Lovaza combined with Warfarin Sodium

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Medication Error Other Serious 7/1/2007 8/27/2007 United States
Primary
Secondary
Concomitant
High Density Lipoprotein Decreased Other Serious 1/1/2007 61 Male 202 lb 9/18/2007 Other Health Professional United States
Primary
Concomitant
Off Label Use 1/1/2007 75 Male 12/10/2007 United States
Primary
Concomitant
Unevaluable Event Hospitalization 65 Male 1/21/2008 Norway
Primary
Secondary
International Normalised Ratio Fluctuation Other Serious 8/28/2007 69 Male 190 lb 3/24/2008 Consumer United States
Primary
Concomitant
Prothrombin Level Decreased Other Serious Male 3/25/2008 United States
Primary
Concomitant
Therapeutic Response Decreased 2/10/2008 Male 4/14/2008 Consumer United States
Primary
Concomitant
Heart Rate Decreased 2/10/2008 Male 4/30/2008 Consumer United States
Primary
Concomitant
Therapeutic Response Decreased 2/10/2008 Male 5/19/2008 Consumer United States
Primary
Concomitant
Weight Increased Other Serious 4/1/2008 42 Female 8/5/2008 Consumer United States
Primary
Concomitant
Nausea 2/19/2008 71 Female 131 lb 7/14/2008 Physician United States
Primary
Concomitant
Urinary Tract Infection 3/1/2008 70 Female 7/7/2008 Consumer United States
Primary
Concomitant
Heart Rate Increased Other Serious 8/15/2008 Male 271 lb 8/26/2008 United States
Primary
Concomitant
Sinus Headache 4/23/2008 Male 193 lb 8/27/2008 United States
Primary
Concomitant
Flushing 4/1/2008 Male 8/27/2008 United States
Primary
Concomitant
Pancreatitis Other Serious 65 Female 10/7/2008 Physician United States
Primary
Concomitant
Weight Decreased Other Serious 65 Female 217 lb 10/29/2008 Physician United States
Primary
Concomitant
Blood Triglycerides Increased 66 Female 12/4/2008 Physician
Primary
Concomitant
Dry Mouth 4/1/2008 80 Male 12/19/2008 Consumer United States
Primary
Concomitant
Weight Increased 57 Male 2/16/2009 Pharmacist United States
Primary
Secondary
Concomitant
Flushing Male 2/24/2009 United States
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Hospitalization 2/28/2009 70 Male 201 lb 3/4/2009 Pharmacist United States
Primary
Secondary
Concomitant
Skin Discolouration Other Serious 2/28/2009 Male 206 lb 3/25/2009 Other Health Professional United States
Primary
Concomitant
Skin Discolouration Other Serious 2/28/2009 Male 206 lb 4/17/2009 Other Health Professional United States
Primary
Concomitant
Kidney Infection Other Serious 65 Female 176 lb 5/21/2009 Consumer United States
Primary
Concomitant
Small Intestinal Haemorrhage Hospitalization 1/19/2009 76 Male 6/15/2009 Pharmacist United States
Primary
Concomitant
Chest Pain Hospitalization Female 6/25/2009 Physician United States
Primary
Concomitant
Lipase Increased Other Serious 1/1/2008 66 Male 8/13/2009 Consumer United States
Primary
Concomitant
Erythema Male 194 lb 8/21/2009 Consumer United States
Primary
Concomitant
Flushing Male 8/22/2009 United States
Primary
Concomitant
Cardiac Flutter 11/16/2008 Male 8/22/2009 United States
Primary
Concomitant
Palpitations Hospitalization 78 Female 9/16/2009 United States
Primary
Concomitant
Quality Of Life Decreased Hospitalization 78 Female 9/25/2009 United States
Primary
Concomitant
Headache Other Serious 9/1/2009 62 Female 201 lb 10/9/2009 Consumer United States
Primary
Secondary
Concomitant
Rheumatoid Arthritis Hospitalization 12/28/2008 Male 10/16/2009 United Kingdom
Primary
Concomitant
Palpitations Other Serious 9/5/2009 Male 10/28/2009 Other Health Professional United States
Primary
Concomitant
Quality Of Life Decreased Hospitalization 78 Female 10/26/2009 United States
Primary
Concomitant
Urinary Tract Infection Hospitalization 7/23/2009 68 Female 226 lb 10/30/2009 Physician United States
Primary
Concomitant
International Normalised Ratio Decreased Other Serious 29 Male 282 lb 11/16/2009 Pharmacist United States
