Dronedarone Hcl combined with Warfarin Sodium

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Renal Disorder Required Intervention 8/17/2009 68 Male 9/8/2009 Pharmacist United States
Primary
Concomitant
International Normalised Ratio Increased Other Serious 10/13/2009 72 Female 11/18/2009 Other Health Professional United States
Primary
Concomitant
Interacting
Thinking Abnormal Other Serious 10/1/2009 Female 11/19/2009 Consumer United States
Primary
Concomitant
Interacting
Oedema Peripheral Hospitalization 10/1/2009 61 Male 11/18/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Respiratory Disorder Other Serious Female 2/9/2010 Consumer United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 2/11/2010 82 Female 125 lb 3/30/2010 Pharmacist United States
Primary
Secondary
Concomitant
Dyspnoea Other Serious 2/12/2010 73 Male 201 lb 4/12/2010 Consumer United States
Primary
Concomitant
International Normalised Ratio Increased Other Serious 2/3/2010 80 Female 4/6/2010 Other Health Professional United States
Primary
Concomitant
International Normalised Ratio Increased Hospitalization 9/18/2009 50 Male 4/29/2010 Physician United States
Primary
Concomitant
Renal Failure Acute Hospitalization 4/20/2010 64 Female 151 lb 4/29/2010 Pharmacist United States
Primary
Secondary
Concomitant
Sepsis Other Serious 3/1/2010 70 Male 5/13/2010 Physician United States
Primary
Concomitant
Ventricular Extrasystoles Other Serious Male 6/15/2010 Consumer United States
Primary
Secondary
Concomitant
International Normalised Ratio Increased Hospitalization 12/11/2009 77 Male 137 lb 12/30/2009 Pharmacist United States
Primary
Secondary
Renal Impairment Other Serious 8/2/2010 82 Female 8/24/2010 Other Health Professional United Kingdom
Primary
Concomitant
Atrial Thrombosis Hospitalization 3/30/2010 63 Male 170 lb 9/7/2010 Physician Canada
Primary
Secondary
Concomitant
Vascular Pseudoaneurysm Hospitalization 6/10/2010 78 Female 9/15/2010 United States
Primary
Concomitant
Vaginal Haemorrhage Other Serious 4/1/2010 73 Female 9/15/2010 Other Health Professional United States
Primary
Concomitant
Palpitations Other Serious 7/23/2010 74 Male 163 lb 9/22/2010 Other Health Professional United Kingdom
Primary
Concomitant
International Normalised Ratio Increased Required Intervention 11/2/2009 59 Male 11/3/2009 Pharmacist United States
Primary
Secondary
Venoocclusive Disease Other Serious 1/1/2008 68 Male 242 lb 10/12/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Cardiac Failure Congestive Other Serious 8/5/2010 78 Male 244 lb 10/15/2010 Physician Canada
Primary
Secondary
Concomitant
Syncope Hospitalization 8/28/2010 70 Female 150 lb 10/29/2010 Physician Canada
Primary
Secondary
Concomitant
Syncope Hospitalization 8/28/2010 70 Female 150 lb 11/5/2010 Physician Canada
Primary
Secondary
Concomitant
Liver Transplant Required Intervention 10/18/2010 72 Female 11/17/2010 Pharmacist United States
Primary
Secondary
Concomitant
International Normalised Ratio Increased Other Serious 9/28/2010 77 Male 244 lb 11/19/2010 Pharmacist United States
Primary
Secondary
Concomitant
Hepatic Enzyme Increased Hospitalization 12/2/2010 161 lb 12/17/2010 Physician Poland
Primary
Concomitant
Cardiac Failure Other Serious 1/24/2011 79 Female 98 lb 2/4/2011 Physician Japan
Primary
Secondary
Concomitant
