Omeprazole combined with Ursodiol

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Viral Infection Other Serious 11/16/2005 84 Female 184 lb 1/13/2006 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Death 11/17/2004 27 Female 6/1/2006 Belgium
Primary
Concomitant
Pancreatitis Acute Hospitalization 11/27/2005 15 Male 7/6/2006 Denmark
Primary
Concomitant
Somnolence Other Serious 8/6/2006 59 Female 150 lb 8/17/2006 Consumer United States
Primary
Concomitant
Ileus Paralytic Hospitalization 9/7/2006 48 Male Pharmacist United States
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 7/19/2006 Male 198 lb 8/1/2006 Pharmacist United States
Primary
Concomitant
Photosensitivity Reaction Hospitalization 10/1/2006 26 Male 11/22/2006 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
White Blood Cell Count Decreased Other Serious 3/5/2007 71 Female 3/21/2007 Japan
Primary
Concomitant
Hepatitis Other Serious 2/15/2007 64 Female 238 lb 4/24/2007 Physician Germany
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 3/5/2007 71 Female 90 lb 5/24/2007 Physician Japan
Primary
Concomitant
Anaphylactic Reaction Other Serious 5/29/2007 17 Female 99 lb 6/13/2007 Other Health Professional United Kingdom
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 3/5/2007 71 Female 90 lb 7/6/2007 Japan
Primary
Concomitant
International Normalised Ratio Increased Life Threatening 7/12/2007 79 Male 157 lb 8/20/2007 United Kingdom
Primary
Secondary
Concomitant
Palpitations Other Serious 8/8/2007 69 8/28/2007 Consumer Ecuador
Primary
Concomitant
Pneumonia Hospitalization 8/21/2002 Male 117 lb 9/5/2007 Physician Japan
Primary
Secondary
Concomitant
Rash Erythematous Other Serious 8/15/2007 1 Female 26 lb 9/13/2007 Other Health Professional United Kingdom
Primary
Concomitant
Pneumonia Hospitalization 8/21/2002 Male 117 lb 11/20/2007 Physician Japan
Primary
Secondary
Concomitant
Lethargy 7/4/2007 Male 43 lb 1/16/2008 Physician United States
Primary
Secondary
Concomitant
Flushing 1/15/2008 31 Male 315 lb 2/7/2008 United States
Primary
Concomitant
Liver Abscess Hospitalization 10/17/2007 Female 123 lb 4/3/2008 Physician United States
Primary
Concomitant
Shock Other Serious 2/1/2008 Male 4/8/2008 Physician Japan
Primary
Concomitant
Distal Intestinal Obstruction Syndrome Other Serious 1/1/2007 13 Female 4/16/2008 Pharmacist United Kingdom
Primary
Concomitant
Shock Other Serious 2/1/2008 Male 4/22/2008 Physician Japan
Primary
Concomitant
Vision Blurred Other Serious 12/24/2007 41 Female 168 lb 3/12/2008 Pharmacist United States
Primary
Concomitant
Shock Other Serious 2/1/2008 Male 5/1/2008 Physician Japan
Primary
Concomitant
Sepsis Other Serious 3/3/2008 Female 148 lb 5/28/2008 Physician Belgium
Primary
Concomitant
Cystic Fibrosis Lung Hospitalization 4/11/2007 Male 87 lb 5/28/2008 Physician United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization Male 6/2/2008 Physician Canada
Primary
Concomitant
Injection Site Pain Female 135 lb 6/12/2008 Consumer United States
Primary
Concomitant
Shock Other Serious 2/1/2008 Male 7/3/2008 Physician Japan
Primary
Concomitant
Sepsis Other Serious 3/3/2008 Female 148 lb 7/10/2008 Physician Belgium
Primary
Concomitant
Dyspepsia Hospitalization 4/30/2008 Male 7/15/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 3/27/2008 21 Male 7/11/2008 Physician France
Primary
Secondary
Concomitant
Blood Albumin Decreased Other Serious Male 7/21/2008 United States
Primary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 6/17/2008 72 Male 7/22/2008 Consumer United States
Primary
