyrexia Hospitalization 11/13/2007 Male 24 lb 1/15/2008 Physician United States
Primary
Concomitant
Liver Function Test Abnormal Hospitalization 1/21/2008 Female 21 lb 1/23/2008 United States
Primary
Secondary
Concomitant
Venous Pressure Jugular Increased Hospitalization 1/21/2008 Female 21 lb 1/28/2008 Canada
Primary
Secondary
Concomitant
Transplant Failure Other Serious 5/12/2006 45 Female 159 lb 2/13/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Venous Pressure Jugular Increased Hospitalization 1/21/2008 Female 21 lb 2/8/2008 United States
Primary
Secondary
Concomitant
Hepatic Function Abnormal Hospitalization 1/1/2005 Female 2/22/2008 Spain
Primary
Concomitant
Respiratory Failure Hospitalization 11/13/2007 Male 24 lb 4/2/2008 Physician United States
Primary
Concomitant
Respiratory Failure Hospitalization 11/13/2007 Male 24 lb 4/4/2008 Physician United States
Primary
Concomitant
Biliary Cirrhosis Primary Hospitalization 1/1/2005 Female 4/4/2008 Spain
Primary
Concomitant
Autoimmune Hepatitis Other Serious 4/1/2007 Female 4/4/2008 Spain
Primary
Concomitant
Spinal Osteoarthritis Hospitalization 5/12/2008 60 Female 200 lb 6/18/2008 Physician United States
Primary
Secondary
Concomitant
Stem Cell Transplant Hospitalization 5/12/2008 60 Female 200 lb 7/14/2008 Physician United States
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 3/27/2008 21 Male 7/11/2008 Physician France
Primary
Secondary
Concomitant
Vomiting Hospitalization 6/30/2008 74 Female 192 lb 9/4/2008 Physician United States
Primary
Secondary
Concomitant
Therapeutic Agent Toxicity Hospitalization 6/30/2008 74 Female 192 lb 9/15/2008 Physician United States
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 7/9/2008 Male 10/27/2008 Consumer United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 7/22/2007 Male 97 lb 11/4/2008 Other Health Professional Brazil
Primary
Concomitant
Bronchopulmonary Aspergillosis Hospitalization Male 141 lb 11/25/2008 Korea, Republic Of
Primary
Concomitant
Neutropenia Other Serious 10/1/2008 Male 121 lb 12/1/2008 Pharmacist United Kingdom
Primary
Concomitant
Pulmonary Embolism Life Threatening 1/2/2008 15 Male 166 lb 12/19/2008 Physician United States
Primary
Secondary
Concomitant
Urinary Tract Infection Life Threatening 2/6/2008 14 Female 97 lb 12/19/2008 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
Oesophagitis Hospitalization 6/9/2008 60 Male 249 lb 1/13/2009 Physician United States
Primary
Secondary
Concomitant
Bronchopulmonary Aspergillosis Hospitalization 9/18/2008 1/20/2009 Physician Korea, Republic Of
Primary
Concomitant
Bronchopulmonary Aspergillosis Hospitalization 9/18/2008 1/21/2009 Physician Korea, Republic Of
Primary
Concomitant
Venoocclusive Liver Disease Life Threatening 12/28/2008 62 Male 2/9/2009 Physician United States
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 11/13/2007 Male 24 lb 4/3/2009 Physician United States
Primary
Concomitant
Platelet Count Decreased Other Serious 3/20/2009 66 Male 4/3/2009 Physician France
Primary
Secondary
Concomitant
Febrile Bone Marrow Aplasia Hospitalization 5/4/2009 3 Male 6/12/2009 France
Primary
Secondary
Concomitant
Urinary Tract Infection Other Serious 5/18/2009 63 Female 131 lb 9/10/2009 Physician United Kingdom
Primary
Concomitant
Urinary Tract Infection Hospitalization 76 Female 9/25/2009 United States
Primary
Concomitant
Wound Infection Hospitalization 29 Female 276 lb 9/29/2009 United States
Primary
Concomitant
Urinary Hesitation Hospitalization 7/28/2008 65 Male 207 lb 10/6/2009 United States
Primary
Secondary
Concomitant
Urinary Hesitation Hospitalization 7/28/2008 65 Male 207 lb 10/5/2009 Physician United States
Primary
Secondary
Concomitant
Rectal Haemorrhage Hospitalization 4/8/2009 47 Male 11/16/2009 Other Health Professional France
Primary
Secondary
Penile Ulceration Required Intervention 7/29/2009 Male 15 lb 11/13/2009 Pharmacist United States
Primary
Concomitant
Tremor Hospitalization 8/16/2009 64 Male 11/23/2009 Other Health Professional United States
Primary
Concomitant
Tremor Hospitalization 8/16/2009 64 Male 12/21/2009 Physician United States
Primary
Concomitant
Thrombosis Other Serious 12/1/2007 Male 3/4/2010 Lawyer United States
Primary
Concomitant
Ventricular Tachycardia Other Serious 1/1/2003 42 Male 3/4/2010 Lawyer United States
Primary
Concomitant
Vomiting Life Threatening 12/14/2007 69 Male 3/4/2010 Lawyer United States
Primary
Secondary
Concomitant