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 10/1/2008 Female 209 lb 11/20/2009 United States
Primary
Concomitant
Vomiting Hospitalization 7/23/2009 68 Female 226 lb 11/25/2009 Physician United States
Primary
Concomitant
Somnolence Hospitalization 1/1/2005 Female 173 lb 12/11/2009 Consumer United States
Primary
Concomitant
Pollakiuria 77 Male 12/9/2009 Consumer United States
Primary
Concomitant
Dehydration Hospitalization 12/15/2009 66 Male 202 lb 12/24/2009 Physician South Africa
Primary
Secondary
Concomitant
Rash Erythematous 3/9/2009 48 Male 1/4/2010 Consumer United States
Primary
Concomitant
Rash 5/1/2009 77 Female 1/4/2010 Consumer United States
Primary
Concomitant
Neutropenia Life Threatening 12/14/2009 Male 184 lb 1/20/2010 United States
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection Hospitalization 84 Female 1/7/2010 United States
Primary
Concomitant
Surgery Hospitalization 66 Male 1/12/2010 Lawyer United States
Primary
Concomitant
Neutropenia Other Serious 12/14/2009 Male 184 lb 2/9/2010 United States
Primary
Secondary
Concomitant
Vertebral Wedging Other Serious 1/1/2003 Female 2/20/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Dyspnoea Exertional 11/1/2009 Male 2/26/2010 Consumer
Primary
Concomitant
Death Death 2/17/2010 Female 3/3/2010 Consumer United States
Primary
Concomitant
Vertebral Wedging Other Serious 1/1/2003 Female 3/4/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Cerebral Haemorrhage Death Male 3/8/2010 Physician United States
Primary
Concomitant
Vertebral Wedging Other Serious 1/1/2003 Female 3/12/2010 Physician United States
Primary
Secondary
Concomitant
Colon Cancer Metastatic Death Female 3/17/2010 Physician United States
Primary
Concomitant
Vertebral Wedging Other Serious 1/1/2003 Female 3/26/2010 Physician United States
Primary
Secondary
Concomitant
Dyspnoea Exertional 11/1/2009 82 Male 205 lb 4/1/2010 Consumer
Primary
Concomitant
Tendon Rupture Other Serious 3/3/2010 81 Female 160 lb 3/25/2010 Physician United States
Primary
Concomitant
Weight Increased Other Serious 5/1/2009 68 Male 273 lb 2/20/2010 United States
Primary
Concomitant
Renal Failure Acute Hospitalization Female 259 lb 4/13/2010 Physician United States
Primary
Concomitant
Vertebral Wedging Other Serious 1/1/2000 61 Female 4/20/2010 Physician United States
Primary
Secondary
Concomitant
Enterovesical Fistula Hospitalization 1/19/2010 79 Male 150 lb 4/23/2010 Physician South Africa
Primary
Secondary
Concomitant
Urethral Stenosis Hospitalization 11/14/2009 79 Male 150 lb 4/26/2010 Physician South Africa
Primary
Secondary
Concomitant
Pain In Extremity Hospitalization 34 Male 262 lb 4/29/2010 Consumer United States
Primary
Secondary
Concomitant
Intestinal Stenosis Other Serious 1/1/2009 50 Male 305 lb 4/30/2010 Consumer United States
Primary
Concomitant
Pain In Extremity Hospitalization 34 Male 262 lb 5/10/2010 Consumer United States
Primary
Secondary
Concomitant
Vertebral Wedging Other Serious 1/1/2000 61 Female 5/12/2010 United States
Primary
Secondary
Concomitant
Vertebral Wedging Other Serious 1/1/2000 61 Female 5/28/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 6/6/2010 74 Female 6/24/2010 Physician United States
Primary
Concomitant
Pulmonary Fibrosis 2/23/2009 84 Female 128 lb 6/30/2010 Physician United States
Primary
Concomitant
Pruritus Hospitalization 1/1/2009 70 Male 185 lb 6/30/2010 Consumer United States
Primary
Concomitant
Somnolence 3/1/2007 82 Male 172 lb 7/12/2010 Consumer United States
Primary
Concomitant
Product Substitution Issue Required Intervention 6/14/2010 53 Female 250 lb 7/12/2010 United States
Primary
Concomitant
Thrombosis Other Serious 6/22/2010 73 Female 7/23/2010 Consumer United States
Primary
Concomitant
Product Quality Issue 8/1/2009 74 Female 152 lb 8/13/2010 Other Health Professional United States
