Omeprazole combined with Tracleer

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Liver Function Test Abnormal Other Serious 3/21/2005 65 Female 106 lb 1/13/2006 Netherlands
Primary
Concomitant
Platelet Count Decreased Other Serious 11/4/2005 72 Female 97 lb 1/18/2006 Physician Japan
Primary
Secondary
Concomitant
Shock Other Serious 11/4/2005 72 Female 97 lb 2/23/2006 Physician Japan
Primary
Secondary
Concomitant
Hepatitis Cholestatic Other Serious 7/1/2003 70 Male 2/28/2006 Spain
Primary
Concomitant
Hepatotoxicity Other Serious Female 132 lb 3/28/2006 United Kingdom
Primary
Concomitant
White Blood Cell Count Increased Hospitalization 12/1/2004 56 Female 4/5/2006 Physician Germany
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 10/21/2005 67 Male 6/7/2006 Physician France
Primary
Concomitant
Vestibular Disorder Hospitalization 12/1/2004 56 Female 6/13/2006 Physician Germany
Primary
Concomitant
Liver Function Test Abnormal Other Serious 6/8/2006 72 Female 179 lb 6/23/2006 Belgium
Primary
Concomitant
Rash Generalised Hospitalization 9/16/2005 59 Female 105 lb 6/30/2006 Physician Japan
Primary
Concomitant
Hepatitis Toxic Other Serious 6/12/2006 69 Female 97 lb 7/10/2006 Physician Belgium
Primary
Concomitant
Weight Increased Other Serious 6/28/2005 57 Female 77 lb 7/10/2006 Physician Japan
Primary
Concomitant
Retroperitoneal Haemorrhage Death 6/17/2006 68 Female 170 lb 7/11/2006 Physician Belgium
Primary
Concomitant
Blood Bilirubin Increased Other Serious 6/12/2006 69 Female 97 lb 7/18/2006 Physician Belgium
Primary
Concomitant
Pneumonia Hospitalization 6/24/2006 71 Female 146 lb 7/20/2006 Netherlands
Primary
Concomitant
Retroperitoneal Haemorrhage Hospitalization 6/1/2006 68 Female 170 lb 7/27/2006 Physician Belgium
Primary
Concomitant
Blood Bilirubin Increased Other Serious 6/12/2006 69 Female 97 lb 8/14/2006 Physician Belgium
Primary
Concomitant
Premature Baby Life Threatening 11/2/2006 Female 4 lb 12/5/2006 Other Health Professional France
Primary
Secondary
Premature Baby Life Threatening 8/24/2006 Female 12/7/2006 France
Primary
Secondary
Unintended Pregnancy Other Serious 3/9/2006 33 Female 112 lb 12/12/2006 France
Primary
Secondary
Premature Baby Other Serious Female 12/19/2006 France
Primary
Secondary
Concomitant
Skin Ulcer Other Serious 3/9/2006 33 Female 112 lb 12/20/2006 France
Primary
Secondary
Premature Baby Life Threatening 11/2/2006 Female 4 lb 12/20/2006 France
Primary
Secondary
Premature Baby Life Threatening 11/2/2006 Female 4 lb 1/11/2007 Other Health Professional France
Primary
Secondary
Pruritus 1/1/2006 81 Male 162 lb 10/24/2006 Pharmacist United States
Primary
Concomitant
Syncope Hospitalization 6/1/2006 62 Male 199 lb 10/24/2006 Other Health Professional United States
Primary
Concomitant
Right Ventricular Failure Hospitalization 11/1/2006 85 Female 1/23/2007 Physician Canada
Primary
Concomitant
Right Ventricular Failure Life Threatening 1/19/2006 33 Female 108 lb 2/9/2007 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 3/5/2007 71 Female 3/21/2007 Japan
Primary
Concomitant
Nasopharyngitis Death 2/14/2007 77 Female 115 lb 3/20/2007 Other Health Professional Netherlands