Secondary
Concomitant
Visual Impairment Hospitalization 1/6/2008 Male 29 lb 7/24/2008 Other Health Professional Brazil
Primary
Concomitant
Visual Impairment Hospitalization 8/22/2007 Male 97 lb 7/24/2008 Other Health Professional Brazil
Primary
Concomitant
Eye Disorder Other Serious 34 Male 7/25/2008 Pharmacist United States
Primary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 6/17/2008 72 Male 7/25/2008 Consumer United States
Primary
Secondary
Concomitant
Vision Blurred Other Serious 1/12/2008 Male 52 lb 7/28/2008 Other Health Professional Brazil
Primary
Concomitant
Vision Blurred Disability 6/4/2008 Female 114 lb 7/28/2008 Other Health Professional Brazil
Primary
Concomitant
Pneumonia Hospitalization 8/21/2002 Male 117 lb 8/11/2008 Physician Japan
Primary
Secondary
Concomitant
Weight Increased Other Serious 5/29/2008 Female 114 lb 8/13/2008 Other Health Professional Brazil
Primary
Concomitant
Pneumonia Hospitalization 6/17/2008 72 Male 8/20/2008 Consumer United States
Primary
Secondary
Concomitant
Scab 10/12/2007 Male 200 lb 8/27/2008 Consumer United States
Primary
Concomitant
Renal Failure Acute Hospitalization 9/24/2008 68 Male 10/7/2008 Physician Japan
Primary
Concomitant
Visual Impairment Hospitalization 1/6/2008 Male 29 lb 10/10/2008 Other Health Professional Brazil
Primary
Concomitant
Weight Increased Other Serious 5/29/2008 Female 114 lb 10/10/2008 Other Health Professional Brazil
Primary
Concomitant
Vision Blurred Other Serious 1/12/2008 Male 52 lb 10/10/2008 Other Health Professional Brazil
Primary
Concomitant
Hepatic Failure Death 9/11/2007 71 Male 10/16/2008 Japan
Primary
Concomitant
Hepatic Failure Death 9/11/2007 71 Male 123 lb 10/22/2008 Japan
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
Shock Other Serious 11/30/2007 Male 35 lb 11/3/2008 Other Health Professional Brazil
Primary
Concomitant
Vision Blurred Hospitalization 12/14/2007 Male 52 lb 11/4/2008 Other Health Professional Brazil
Primary
Concomitant
Vision Blurred Other Serious 5/21/2008 Male 194 lb 11/4/2008 Other Health Professional Brazil
Primary
Secondary
Concomitant
Vomiting Hospitalization 7/22/2007 Male 97 lb 11/4/2008 Other Health Professional Brazil
Primary
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
Distal Intestinal Obstruction Syndrome Other Serious 1/1/2007 13 Female 11/11/2008 Pharmacist United Kingdom
Primary
Concomitant
Swollen Tongue Other Serious 10/21/2008 56 Male 191 lb 11/26/2008 Other Health Professional United Kingdom
Primary
Concomitant
Pyrexia Life Threatening 10/26/2008 34 Female 11/13/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 9/24/2008 68 Male 11/26/2008 Physician Japan
Primary
Concomitant
Drug Level Increased Other Serious 9/21/2008 1 Female 1/19/2009 Other Health Professional United Kingdom
Primary
Concomitant
Interacting
Pyrexia Hospitalization 12/21/2008 Female 1/13/2009 Consumer Canada
Primary
Concomitant
Cystic Fibrosis Lung Hospitalization 4/11/2007 Male 87 lb 2/14/2009 Physician United States
Primary
Secondary
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
Weight Increased Hospitalization 3/31/2003 5 Male 41 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
Viral Upper Respiratory Tract Infection Life Threatening 10/26/2008 34 Female 4/13/2009 Physician United States
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 3/30/2009 66 Male 6/16/2009 Physician Italy
Primary
Concomitant
Oedema Other Serious 7/2/2008 14 Female 6/18/2009 Physician United States
Primary
Secondary
Concomitant
Febrile Neutropenia Other Serious 40 Male 165 lb 6/25/2009 Physician Spain
