Pradaxa combined with Sotalol Hcl

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Melaena 11/10/2010 74 Female 12/8/2010 Consumer
Primary
Concomitant
Haematochezia 11/6/2010 61 Male 12/27/2010 Consumer
Primary
Concomitant
Headache 12/20/2010 75 Male 1/12/2011 Consumer
Primary
Concomitant
Dyspepsia 11/18/2010 Female 1/21/2011 Consumer
Primary
Concomitant
Dizziness 1/19/2011 54 Female 2/10/2011 Consumer United States
Primary
Concomitant
Dyspepsia 12/1/2010 71 Female 2/15/2011 Consumer United States
Primary
Concomitant
Anaphylactic Reaction Other Serious 1/25/2011 46 Female 2/15/2011 Consumer United States
Primary
Concomitant
Pulse Abnormal 1/24/2011 84 Male 2/16/2011 Consumer United States
Primary
Concomitant
Abdominal Pain Upper 11/10/2010 67 Female 2/16/2011 Consumer United States
Primary
Concomitant
Transient Ischaemic Attack Other Serious 2/2/2011 76 Female 168 lb 2/18/2011 Physician Netherlands
Primary
Concomitant
Malaise 11/26/2010 69 Female 2/22/2011 Consumer United States
Primary
Concomitant
Cystitis 1/19/2011 83 Female 2/22/2011 Consumer United States
Primary
Concomitant
Eating Disorder 12/17/2010 70 Male 2/24/2011 Other Health Professional United States
Primary
Concomitant
Flatulence 11/1/2010 73 Female 2/24/2011 Consumer United States
Primary
Secondary
Concomitant
Lethargy 1/31/2011 71 Male 2/24/2011 Consumer United States
Primary
Concomitant
Nightmare 2/17/2011 73 Female 3/22/2011 Consumer United States
Primary
Concomitant
Abdominal Distension 2/17/2011 66 Female 3/22/2011 Consumer United States
Primary
Concomitant
Headache 1/1/2011 74 Female 3/22/2011 Consumer United States
Primary
Concomitant
Nausea 3/1/2011 77 Female 3/23/2011 Consumer United States
Primary
Concomitant
Headache 1/1/2011 87 Male 3/23/2011 Consumer United States
Primary
Concomitant
Atrial Fibrillation 1/1/2011 77 Male 3/25/2011 Consumer United States
Primary
Secondary
Concomitant
Diarrhoea 2/25/2011 81 Female 3/25/2011 Consumer United States
Primary
Concomitant
Arthralgia 3/4/2011 69 Female 3/28/2011 Consumer United States
Primary
Concomitant
Headache Hospitalization 11/1/2010 71 Female 3/28/2011 Consumer United States
Primary
Concomitant
Gait Disturbance Other Serious 3/1/2011 76 Female 3/29/2011 Consumer United States
Primary
Concomitant
Abdominal Discomfort 94 Female 3/29/2011 Consumer United States
Primary
Concomitant
No Adverse Event 69 Female 3/29/2011 Consumer United States
Primary
Concomitant
Chest Discomfort 12/1/2010 69 Male 3/30/2011 Consumer United States
Primary
Concomitant
Deafness Female 4/13/2011 Consumer United States
Primary
Concomitant
Dysgeusia 2/2/2011 69 Male 4/14/2011 Pharmacist United States
Primary
Concomitant
Headache 11/1/2010 71 Female 4/14/2011 Consumer United States
Primary
Concomitant
Dizziness 3/1/2011 83 Female 4/14/2011 Consumer United States
Primary
Concomitant
Visual Acuity Reduced 1/19/2011 83 Female 4/14/2011 Consumer United States
Primary
Concomitant
Throat Irritation 2/2/2011 78 Male 4/15/2011 Consumer United States
Primary
Concomitant
Bladder Pain 1/1/2011 85 Female 4/15/2011 Consumer United States
Primary
Concomitant
Headache 1/1/2011 72 Female 4/20/2011 Consumer United States
Primary
Secondary
Concomitant
Feeling Abnormal Other Serious 3/1/2011 76 Female 4/21/2011 Consumer United States
Primary
Concomitant
Flatulence 1/1/2011 60 Male 4/21/2011 Consumer United States
Primary
Secondary
Concomitant
Dizziness 1/31/2011 84 Female 4/22/2011 Consumer United States
