Amiodarone Hcl combined with Pradaxa

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Wound Secretion Other Serious 3/28/2010 75 Female 198 lb 10/25/2010
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Death 11/1/2010 Male 11/22/2010 Physician
Primary
Concomitant
Rhinorrhoea 12/1/2010 57 Male 1/7/2011 Consumer
Primary
Concomitant
Headache 12/30/2010 67 Male 1/20/2011 Consumer
Primary
Secondary
Concomitant
Oxygen Saturation Decreased Other Serious 1/1/2011 47 Female 1/21/2011 Consumer
Primary
Concomitant
Musculoskeletal Pain 1/10/2011 83 Female 1/21/2011 Consumer
Primary
Concomitant
Heart Rate Decreased Other Serious 11/1/2010 85 Female 1/25/2011 Consumer
Primary
Concomitant
Gastrointestinal Haemorrhage Hospitalization Female 140 lb 1/27/2011 Pharmacist
Primary
Concomitant
Drug Interaction Hospitalization 1/1/2011 84 Female 137 lb 1/26/2011 Pharmacist United States
Primary
Concomitant
Haemorrhage Hospitalization 12/1/2010 83 Female 2/4/2011 Consumer
Primary
Concomitant
Haematochezia Hospitalization 12/29/2010 75 Male 2/7/2011 Consumer
Primary
Secondary
Ageusia 2/9/2011 82 Female 2/22/2011 Consumer United States
Primary
Concomitant
Atrial Fibrillation Hospitalization 2/12/2011 85 Female 2/22/2011 Consumer United States
Primary
Concomitant
Constipation 1/26/2011 82 Female 2/24/2011 Consumer United States
Primary
Concomitant
Headache 12/1/2010 68 Male 2/24/2011 Consumer United States
Primary
Secondary
Concomitant
Eructation 1/22/2011 75 Male 2/28/2011 Consumer United States
Primary
Concomitant
Dysgeusia 2/7/2011 77 Female 3/4/2011 Consumer United States
Primary
Secondary
Headache 1/1/2011 82 Female 3/16/2011 Consumer United States
Primary
Concomitant
Headache Other Serious 3/10/2011 70 Female 3/17/2011 Consumer United States
Primary
Secondary
Concomitant
Diarrhoea Hospitalization 9/1/2006 56 Male 3/17/2011 Consumer United States
Primary
Secondary
Concomitant
Dysstasia 2/1/2011 78 Female 3/17/2011 Consumer United States
Primary
Concomitant
Muscle Spasms Hospitalization 1/7/2011 70 Female 106 lb 3/18/2011 Physician United States
Primary
Concomitant
Abdominal Pain 12/1/2010 89 Female 3/18/2011 Consumer United States
Primary
Concomitant
Diarrhoea 12/6/2010 74 Male 3/18/2011 Consumer United States
Primary
Concomitant
Headache 12/22/2010 67 Male 3/18/2011 Consumer United States
Primary
Secondary
Concomitant
Abdominal Distension 2/19/2011 70 Female 3/21/2011 Consumer United States
Primary
Concomitant
Thrombocytopenia 3/21/2011 Physician United States
Primary
Concomitant
Formication 2/16/2011 Male 3/21/2011 Consumer United States
Primary
Concomitant
Constipation Hospitalization 11/1/2010 85 Female 144 lb 3/22/2011 Physician United States
Primary
Concomitant
Asthenia 2/22/2011 76 Male 3/23/2011 Consumer United States
Primary
Secondary
Concomitant
Nausea 1/1/2011 83 Female 3/23/2011 Consumer United States
Primary
Concomitant
Asthenia 2/3/2011 83 Female 3/23/2011 Consumer United States
Primary
Concomitant
Pleural Effusion Life Threatening 2/10/2011 Male 187 lb 3/24/2011 Pharmacist United States
Primary
Concomitant
Cholecystitis Chronic Hospitalization 2/1/2011 71 Female 3/24/2011 Physician United States
Primary
Concomitant
Swollen Tongue 2/1/2011 67 Male 3/25/2011 Consumer United States
Primary
Concomitant
Erythema 1/1/2011 75 Male 3/25/2011 Consumer United States
Primary
Concomitant
Haematochezia 1/1/2011 78 Female 3/25/2011 Consumer United States
Primary
Secondary
Concomitant
Ulcer Life Threatening 2/12/2011 75 Female 3/25/2011 Physician United States
Primary