Primary
Concomitant
Pneumonia Hospitalization 3/15/2007 84 Female 3/30/2007 Physician United States
Primary
Concomitant
Sudden Death Death 10/27/2004 52 Female 174 lb 4/12/2007 Physician Australia
Primary
Concomitant
Sepsis Required Intervention 3/29/2007 58 Female 132 lb 5/8/2007 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
White Blood Cell Count Decreased Death 3/14/2007 79 Female 5/24/2007 Sweden
Primary
Concomitant
Aortic Valve Stenosis Death 5/18/2007 70 Female 7/9/2007 Other Health Professional Netherlands
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 3/5/2007 71 Female 90 lb 7/6/2007 Japan
Primary
Concomitant
Anaemia Hospitalization 7/1/2007 Female 8/23/2007 Physician Japan
Primary
Concomitant
Cardiac Failure Hospitalization 6/11/2007 74 Female 68 lb 9/17/2007 Physician Japan
Primary
Concomitant
Pleural Fibrosis Other Serious 1/1/2007 53 Female 194 lb 9/21/2007 Other Health Professional Belgium
Primary
Concomitant
Pleural Fibrosis Other Serious 1/1/2007 53 Female 194 lb 10/16/2007 Other Health Professional Belgium
Primary
Concomitant
Pneumonia Bacterial Other Serious 1/1/2007 53 Female 194 lb 10/30/2007 Other Health Professional Belgium
Primary
Concomitant
Cardiac Failure Hospitalization 6/11/2007 74 Female 68 lb 10/30/2007 Japan
Primary
Concomitant
Liver Function Test Abnormal Other Serious 6/1/2005 51 Female 112 lb 10/30/2007 Physician Australia
Primary
Concomitant
Metastatic Carcinoma Of The Bladder Death 9/16/2007 77 Male 176 lb 11/8/2007 Belgium
Primary
Concomitant
Sudden Cardiac Death Hospitalization 9/16/2005 59 Female 105 lb 11/19/2007 Physician Japan
Primary
Concomitant
Prothrombin Level Decreased Other Serious 8/19/2004 67 Female 12/11/2007 Physician Austria
Primary
Concomitant
Mania Required Intervention 11/21/2007 77 Female 12/14/2007 Pharmacist United Kingdom
Primary
Secondary
Concomitant
Pyrexia Other Serious 56 Female 12/21/2007 Physician Israel
Primary
Concomitant
Nausea Other Serious 12/16/2007 56 Female 1/9/2008 Physician Israel
Primary
Concomitant
Pyrexia Other Serious 12/16/2007 56 Female 1/25/2008 Physician Israel
Primary
Concomitant
Vasculitis Necrotising Other Serious 11/1/2007 59 Female 150 lb 1/30/2008 Consumer Germany
Primary
Concomitant
Mania Required Intervention 11/21/2007 77 Female 106 lb 2/1/2008 Pharmacist United Kingdom
Primary
Secondary
Concomitant
Weight Increased Other Serious 1/21/2008 20 Male 152 lb 2/12/2008 Physician Germany
Primary
Secondary
Concomitant
Vasculitis Necrotising Other Serious 11/1/2007 59 Female 150 lb 2/22/2008 Other Health Professional Germany
Primary
Concomitant
Respiratory Failure Other Serious 11/1/2007 70 Female 3/11/2008 Physician United States
Primary
Concomitant
Vasculitis Necrotising Required Intervention 11/1/2007 59 Female 150 lb 3/11/2008 Other Health Professional Germany
Primary
Concomitant
Pyrexia Other Serious 12/16/2007 56 Female 3/18/2008 Physician Israel
Primary
Concomitant
Off Label Use Hospitalization 3/7/2008 67 Female 118 lb 3/19/2008 Physician Germany
Primary
Concomitant
Renal Failure Other Serious 11/5/2007 45 Male 3/19/2008 Physician Spain
Primary