Primary
Secondary
Concomitant
Febrile Neutropenia Other Serious 5/9/2009 41 Male 165 lb 7/1/2009 Physician Spain
Primary
Secondary
Concomitant
Renal Failure Other Serious 6/4/2009 60 Female 7/2/2009 United States
Primary
Concomitant
Pneumonia Legionella Other Serious 6/4/2009 60 Female 7/20/2009 United States
Primary
Concomitant
Renal Failure Acute Other Serious 3/30/2009 66 Male 7/22/2009 Physician Italy
Primary
Concomitant
Anaphylactoid Reaction Other Serious 6/18/2009 71 Male 7/22/2009 Other Health Professional Japan
Primary
Concomitant
Diarrhoea Hospitalization 3/11/2008 33 7/31/2009 Other Health Professional Spain
Primary
Concomitant
Anaphylactoid Reaction Other Serious 6/18/2009 71 Male 8/11/2009 Other Health Professional Japan
Primary
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
Drug Ineffective Other Serious Male 9/28/2009 Physician United States
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
Drug Ineffective Other Serious Male 165 lb 10/5/2009 Physician United States
Primary
Concomitant
Renal Failure Chronic Hospitalization 7/20/2009 71 Male 10/21/2009 Japan
Primary
Secondary
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
Acute Myeloid Leukaemia Death 9/30/2009 Female 114 lb 11/19/2009 United States
Primary
Secondary
Concomitant
Medication Error 10/21/2009 69 Female 184 lb 12/22/2009 Consumer United States
Primary
Concomitant
Unresponsive To Stimuli Hospitalization 12/16/2009 Male 229 lb 12/23/2009 Physician United States
Primary
Secondary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 1/1/2009 41 Male 158 lb 12/17/2009 United States
Primary
Concomitant
Unresponsive To Stimuli Hospitalization 12/16/2009 Male 229 lb 1/5/2010 Physician United States
Primary
Secondary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 1/1/2009 41 Male 158 lb 12/16/2009 Physician United States
Primary
Concomitant
Viral Haemorrhagic Cystitis Required Intervention 6/8/2009 41 Male 158 lb 1/8/2010 Physician United States
Primary
Concomitant
Viral Haemorrhagic Cystitis Required Intervention 6/8/2009 41 Male 158 lb 1/4/2010 Physician United States
Primary
Concomitant
Vomiting Hospitalization 4/24/2009 31 Female 2/22/2010 Physician United States
Primary
Secondary
Concomitant
Vomiting Life Threatening 12/14/2007 69 Male 3/4/2010 Lawyer United States
Primary
Secondary
Concomitant
Hydrocele Female Hospitalization 1/1/2009 10 Male 40 lb 3/2/2010 Consumer France
Primary
Concomitant
Liver Function Test Abnormal Other Serious 7/30/2009 53 Male 207 lb 4/6/2010 Physician United States
Primary
Concomitant
Liver Function Test Abnormal Other Serious 7/30/2009 53 Male 207 lb 4/7/2010 Physician United States
Primary
Concomitant
Vomiting Required Intervention 6/8/2009 41 Male 158 lb 3/31/2010 Physician United States
Primary
Concomitant
Liver Function Test Abnormal Other Serious 7/30/2009 53 Male 207 lb 4/23/2010 Physician United States
Primary
Concomitant
Splenomegaly Hospitalization 3/7/2008 4/30/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Muscular Weakness Hospitalization 7/1/2009 67 Female 5/19/2010 Consumer United States
Primary
Secondary
Concomitant
Renal Disorder Other Serious 5/7/2010 84 Male 5/20/2010 Japan
Primary
Secondary
Liver Function Test Abnormal Other Serious 7/30/2009 53 Male 207 lb 6/4/2010 Physician United States
Primary
Concomitant
Renal Disorder Other Serious 5/7/2010 84 Male 6/1/2010 Japan
Primary
Secondary
Staphylococcal Sepsis Hospitalization 12/14/2009 72 Male 132 lb 6/4/2010 Physician Japan
Primary
Secondary
Concomitant