Muscle Spasms 11/1/2010 68 Female 175 lb 2/12/2011 Physician United States
Primary
Secondary
Concomitant
Productive Cough Hospitalization 72 Male 5/19/2011 Other Health Professional United States
Primary
Concomitant
Cardiac Failure Other Serious 1/24/2011 79 Female 98 lb 6/7/2011 Physician Japan
Primary
Concomitant
Renal Failure Hospitalization 6/8/2011 74 Male 234 lb 6/22/2011 Physician Sweden
Primary
Concomitant
Transient Ischaemic Attack Hospitalization 4/6/2011 71 Male 6/23/2011 Physician Russian Federation
Primary
Concomitant
Bladder Disorder Hospitalization 12/8/2009 75 Female 126 lb 6/22/2011 Consumer United States
Primary
Secondary
Renal Failure Hospitalization 6/8/2011 74 Male 234 lb 6/28/2011 Physician Sweden
Primary
Concomitant
Dyspnoea Other Serious 5/20/2011 77 Female 6/29/2011 Other Health Professional United Kingdom
Primary
Concomitant
Blood Iron Increased Hospitalization 5/1/2011 89 Female 6/24/2011 Other Health Professional United States
Primary
Concomitant
Syncope Hospitalization 4/26/2011 76 Male 220 lb 7/1/2011 Physician United States
Primary
Concomitant
Renal Failure Hospitalization 5/25/2011 74 Male 234 lb 7/8/2011 Physician Sweden
Primary
Concomitant
Renal Failure Acute Other Serious 6/27/2011 79 Male 218 lb 7/8/2011 Physician Argentina
Primary
Concomitant
Renal Failure Acute Other Serious 6/27/2011 79 Male 218 lb 7/13/2011 Physician Argentina
Primary
Concomitant
Bladder Disorder Hospitalization 12/1/2010 75 Female 126 lb 7/15/2011 Consumer United States
Primary
Secondary
Cardiac Death Death 5/27/2011 73 Female 165 lb 7/15/2011 Physician Argentina
Primary
Concomitant
Cardiac Death Death 3/4/2011 79 Male 141 lb 7/15/2011 Physician Belgium
Primary
Concomitant
Cardiac Death Death 6/30/2011 70 Female 212 lb 7/15/2011 Physician Brazil
Primary
Concomitant
Atrial Flutter Hospitalization 5/1/2011 75 Male 265 lb 7/15/2011 Physician Israel
Primary
Concomitant
Rectal Haemorrhage Hospitalization 2/9/2011 80 Female 132 lb 7/15/2011 Physician Argentina
Primary
Concomitant
Aspartate Aminotransferase Increased Hospitalization 4/3/2011 74 Male 161 lb 7/15/2011 Physician Russian Federation
Primary
Concomitant
Cardiac Death Death 2/28/2011 78 Male 190 lb 7/15/2011 Physician United States
Primary
Concomitant
Ischaemic Stroke Hospitalization 6/15/2011 68 Female 146 lb 7/15/2011 Physician Ukraine
Primary
Concomitant
International Normalised Ratio Increased Hospitalization 4/10/2011 69 Female 154 lb 7/15/2011 Physician Czech Republic
Primary
Concomitant
Ischaemic Stroke Hospitalization 3/27/2011 76 Female 154 lb 7/15/2011 Physician United States
Primary
Concomitant
Cardiac Failure Hospitalization 5/18/2011 75 Male 185 lb 7/15/2011 Physician Brazil
Primary
Concomitant
Cardiac Failure Other Serious Female 7/18/2011 Physician Canada
Primary
Secondary
Concomitant
Pain Hospitalization 12/8/2009 75 Female 126 lb 7/18/2011 Consumer United States
Primary
Secondary
Hypertensive Crisis Hospitalization 3/15/2011 Male 254 lb 7/19/2011 Physician Russian Federation
Primary
Concomitant
Ventricular Tachycardia Hospitalization 5/5/2011 72 Female 229 lb 7/19/2011 Physician Denmark
Primary
Concomitant
Angina Unstable Hospitalization 4/24/2011 72 Female 280 lb 7/19/2011 Physician Finland
Primary
Concomitant
Cardiac Failure Other Serious 1/30/2011 84 Male 227 lb 7/19/2011 Physician United States
Primary
Concomitant