Primary
Secondary
Concomitant
Oesophageal Irritation 3/1/2011 77 Male 4/25/2011 Consumer United States
Primary
Concomitant
Constipation 1/1/2011 65 Male 5/4/2011 Consumer United States
Primary
Concomitant
Headache 2/22/2011 75 Female 5/4/2011 Consumer United States
Primary
Concomitant
Throat Irritation 1/13/2011 84 Male 5/4/2011 Consumer United States
Primary
Concomitant
Tinnitus Male 5/4/2011 Consumer United States
Primary
Concomitant
Cardiac Failure Congestive Hospitalization 4/15/2011 77 Female 173 lb 5/3/2011 Other Health Professional United States
Primary
Secondary
Flushing 1/26/2011 80 Female 5/6/2011 Consumer United States
Primary
Concomitant
Head Injury Hospitalization 3/4/2011 83 Female 174 lb 5/10/2011 Physician Israel
Primary
Concomitant
Gastrointestinal Pain 2/3/2011 81 Female 5/10/2011 Consumer United States
Primary
Concomitant
Dizziness 3/1/2011 83 Female 5/17/2011 Consumer United States
Primary
Concomitant
Fatigue 2/1/2011 89 Female 5/17/2011 Consumer United States
Primary
Concomitant
Dysarthria 4/27/2011 80 Female 5/18/2011 Consumer United States
Primary
Concomitant
Decreased Appetite 4/24/2011 82 Male 5/18/2011 Consumer United States
Primary
Concomitant
Joint Swelling 4/1/2011 74 Female 5/19/2011 Consumer United States
Primary
Secondary
Concomitant
Pyelonephritis Hospitalization 5/1/2011 Male 5/19/2011 Consumer United States
Primary
Secondary
Concomitant
Confusional State 3/1/2011 82 Female 5/19/2011 Consumer United States
Primary
Concomitant
Haemorrhage 4/1/2011 78 Male 5/19/2011 Consumer United States
Primary
Concomitant
Dyspepsia 1/30/2011 66 Male 5/20/2011 Consumer United States
Primary
Concomitant
Diarrhoea 1/1/2011 67 Male 5/23/2011 Consumer United States
Primary
Concomitant
Nervousness 3/11/2011 81 Female 5/24/2011 Consumer United States
Primary
Concomitant
Nightmare 2/17/2011 73 Female 5/24/2011 Consumer United States
Primary
Concomitant
Flatulence 4/3/2011 74 Female 5/25/2011 Consumer United States
Primary
Concomitant
Renal Pain 2/24/2011 75 Male 5/31/2011 Consumer United States
Primary
Concomitant
Pain In Jaw 5/13/2011 69 Female 6/1/2011 Consumer United States
Primary
Concomitant
Decreased Appetite 2/1/2011 77 Female 106 lb 6/1/2011 Consumer United States
Primary
Secondary
Concomitant
Confusional State 5/17/2011 68 Female 6/3/2011 Consumer United States
Primary
Concomitant
Eyelid Bleeding Life Threatening 1/20/2011 82 Male 113 lb 2/1/2011 Pharmacist United States
Primary
Concomitant
Melanocytic Naevus 2/22/2011 83 Male 6/6/2011 Consumer United States
Primary
Concomitant
Dyspnoea 12/1/2010 84 Female 6/7/2011 Consumer United States
Primary
Secondary
Concomitant
Chest Pain Other Serious 3/1/2011 62 Male 6/7/2011 Consumer United States
Primary
Concomitant
Dysarthria 4/27/2011 80 Female 6/7/2011 Consumer United States
Primary
Concomitant
Dyspepsia 3/31/2011 56 Male 6/7/2011 Consumer United States
Primary
Concomitant
Cardiac Disorder Hospitalization 5/22/2011 80 Female 6/8/2011 Consumer United States
Primary
Concomitant
Pruritus 3/8/2011 Female 6/8/2011 Consumer United States
Primary
Concomitant
Dyspepsia 2/17/2011 73 Female 6/8/2011 Consumer United States
Primary
Concomitant
Hot Flush Female 6/9/2011 Consumer United States
Primary
Concomitant
Fall 5/19/2011 71 Male 6/9/2011 Consumer United States
Primary
Concomitant
Lip Pain Male 6/14/2011 Consumer United States
Primary
Concomitant
