Sotalol Hcl combined with Warfarin Sodium

Reports:


Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Therapy Non-responder Other Serious Male 225 lb 1/18/2006 United States
Primary
Concomitant
Procedural Site Reaction Hospitalization 11/21/2005 Male 2/15/2006 Pharmacist United States
Primary
Concomitant
Psychotic Disorder Hospitalization 6/1/2005 59 Male 262 lb 2/28/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Visual Disturbance Hospitalization 6/1/2005 Male 263 lb 3/1/2006 Physician United States
Primary
Secondary
Concomitant
Wound Infection Staphylococcal Hospitalization 10/1/2005 77 Female 133 lb 2/22/2006 Physician United States
Primary
Concomitant
Psychotic Disorder Hospitalization 1/19/2006 59 Male 262 lb 3/10/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Treatment Noncompliance Hospitalization 57 Female 3/17/2006 United States
Primary
Secondary
Concomitant
Therapy Non-responder Hospitalization 64 Female 4/13/2006 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Rhabdomyolysis Other Serious 12/6/2004 83 Female 169 lb 2/21/2006 Pharmacist United States
Primary
Secondary
Concomitant
International Normalised Ratio Increased Other Serious 3/22/2006 81 Male 162 lb 5/8/2006
Primary
Secondary
Concomitant
Metabolic Acidosis Hospitalization 64 Female 5/8/2006 Consumer United Kingdom
Primary
Secondary
Concomitant
Renal Failure Hospitalization 64 Female 5/9/2006 Consumer United Kingdom
Primary
Secondary
Concomitant
International Normalised Ratio Increased Other Serious 3/22/2006 81 Male 162 lb 5/9/2006 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Pulmonary Embolism Death 12/26/2005 69 Female 5/24/2006 Other Health Professional United Kingdom
Primary
Concomitant
Middle Insomnia 1/25/2006 68 Female 130 lb 4/3/2006 Consumer United States
Primary
Concomitant
Middle Insomnia 2/8/2006 75 Male 180 lb 4/3/2006 Consumer United States
Primary
Concomitant
Viral Infection Hospitalization 69 Female 176 lb 6/16/2006 Canada
Primary
Concomitant
Interacting
Therapy Non-responder Hospitalization 64 Female 6/13/2006 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Pulmonary Embolism Death 12/26/2005 Female 6/28/2006 Other Health Professional United Kingdom
Primary
Concomitant
Nervous System Disorder Other Serious 58 Female 176 lb 7/14/2006 Physician United Kingdom
Primary
Secondary
Concomitant
Macular Oedema Other Serious 4/12/2006 Male 7/18/2006 Pharmacist United States
Primary
Concomitant
Syncope Hospitalization 5/16/2006 64 Male Pharmacist United States
Primary
Secondary
Concomitant
Renal Impairment Life Threatening 64 Female 8/12/2006 Physician United Kingdom
Primary
Secondary
Concomitant
Streptococcal Infection Hospitalization 10/8/2005 66 Female 9/13/2006 United States
Primary
Secondary
Concomitant
Blindness Unilateral Other Serious 1/1/2005 76 Male 10/11/2006 Sweden
Primary
Concomitant
Sepsis Hospitalization 10/30/2006 69 223 lb 12/15/2006 Other Health Professional United Kingdom
Primary
Concomitant
Thrombocytopenia Other Serious 62 Male 1/8/2007 Consumer United Kingdom
Primary
Secondary
Chest Pain Other Serious 7/7/2006 75 Male 165 lb 11/16/2006 United States
Primary
Concomitant
Vomiting Hospitalization 5/30/2003 56 Female 173 lb 2/15/2007 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Myopathy Required Intervention 72 Female 4/12/2007 Norway
Primary
Secondary
Concomitant
Torsade De Pointes Life Threatening 44 Female 5/9/2007 Consumer Canada
Primary
Secondary
Myalgia Other Serious 73 Male 198 lb 6/14/2007 Other Health Professional United Kingdom
Primary
Concomitant
Renal Failure Life Threatening 64 Female 8/6/2007 United Kingdom
Primary
Secondary
Concomitant
International Normalised Ratio Increased Other Serious 6/1/2007 62 Male 315 lb 8/21/2007 Pharmacist United States
Primary
Secondary
Concomitant
Ventricular Tachycardia Other Serious 9/14/2006 78 Male 8/30/2007 Physician Japan
Primary
Secondary
Concomitant