Cardiac Failure Hospitalization 2/13/2011 90 Male 170 lb 7/19/2011 Physician Israel
Primary
Concomitant
Implantable Defibrillator Insertion Hospitalization 4/8/2011 78 Male 262 lb 7/19/2011 Physician United States
Primary
Concomitant
Cardiac Failure Other Serious 11/8/2010 77 Female 163 lb 7/19/2011 Physician Czech Republic
Primary
Concomitant
Cardiac Failure Hospitalization 3/17/2011 68 Female 243 lb 7/19/2011 Physician Israel
Primary
Concomitant
Cardiac Failure Other Serious 11/1/2010 74 Male 157 lb 7/19/2011 Physician Czech Republic
Primary
Concomitant
Syncope Hospitalization 5/30/2011 70 Male 139 lb 7/19/2011 Physician Italy
Primary
Concomitant
Cardiac Failure Other Serious 1/18/2011 68 Female 163 lb 7/19/2011 Physician Denmark
Primary
Concomitant
Cardiac Failure Other Serious 11/12/2010 76 Male 165 lb 7/19/2011 Physician Czech Republic
Primary
Concomitant
Bradyarrhythmia Hospitalization 4/25/2011 66 Female 262 lb 7/19/2011 Physician Czech Republic
Primary
Concomitant
Cardiac Failure Other Serious 3/30/2011 72 Male 172 lb 7/19/2011 Physician Czech Republic
Primary
Concomitant
Hypertension Hospitalization 5/23/2011 84 Female 159 lb 7/19/2011 Physician Israel
Primary
Concomitant
Cardiac Failure Other Serious 2/5/2011 Male 216 lb 7/19/2011 Physician Czech Republic
Primary
Concomitant
Non-cardiac Chest Pain Hospitalization 6/22/2011 78 Female 163 lb 7/19/2011 Physician United States
Primary
Concomitant
Cardiac Failure Other Serious 2/2/2011 76 Female 185 lb 7/19/2011 Physician United States
Primary
Concomitant
Cardiac Failure Other Serious 3/1/2011 82 Male 223 lb 7/19/2011 Physician United States
Primary
Concomitant
Oedema Hospitalization 4/14/2011 78 Female 220 lb 7/19/2011 Physician France
Primary
Concomitant
Fluid Imbalance Hospitalization 3/28/2011 76 Female 187 lb 7/19/2011 Physician Denmark
Primary
Concomitant
Haemorrhage Hospitalization 1/18/2011 Female 207 lb 7/19/2011 Physician United States
Primary
Concomitant
Cardiac Failure Hospitalization 10/11/2010 80 Male 220 lb 7/19/2011 Physician United States
Primary
Concomitant
Dyspnoea Hospitalization 6/12/2011 78 Male 212 lb 7/19/2011 Physician Finland
Primary
Concomitant
Atrioventricular Block Hospitalization 6/22/2011 75 Female 88 lb 7/19/2011 Physician Mexico
Primary
Concomitant
Cardiac Failure Hospitalization 11/18/2010 Female 176 lb 7/19/2011 Physician United States
Primary
Concomitant
Bradyarrhythmia Hospitalization 6/12/2011 70 Female 229 lb 7/19/2011 Physician Russian Federation
Primary
Concomitant
Cardiac Failure Other Serious 2/1/2011 82 Male 240 lb 7/19/2011 Physician Israel
Primary
Concomitant
Cardiac Failure Other Serious 6/10/2011 67 Male 157 lb 7/19/2011 Physician Russian Federation
Primary
Concomitant
Cardiac Failure Other Serious 2/13/2011 90 Male 174 lb 7/19/2011 Physician United States
Primary
Concomitant
Cardiac Failure Other Serious 1/5/2011 75 Female 196 lb 7/19/2011 Physician United States
Primary
Concomitant
Cardiac Failure Hospitalization 5/15/2011 74 Male 256 lb 7/19/2011 Physician Russian Federation
Primary
Concomitant
Cardiac Failure Other Serious 5/8/2011 75 Female 240 lb 7/20/2011 Physician South Africa
Primary
Concomitant
Lip Injury Hospitalization 4/26/2011 76 Male 220 lb 7/20/2011 Physician United States
Primary
Concomitant
Angina Unstable Hospitalization 3/12/2011 70 Male 198 lb 7/20/2011 Physician Czech Republic
Primary