Concomitant
Haematochezia 2/1/2011 81 Female 3/25/2011 Consumer United States
Primary
Concomitant
Diarrhoea 2/13/2011 77 Male 3/25/2011 Consumer United States
Primary
Concomitant
Creatinine Renal Clearance 11/29/2010 Male 3/25/2011 Other Health Professional United States
Primary
Concomitant
Urticaria Hospitalization 1/1/2011 47 Female 196 lb 3/25/2011 Physician United States
Primary
Concomitant
Fluid Retention Hospitalization 2/1/2011 58 Male 3/30/2011 Consumer United States
Primary
Concomitant
Myocardial Infarction Hospitalization 3/14/2011 59 Female 3/30/2011 Other Health Professional United States
Primary
Concomitant
Activities Of Daily Living Impaired 3/1/2011 70 Female 3/30/2011 Consumer United States
Primary
Concomitant
Pain In Extremity 2/1/2011 86 Male 3/30/2011 Consumer United States
Primary
Concomitant
Diarrhoea Hospitalization 9/1/2006 56 Male 3/31/2011 Consumer United States
Primary
Secondary
Concomitant
Fear 3/7/2011 64 Female 4/5/2011 Consumer United States
Primary
Concomitant
Gynaecomastia 1/1/2011 75 Male 4/6/2011 Consumer United States
Primary
Concomitant
Dyspepsia Male 4/7/2011 Consumer United States
Primary
Concomitant
Abdominal Discomfort 12/1/2010 89 Female 4/8/2011 Consumer United States
Primary
Concomitant
Colitis Life Threatening 3/28/2010 75 Female 198 lb 4/8/2011 Physician Germany
Primary
Secondary
Concomitant
Gastric Ulcer Life Threatening 3/28/2010 75 Female 198 lb 4/15/2011 Physician Germany
Primary
Secondary
Concomitant
Arthritis 2/1/2011 75 Male 4/15/2011 Consumer United States
Primary
Concomitant
Dyspepsia 3/19/2011 69 Male 4/15/2011 Consumer United States
Primary
Concomitant
Musculoskeletal Pain 1/10/2011 83 Female 4/15/2011 Consumer United States
Primary
Concomitant
Fatigue 2/22/2011 88 Female 4/15/2011 Consumer United States
Primary
Concomitant
Dizziness 3/16/2011 79 Female 4/19/2011 Consumer United States
Primary
Secondary
Concomitant
Viith Nerve Paralysis Other Serious 1/1/2011 60 Female 4/19/2011 Consumer United States
Primary
Concomitant
Acute Myocardial Infarction Life Threatening 3/14/2011 59 Female 145 lb 4/19/2011 Physician United States
Primary
Concomitant
Heart Rate Irregular Hospitalization Female 4/29/2011 Consumer United States
Primary
Concomitant
Dyspnoea 1/27/2011 82 Female 5/4/2011 Consumer United States
Primary
Concomitant
Heart Rate Increased 2/1/2011 78 Female 5/4/2011 Consumer United States
Primary
Concomitant
Colitis Other Serious 3/28/2010 75 Female 198 lb 5/6/2011 Physician Germany
Primary
Secondary
Concomitant
Dyspepsia Other Serious Female 5/6/2011 Consumer United States
Primary
Concomitant
Foreign Body Female 5/6/2011 Consumer United States
Primary
Concomitant
Ear Discomfort Female 5/12/2011 Consumer United States
Primary
Concomitant
Oedema Peripheral 2/1/2011 68 Male 5/12/2011 Consumer United States
Primary
Concomitant
Dizziness 12/1/2010 84 Female 5/12/2011 Consumer United States
Primary
Secondary
Concomitant
Arthralgia 3/1/2011 71 Female 5/16/2011 Consumer United States
Primary
Concomitant
Eye Discharge 3/10/2011 86 Male 5/16/2011 Consumer United States
Primary
Concomitant
Oesophageal Pain 1/1/2011 75 Female 5/16/2011 Consumer United States
Primary
Concomitant
Fatigue Hospitalization 2/27/2011 73 Female 5/16/2011 Consumer United States
Primary
Secondary
Concomitant
International Normalised Ratio Increased 1/1/2011 55 Male 208 lb 5/16/2011 Other Health Professional United States
Primary
Concomitant
Glossodynia 4/4/2011 78 Female 5/17/2011 Consumer United States
Primary
Concomitant
