Pradaxa combined with Sotalol

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Viith Nerve Paralysis Hospitalization 11/18/2010 73 Female 12/3/2010 Consumer
Primary
Concomitant
Pain 11/1/2010 67 Female 12/16/2010 Consumer
Primary
Concomitant
Nausea 11/26/2010 87 Female 12/17/2010 Consumer
Primary
Concomitant
Vertigo 11/23/2010 66 Male 12/21/2010 Consumer
Primary
Concomitant
Hiccups 12/4/2010 Female 12/22/2010 Consumer
Primary
Concomitant
Oropharyngeal Pain Hospitalization 11/18/2010 73 Female 1/4/2011 Consumer
Primary
Concomitant
Blood Pressure Increased 12/11/2010 67 Male 1/7/2011 Consumer
Primary
Concomitant
Constipation 12/22/2010 53 Female 1/7/2011 Consumer
Primary
Concomitant
Ocular Hyperaemia 12/14/2010 83 Female 1/7/2011 Consumer
Primary
Concomitant
Muscle Spasms 12/20/2010 64 Female 1/10/2011 Consumer
Primary
Concomitant
Hot Flush 12/21/2010 73 Male 1/12/2011 Consumer
Primary
Concomitant
Wheezing 12/1/2010 79 Male 1/12/2011 Consumer
Primary
Secondary
Concomitant
Weight Decreased 11/1/2010 71 Female 1/13/2011 Consumer
Primary
Concomitant
Abdominal Discomfort 11/23/2010 66 Male 1/14/2011 Consumer
Primary
Concomitant
Cerebrovascular Accident Death 12/29/2010 69 Male 1/14/2011 Consumer
Primary
Concomitant
Dizziness 1/1/2011 67 Female 1/14/2011 Consumer
Primary
Concomitant
Vomiting 12/4/2010 Female 1/18/2011 Consumer
Primary
Concomitant
Abdominal Pain Upper 12/31/2010 76 Male 1/18/2011 Consumer
Primary
Concomitant
Alopecia 12/1/2010 85 Female 1/18/2011 Consumer
Primary
Secondary
Concomitant
Heart Rate Decreased 12/30/2010 86 Female 1/19/2011 Consumer
Primary
Secondary
Pollakiuria 1/6/2011 82 Male 1/19/2011 Consumer
Primary
Concomitant
Dizziness 11/23/2010 66 Male 1/20/2011 Consumer
Primary
Concomitant
Vertigo Hospitalization 11/18/2010 73 Female 1/31/2011 Physician
Primary
Concomitant
Pruritus Female 3/30/2011 Consumer United States
Primary
Concomitant
Decreased Appetite 1/1/2011 81 Male 4/1/2011 Consumer United States
Primary
Concomitant
Atrial Fibrillation 2/1/2011 84 Female 4/4/2011 Consumer United States
Primary
Concomitant
Dyspepsia 2/24/2011 75 Male 4/4/2011 Consumer United States
Primary
Concomitant
No Adverse Event 69 Female 4/5/2011 Consumer United States
Primary
Concomitant
Erythema 3/10/2011 68 Male 4/6/2011 Consumer United States
Primary
Concomitant
Cough 2/1/2011 66 Male 4/8/2011 Consumer United States
Primary
Secondary
Concomitant
Diarrhoea 1/1/2011 67 Male 4/8/2011 Consumer United States
Primary
Concomitant
Fatigue 2/1/2011 89 Female 4/8/2011 Consumer United States
Primary
Concomitant
Haemorrhage Hospitalization Male 4/8/2011 Physician United States
Primary
Concomitant
Haemorrhagic Stroke Hospitalization 1/1/2011 58 Male 4/18/2011 Physician United States
Primary
Concomitant
Hypotension 1/24/2011 84 Male 4/19/2011 Consumer United States
Primary
Concomitant
Rectal Haemorrhage Hospitalization 1/15/2011 86 Male 4/21/2011 Consumer United States
Primary
Concomitant
Abdominal Pain Upper 12/31/2010 76 Male 239 lb 4/21/2011 Other Health Professional United States
Primary
Concomitant
Nausea 1/1/2011 82 Female 4/21/2011 Consumer United States
Primary
Concomitant
Activated Partial Thromboplastin Time Prolonged Hospitalization 1/10/2011 85 Female 100 lb 4/22/2011 Physician United States
Primary
Concomitant
Local Swelling 4/8/2011 Female 4/22/2011 Consumer United States
Primary
Concomitant
Back Pain 3/1/2011 68 Male 4/22/2011 Consumer United States
Primary
Secondary
Concomitant