Primary
Concomitant
Pruritus Female 170 lb 8/27/2010 United States
Primary
Concomitant
Flushing Female 210 lb 8/28/2010 United States
Primary
Concomitant
Headache 11/1/2009 57 Male 180 lb 8/28/2010 United States
Primary
Concomitant
Flushing Male 185 lb 8/28/2010 United States
Primary
Concomitant
Flushing 1/1/2009 78 Female 152 lb 8/28/2010 United States
Primary
Concomitant
Vascular Graft Other Serious 1/1/2003 56 Female 212 lb 8/30/2010 Consumer United States
Primary
Concomitant
Feeling Abnormal Life Threatening Female 8/30/2010 United States
Primary
Secondary
Concomitant
Pollakiuria 1/1/2010 87 Male 161 lb 8/31/2010 Consumer United States
Primary
Concomitant
International Normalised Ratio Increased Required Intervention 6/14/2010 53 Female 250 lb 8/27/2010 United States
Primary
Concomitant
Subdural Haematoma Other Serious 2/1/2010 59 Male 192 lb 9/14/2010 Other Health Professional Canada
Primary
Concomitant
Subdural Haematoma Other Serious 2/1/2010 59 Male 192 lb 9/15/2010 Other Health Professional Canada
Primary
Concomitant
Off Label Use Other Serious 5/25/2010 73 Female 130 lb 9/30/2010 Consumer United States
Primary
Concomitant
Vertebral Wedging Other Serious 1/1/2000 61 Female 10/7/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Vertebral Wedging Other Serious 1/1/2000 61 Female 10/19/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Off Label Use Other Serious 5/25/2010 73 Female 130 lb 10/21/2010 Consumer United States
Primary
Concomitant
Pain Required Intervention 5/1/2002 79 Male 140 lb 11/5/2010 United States
Primary
Concomitant
Drug Effect Decreased Other Serious 1/1/2006 77 Female 130 lb 10/20/2010 Physician United States
Primary
Concomitant
Constipation 11/1/2010 90 Male 200 lb 12/8/2010 Consumer United States
Primary
Concomitant
Drug Ineffective 11/1/2010 90 Male 200 lb 12/21/2010 Consumer United States
Primary
Concomitant
Palpitations Hospitalization 62 Male 277 lb 12/29/2010 United States
Primary
Secondary
Concomitant
Cellulitis Other Serious 9/2/2010 81 Female 148 lb 1/25/2011 Consumer United States
Primary
Concomitant
Toxicity To Various Agents Hospitalization 1/14/2011 70 Female 2/1/2011 Consumer United States
Primary
Secondary
Concomitant
International Normalised Ratio Increased Life Threatening 1/14/2011 70 Female 2/4/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Dizziness 79 Male 2/28/2011 Consumer United States
Primary
Concomitant
International Normalised Ratio Increased Life Threatening 1/14/2011 70 Female 3/3/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Myocardial Infarction Other Serious 10/1/2010 58 Male 217 lb 5/6/2011 Physician United States
Primary
Concomitant
Ear Infection Fungal Hospitalization 9/13/2010 43 Female 190 lb 4/28/2011 Physician United States
Primary
Secondary
Concomitant
Fluid Retention Other Serious 5/1/2011 73 Male 5/23/2011 Consumer United States
Primary
Concomitant
Metastases To Lung Death 66 Male 5/13/2011 Lawyer United States
Primary
Concomitant
Osteopenia 6/1/2010 60 Female 263 lb 5/26/2011 Consumer United States
Primary
Concomitant
Subdural Haematoma Hospitalization 2/1/2010 59 Male 192 lb 6/7/2011 Other Health Professional Canada
Primary
Concomitant
Leukopenia Other Serious 6/23/2010 51 Male 6/22/2011 Physician United States
Primary
Concomitant
Foot Deformity Hospitalization Female 6/30/2011 Consumer United States
Primary
Concomitant
Insomnia Hospitalization 7/1/2011 74 Male 178 lb 7/18/2011 Consumer United States
Primary
Secondary
Concomitant
Chronic Right Ventricular Failure Other Serious 7/23/2005 84 Female 7/18/2011 Physician United States
Primary
Secondary
Concomitant
Headache Other Serious 6/29/2011 78 Female 7/19/2011 Other Health Professional United States
Primary
Concomitant
Pulmonary Hypertension Hospitalization 1/20/2011 83 Female 198 lb 7/20/2011 Physician United States
Primary