Fatigue 2/3/2011 83 Female 5/17/2011 Consumer United States
Primary
Concomitant
Coagulopathy Hospitalization Male 255 lb 5/18/2011 Physician United States
Primary
Secondary
Concomitant
Breast Tenderness 2/1/2011 75 Male 5/18/2011 Consumer United States
Primary
Concomitant
Atrial Fibrillation 4/7/2011 75 Male 5/18/2011 Consumer United States
Primary
Concomitant
Gingival Pain 2/1/2011 67 Female 5/19/2011 Consumer United States
Primary
Concomitant
Heart Rate Decreased Hospitalization 3/1/2011 76 Female 5/20/2011 Consumer United States
Primary
Concomitant
Pain Female 5/20/2011 Consumer United States
Primary
Concomitant
Flatulence 59 Male 5/20/2011 Physician United States
Primary
Concomitant
Haemoglobin Decreased Life Threatening 1/1/2011 84 Female 5/20/2011 Physician United States
Primary
Secondary
Concomitant
Epistaxis Hospitalization 76 Female 5/23/2011 Pharmacist United States
Primary
Concomitant
Asthenopia 3/1/2011 58 Male 5/24/2011 Consumer United States
Primary
Concomitant
Renal Failure Hospitalization 3/28/2010 75 Female 198 lb 5/24/2011 Physician Germany
Primary
Secondary
Concomitant
Blood Urine Present 2/27/2011 78 Female 210 lb 5/24/2011 Other Health Professional United States
Primary
Concomitant
Pruritus 3/1/2011 66 Male 5/24/2011 Consumer United States
Primary
Concomitant
Pulmonary Oedema Hospitalization 2/23/2011 88 Female 5/26/2011 Physician United States
Primary
Concomitant
Wound Secretion Life Threatening 3/28/2010 75 Female 198 lb 5/26/2011 Physician Germany
Primary
Secondary
Concomitant
Weight Decreased 1/1/2011 79 Male 5/27/2011 Consumer United States
Primary
Concomitant
Nausea 3/1/2011 89 Male 5/27/2011 Consumer United States
Primary
Concomitant
Hot Flush Hospitalization 2/27/2011 73 Female 5/27/2011 Consumer United States
Primary
Secondary
Concomitant
Cardiac Failure Death 1/1/2010 74 Male 5/27/2011 Physician Canada
Primary
Concomitant
Hepatic Enzyme Increased 4/7/2011 74 Male 190 lb 5/31/2011 Physician United States
Primary
Concomitant
Gastrooesophageal Reflux Disease Hospitalization 3/1/2011 70 Male 5/31/2011 Consumer United States
Primary
Concomitant
Pain In Extremity Other Serious 5/15/2011 83 Male 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
Haemorrhage Intracranial Other Serious 2/2/2011 83 Female 6/2/2011 Pharmacist United States
Primary
Concomitant
Neck Pain Hospitalization 2/25/2011 72 Male 6/2/2011 Physician United States
Primary
Concomitant
Sepsis Hospitalization 5/24/2011 83 Female 6/2/2011 Physician Chile
Primary
Concomitant
Subdural Haemorrhage Death 3/31/2011 95 Male 176 lb 6/2/2011 Pharmacist United States
Primary
Secondary
Concomitant
Anxiety 5/1/2011 84 Male 6/2/2011 Consumer United States
Primary
Concomitant
Nausea Hospitalization 4/1/2011 72 Male 6/3/2011 Consumer United States
Primary
Concomitant
Oral Pain 5/18/2011 75 Female 6/5/2011 Consumer United States
Primary
Concomitant
Dyspnoea 12/1/2010 84 Female 6/7/2011 Consumer United States
Primary
Secondary
Concomitant
Activated Partial Thromboplastin Time Abnormal Female 6/7/2011 Physician United States
Primary
Concomitant
Motion Sickness Male 6/7/2011 Physician United States
Primary
Concomitant
Insomnia 2/1/2011 81 Female 6/7/2011 Physician United States
Primary
Concomitant
Palpitations 1/27/2011 82 Female 6/8/2011 Consumer United States
Primary
Concomitant
Dyspepsia 4/17/2011 77 Male 6/9/2011 Consumer United States
Primary
Secondary
Concomitant
Pain In Extremity Other Serious 5/15/2011 83 Male 6/10/2011 Consumer United States
Primary
Concomitant
