Pradaxa combined with Warfarin Sodium

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Pleural Effusion Hospitalization 11/1/2010 71 Female 12/9/2010 Consumer
Primary
Concomitant
Pleural Effusion Hospitalization 11/1/2010 72 Female 12/13/2010 Consumer
Primary
Concomitant
Headache 11/13/2010 Female 12/22/2010 Consumer
Primary
Concomitant
Depression Life Threatening 12/22/2010 62 Female 170 lb 1/1/2011 Consumer United States
Primary
Secondary
Musculoskeletal Discomfort 12/12/2010 70 Female 265 lb 1/18/2011 Consumer
Primary
Secondary
Concomitant
Pain 1/1/2011 66 Male 1/21/2011 Physician
Primary
Concomitant
Sinusitis 12/19/2010 76 Female 2/4/2011 Physician
Primary
Concomitant
Atrial Fibrillation Hospitalization 11/1/2010 72 Female 2/25/2011 Consumer United States
Primary
Concomitant
Ankle Fracture Hospitalization 12/17/2010 84 Female 216 lb 2/23/2011 Pharmacist United States
Primary
Secondary
Concomitant
Rectal Haemorrhage Hospitalization 2/19/2011 85 Male 3/11/2011 Physician United States
Primary
Secondary
Haematemesis Hospitalization 3/9/2011 Female 3/17/2011 Physician United States
Primary
Secondary
Cellulitis 12/29/2010 80 Female 184 lb 3/18/2011 Other Health Professional United States
Primary
Concomitant
Medication Residue 1/7/2011 78 Female 110 lb 3/18/2011 Pharmacist United States
Primary
Concomitant
Rectal Haemorrhage Hospitalization 2/19/2011 85 Male 3/22/2011 Physician United States
Primary
Secondary
Diarrhoea 3/1/2011 81 Female 3/31/2011 Consumer United States
Primary
Concomitant
Asthenia Required Intervention 2/1/2011 75 Female 3/21/2011 Pharmacist United States
Primary
Secondary
Concomitant
Haemorrhage Other Serious 12/1/2010 Female 4/14/2011 Consumer United States
Primary
Secondary
Haematuria Hospitalization 2/19/2011 85 Male 4/18/2011 Physician United States
Primary
Secondary
Unresponsive To Stimuli Death 4/4/2011 60 Male 4/19/2011 Consumer United States
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 81 Female 5/2/2011 Physician United States
Primary
Secondary
Visual Impairment Male 5/6/2011 Consumer United States
Primary
Concomitant
Ear Discomfort Female 5/12/2011 Consumer United States
Primary
Concomitant
Urticaria Hospitalization 4/30/2011 72 Female 5/5/2011 United States
Primary
Concomitant
Abdominal Discomfort 1/22/2011 66 Male 5/16/2011 Consumer United States
Primary
Concomitant
Sinusitis 12/1/2010 76 Female 5/16/2011 Physician United States
Primary
Concomitant
Depression Other Serious 1/1/2009 76 Female 195 lb 5/9/2011 United States
Primary
Secondary
Odynophagia Female 5/18/2011 Consumer United States
Primary
Concomitant
Rectal Haemorrhage Hospitalization 4/1/2011 Male 5/19/2011 Consumer United States
Primary
Concomitant
Vaginal Haemorrhage 2/7/2011 73 Female 5/20/2011 Consumer United States
Primary
Concomitant
Cerebrovascular Accident Life Threatening Female 5/23/2011 Consumer United States
Primary
Concomitant
Epistaxis 3/8/2011 75 Female 5/24/2011 Consumer United States
Primary
Concomitant
Gastritis Other Serious 4/19/2011 75 Female 5/25/2011 Physician Japan
Primary
Secondary
Concomitant
Hypothyroidism 4/7/2011 71 Female 5/26/2011 Consumer United States
Primary
Concomitant
Dizziness 4/26/2011 82 Male 5/27/2011 Consumer United States
Primary
Concomitant
Mallory-weiss Syndrome Hospitalization 4/16/2011 73 Female 5/27/2011 Physician Japan
Primary
Concomitant
Pneumonia Hospitalization 4/11/2011 64 Male 6/1/2011 Physician Japan
Primary
Secondary
Concomitant
Cerebrovascular Accident Other Serious 5/14/2011 6/1/2011 Physician United States
Primary
Concomitant
Depressed Mood 1/31/2011 76 Male 250 lb 6/1/2011 Other Health Professional United States
Primary
Concomitant
Rectal Haemorrhage Hospitalization 3/28/2011 79 Male 6/3/2011 Physician Japan
Primary
Concomitant