Concomitant
Cardiac Failure Hospitalization 3/3/2011 71 Female 150 lb 7/20/2011 Physician Brazil
Primary
Concomitant
Pulmonary Hypertension Hospitalization 1/20/2011 83 Female 198 lb 7/20/2011 Physician United States
Primary
Concomitant
Gastrointestinal Ulcer Haemorrhage Hospitalization 3/31/2011 78 Male 187 lb 7/20/2011 Physician Czech Republic
Primary
Concomitant
Cardiac Failure Other Serious 4/11/2011 76 Female 172 lb 7/20/2011 Physician Italy
Primary
Concomitant
Cardiac Failure Other Serious 4/16/2011 81 Male 179 lb 7/20/2011 Physician Slovakia (Slovak Republic)
Primary
Concomitant
Ventricular Tachycardia Hospitalization 5/30/2011 68 Male 185 lb 7/20/2011 Physician Canada
Primary
Concomitant
Renal Failure Chronic Hospitalization 1/7/2011 85 Male 159 lb 7/20/2011 Physician Korea, Republic Of
Primary
Concomitant
Pleural Effusion Hospitalization 3/28/2011 78 Male 185 lb 7/20/2011 Physician Australia
Primary
Concomitant
Cardiac Failure Other Serious 6/1/2011 68 Male 119 lb 7/20/2011 Physician Brazil
Primary
Concomitant
Respiratory Disorder Hospitalization 10/26/2010 84 Female 115 lb 7/20/2011 Physician United States
Primary
Concomitant
Mental Status Changes Hospitalization 4/21/2011 65 Male 236 lb 7/20/2011 Physician United States
Primary
Concomitant
Cardiac Failure Other Serious 3/1/2011 76 Male 207 lb 7/20/2011 Physician Canada
Primary
Concomitant
Cardiac Procedure Complication Hospitalization 2/16/2011 69 Female 157 lb 7/20/2011 Physician Sweden
Primary
Concomitant
Cardiac Failure Hospitalization 5/15/2011 71 Female 176 lb 7/20/2011 Physician United States
Primary
Concomitant
Myocardial Infarction Hospitalization 6/3/2011 70 Male 123 lb 7/20/2011 Physician Brazil
Primary
Concomitant
Cardiac Failure Hospitalization 4/27/2011 82 Male 146 lb 7/20/2011 Physician Spain
Primary
Concomitant
Cardiac Failure Other Serious 2/21/2011 72 Female 143 lb 7/20/2011 Physician Russian Federation
Primary
Concomitant
Cardiac Failure Other Serious 4/16/2011 84 Male 203 lb 7/20/2011 Physician United States
Primary
Concomitant
Chronic Obstructive Pulmonary Disease Hospitalization 2/21/2011 80 Female 194 lb 7/20/2011 Physician United States
Primary
Concomitant
Cardiac Failure Other Serious 12/14/2010 80 Female 128 lb 7/20/2011 Physician Norway
Primary
Concomitant
Atrial Fibrillation Other Serious 6/20/2011 71 Male 152 lb 7/20/2011 Physician Brazil
Primary
Concomitant
Cardiac Failure Hospitalization 12/18/2010 67 Male 278 lb 7/20/2011 Physician Canada
Primary
Concomitant
Pulmonary Embolism Hospitalization 5/6/2011 75 Female 258 lb 7/20/2011 Physician United States
Primary
Concomitant
Bradycardia Hospitalization 2/11/2011 73 Female 168 lb 7/20/2011 Physician Russian Federation
Primary
Concomitant
Cardiac Failure Other Serious 4/4/2011 71 Male 201 lb 7/20/2011 Physician Sweden
Primary
Concomitant
Cardiac Failure Hospitalization 3/1/2011 78 Male 289 lb 7/20/2011 Physician United States
Primary
Concomitant
Cardiac Failure Other Serious 2/7/2011 83 Male 190 lb 7/20/2011 Physician Australia
Primary
Concomitant
Cardiac Failure Other Serious 5/19/2011 79 Male 209 lb 7/20/2011 Physician Australia
Primary
Concomitant
Cardiac Failure Hospitalization 6/9/2011 72 Male 243 lb 7/20/2011 Physician Australia
Primary
Concomitant
Cardiac Failure Other Serious 5/27/2011 78 Male 205 lb 7/20/2011 Physician United States
Primary