Concomitant
Therapeutic Agent Toxicity Other Serious 11/1/2007 70 Female 3/24/2008 Physician United States
Primary
Concomitant
Gamma-glutamyltransferase Increased Hospitalization 3/7/2008 67 Female 118 lb 4/1/2008 Other Health Professional Germany
Primary
Concomitant
Off Label Use Hospitalization 2/17/2008 67 Female 118 lb 4/14/2008 Consumer Germany
Primary
Secondary
Concomitant
Renal Failure Other Serious 11/5/2007 45 Male 4/25/2008 Spain
Primary
Concomitant
Liver Function Test Abnormal Hospitalization 2/17/2008 67 Female 118 lb 7/10/2008 Germany
Primary
Secondary
Concomitant
Vasculitis Necrotising Required Intervention 11/1/2007 59 Female 150 lb 7/18/2008 Consumer Germany
Primary
Concomitant
Haemoptysis Death 5/6/2007 18 Female 10/1/2008 Physician Japan
Primary
Secondary
Concomitant
Vasculitis Necrotising Required Intervention 11/1/2007 59 Female 150 lb 10/1/2008 Other Health Professional Germany
Primary
Concomitant
Vomiting Other Serious 9/1/2008 70 Female 10/10/2008 Physician United States
Primary
Secondary
Concomitant
Vasculitis Necrotising Required Intervention 11/1/2007 59 Female 150 lb 10/14/2008 Physician Germany
Primary
Concomitant
Nausea Other Serious 9/20/2008 52 Female 104 lb 10/22/2008 Physician Japan
Primary
Secondary
Concomitant
Pharyngeal Oedema Hospitalization 3/26/2008 53 Female 183 lb 12/5/2008 Physician Netherlands
Primary
Concomitant
Melaena Other Serious 7/9/2008 79 Male 97 lb 12/11/2008 Physician France
Primary
Concomitant
Skin Ulcer Other Serious 11/16/2008 50 Female 1/5/2009 Physician Israel
Primary
Concomitant
Weight Increased Other Serious 1/21/2008 Male 152 lb 1/21/2009 Physician Germany
Primary
Concomitant
Skin Ulcer Other Serious 11/16/2008 50 Female 2/17/2009 Physician Israel
Primary
Concomitant
Tuberculosis Other Serious 6/20/2008 52 Male 139 lb 4/22/2009 Physician France
Primary
Secondary
Concomitant
Premature Baby Other Serious 11/2/2006 Female 4 lb 6/23/2009 France
Primary
Secondary
Tuberculosis Other Serious 6/20/2008 52 Male 139 lb 6/23/2009 Physician France
Primary
Secondary
Concomitant
Unintended Pregnancy Other Serious 6/13/2006 33 Female 112 lb 6/23/2009 France
Primary
Secondary
Wheezing Hospitalization 4/23/2009 27 Female 7/2/2009 Physician United States
Primary
Secondary
Concomitant
Malaise Other Serious 1/1/2009 Female 98 lb 7/10/2009 Consumer United States
Primary
Concomitant
Malaise Other Serious 1/1/2009 Female 98 lb 7/23/2009 Consumer United States
Primary
Concomitant
Malaise Other Serious 1/1/2009 Female 98 lb 8/5/2009 Consumer United States
Primary
Concomitant
Liver Function Test Abnormal Hospitalization 72 Male 7/30/2009 Physician United States
Primary
Concomitant
Dyspnoea Other Serious 9/20/2008 52 8/17/2009 Pharmacist Japan
Primary
Secondary
Concomitant
Red Blood Cell Count Decreased Hospitalization 72 Male 8/11/2009 Physician United States
Primary
Concomitant
Pulmonary Oedema Hospitalization 7/29/2009 74 Female 8/20/2009 Physician Israel
Primary
Concomitant
Malaise Other Serious 1/1/2009 Female 98 lb 9/18/2009 Consumer United States
Primary
Concomitant
Respiratory Failure Hospitalization 11/10/2007 78 Male 123 lb 9/17/2009 Consumer Japan