Cardiac Failure Acute Hospitalization 4/11/2011 64 Male 6/3/2011 Physician Japan
Primary
Secondary
Concomitant
Abdominal Pain Upper 2/1/2011 Female 6/7/2011 Consumer United States
Primary
Concomitant
Dyspepsia 3/1/2011 81 Female 6/8/2011 Consumer United States
Primary
Concomitant
Erythema 1/1/2011 69 Male 6/8/2011 Consumer United States
Primary
Concomitant
Blood Creatine Increased Other Serious 4/11/2011 64 Male 6/8/2011 Physician Japan
Primary
Secondary
Concomitant
Gastritis Other Serious 4/9/2011 75 Female 143 lb 6/9/2011 Physician Japan
Primary
Secondary
Concomitant
International Normalised Ratio Increased Hospitalization 5/1/2011 Female 6/10/2011 Physician Japan
Primary
Secondary
Arrhythmia Hospitalization 3/13/2011 72 Female 6/10/2011 Consumer United States
Primary
Concomitant
Feeling Abnormal Other Serious 3/24/2011 Female 6/13/2011 Consumer United States
Primary
Concomitant
Rash 5/19/2011 72 Female 6/13/2011 Physician Japan
Primary
Concomitant
Aspartate Aminotransferase Increased Other Serious 5/23/2011 52 Male 6/17/2011 Physician Japan
Primary
Concomitant
Pain 4/14/2011 87 Female 161 lb 6/22/2011 Physician United States
Primary
Concomitant
Bladder Disorder Hospitalization 12/8/2009 75 Female 126 lb 6/22/2011 Consumer United States
Primary
Secondary
Eructation 4/1/2011 65 Female 6/27/2011 Consumer United States
Primary
Concomitant
Insomnia 3/1/2011 81 Female 6/28/2011 Consumer United States
Primary
Concomitant
Cardiac Failure Hospitalization 4/11/2011 64 Male 7/5/2011 Physician Japan
Primary
Secondary
Concomitant
Oesophageal Pain 5/19/2011 87 Female 7/6/2011 Consumer United States
Primary
Concomitant
Haemorrhagic Diathesis Hospitalization 7/4/2011 93 Female 7/7/2011 Pharmacist Japan
Primary
Secondary
Concomitant
Oesophageal Disorder Other Serious 6/4/2011 79 Male 154 lb 7/8/2011 Physician Japan
Primary
Concomitant
Cerebral Infarction Hospitalization 6/29/2011 73 Male 7/11/2011 Physician Japan
Primary
Secondary
Concomitant
Exercise Tolerance Decreased 6/1/2011 71 Male 7/12/2011 Consumer United States
Primary
Concomitant
Chest Discomfort Hospitalization 7/4/2011 93 Female 7/13/2011 Physician Japan
Primary
Secondary
Concomitant
Bladder Disorder Hospitalization 12/1/2010 75 Female 126 lb 7/15/2011 Consumer United States
Primary
Secondary
Pain Hospitalization 12/8/2009 75 Female 126 lb 7/18/2011 Consumer United States
Primary
Secondary
Heart Rate Increased Hospitalization 5/27/2011 66 Female 7/19/2011 Consumer United States
Primary
Concomitant
Abdominal Discomfort Hospitalization 6/23/2011 72 Male 246 lb 7/15/2011 Consumer United States
Primary
Concomitant
Throat Tightness Other Serious 3/24/2011 Female 7/20/2011 Physician United States
Primary
Concomitant
Dysphagia Other Serious 5/1/2011 77 Male 7/21/2011 Consumer United States
Primary
Concomitant
Rectal Haemorrhage Other Serious Male 183 lb 7/22/2011 Physician Australia
Primary
Secondary
Concomitant
Melaena Life Threatening 7/7/2011 92 Male 7/27/2011 Pharmacist New Zealand
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 7/7/2011 92 Male 7/27/2011 Pharmacist New Zealand
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 7/7/2011 92 Male 7/27/2011 Pharmacist New Zealand
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 7/7/2011 92 Male 7/27/2011 Pharmacist New Zealand
Primary
Secondary
Concomitant
Death Death 7/26/2011 90 Female 7/29/2011 Physician New Zealand
Primary
Concomitant
Gastritis Hospitalization 7/1/2011 92 Male 7/29/2011 Physician New Zealand
Primary
Concomitant
Dehydration Hospitalization 7/11/2011 75 Male 8/1/2011 Physician Japan
Primary
Secondary
Concomitant
Pain Hospitalization 5/1/2010 75 Female 278 lb 7/20/2011 Consumer United States
Primary
Secondary
Confusional State Hospitalization 7/7/2011 80 Female 8/3/2011 Physician New Zealand
Primary
Secondary