Pulmonary Haemorrhage Hospitalization 3/28/2011 83 Female 6/10/2011 Physician United States
Primary
Concomitant
Haematuria Other Serious 3/1/2011 76 Female 6/10/2011 Consumer United States
Primary
Concomitant
International Normalised Ratio Increased Other Serious 6/1/2011 80 Male 6/14/2011 Pharmacist Japan
Primary
Concomitant
Chest Pain 4/1/2011 76 Female 6/14/2011 Consumer United States
Primary
Concomitant
Haemorrhage Other Serious 1/7/2011 63 Female 6/15/2011 Consumer United States
Primary
Concomitant
Dizziness 12/10/2010 85 Female 6/16/2011 Physician United States
Primary
Secondary
Concomitant
Dizziness 3/1/2011 89 Male 178 lb 6/16/2011 Consumer United States
Primary
Concomitant
Renal Impairment 2/1/2011 78 Female 6/17/2011 Consumer United States
Primary
Concomitant
Erythema 3/10/2011 86 Male 148 lb 6/17/2011 Other Health Professional United States
Primary
Concomitant
Paraesthesia 6/1/2011 80 Male 6/22/2011 Consumer United States
Primary
Concomitant
Renal Impairment Hospitalization 5/4/2011 76 Male 125 lb 6/22/2011 Physician Japan
Primary
Secondary
Concomitant
Disseminated Intravascular Coagulation Hospitalization 6/13/2011 80 Male 6/22/2011 Physician Japan
Primary
Concomitant
Bladder Disorder Hospitalization 12/8/2009 75 Female 126 lb 6/22/2011 Consumer United States
Primary
Secondary
Glossodynia 4/4/2011 78 Female 6/24/2011 Consumer United States
Primary
Concomitant
Diarrhoea 5/1/2011 73 Male 6/24/2011 Consumer United States
Primary
Concomitant
Flatulence 71 Male 207 lb 6/24/2011 Physician United States
Primary
Concomitant
Diverticulitis Intestinal Haemorrhagic Hospitalization 1/1/2011 89 Male 6/24/2011 Consumer United States
Primary
Concomitant
Dizziness Other Serious Female 6/28/2011 Physician United States
Primary
Concomitant
Rash Hospitalization 1/1/2011 90 Female 6/28/2011 Consumer United States
Primary
Concomitant
Blood Creatinine Increased 4/1/2011 Female 6/29/2011 Consumer United States
Primary
Concomitant
Decreased Appetite 5/1/2011 78 Male 7/1/2011 Consumer United States
Primary
Concomitant
Ventricular Fibrillation Life Threatening 6/20/2011 60 Male 190 lb 7/5/2011 Physician Australia
Primary
Concomitant
Confusional State 5/16/2011 59 Male 7/5/2011 Physician United States
Primary
Concomitant
Renal Impairment Other Serious 6/24/2011 55 Male 7/5/2011 Physician Japan
Primary
Secondary
Concomitant
Chest Pain 5/12/2011 68 Male 7/6/2011 Consumer United States
Primary
Concomitant
Chest Discomfort 6/4/2011 80 Male 7/7/2011 Consumer United States
Primary
Concomitant
Rash Macular 5/28/2011 84 Female 7/7/2011 Consumer United States
Primary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 2/24/2011 85 Female 7/7/2011 Physician United States
Primary
Concomitant
Pulmonary Embolism Hospitalization Female 7/8/2011 Physician Colombia
Primary
Concomitant
Vision Blurred 6/1/2011 89 Female 7/8/2011 Consumer United States
Primary
Concomitant
Hepatitis 4/19/2011 73 Female 7/8/2011 Physician United States
Primary
Concomitant
Activated Partial Thromboplastin Time Prolonged 72 Female 122 lb 7/11/2011 Physician United States
Primary
Concomitant
Abdominal Discomfort 1/1/2011 78 Male 7/12/2011 Consumer United States
Primary
Concomitant
Ear Lobe Infection 90 Female 7/12/2011 Consumer United States
Primary
Concomitant
Rosacea 5/30/2011 Male 7/12/2011 Consumer United States
Primary
Concomitant
Blood Pressure Decreased 1/2/2011 82 Male 7/14/2011 Consumer United States
Primary
Secondary
Concomitant
Asthenia 6/28/2011 76 Male 7/14/2011 Consumer United States
Primary
Concomitant

Drug Data