Primary
Concomitant
Respiratory Tract Infection Hospitalization 9/7/2009 1 Female 10/1/2009 Physician Canada
Primary
Concomitant
Cardiac Failure Death 2/1/2009 70 Female 10/22/2009 Physician Israel
Primary
Concomitant
Mania Other Serious 10/1/2007 77 Female 106 lb 11/18/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Mania Required Intervention 11/21/2007 77 Female 106 lb 12/7/2009 Pharmacist United Kingdom
Primary
Secondary
Concomitant
Right Ventricular Failure Other Serious 2/1/2009 68 Female 1/5/2010 Physician United States
Primary
Concomitant
Dyspnoea Other Serious 9/20/2008 52 Female 101 lb 2/16/2010 Japan
Primary
Secondary
Concomitant
Skin Haemorrhage Other Serious 1/20/2010 69 Female 2/4/2010 Italy
Primary
Concomitant
Pneumonia Hospitalization 30 Male 3/26/2010 Other Health Professional Israel
Primary
Concomitant
Muscular Weakness Other Serious 3/1/2010 67 Female 120 lb 4/2/2010 Consumer United States
Primary
Concomitant
Anxiety Hospitalization 3/17/2010 79 Female 4/12/2010 Other Health Professional Switzerland
Primary
Concomitant
Viral Upper Respiratory Tract Infection Required Intervention 2/25/2010 88 Female 4/8/2010 Physician United States
Primary
Concomitant
Skin Ulcer Other Serious 11/1/2009 48 Female 4/8/2010 Other Health Professional Israel
Primary
Concomitant
Hepatitis Toxic Other Serious 12/29/2009 74 Female 4/13/2010 Belgium
Primary
Concomitant
Right Ventricular Failure Other Serious 9/20/2008 52 Female 101 lb 4/27/2010 Japan
Primary
Secondary
Concomitant
Muscular Weakness Other Serious 2/15/2010 67 Female 125 lb 5/7/2010 Physician United States
Primary
Concomitant
Right Ventricular Failure Other Serious 9/20/2008 52 Female 101 lb 5/19/2010 Japan
Primary
Secondary
Concomitant
Hepatic Cirrhosis Death 4/24/2010 63 Male 6/8/2010 Physician United States
Primary
Concomitant
Limb Injury Hospitalization 5/25/2010 72 Female 7/16/2010 France
Primary
Concomitant
Vomiting Required Intervention 6/15/2010 56 Female 8/4/2010 Physician United States
Primary
Concomitant
Hepatic Congestion Hospitalization 7/15/2010 76 Female 110 lb 8/6/2010 Ireland
Primary
Concomitant
Uterine Enlargement Hospitalization 1/1/2010 22 Female 8/16/2010 Physician United Kingdom
Primary
Concomitant
Hepatic Congestion Hospitalization 7/15/2010 76 Female 110 lb 8/17/2010 Ireland
Primary
Concomitant
Limb Injury Hospitalization 5/25/2010 72 Female 8/18/2010 Physician France
Primary
Concomitant
Hyperthyroidism Hospitalization 7/1/2010 49 Male 150 lb 8/31/2010 Other Health Professional United States
Primary
Concomitant
Hyperthyroidism Hospitalization 7/1/2010 Male 150 lb 9/16/2010 United States
Primary
Concomitant
Hyperkalaemia Hospitalization Female 9/30/2010 Physician United States
Primary
Secondary
Concomitant
Respiratory Tract Infection Hospitalization 7/15/2010 76 Female 110 lb 9/28/2010 Ireland
Primary
Concomitant
Uterine Enlargement Other Serious 1/1/2010 22 Female 10/1/2010 Physician United Kingdom
Primary
Concomitant
Respiratory Arrest Life Threatening 7/26/2010 70 Female 11/2/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Pulmonary Hypertension 1/1/2006 76 Female 147 lb 11/29/2010 Consumer United States