Gastric Cancer Other Serious 7/1/2011 92 Male 108 lb 8/4/2011 Physician New Zealand
Primary
Concomitant
Death Death 7/25/2011 90 Female 8/4/2011 Physician New Zealand
Primary
Concomitant
Rectal Cancer Other Serious 7/8/2011 80 Male 205 lb 8/5/2011 Physician New Zealand
Primary
Secondary
Pulmonary Haemorrhage Other Serious 4/11/2011 64 Male 107 lb 8/5/2011 Physician Japan
Primary
Secondary
Concomitant
Rectal Haemorrhage Hospitalization 7/11/2011 82 Male 110 lb 8/8/2011 Physician New Zealand
Primary
Secondary
Cardiac Failure Acute Hospitalization 90 Female 8/8/2011 Physician New Zealand
Primary
Concomitant
Headache Other Serious 6/1/2011 85 Male 8/8/2011 Physician Japan
Primary
Concomitant
Heart Rate Increased Hospitalization 5/27/2011 66 Female 208 lb 8/8/2011 Physician United States
Primary
Concomitant
Transient Ischaemic Attack Other Serious 6/2/2011 68 Female 8/9/2011 Consumer United States
Primary
Concomitant
Drug Ineffective Hospitalization 6/29/2011 73 Male 8/10/2011 Physician Japan
Primary
Secondary
Concomitant
Dehydration Hospitalization 6/1/2011 85 Male 95 lb 8/12/2011 Physician Japan
Primary
Concomitant
Gastric Cancer Hospitalization 7/19/2011 70 Male 130 lb 8/15/2011 Physician Japan
Primary
Secondary
Concomitant
Haemorrhage Intracranial Hospitalization 70 Female 8/16/2011 Physician New Zealand
Primary
Concomitant
Deep Vein Thrombosis Other Serious 7/4/2011 80 Female 137 lb 8/18/2011 Other Health Professional United Kingdom
Primary
Concomitant
Sudden Death Other Serious 8/1/2011 85 Male 8/19/2011 Consumer Australia
Primary
Secondary
Concomitant
Constipation 4/20/2011 Male 8/23/2011 Consumer United States
Primary
Concomitant
Dehydration Hospitalization 6/1/2011 85 Male 95 lb 8/24/2011 Physician Japan
Primary
Concomitant
Cerebrovascular Accident Death 8/25/2011 Physician Australia
Primary
Secondary
Weight Decreased 6/9/2011 67 Male 8/26/2011 Consumer United States
Primary
Concomitant
Transient Ischaemic Attack Other Serious 6/2/2011 68 Female 9/1/2011 Consumer United States
Primary
Concomitant
Pneumonia Life Threatening 4/11/2011 64 Male 107 lb 9/2/2011 Physician Japan
Primary
Secondary
Concomitant
Fall Death 8/9/2011 85 Male 9/12/2011 Physician Australia
Primary
Secondary
Concomitant
Pulmonary Alveolar Haemorrhage Hospitalization 6/21/2011 74 Female 154 lb 9/12/2011 Physician Japan
Primary
Concomitant
Femoral Neck Fracture Hospitalization 7/24/2011 67 Female 152 lb 9/14/2011 Physician New Zealand
Primary
Concomitant
Gastrointestinal Haemorrhage Death 1/20/2010 87 Male 154 lb 9/15/2011 Physician Denmark
Primary
Secondary
Pulmonary Oedema Hospitalization 4/9/2011 70 Male 178 lb 9/16/2011 Physician United States
Primary
Concomitant
Ischaemic Stroke Hospitalization 7/1/2011 64 Male 202 lb 9/19/2011 Physician United States
Primary
Concomitant
Flatulence 7/17/2011 75 Female 9/20/2011 Consumer United States
Primary
Concomitant
Lung Infiltration Hospitalization 7/11/2011 82 Male 110 lb 9/21/2011 Physician New Zealand
Primary
Secondary
International Normalised Ratio Increased Hospitalization 5/1/2011 85 Female 116 lb 9/26/2011 Physician Japan
Primary
Secondary
Intestinal Obstruction Other Serious 9/8/2011 78 Female 9/26/2011 Physician Japan
Primary
Concomitant
Weight Decreased Hospitalization 1/1/2011 73 Male 9/28/2011 Physician United States
Primary
Concomitant
Haemorrhoidal Haemorrhage 1/1/2011 68 Female 10/3/2011 Consumer United States
Primary
Concomitant
Cerebral Infarction Disability 8/23/2011 74 Male 139 lb 10/5/2011 Physician Japan
Primary
Secondary
Concomitant
Cerebral Artery Embolism Other Serious 7/1/2011 82 Female 10/6/2011 Physician New Zealand
Primary
Concomitant
Melaena Other Serious 7/16/2011 70 Male 130 lb 10/6/2011 Physician Japan
Primary
Secondary
Concomitant
Dyspnoea 8/7/2011 71 Female 10/11/2011 Consumer United States