Blood Potassium Decreased 11/1/2010 65 Male 4/22/2011 Consumer United States
Primary
Secondary
Concomitant
Arthralgia 3/25/2011 72 Male 4/22/2011 Consumer United States
Primary
Concomitant
Oesophageal Spasm 3/1/2011 59 Female 4/22/2011 Consumer United States
Primary
Concomitant
Headache 4/12/2011 Female 4/22/2011 Consumer United States
Primary
Concomitant
Hypotension 1/24/2011 84 Male 4/24/2011 Consumer United States
Primary
Concomitant
Blood Urine Present 12/1/2010 71 Female 4/25/2011 Consumer United States
Primary
Concomitant
Eye Haemorrhage 1/1/2011 82 Female 11/9/2011 Consumer United States
Primary
Concomitant
Weight Decreased 9/1/2011 81 Male 11/10/2011 Pharmacist United States
Primary
Secondary
Concomitant
Atrial Fibrillation Other Serious 1/1/2010 64 Male 11/10/2011 Consumer United States
Primary
Concomitant
Nipple Pain 1/1/2011 62 Male 215 lb 4/23/2012 Consumer United States
Primary
Concomitant
Nipple Pain 1/1/2011 62 Male 214 lb 5/17/2012 Physician United States
Primary
Concomitant
Pulmonary Embolism Life Threatening 2/11/2012 69 Male 6/8/2012 Physician Australia
Primary
Concomitant
Hemiplegia Death 11/21/2010 70 Male 165 lb 5/1/2013 Consumer Us
Primary
Concomitant
Tooth Extraction 3/7/2012 76 Female 8/28/2012 Consumer Us
Primary
Concomitant
Transient Ischaemic Attack Other Serious 11/2011 Female 2/4/2013 Consumer Us
Primary
Concomitant
Hyperthyroidism Other Serious 70 Male 10/10/2012 Physician Gb
Primary
Concomitant
Skin Warm 2010 Male 8/29/2012 Consumer Us
Primary
Secondary
Concomitant
Hyperthyroidism Other Serious 6/22/2012 69 Male 196 lb 12/13/2012 Other Health Professional Gb
Primary
Concomitant
Pericardial Haemorrhage Hospitalization 3/11/2012 63 Male 236 lb 2/2/2013 Consumer Us
Primary
Concomitant
Fungal Infection 3/2012 Female 9/7/2012 Consumer Us
Primary
Secondary
Concomitant
Rash Erythematous 3/2012 67 Female 7/3/2013 Consumer Us
Primary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 7/27/2011 82 Female 143 lb 3/8/2013 Consumer Us
Primary
Concomitant
Urinary Retention Death 2012 Male 227 lb 10/29/2012 Physician Au
Primary
Concomitant
Rectal Haemorrhage Hospitalization 9/16/2012 65 Male 348 lb 9/18/2012 Pharmacist Us
Primary
Concomitant
Sudden Death Death 8/30/2012 67 Female 150 lb 10/8/2012 Physician Au
Primary
Concomitant
Dysgeusia 2012 Male 71 lb 9/28/2012 Consumer Us
Primary
Concomitant
Red Blood Cell Count Decreased 6/6/2012 89 Male 10/2/2012 Consumer Us
Primary
Concomitant
Viral Infection Other Serious 9/2012 52 Male 270 lb 11/22/2012 Physician Us
Primary
Concomitant
Gynaecomastia Male 10/18/2012 Consumer Us
Primary
Concomitant
Hypertension Hospitalization 12/2011 Female 209 lb 10/29/2012 Other Health Professional Us
Primary
Concomitant
Sinus Arrest Hospitalization 7/2012 Male 185 lb 11/9/2012 Other Health Professional Us
Primary
Concomitant
Haemorrhagic Stroke Other Serious 3/13/2012 78 Female 10/29/2012 Physician Us
Primary
Concomitant
Cerebrovascular Accident Life Threatening 10/19/2012 58 Female 132 lb 10/23/2012 Physician In
Primary
Concomitant
Condition Aggravated 10/2012 Female 11/5/2012 Consumer Us
Primary
Concomitant
Off Label Use Other Serious 73 Male 250 lb 12/26/2012 Us
Primary
Secondary
Concomitant
Haematoma Hospitalization Female 11/7/2012 Physician Au
Primary
Concomitant
Cerebral Haemorrhage Hospitalization 10/31/2012 89 Male 11/26/2012 Other Health Professional Us
Primary
Concomitant
Cerebral Haematoma Death 7/16/2012 89 Male 172 lb 12/22/2012 Physician Fr