Rectal Haemorrhage 4/1/2011 70 Male 6/15/2011 Consumer United States
Primary
Concomitant
Liver Function Test Abnormal Hospitalization Male 6/15/2011 Pharmacist Ireland
Primary
Concomitant
Fatigue 3/1/2011 76 Male 6/16/2011 Consumer United States
Primary
Concomitant
Fatigue 2/1/2011 89 Female 120 lb 6/17/2011 Physician United States
Primary
Concomitant
Chest Pain 12/1/2010 77 Female 176 lb 6/17/2011 Other Health Professional United States
Primary
Concomitant
Atrial Fibrillation 84 Female 6/17/2011 Consumer United States
Primary
Secondary
Flatulence 4/3/2011 74 Female 173 lb 6/20/2011 Other Health Professional United States
Primary
Concomitant
Diarrhoea 1/1/2011 72 Female 6/22/2011 Consumer United States
Primary
Concomitant
Bladder Disorder Hospitalization 12/8/2009 75 Female 126 lb 6/22/2011 Consumer United States
Primary
Secondary
Dyspepsia 2/24/2011 75 Male 151 lb 6/24/2011 Physician United States
Primary
Concomitant
Headache 6/1/2011 62 Male 6/24/2011 Consumer United States
Primary
Concomitant
Throat Irritation 2/22/2011 83 Male 6/24/2011 Consumer United States
Primary
Concomitant
Melaena Hospitalization 6/6/2011 87 Female 6/24/2011 Consumer United States
Primary
Concomitant
Dyspepsia 11/1/2010 69 Female 6/27/2011 Consumer United States
Primary
Concomitant
Dyspnoea 6/9/2011 82 Male 6/27/2011 Consumer United States
Primary
Concomitant
Liver Function Test Abnormal Hospitalization Male 6/27/2011 Pharmacist Ireland
Primary
Concomitant
Abdominal Pain Upper 5/30/2011 62 Female 7/1/2011 Consumer United States
Primary
Concomitant
Dyspepsia 3/8/2011 Female 7/5/2011 Physician United States
Primary
Concomitant
Renal Cyst Other Serious 11/1/2010 65 Male 7/5/2011 Consumer United States
Primary
Secondary
Concomitant
Arthralgia 2/1/2011 72 Female 7/6/2011 Consumer United States
Primary
Concomitant
Nausea 6/14/2011 68 Male 7/7/2011 Consumer United States
Primary
Concomitant
Anaemia 6/1/2011 80 Female 7/7/2011 Consumer United States
Primary
Concomitant
Gingival Bleeding 4/1/2011 70 Male 218 lb 7/7/2011 Consumer United States
Primary
Concomitant
Confusional State 3/12/2011 82 Female 112 lb 7/8/2011 Consumer United States
Primary
Concomitant
Acute Myocardial Infarction Life Threatening 7/5/2011 85 Female 111 lb 7/7/2011 Physician United States
Primary
Concomitant
Escherichia Sepsis Hospitalization Male 7/12/2011 Pharmacist Ireland
Primary
Concomitant
Pyrexia 2/23/2011 79 Female 7/13/2011 Consumer United States
Primary
Concomitant
Abdominal Pain Upper 6/9/2011 82 Male 7/13/2011 Consumer United States
Primary
Concomitant
Dizziness 6/17/2011 78 Female 7/14/2011 Consumer United States
Primary
Concomitant
Headache 6/1/2011 62 Male 7/14/2011 Consumer United States
Primary
Concomitant
Vertigo 11/23/2010 66 Male 7/14/2011 Consumer United States
Primary
Concomitant
Contusion 3/1/2011 76 Female 7/15/2011 Physician United States
Primary
Concomitant
Bladder Disorder Hospitalization 12/1/2010 75 Female 126 lb 7/15/2011 Consumer United States
Primary
Secondary
Gastrointestinal Haemorrhage Hospitalization 6/1/2011 86 Female 7/15/2011 Physician United States
Primary
Concomitant
Bladder Disorder Other Serious 12/8/2009 75 Female 126 lb 7/18/2011 Consumer United States
Primary
Secondary
Pain Hospitalization 12/8/2009 75 Female 126 lb 7/18/2011 Consumer United States
Primary
Secondary
Dyspepsia 3/1/2011 65 Male 7/18/2011 Consumer United States
Primary
Concomitant
Dizziness 6/13/2011 78 Female 7/19/2011 Consumer United States