Primary
Concomitant
Abdominal Pain Upper 8/1/2011 84 Male 10/11/2011 Consumer United States
Primary
Concomitant
Apathy Other Serious 79 Female 10/12/2011 Physician Australia
Primary
Secondary
Apathy Other Serious 79 Female 10/12/2011 Physician Australia
Primary
Secondary
Apathy Other Serious 79 Female 10/12/2011 Physician Australia
Primary
Secondary
Suicidal Ideation Other Serious 79 Female 10/12/2011 Physician Australia
Primary
Secondary
Malaise Death 10/1/2011 91 Male 10/14/2011 Physician New Zealand
Primary
Secondary
Embolic Cerebral Infarction Hospitalization 9/22/2011 72 Female 10/17/2011 Physician Japan
Primary
Concomitant
Vomiting Death 5/7/2011 70 Female 102 lb 10/20/2011 Physician Japan
Primary
Concomitant
Insomnia 8/15/2011 84 Male 10/20/2011 Consumer United States
Primary
Concomitant
Large Intestine Carcinoma Hospitalization 5/25/2011 85 Male 138 lb 10/20/2011 Physician Japan
Primary
Secondary
Gastrooesophageal Reflux Disease 9/30/2011 76 Male 10/21/2011 Consumer United States
Primary
Concomitant
Coagulopathy Hospitalization 7/16/2011 70 Male 130 lb 10/24/2011 Physician Japan
Primary
Secondary
Concomitant
Ischaemic Stroke Hospitalization 10/13/2011 83 Female 10/25/2011 Physician Canada
Primary
Concomitant
Decreased Appetite Hospitalization 1/1/2011 73 Male 10/25/2011 Physician United States
Primary
Concomitant
Rectal Haemorrhage Hospitalization 5/25/2011 85 Male 138 lb 10/26/2011 Physician Japan
Primary
Secondary
Blood Thyroid Stimulating Hormone Increased 4/7/2011 71 Female 10/30/2011 Consumer United States
Primary
Concomitant
Cerebrovascular Accident Other Serious 10/31/2011 Physician United States
Primary
Concomitant
Gaze Palsy Hospitalization 4/17/2009 74 Male 123 lb 11/2/2011 Physician Japan
Primary
Concomitant
Death Other Serious Female 11/2/2011 Other Health Professional New Zealand
Primary
Concomitant
Renal Failure Other Serious Female 11/3/2011 Other Health Professional New Zealand
Primary
Secondary
Concomitant
Medication Error Life Threatening Male 11/3/2011 Other Health Professional New Zealand
Primary
Concomitant
Death Death Female 11/3/2011 Other Health Professional New Zealand
Primary
Secondary
Concomitant
Hypokalaemia Other Serious Female 11/3/2011 Other Health Professional New Zealand
Primary
Secondary
Concomitant
Melaena Life Threatening Male 11/3/2011 Other Health Professional New Zealand
Primary
Secondary
Concomitant
International Normalised Ratio Increased Life Threatening Male 11/3/2011 Other Health Professional New Zealand
Primary
Secondary
Concomitant
International Normalised Ratio Increased Life Threatening Male 11/3/2011 Other Health Professional New Zealand
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Life Threatening Male 11/3/2011 Other Health Professional New Zealand
Primary
Secondary
Concomitant
Hypokalaemia Death Female 11/3/2011 Other Health Professional New Zealand
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 8/15/2011 84 Male 284 lb 11/3/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Atrial Fibrillation Other Serious Male 170 lb 11/4/2011 Consumer United States
Primary
Concomitant
Convulsion Death 80 Male 11/4/2011 Other Health Professional New Zealand
Primary
Concomitant
Medication Error Life Threatening 8/1/2011 81 Male 11/7/2011 Pharmacist New Zealand
Primary
Concomitant
Activated Partial Thromboplastin Time Prolonged Death 9/7/2011 88 Female 11/7/2011 Other Health Professional New Zealand
Primary
Secondary
Concomitant
Transient Ischaemic Attack Other Serious Male 11/7/2011 Consumer New Zealand
Primary
Concomitant
Rectal Haemorrhage Other Serious 7/1/2011 92 Male 11/7/2011 Pharmacist New Zealand
Primary
Concomitant
Rectal Haemorrhage Life Threatening 5/25/2011 85 Male 138 lb 11/7/2011 Physician Japan
Primary
Secondary

Drug Data