Ventricular Tachycardia Other Serious 9/14/2006 78 Male 9/7/2007 Physician United States
Primary
Secondary
Concomitant
Ventricular Tachycardia Other Serious 9/14/2006 78 Male 9/10/2007 Physician United States
Primary
Secondary
Concomitant
Renal Failure Other Serious 64 Female 9/7/2007 Physician United States
Primary
Secondary
Concomitant
Ventricular Tachycardia Other Serious 9/14/2006 78 Male 9/12/2007 Physician United States
Primary
Secondary
Concomitant
Renal Failure Life Threatening 64 Female 9/4/2007 United Kingdom
Primary
Secondary
Concomitant
Vision Blurred Hospitalization 68 Female 9/7/2007 Sweden
Primary
Concomitant
Walking Aid User Other Serious 46 Male 9/28/2007 Consumer United States
Primary
Secondary
Walking Aid User Other Serious 46 Male 10/4/2007 Consumer United States
Primary
Secondary
Aspartate Aminotransferase Increased Other Serious 2/24/2006 76 Female 175 lb 10/23/2007 Other Health Professional United States
Primary
Concomitant
Scrotal Pain 5/1/2007 73 Male 248 lb 10/9/2007 Consumer United States
Primary
Concomitant
Weight Decreased 12/1/2006 73 Male 276 lb 10/8/2007 Consumer United States
Primary
Concomitant
Renal Disorder Life Threatening 12/18/2007 70 Male 132 lb 2/20/2008 Physician Japan
Primary
Secondary
Concomitant
Hepatic Steatosis Other Serious 7/1/2005 65 Male 3/10/2008 Other Health Professional France
Primary
Concomitant
Skin Discolouration Other Serious 64 Female 3/21/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Renal Impairment Life Threatening 64 Female 3/31/2008 United Kingdom
Primary
Secondary
Concomitant
Rash Maculo-papular Life Threatening 2/15/2008 Male 346 lb 4/23/2008 Other Health Professional United States
Primary
Concomitant
Torsade De Pointes Other Serious 1/1/2004 44 Female 4/24/2008 Physician Canada
Primary
Concomitant
Myocardial Infarction Other Serious 3/16/2002 45 Male 302 lb 4/29/2008 Consumer United States
Primary
Concomitant
Pharmaceutical Product Complaint Other Serious 1/18/2008 59 Male 4/9/2008 Pharmacist United States
Primary
Concomitant
Cyst Other Serious Female 234 lb 4/30/2008 Consumer United Kingdom
Primary
Concomitant
Ventricular Tachycardia Hospitalization 7/27/2005 Male 6/2/2008 Other Health Professional France
Primary
Concomitant
International Normalised Ratio Decreased Other Serious 3/12/2008 81 Female 5/29/2008 United Kingdom
Primary
Secondary
Concomitant
Myalgia Other Serious Female 140 lb 6/5/2008 United States
Primary
Concomitant
Palpitations Hospitalization 1/1/2005 Female 5/28/2008 Consumer United States
Primary
Concomitant
Pemphigoid Hospitalization 10/2/2007 Female 215 lb 6/5/2008 Physician United Kingdom
Primary
Concomitant
Skin Discolouration Other Serious 64 Female 6/10/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Heart Rate Increased Other Serious 5/28/2008 79 Male 6/12/2008 Consumer United States
Primary
Concomitant
Palpitations Hospitalization 6/1/2000 Female 6/20/2008 Consumer United States
Primary
Concomitant
Spinal Fracture Other Serious 10/2/2007 Female 215 lb 6/27/2008 Physician United Kingdom
Primary
Concomitant
Renal Failure Hospitalization 75 Female 6/30/2008 Other Health Professional Sweden
Primary
Concomitant
Weight Decreased Hospitalization 80 Female 132 lb 7/14/2008 Physician Australia
Primary
Concomitant
Renal Failure Hospitalization 5/3/2008 Female 7/23/2008 Other Health Professional Sweden
Primary
Secondary
Concomitant
Intra-abdominal Haemorrhage Hospitalization 1/1/2007 72 Female 7/29/2008 Consumer United States
Primary
Secondary
Concomitant
International Normalised Ratio Abnormal 71 Male 7/29/2008 Consumer United States
Primary
Secondary
Concomitant
Pain Other Serious 6/17/2008 Female 145 lb 8/1/2008 Consumer United States
Primary
Concomitant
Pain Other Serious 6/1/2008 Female 145 lb 8/11/2008 Consumer United States
Primary
Secondary
Concomitant
Staphylococcal Sepsis Hospitalization 85 Female 8/22/2008 Other Health Professional Sweden
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 4/19/2000 Female 8/20/2008 Physician Canada