Splenomegaly Hospitalization 3/7/2008 4/30/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Disorder Other Serious 5/7/2010 84 Male 5/20/2010 Japan
Primary
Secondary
Thrombosis Other Serious 12/1/2007 54 Male 163 lb 6/3/2010 Other Health Professional United States
Primary
Concomitant
Ventricular Tachycardia Other Serious 1/1/2008 62 Male 6/3/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Disorder Other Serious 5/7/2010 84 Male 6/1/2010 Japan
Primary
Secondary
Intestinal Obstruction Female 113 lb 5/11/2010 Consumer United States
Primary
Concomitant
Vomiting Other Serious 1/2/2007 69 Male 187 lb 6/7/2010 Lawyer United States
Primary
Secondary
Concomitant
Laryngeal Oedema Life Threatening 3/25/2010 62 Female 4/30/2010 Portugal
Primary
Concomitant
Condition Aggravated Hospitalization 9/25/2008 51 Male 141 lb 6/11/2010 Physician Korea, Republic Of
Primary
Concomitant
Venoocclusive Disease Other Serious 5/13/2010 31 Female 176 lb 6/16/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 5/13/2010 31 Female 6/17/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Wheezing Other Serious 29 Female 125 lb 6/14/2010 United States
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
Muscle Atrophy Other Serious 1/1/2008 70 Male 154 lb 7/21/2010 Other Health Professional United Kingdom
Primary
Concomitant
Thrombosis Other Serious 12/1/2007 54 Male 163 lb 7/21/2010 Other Health Professional United States
Primary
Concomitant
Fatigue Other Serious 11/1/2008 60 Female 154 lb 7/23/2010 Consumer United States
Primary
Concomitant
Venoocclusive Disease Other Serious 4/30/2010 31 Female 7/27/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Muscle Atrophy Other Serious 1/1/2008 70 Male 154 lb 7/26/2010 United Kingdom
Primary
Concomitant
Muscle Atrophy Other Serious 1/1/2008 70 Male 154 lb 8/2/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Muscle Atrophy Other Serious 1/1/2008 Male 154 lb 8/3/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Muscle Atrophy Other Serious 1/1/2008 70 Male 154 lb 7/29/2010 Other Health Professional
Primary
Concomitant
Muscle Atrophy Other Serious 1/1/2008 154 lb 7/29/2010 United Kingdom
Primary
Concomitant
Muscle Atrophy Other Serious 1/1/2008 Male 154 lb 7/30/2010 Other Health Professional United Kingdom
Primary
Concomitant
Sepsis Hospitalization 6/22/2010 55 Male 189 lb 8/10/2010 Other Health Professional United States
Primary
Concomitant
Oedema Peripheral Hospitalization 5/4/2009 58 Female 256 lb 8/20/2010 Physician Poland
Primary
Secondary
Concomitant
Respiratory Disorder Hospitalization 6/29/2010 54 Female 110 lb 8/17/2010 Physician 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 4/30/2010 32 Female 9/7/2010 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
Vomiting Other Serious 12/14/2007 69 Male 187 lb 10/11/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 6/29/2010 54 Female 110 lb 10/14/2010 Physician United States
Primary
Concomitant
Thrombosis Other Serious 12/1/2007 54 Male 163 lb 10/25/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Thrombosis Other Serious 12/1/2007 54 Male 163 lb 11/2/2010 Lawyer United States
Primary
Secondary
Concomitant
Tachycardia Hospitalization 4/28/2010 19 Female 115 lb 11/8/2010 Physician Japan
Primary
Concomitant
Somnolence Hospitalization Male 116 lb 11/15/2010 Other Health Professional Taiwan, Province Of China
Primary
Secondary
Vomiting Other Serious 6/12/2010 12/1/2010 Consumer Japan
Primary
Concomitant
Wheezing Other Serious 1/1/2010 12/2/2010 Other Health Professional United States
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
Vomiting Other Serious 29 Female 276 lb 12/15/2010 United States
Primary
Concomitant
Therapeutic Response Decreased Other Serious 7/1/2009 48 Female 115 lb 1/6/2011 Physician Japan
Primary
Concomitant
Blood Pressure Increased Other Serious 8/9/2009 48 Female 115 lb 1/10/2011 Physician Japan
Primary
Secondary
Concomitant
Colon Cancer Other Serious 11/1/2008 60 Female 154 lb 1/13/2011 Consumer United States
Primary
Concomitant
Multi-organ Failure Death 10/22/2010 54 Male 176 lb 1/21/2011 Physician Japan
Primary
Concomitant
Leg Amputation Other Serious 29 Female 276 lb 1/5/2011 United States
Primary
Concomitant
Vomiting Hospitalization 12/14/2007 69 Male 187 lb 1/31/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Other Serious 8/13/2010 77 Male 194 lb 2/8/2011 Physician United States
Primary
Secondary
Concomitant
Respiratory Failure Death 9/1/2010 4 Male 32 lb 12/14/2010 Physician United States
Primary