Concomitant
Cardiac Failure Hospitalization 2/25/2011 75 Male 179 lb 7/20/2011 Physician Canada
Primary
Concomitant
Renal Failure Hospitalization 5/25/2011 Male 234 lb 7/20/2011 Physician Sweden
Primary
Concomitant
Cardiac Failure Hospitalization 12/28/2010 74 Male 225 lb 7/20/2011 Physician Canada
Primary
Concomitant
Cardiac Failure Hospitalization 12/4/2010 73 Female 185 lb 7/20/2011 Physician United States
Primary
Concomitant
Anaemia Hospitalization 4/18/2011 Male 190 lb 7/20/2011 Physician United States
Primary
Concomitant
Renal Cancer Hospitalization 4/22/2011 81 Male 192 lb 7/20/2011 Physician Israel
Primary
Concomitant
Haematoma Hospitalization 3/5/2011 74 Male 152 lb 7/20/2011 Physician Brazil
Primary
Concomitant
Pneumonia Bacterial Hospitalization 2/27/2011 Male 176 lb 7/20/2011 Physician Canada
Primary
Concomitant
Renal Failure Acute Hospitalization 2/2/2011 90 Female 185 lb 7/20/2011 Physician United States
Primary
Concomitant
Bronchopneumonia Hospitalization 5/27/2011 86 Male 132 lb 7/20/2011 Physician Brazil
Primary
Concomitant
Cardiac Failure Congestive Death 12/8/2010 79 Female 142 lb 7/22/2011 Physician Canada
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 6/27/2011 79 Male 218 lb 7/29/2011 Physician Argentina
Primary
Concomitant
Pain Hospitalization 5/1/2010 75 Female 278 lb 7/20/2011 Consumer United States
Primary
Secondary
Ventricular Tachycardia Hospitalization 1/1/2011 Female 165 lb 8/4/2011 Physician Israel
Primary
Concomitant
Cardiac Failure Other Serious 1/19/2011 76 Male 181 lb 8/4/2011 Physician Israel
Primary
Concomitant
Cardiac Death Death 2/28/2011 78 Male 190 lb 8/4/2011 Physician United States
Primary
Concomitant
Cardiac Failure Death 6/25/2011 85 Female 163 lb 8/4/2011 Physician Czech Republic
Primary
Concomitant
Death Death 79 Male 154 lb 8/4/2011 Physician Canada
Primary
Concomitant
Ischaemic Stroke Hospitalization 7/5/2011 80 Female 176 lb 8/4/2011 Physician Russian Federation
Primary
Concomitant
Cerebrovascular Accident Hospitalization 7/3/2011 65 Male 225 lb 8/4/2011 Physician Russian Federation
Primary
Concomitant
Hypertension Hospitalization 4/5/2011 88 Female 165 lb 8/4/2011 Physician Russian Federation
Primary
Concomitant
Cardiac Failure Hospitalization 7/6/2011 73 Female 187 lb 8/4/2011 Physician Russian Federation
Primary
Concomitant
Angina Pectoris Hospitalization 3/11/2011 72 Male 198 lb 8/4/2011 Physician Russian Federation
Primary
Concomitant
Cardiac Failure Hospitalization 6/28/2011 88 Male 163 lb 8/4/2011 Physician United States
Primary
Concomitant
Cardiac Pacemaker Insertion Hospitalization 10/21/2010 71 Male 185 lb 8/4/2011 Physician United States
Primary
Concomitant
Upper Limb Fracture Hospitalization 4/26/2011 76 Male 220 lb 8/5/2011 Physician United States
Primary
Concomitant
Renal Failure Hospitalization 5/25/2011 74 Male 234 lb 8/5/2011 Physician Sweden
Primary
Concomitant
Angina Unstable Hospitalization 6/16/2011 72 Female 146 lb 8/5/2011 Physician United States
Primary
Concomitant
Implantable Defibrillator Insertion Hospitalization 4/8/2011 78 Male 262 lb 8/12/2011 Physician United States
Primary
Concomitant
Erysipelas Hospitalization 5/5/2011 72 Female 229 lb 8/12/2011 Physician Denmark
Primary
Concomitant
Cardiac Failure Hospitalization 2/2/2011 90 Female 185 lb 8/12/2011 Physician United States
Primary
Concomitant

Drug Data