Primary
Concomitant
Urinary Tract Infection Other Serious 10/2/2007 Female 199 lb 8/29/2008 Physician United Kingdom
Primary
Concomitant
Paraesthesia 5/16/2008 Male 234 lb 8/29/2008 United States
Primary
Concomitant
International Normalised Ratio Increased 4/13/2008 91 Male 9/3/2008 Pharmacist United States
Primary
Concomitant
Confusional State 6/30/2008 93 Female 128 lb 9/2/2008 United States
Primary
Concomitant
Pain In Extremity Required Intervention 2/1/2007 68 Female 551 lb 8/29/2008 Consumer United States
Primary
Concomitant
Weight Decreased 6/1/2008 Male 193 lb 9/13/2008 Consumer United States
Primary
Concomitant
Joint Swelling Other Serious 6/27/2008 61 Male 238 lb 10/3/2008 Other Health Professional United Kingdom
Primary
Concomitant
Joint Swelling Other Serious 6/27/2008 61 Male 10/14/2008 Other Health Professional United Kingdom
Primary
Concomitant
Tachypnoea Hospitalization 5/6/2008 89 Female 10/15/2008 Pharmacist United States
Primary
Secondary
Joint Swelling Other Serious 6/27/2008 61 Male 238 lb 10/14/2008 Other Health Professional United Kingdom
Primary
Concomitant
Joint Swelling Other Serious 6/27/2008 61 Male 10/15/2008 United Kingdom
Primary
Concomitant
Skin Disorder Other Serious 64 Female 10/22/2008 United Kingdom
Primary
Secondary
Concomitant
Torsade De Pointes Life Threatening 11/25/2002 45 Female 10/31/2008 United Kingdom
Primary
Concomitant
Torsade De Pointes Other Serious 44 Female 11/3/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Product Quality Issue Life Threatening 11/8/2008 66 Female 180 lb 11/9/2008 United States
Primary
Concomitant
Respiratory Failure Hospitalization 5/1/2008 Male 11/20/2008 Other Health Professional United States
Primary
Concomitant
Nasal Congestion 9/22/2008 67 Male 11/14/2008 United States
Primary
Concomitant
Hyperhidrosis 8/1/2008 Male 11/26/2008 United States
Primary
Concomitant
Stomatitis Male 190 lb 11/26/2008 Other Health Professional United States
Primary
Concomitant
Rash Macular 10/12/2008 Female 11/26/2008 United States
Primary
Concomitant
Pyrexia Hospitalization 12/13/2006 63 Male 262 lb 12/5/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Weight Decreased 6/1/2008 Male 193 lb 12/12/2008 Consumer United States
Primary
Concomitant
Rash Macular 1/1/2008 81 Male 12/10/2008 Consumer United States
Primary
Secondary
Concomitant
Pyrexia Hospitalization 12/13/2006 63 Male 262 lb 12/23/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Swelling Face Hospitalization 3/19/2008 77 Male 215 lb 1/12/2009 United States
Primary
Concomitant
Weight Decreased Female 94 lb 1/29/2009 United States
Primary
Secondary
Weight Increased 57 Male 2/16/2009 Pharmacist United States
Primary
Secondary
Concomitant
Dyspnoea Other Serious 10/27/2008 Male 220 lb 2/23/2009 Physician United States
Primary
Concomitant
Ill-defined Disorder Other Serious 11/11/2008 Female 243 lb 3/3/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Muscle Twitching Other Serious 2/18/2009 77 Female 133 lb 3/4/2009 Consumer United States
Primary
Concomitant
Cerebrovascular Accident Hospitalization 3/25/2009 Female 175 lb 4/3/2009 Physician United States
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 3/20/2009 Male 181 lb 4/21/2009 Other Health Professional United Kingdom
Primary
Concomitant
Cerebrovascular Accident Hospitalization 3/25/2009 Female 175 lb 4/21/2009 Physician United States
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 3/20/2009 Male 181 lb 4/22/2009 Consumer United Kingdom
Primary
Concomitant
Cerebrovascular Accident Life Threatening 3/25/2009 Female 175 lb 5/6/2009 Physician United States
Primary
Concomitant
Supraventricular Extrasystoles Other Serious Male 216 lb 5/15/2009 United Kingdom
Primary
Concomitant
Hand Deformity Other Serious 4/1/2009 Male 7/30/2009 Other Health Professional United Kingdom
Primary
Concomitant
Skin Ulcer Hospitalization 7/6/2009 Male 213 lb 8/3/2009 Physician United Kingdom
Primary