Concomitant
Hepatosplenomegaly Death 1/27/2011 68 Male 2/15/2011 Other Health Professional United States
Primary
Concomitant
Somnolence Death 8/13/2010 77 Male 194 lb 3/3/2011 Physician United States
Primary
Secondary
Concomitant
Infusion Related Reaction Hospitalization 9/22/2008 55 Male 195 lb 3/4/2011 Other Health Professional United States
Primary
Concomitant
Cystitis Haemorrhagic Death 10/14/2010 49 Male 2/23/2011 Physician United States
Primary
Concomitant
Abdominal Distension Other Serious 10/7/2010 49 Male 3/10/2011 Other Health Professional United States
Primary
Concomitant
Female Genital Tract Fistula Hospitalization 1/28/2010 54 Female 101 lb 3/23/2011 Physician Korea, Republic Of
Primary
Concomitant
Bacterial Test Positive Other Serious 11/20/2010 57 Female 3/11/2011 Other Health Professional United States
Primary
Concomitant
Hepatic Enzyme Increased Other Serious 1/1/2010 48 Female 128 lb 3/28/2011 Other Health Professional United States
Primary
Concomitant
Thrombocytopenia Death 81 Female 4/5/2011 Pharmacist Canada
Primary
Concomitant
Platelet Count Abnormal Other Serious 1/1/2008 62 Male 4/18/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Arrhythmia Other Serious 12/1/2007 54 Male 163 lb 4/18/2011 Other Health Professional United States
Primary
Secondary
Concomitant
General Physical Health Deterioration Hospitalization 1/31/2011 8 Male 3/24/2011 Other Health Professional Canada
Primary
Concomitant
Rash Hospitalization 3/15/2010 54 Female 95 lb 4/20/2011 Physician Japan
Primary
Secondary
Concomitant
Paraesthesia Other Serious 4/3/2011 58 Male 152 lb 4/6/2011 Pharmacist United States
Primary
Concomitant
Fungal Infection Other Serious 10/13/2009 36 Male 143 lb 4/27/2011 Physician Japan
Primary
Concomitant
Wound Infection Hospitalization 29 Female 276 lb 4/13/2011 United States
Primary
Concomitant
White Blood Cell Count Increased Other Serious 56 Male 4/28/2011 Other Health Professional Korea, Republic Of
Primary
Concomitant
Diarrhoea Hospitalization 3/12/2010 54 Female 95 lb 5/19/2011 Physician Japan
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
Candida Test Positive Hospitalization 3/12/2010 54 Female 95 lb 5/25/2011 Physician Japan
Primary
Secondary
Concomitant
Hyperuricaemia Hospitalization 3/15/2010 54 Female 95 lb 6/1/2011 Physician Japan
Primary
Secondary
Concomitant
Liver Disorder Hospitalization 3/26/2010 54 Female 95 lb 6/3/2011 Physician Japan
Primary
Secondary
Concomitant
Drug Interaction Hospitalization 1 Female 16 lb 6/1/2011 Other Health Professional Canada
Primary
Secondary
Concomitant
Leukocytosis Other Serious 56 Male 6/9/2011 Other Health Professional Korea, Republic Of
Primary
Concomitant
Disseminated Intravascular Coagulation Death 7/30/2010 49 Male 110 lb 6/16/2011 Physician Japan
Primary
Secondary
Concomitant
Alanine Aminotransferase Increased Other Serious 6/17/2011 67 Male 7/6/2011 Physician United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 10/7/2010 49 Male 6/29/2011 Other Health Professional United States
Primary
Concomitant
Pulseless Electrical Activity Death 1/25/2011 66 Male 6/30/2011 Other Health Professional United States
Primary
Concomitant
Thrombocytopenia Death 12/1/2007 54 Male 163 lb 7/22/2011 Lawyer United States
Primary
Secondary
Concomitant
Cardiac Output Decreased Other Serious 12/1/2007 54 Male 163 lb 7/22/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 11/17/2010 57 Female 7/21/2011 Other Health Professional United States
Primary
Concomitant
Tumour Lysis Syndrome Death 5/18/2011 69 Female 121 lb 8/4/2011 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Rash Hospitalization 3/15/2010 54 Female 95 lb 8/4/2011 Physician Japan
Primary
Secondary
Concomitant
Hepatic Failure Hospitalization 6/16/2011 23 Male 307 lb 8/18/2011 Physician United States
Primary
Secondary
Concomitant
Hepatic Failure Death 8/26/2011 44 8/30/2011 Physician Korea, Republic Of
Primary
Concomitant
Bradycardia Life Threatening 1/25/2011 66 Male 9/8/2011 Pharmacist United States
Primary
Concomitant
Cytomegalovirus Colitis Hospitalization 10/25/2010 56 Male 243 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
Respiratory Failure Life Threatening 11/17/2010 57 Female 10/10/2011 Physician United States
Primary
Concomitant
Pancreatitis Hospitalization 5/31/2011 74 Male 155 lb 10/18/2011 Physician United States
Primary
Secondary
Concomitant
Haematemesis Other Serious 4 Male 38 lb 10/14/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant

Drug Data