Primary
Concomitant
Sensory Disturbance Hospitalization 8/8/2012 83 Female 1/23/2013 Physician Us
Primary
Concomitant
Nausea 2012 Female 11/28/2012 Consumer Us
Primary
Concomitant
Prostatic Operation Other Serious 2011 Male 220 lb 11/30/2012 Consumer Country Not Specified
Primary
Concomitant
Viith Nerve Paralysis Hospitalization 11/18/2012 69 Female 12/10/2012 Other Health Professional Au
Primary
Concomitant
Headache Death 11/2012 Male 170 lb 1/3/2013 Physician Us
Primary
Concomitant
Vomiting Life Threatening 11/11/2012 77 Female 256 lb 1/9/2013 Physician Au
Primary
Concomitant
Myocardial Infarction Death Female 12/10/2012 Physician Au
Primary
Concomitant
Gastrointestinal Angiodysplasia Haemorrhagic Hospitalization 9/6/2012 86 Male 155 lb 12/13/2012 Physician Us
Primary
Concomitant
Cerebral Infarction Hospitalization 70 Male 5/31/2013 Physician Au
Primary
Concomitant
Off Label Use 68 Female 146 lb 12/18/2012 Consumer Us
Primary
Secondary
Concomitant
Renal Neoplasm Hospitalization 11/2011 74 Female 3/8/2013 Other Health Professional Ca
Primary
Concomitant
Off Label Use Other Serious 73 Male 250 lb 12/27/2012 Consumer Us
Primary
Secondary
Concomitant
Product Quality Issue 6/2012 Male 159 lb 1/16/2013 Consumer Us
Primary
Secondary
Concomitant
Loss Of Consciousness Hospitalization 1/2013 Female 1/29/2013 Other Health Professional Us
Primary
Concomitant
Cerebrovascular Accident Hospitalization 8/8/2012 83 Female 201 lb 6/5/2013 Physician Us
Primary
Concomitant
Thrombophlebitis Hospitalization 11/28/2011 76 Male 1/17/2013 Other Health Professional Fr
Primary
Concomitant
Respiratory Failure Hospitalization 2/1/2012 76 Male 220 lb 4/1/2013 Consumer Us
Primary
Concomitant
Nausea Male 265 lb 1/21/2013 Consumer Us
Primary
Concomitant
Melaena 1/20/2013 82 Female 154 lb 6/13/2013 Consumer Us
Primary
Concomitant
Haemorrhagic Anaemia Hospitalization 9/29/2011 70 Male 293 lb 7/25/2013 Consumer Us
Primary
Concomitant
Testicular Pain 6/2012 Male 2/5/2013 Consumer Us
Primary
Concomitant
Thrombin Time Prolonged Hospitalization 11/16/2012 87 Female 110 lb 4/11/2013 Physician Au
Primary
Concomitant
Pruritus 2012 86 Female 159 lb 8/2/2013 Physician Us
Primary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 2/15/2011 90 Female 103 lb 5/17/2013 Consumer Us
Primary
Concomitant
Upper Gastrointestinal Haemorrhage Life Threatening 2/4/2013 88 Female 4/18/2013 Physician Us
Primary
Concomitant
Saliva Discolouration 1/2013 Female 2/11/2013 Consumer Us
Primary
Concomitant
Upper Gastrointestinal Haemorrhage Hospitalization 1/20/2012 78 Male 249 lb 6/7/2013 Consumer Us
Primary
Concomitant
Vision Blurred Other Serious Female 4/8/2013 Consumer Us
Primary
Concomitant
Atrial Fibrillation Other Serious 83 Female 3/7/2013 Physician Au
Primary
Secondary
Cerebral Haemorrhage Hospitalization 3/6/2011 75 Male 185 lb 8/26/2013 Consumer Us
Primary
Concomitant
Upper Gastrointestinal Haemorrhage Death 9/26/2011 86 Female 170 lb 3/14/2013 Consumer Us
Primary
Concomitant
Pancreatitis Hospitalization 11/11/2012 77 Female 3/15/2013 Other Health Professional Au
Primary
Secondary
Product Quality Issue 3/11/2013 75 Female 3/21/2013 Consumer Us
Primary
Secondary
Concomitant
Heart Rate Increased 2012 Female 132 lb 4/5/2013 Consumer Us
Primary
Secondary
Concomitant
Pharyngeal Oedema Other Serious Male 160 lb 4/11/2013 Physician Us
Primary
Secondary
Concomitant
Atrial Fibrillation 2/2013 72 Male 4/12/2013 Consumer Us
Primary