Concomitant
Nausea Hospitalization 6/29/2007 75 Female 8/7/2009 Other Health Professional Australia
Primary
Secondary
Concomitant
Hand Deformity Other Serious 4/1/2009 76 Male 8/6/2009 United Kingdom
Primary
Concomitant
Erythema Male 194 lb 8/21/2009 Consumer United States
Primary
Concomitant
Flushing Male 8/22/2009 United States
Primary
Concomitant
Cerebrovascular Accident Life Threatening 3/25/2009 Female 175 lb 8/31/2009 Physician United States
Primary
Concomitant
Orthostatic Hypotension Other Serious 1/8/2009 Male 154 lb 11/2/2009 Physician Japan
Primary
Concomitant
Ventricular Tachycardia Hospitalization 75 Male 178 lb 10/26/2009 United States
Primary
Concomitant
Product Quality Issue Life Threatening 11/8/2008 66 Female 180 lb 11/9/2009 Consumer United States
Primary
Concomitant
Upper Respiratory Tract Infection Death 74 Male 11/4/2009 United States
Primary
Concomitant
Myalgia Other Serious 4/23/2007 73 Male 11/10/2009 Other Health Professional United Kingdom
Primary
Concomitant
Skin Exfoliation Other Serious 12/25/2006 79 Male 168 lb 11/23/2009 Other Health Professional United Kingdom
Primary
Concomitant
Death Death 11/11/2009 Male 212 lb 11/24/2009 Physician United States
Primary
Secondary
Concomitant
Orthostatic Hypotension Other Serious 1/8/2009 Male 154 lb 11/29/2009 Physician Japan
Primary
Concomitant
Rib Fracture Hospitalization 67 Male 11/18/2009 United States
Primary
Concomitant
Unevaluable Event Death 72 Female 11/18/2009 United States
Primary
Concomitant
Upper Respiratory Tract Infection Hospitalization 74 Male 196 lb 11/16/2009 United States
Primary
Concomitant
Thyroid Disorder Other Serious 4/21/2008 66 Female 137 lb 11/18/2009 United States
Primary
Concomitant
Skin Exfoliation Other Serious 12/25/2006 79 Male 12/2/2009 Other Health Professional United Kingdom
Primary
Concomitant
Circulatory Collapse Death 11/15/2009 84 Female 132 lb 12/3/2009 Other Health Professional United Kingdom
Primary
Concomitant
Skin Exfoliation Other Serious 12/25/2006 79 Male 168 lb 11/30/2009 United Kingdom
Primary
Concomitant
Vertigo Other Serious 73 Male 12/4/2009 Other Health Professional Australia
Primary
Concomitant
Skin Exfoliation Other Serious 12/25/2006 79 Male 168 lb 11/30/2009
Primary
Concomitant
Restlessness Other Serious 62 Male 11/28/2009 United States
Primary
Concomitant
Respiratory Arrest Death 12/4/2009 Male 166 lb 12/8/2009 Pharmacist United States
Primary
Concomitant
Respiratory Failure Other Serious 1/1/1999 42 Male 150 lb 12/10/2009 Lawyer United States
Primary
Concomitant
White Blood Cells Urine Positive Death 11/11/2009 75 Male 212 lb 12/4/2009 Physician United States
Primary
Secondary
Concomitant
Nausea 6/22/2009 88 Male 12/9/2009 Consumer United States
Primary
Concomitant
Vomiting Hospitalization 75 Female 12/28/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Swollen Tongue 7/24/2009 83 Female 143 lb 1/8/2010 Consumer United States
Primary
Secondary
Concomitant
Sudden Death Death 11/11/2009 75 Male 212 lb 12/24/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection Hospitalization 74 Male 196 lb 1/12/2010 United States
Primary
Concomitant
Pneumonia Streptococcal Hospitalization 2/11/2010 Male 175 lb 3/9/2010 United States
Primary
Concomitant
Use Of Accessory Respiratory Muscles Life Threatening 77 Male 3/6/2010 United Kingdom
Primary
Concomitant
Weight Decreased Other Serious 1/1/2008 Male 179 lb 3/22/2010 Consumer United States
Primary
Concomitant
Sepsis Hospitalization 12/1/2009 Female 147 lb 3/31/2010 Physician United Kingdom
Primary
Concomitant
Vomiting Hospitalization 79 Male 3/31/2010 United States
Primary
Concomitant
Flatulence 80 Male 181 lb 4/8/2010 Consumer United States
Primary
Concomitant
Rheumatoid Arthritis Disability 3/1/2010 72 Female 4/12/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
International Normalised Ratio Increased Required Intervention 12/28/2009 39 Female 104 lb 12/29/2009 Pharmacist United States
Primary
Concomitant