Primary
Concomitant
Hepatic Enzyme Increased Other Serious 3/1/2010 58 Male 11/30/2010 Physician Israel
Primary
Concomitant
Tumour Necrosis Other Serious 10/1/2010 36 Female 12/6/2010 Other Health Professional Italy
Primary
Concomitant
Lesion Excision Other Serious 10/1/2010 36 Female 1/4/2011 Physician Italy
Primary
Concomitant
Alanine Aminotransferase Increased 2/16/2010 60 Female 1/10/2011 Japan
Primary
Concomitant
Pneumonia Hospitalization 12/1/2010 2/2/2011 Pharmacist United States
Primary
Concomitant
Dyspnoea Death 3/1/2010 2/8/2011 Physician United States
Primary
Concomitant
Abdominal Pain Other Serious 10/1/2009 58 Female 123 lb 2/16/2011 Physician Germany
Primary
Concomitant
Ocular Hyperaemia Other Serious 2/18/2011 Other Health Professional Germany
Primary
Concomitant
Anaemia Other Serious 5/28/2010 76 Female 193 lb 1/14/2011 Physician United States
Primary
Concomitant
Liver Function Test Abnormal Required Intervention 4/15/2010 45 Female 154 lb 1/14/2011 Physician United States
Primary
Concomitant
Device Related Sepsis Hospitalization 41 Male 2/22/2011 United States
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Life Threatening 5/1/2008 3/4/2011 Other Health Professional United States
Primary
Concomitant
Dermatitis Exfoliative Hospitalization 9/1/2009 58 Female 3/5/2011 Physician France
Primary
Concomitant
Small Cell Lung Cancer Stage Unspecified Other Serious 3/1/2010 3/9/2011 Pharmacist United States
Primary
Concomitant
Blood Alkaline Phosphatase Increased Other Serious 12/18/2010 3/12/2011 Other Health Professional United States
Primary
Concomitant
Throat Irritation Other Serious 3/18/2011 Other Health Professional Germany
Primary
Concomitant
International Normalised Ratio Increased Hospitalization 3/6/2011 4/7/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Anaemia Other Serious 3/1/2011 89 Female 104 lb 4/12/2011 Consumer United States
Primary
Concomitant
Chills Death 3/6/2011 4/29/2011 Physician United States
Primary
Secondary
Concomitant
Renal Cell Carcinoma Other Serious 12/18/2010 4/29/2011 Other Health Professional United States
Primary
Concomitant
Interstitial Lung Disease Other Serious 4/25/2011 24 Female 5/5/2011 Physician Japan
Primary
Concomitant
Pruritus Death 6/24/2009 82 Female 5/9/2011 Physician Netherlands
Primary
Concomitant
Infection Hospitalization 1/4/2010 59 Female 107 lb 5/25/2011 Physician Japan
Primary
Concomitant
Dizziness 6/14/2010 66 Female 80 lb 5/19/2011 Consumer United States
Primary
Concomitant
Nausea 12/14/2010 72 Female 161 lb 5/19/2011 Consumer United States
Primary
Concomitant
Death Death 4/30/2011 5/31/2011 Pharmacist United States
Primary
Concomitant
Bronchoscopy Other Serious 4/25/2011 24 Female 6/1/2011 Physician Japan
Primary
Concomitant
Hepatomegaly Other Serious 3/1/2011 89 Female 104 lb 6/2/2011 Physician United States
Primary
Concomitant
Gamma-glutamyltransferase Increased Hospitalization 3/9/2011 81 Male 121 lb 6/2/2011 Physician Japan
Primary
Concomitant
Resuscitation Hospitalization 3/6/2011 6/2/2011 Other Health Professional United States
Primary
Secondary
Concomitant

Drug Data