Neutropenia Hospitalization 5/3/2010 11 Male 77 lb 6/7/2010 Physician Switzerland
Primary
Secondary
Concomitant
Vomiting Other Serious 1/2/2007 69 Male 187 lb 6/7/2010 Lawyer United States
Primary
Secondary
Concomitant
Staphylococcal Sepsis Hospitalization 12/14/2009 72 Male 132 lb 6/14/2010 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 10/19/2009 54 Male 132 lb 6/21/2010 Other Health Professional Japan
Primary
Concomitant
Vaginal Haemorrhage Other Serious 1/1/2008 32 Female 122 lb 6/21/2010 Consumer United States
Primary
Secondary
Concomitant
Death Death 8/5/2008 74 Male 150 lb 7/27/2010 Physician India
Primary
Secondary
Concomitant
Pyrexia Other Serious 9/21/2009 37 Female 93 lb 8/9/2010 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 3/11/2009 23 Female 97 lb 8/17/2010 Physician Japan
Primary
Concomitant
Therapeutic Agent Toxicity Hospitalization 7/15/2010 69 Female 8/14/2010 Pharmacist United States
Primary
Secondary
Concomitant
Pyrexia Hospitalization 7/31/2010 9 Female 59 lb 8/13/2010 Other Health Professional United States
Primary
Concomitant
Flushing 12/17/2009 62 Female 174 lb 8/28/2010 United States
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 3/11/2009 23 Female 97 lb 8/31/2010 Physician Japan
Primary
Concomitant
Withdrawal Syndrome Other Serious Female 9/2/2010 Pharmacist United States
Primary
Concomitant
Restlessness Required Intervention 53 Female 9/21/2010 Other Health Professional United States
Primary
Concomitant
Withdrawal Syndrome Hospitalization 53 Female 9/28/2010 Pharmacist 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
Pelvic Fluid Collection Other Serious 8/7/2010 63 Female 10/11/2010 Consumer United States
Primary
Concomitant
Pulmonary Haemorrhage Life Threatening 2/8/2010 15 Female 110 lb 10/15/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Pulmonary Alveolar Haemorrhage Other Serious 10/17/2010 77 Male 134 lb 11/1/2010 Physician Japan
Primary
Concomitant
Pruritus Other Serious 1/1/2008 53 Male 245 lb 11/1/2010 Consumer United States
Primary
Concomitant
Constipation Hospitalization 10/1/2009 12 Male 10/25/2010 France
Primary
Concomitant
Pulmonary Alveolar Haemorrhage Other Serious 10/17/2010 77 Male 134 lb 11/9/2010 Physician Japan
Primary
Concomitant
Urticaria Hospitalization 6/24/2010 44 Female 12/1/2010 Pharmacist 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
Anaphylactic Shock Life Threatening 9/22/2010 78 Male 160 lb 12/15/2010 Physician Japan
Primary
Concomitant
Hip Fracture Other Serious 8/7/2010 63 Female 12/15/2010 Physician United States
Primary
Concomitant
Constipation Hospitalization 10/12/2009 12 Male 12/3/2010 France
Primary
Concomitant
Hernia Hospitalization 1/26/2010 55 Male 12/9/2010 Consumer United States
Primary
Concomitant
Sepsis Life Threatening 7/28/2010 30 Female 99 lb 1/6/2011 Physician Japan
Primary
Concomitant
Hyperkalaemia Other Serious 2/9/2010 66 Male 12/22/2010 Belgium
Primary
Secondary
Concomitant
Yellow Skin Hospitalization 11/1/2010 Female 1/11/2011 United States
Primary
Concomitant
Multi-organ Failure Death 10/22/2010 54 Male 176 lb 1/21/2011 Physician Japan
Primary
Concomitant
Seroma Other Serious 1/14/2010 55 Male 201 lb 1/14/2011 Physician United States
Primary
Concomitant
Vomiting Hospitalization 12/14/2007 69 Male 187 lb 1/31/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Growing Pains Hospitalization 67 Female 1/31/2011 Consumer United States
Primary
Concomitant
Peritonitis Bacterial Death Male 1/20/2011 Other Health Professional United States
Primary
Concomitant

Drug Data