Concomitant
Head Injury Life Threatening 2013 Female 154 lb 5/10/2013 Physician Au
Primary
Concomitant
Jaundice Cholestatic Hospitalization 3/21/2013 77 Male 4/25/2013 Physician Fr
Primary
Secondary
Concomitant
Cholangiocarcinoma Other Serious 11/2012 69 Male 4/29/2013 Physician Be
Primary
Concomitant
Skin Necrosis Hospitalization 2/2013 70 Female 6/7/2013 Physician Fr
Primary
Concomitant
Sinus Bradycardia Hospitalization 4/30/2011 88 Male 127 lb 9/10/2013 Consumer Us
Primary
Concomitant
Precancerous Skin Lesion Other Serious 4/2013 83 Female 180 lb 5/8/2013 Consumer Country Not Specified
Primary
Concomitant
Lower Gastrointestinal Haemorrhage Hospitalization 2/21/2012 77 Male 160 lb 6/28/2013 Consumer Us
Primary
Concomitant
Vitreous Haemorrhage Other Serious 9/21/2011 59 Male 225 lb 6/28/2013 Consumer Us
Primary
Concomitant
Gastrointestinal Haemorrhage Death 2013 77 Male 5/28/2013 Physician Us
Primary
Concomitant
Hip Fracture Hospitalization 9/2012 80 Female 5/14/2013 Physician Ca
Primary
Concomitant
Increased Upper Airway Secretion Disability 1/2013 77 Male 170 lb 5/14/2013 Consumer Us
Primary
Secondary
Concomitant
Crohn's Disease Other Serious 3/2012 65 Female 5/20/2013 Consumer Us
Primary
Concomitant
Fall 2012 Male 146 lb 5/27/2013 Consumer Us
Primary
Concomitant
Psoriasis Other Serious 2012 Female 280 lb 5/29/2013 Consumer Country Not Specified
Primary
Concomitant
Tricuspid Valve Disease Hospitalization 2/6/2012 71 Female 112 lb 5/31/2013 Consumer Us
Primary
Concomitant
Vein Disorder 1/2013 68 Female 240 lb 6/1/2013 Consumer Us
Primary
Concomitant
Lower Gastrointestinal Haemorrhage Hospitalization 6/29/2011 88 Female 115 lb 6/6/2013 Consumer Us
Primary
Concomitant
Pain In Extremity 1/2012 76 Male 172 lb 7/17/2013 Physician Us
Primary
Concomitant
Atrial Fibrillation Hospitalization 6/2013 68 Male 165 lb 6/28/2013 Consumer Us
Primary
Concomitant
Gastrointestinal Tract Irritation Hospitalization 9/2011 54 Female 7/7/2013 Consumer Us
Primary
Concomitant
Thrombocytosis 7/1/2013 71 Female 7/10/2013 Physician Us
Primary
Concomitant
Weight Decreased 12/2012 61 Male 154 lb 7/12/2013 Consumer Us
Primary
Concomitant
Atrial Fibrillation Hospitalization 7/1/2013 80 Female 174 lb 7/12/2013 Consumer Us
Primary
Concomitant
Cerebrovascular Accident Other Serious 7/18/2011 69 Female 161 lb 8/7/2013 Physician Us
Primary
Concomitant
Goitre Hospitalization 5/2013 Male 7/17/2013 Consumer Us
Primary
Concomitant
Pneumonia Hospitalization 3/2013 74 Female 324 lb 7/20/2013 Consumer Us
Primary
Concomitant
Off Label Use 1/2013 64 Male 225 lb 8/20/2013 Consumer Us
Primary
Secondary
Concomitant
Hyperhidrosis 4/2013 72 Female 190 lb 7/23/2013 Consumer Us
Primary
Secondary
Concomitant
Cardiac Failure Congestive Other Serious 6/23/2013 89 Female 134 lb 9/23/2013 Physician Us
Primary
Concomitant
Cerebral Infarction Hospitalization 11/25/2012 81 Male 8/2/2013 Other Health Professional Fr
Primary
Concomitant
Pain In Extremity Disability 5/1/2013 78 Female 195 lb 7/26/2013 Us
Primary
Concomitant
Upper Gastrointestinal Haemorrhage Hospitalization 7/2012 84 Male 219 lb 8/30/2013 Consumer Us
Primary
Concomitant
Melaena Life Threatening 8/5/2013 66 Female 9/13/2013 Other Health Professional Fr
Primary
Concomitant
Accidental Overdose 8/2/2013 75 Male 165 lb 8/24/2013 Consumer Us
Primary
Concomitant
Rash Morbilliform Hospitalization 6/28/2013 63 Male 198 lb 9/3/2013 Other Health Professional Fr
Primary
Secondary

Drug Data