Concomitant
Epistaxis 1/1/2009 74 Female 152 lb 7/25/2011 Consumer United States
Primary
Concomitant
Blood Pressure Abnormal Hospitalization 6/1/2011 67 Male 272 lb 7/25/2011 Other Health Professional United States
Primary
Concomitant
Osteoarthritis Other Serious 1/1/2007 70 Female 8/1/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Movement Disorder Other Serious 6/29/2011 78 Female 8/5/2011 Other Health Professional United States
Primary
Concomitant
Muscle Spasms Female 128 lb 8/5/2011 Consumer United States
Primary
Concomitant
High Density Lipoprotein Decreased 1/1/2009 60 Male 8/5/2011 Consumer United States
Primary
Concomitant
Pruritus 12/1/2010 54 Male 243 lb 8/6/2011 Consumer United States
Primary
Concomitant
Flushing Male 205 lb 8/6/2011 Consumer United States
Primary
Concomitant
Cardiac Failure Congestive Other Serious 1/1/2001 62 Female 8/10/2011 Lawyer United States
Primary
Secondary
Concomitant
Pulmonary Hypertension Hospitalization 1/20/2011 83 Female 198 lb 8/17/2011 Physician United States
Primary
Secondary
Concomitant
Heart Rate Increased Hospitalization 6/1/2011 67 Male 272 lb 8/24/2011 Other Health Professional United States
Primary
Concomitant
Weight Decreased 6/9/2011 67 Male 8/26/2011 Consumer United States
Primary
Concomitant
Abnormal Loss Of Weight Hospitalization 7/1/2011 74 Male 178 lb 8/30/2011 Consumer United States
Primary
Secondary
Concomitant
Bronchopneumonia Other Serious 82 Male 229 lb 9/14/2011 Consumer United States
Primary
Concomitant
Stevens-johnson Syndrome Hospitalization 7/1/2011 74 Male 178 lb 9/22/2011 Consumer United States
Primary
Secondary
Concomitant
Pericardial Haemorrhage Death 1/14/2011 70 Female 9/23/2011 Consumer United States
Primary
Secondary
Concomitant
Atrial Flutter Hospitalization 6/9/2011 67 Male 272 lb 9/23/2011 Physician United States
Primary
Concomitant
Abscess Hospitalization 9/13/2010 43 Female 205 lb 9/19/2011 Physician United States
Primary
Secondary
Concomitant
Bradycardia Hospitalization 1/20/2011 83 Female 198 lb 10/5/2011 Physician United States
Primary
Secondary
Concomitant
Blood Creatinine Increased Other Serious 8/1/2011 10/13/2011 Consumer United States
Primary
Concomitant
Dyspepsia Other Serious 7/7/2011 62 Female 200 lb 10/14/2011 Consumer United States
Primary
Concomitant
International Normalised Ratio Increased Hospitalization 1/14/2011 70 Female 10/21/2011 Consumer United States
Primary
Secondary
Concomitant
Death Death 61 Male 11/2/2011 Consumer United States
Primary
Concomitant
Eructation Other Serious 7/7/2011 62 Female 200 lb 11/4/2011 Physician United States
Primary
Concomitant
Haemoptysis Other Serious 1/1/2011 89 Male 155 lb 10/27/2011 Consumer United States
Primary
Concomitant
Pain In Extremity Disability 74 Female 11/16/2011 Physician Canada
Primary
Secondary
Concomitant
Pyrexia Hospitalization 10/11/2011 80 Male 211 lb 11/17/2011 Other Health Professional United States
Primary
Concomitant
Oedema Peripheral Other Serious 1/1/2011 89 Male 155 lb 11/22/2011 Consumer United States
Primary
Concomitant
Energy Increased Other Serious 11/28/2011 57 Male 12/9/2011 Other Health Professional United States
Primary
Concomitant
Cardiomegaly Hospitalization 3/14/2008 66 Male 210 lb 12/7/2011 Lawyer United States
Primary
Concomitant
International Normalised Ratio Abnormal 12/20/2011 Consumer United States
Primary
Secondary
Hyperaesthesia 4/15/2011 75 Male 12/20/2011 Consumer United States
Primary
Concomitant
Product Quality Issue 7/3/2011 64 Male 12/20/2011 Consumer United States
Primary
Concomitant
Dyspnoea Hospitalization 5/6/2011 80 Male 1/17/2012 Consumer United States
Primary
Concomitant
Renal Disorder Hospitalization 7/1/2011 63 Female 1/20/2012 Consumer United States
Primary
Concomitant
Blood Pressure Increased 3/30/2011 69 Male 290 lb 1/27/2012 Consumer United States
Primary
Concomitant

Drug Data