Primary
Concomitant
Dyspnoea Life Threatening 4/1/2011 68 Male 322 lb 7/19/2011 Physician United States
Primary
Concomitant
Heart Rate Irregular 1/1/2011 72 Female 7/20/2011 Consumer United States
Primary
Concomitant
Cardiac Disorder Hospitalization 5/22/2011 80 Female 7/20/2011 Consumer United States
Primary
Concomitant
Abdominal Mass Other Serious 1/1/2010 64 Male 7/21/2011 Consumer United States
Primary
Concomitant
Blood Urine Present 11/1/2010 71 Female 7/25/2011 Consumer United States
Primary
Concomitant
Chest Pain Hospitalization 5/22/2011 80 Female 7/27/2011 Consumer United States
Primary
Concomitant
Subdural Haematoma Other Serious 7/12/2011 82 Male 8/1/2011 Other Health Professional United States
Primary
Concomitant
Haematuria Disability 7/10/2011 83 Male 192 lb 8/4/2011 Physician Australia
Primary
Secondary
Concomitant
Oropharyngeal Pain 3/1/2011 77 Male 8/10/2011 Consumer United States
Primary
Concomitant
Dyspepsia 11/1/2010 71 Female 8/10/2011 Consumer United States
Primary
Concomitant
Chest Discomfort 7/1/2011 69 Female 8/10/2011 Consumer United States
Primary
Concomitant
Sensation Of Foreign Body 7/1/2011 67 Female 8/10/2011 Consumer United States
Primary
Concomitant
Oesophageal Spasm Hospitalization 7/26/2011 75 Female 8/15/2011 Consumer United States
Primary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 6/23/2011 67 Female 8/16/2011 Physician Australia
Primary
Secondary
Concomitant
Dizziness 6/18/2011 78 Female 8/17/2011 Consumer United States
Primary
Concomitant
Pulmonary Oedema Hospitalization 8/8/2011 70 Male 8/18/2011 Physician United States
Primary
Concomitant
Haemorrhoids 3/1/2011 76 Female 8/19/2011 Physician United States
Primary
Concomitant
Cerebral Ischaemia Hospitalization 3/21/2011 78 Male 8/19/2011 Other Health Professional United States
Primary
Concomitant
Dyspepsia 4/1/2011 72 Male 8/23/2011 Other Health Professional United States
Primary
Concomitant
Petechiae Other Serious 7/1/2011 56 Male 8/23/2011 Consumer United States
Primary
Concomitant
Splenic Embolism Hospitalization 8/14/2011 74 Male 163 lb 8/31/2011 Physician Australia
Primary
Concomitant
Weight Decreased 6/1/2011 69 Female 8/31/2011 Consumer United States
Primary
Secondary
Concomitant
Bone Pain Male 167 lb 9/1/2011 Other Health Professional United States
Primary
Concomitant
Constipation 8/1/2011 67 Male 9/8/2011 Consumer United States
Primary
Secondary
Petechiae Male 9/8/2011 Consumer United States
Primary
Concomitant
Chest Discomfort Female 9/12/2011 Consumer United States
Primary
Concomitant
Sensation Of Foreign Body 7/15/2011 69 Female 9/13/2011 Consumer United States
Primary
Concomitant
Early Satiety 8/28/2011 75 Female 9/13/2011 Consumer United States
Primary
Concomitant
Pulmonary Embolism Death 8/22/2011 81 Male 9/15/2011 Physician Australia
Primary
Concomitant
Pulmonary Embolism Death 8/22/2011 81 Male 9/15/2011 Physician Australia
Primary
Concomitant
Pulmonary Embolism Death 8/22/2011 81 Male 9/15/2011 Physician Australia
Primary
Concomitant
Pulmonary Embolism Death 8/22/2011 81 Male 9/15/2011 Physician Australia
Primary
Concomitant
Pulmonary Oedema Hospitalization 4/9/2011 70 Male 178 lb 9/16/2011 Physician United States
Primary
Concomitant
Stomatitis 1/1/2011 68 Female 9/19/2011 Consumer United States
Primary
Concomitant
Subdural Haematoma Hospitalization 82 Male 9/19/2011 Physician United States
Primary
Concomitant

Drug Data