Isosorbide Mononitrate combined with Warfarin Sodium

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Thrombosis Hospitalization 1/20/2001 Male 1/3/2006 France
Primary
Concomitant
Deep Vein Thrombosis Hospitalization 2/20/2002 Female 1/4/2006 Finland
Primary
Concomitant
Skin Oedema Other Serious 1/1/2005 79 Male 1/13/2006 United Kingdom
Primary
Secondary
Concomitant
Pancreatitis Acute Other Serious 1/7/2006 74 Male 1/18/2006 Other Health Professional United States
Primary
Concomitant
Renal Failure Chronic Life Threatening 12/11/2005 84 Female 88 lb 1/23/2006 Physician Japan
Primary
Concomitant
Pneumonitis Death 6/1/2005 69 Male 1/30/2006 United Kingdom
Primary
Concomitant
Pneumonitis Death 6/1/2005 69 Male 2/6/2006 United Kingdom
Primary
Concomitant
Skin Oedema Other Serious 1/1/2005 79 Male 2/7/2006 Physician United Kingdom
Primary
Secondary
Concomitant
Procedural Site Reaction Hospitalization 11/21/2005 Male 2/15/2006 Pharmacist United States
Primary
Concomitant
Renal Failure Chronic Life Threatening 12/11/2005 84 Female 88 lb 2/13/2006 Physician Japan
Primary
Concomitant
Vomiting Other Serious 8/1/2001 76 Female 99 lb 2/24/2006 Physician United Kingdom
Primary
Concomitant
Vomiting Other Serious 8/1/2001 76 Female 99 lb 3/2/2006 Physician United Kingdom
Primary
Concomitant
Myocardial Infarction Hospitalization 4/1/2004 60 Male 3/17/2006 Consumer Brazil
Primary
Concomitant
Haemolysis Other Serious 89 Male 3/23/2006 Pharmacist Japan
Primary
Concomitant
Myocardial Infarction Death 4/24/2004 67 Male 165 lb 4/24/2006 Physician United States
Primary
Concomitant
Sepsis Hospitalization 9/25/2005 Female 108 lb 5/1/2006 Other Health Professional United Kingdom
Primary
Concomitant
Treatment Noncompliance Hospitalization 2/26/2006 Male 258 lb 5/2/2006 Pharmacist United States
Primary
Secondary
Concomitant
Sepsis Hospitalization 9/25/2005 Female 108 lb 5/19/2006 Other Health Professional United Kingdom
Primary
Concomitant
Myocardial Infarction Life Threatening 12/1/2005 70 Female 126 lb 5/25/2006 Physician Japan
Primary
Secondary
Concomitant
Chest Pain Hospitalization 10/31/2004 89 Female 6/8/2006 Other Health Professional Sweden
Primary
Secondary
Concomitant
Vomiting Hospitalization 2/10/2004 81 Male 157 lb 7/2/2006 Physician Japan
Primary
Concomitant
Non-cardiac Chest Pain Hospitalization 2/23/2006 77 Female 6/23/2006 Physician United Kingdom
Primary
Concomitant
Non-cardiac Chest Pain Other Serious 2/23/2006 77 Female 6/27/2006 Physician United Kingdom
Primary
Concomitant
Delirium Hospitalization 7/9/2006 62 Male 7/25/2006 Physician Japan
Primary
Concomitant
Haematemesis Hospitalization 6/14/2006 72 Male 123 lb 7/7/2006 Pharmacist United States
Primary
Concomitant
Renal Impairment Disability 4/7/2006 77 Male 128 lb 7/21/2006 Physician Japan
Primary
Concomitant
Rhabdomyolysis Hospitalization 5/5/2001 77 Male 7/21/2006 United States
Primary
Concomitant
Skin Lesion 1/1/2005 Male 161 lb 8/4/2006 Other Health Professional United States
Primary
Concomitant
Multi-organ Failure Other Serious 7/2/2006 77 Female 99 lb 7/21/2006 Physician United Kingdom
Primary
Concomitant
Pancytopenia Hospitalization 6/30/2006 Male 8/3/2006 Other Health Professional Japan
Primary
Concomitant
Prothrombin Time Prolonged Hospitalization 6/1/2006 69 Male 8/10/2006 Physician Japan
Primary
Secondary
Concomitant
Logorrhoea Hospitalization 7/9/2006 62 Male 126 lb 8/18/2006 Physician Japan
Primary
Concomitant
Periorbital Oedema 5/1/2006 72 Male 143 lb 8/29/2006 Consumer United States
Primary
Concomitant
Pneumonia Hospitalization 2/25/2006 79 Female 8/29/2006 Denmark
Primary
Secondary
Concomitant
Blood Amylase Increased Other Serious 5/1/2005 78 Male 9/5/2006 United Kingdom
Primary
Concomitant
Intracranial Aneurysm Hospitalization 6/21/2006 Male 9/11/2006 Pharmacist United States
Primary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 6/20/2006 Male 9/11/2006 Pharmacist United States
Primary
Secondary
Concomitant
Sudden Death Death Male 9/14/2006 Physician Japan
Primary
Concomitant
Rash Required Intervention 5/13/2006 47 Female 242 lb 5/23/2006 Pharmacist United States
Primary
Concomitant
Visual Field Defect Other Serious 6/1/2006 58 Male 9/20/2006 Japan
Primary
Concomitant
Vasculitic Rash Hospitalization 5/18/2006 Male 9/21/2006 Pharmacist United States
Primary
Concomitant
Vasculitic Rash Hospitalization 5/18/2006 Male 9/21/2006 Pharmacist United States
Primary
Concomitant
Vasculitic Rash Hospitalization 5/18/2006 Male 9/21/2006 Pharmacist United States
Primary
Concomitant
Ill-defined Disorder Hospitalization 7/7/2006 82 Male 192 lb 10/4/2006 Pharmacist United States
Primary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 6/13/2006 77 Male 311 lb 10/4/2006 Pharmacist United States
Primary
Concomitant
Death Death 67 Female 162 lb 1/30/2006 Physician United States
Primary
Concomitant
Vomiting Hospitalization 1/26/2005 76 Female 110 lb 10/18/2006 Physician Japan
Primary
Secondary
Concomitant
Po2 Decreased Life Threatening 7/21/2006 70 Female 10/12/2006 United Kingdom
Primary
Secondary
Concomitant
Prothrombin Time Prolonged Other Serious 6/1/2006 69 Male 10/13/2006 Physician Japan
Primary
Secondary
Concomitant
Restlessness Hospitalization 9/20/2006 71 Male 95 lb 10/30/2006 Physician Japan
Primary
Concomitant
Pollakiuria Other Serious 7/1/2006 65 Female 88 lb 10/17/2006 Physician United Kingdom
Primary
Concomitant
White Blood Cell Count Increased Other Serious 1/2/2006 91 Female 86 lb 10/26/2006 Physician Japan
Primary
Concomitant
Thrombosis Other Serious 12/8/2005 84 Male 10/31/2006 United States
Primary
Concomitant
Vomiting Hospitalization 10/5/2006 91 Female 11/3/2006 Sweden
Primary
Secondary
Concomitant
Sudden Death Hospitalization 7/4/2005 Male 11/13/2006 Physician Japan
Primary
Concomitant
Somnolence Hospitalization 9/20/2006 71 Male 95 lb 11/13/2006 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 1/26/2005 76 Female 110 lb 11/17/2006 Physician Japan
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Hospitalization 8/10/2006 75 Male 231 lb 11/21/2006 Pharmacist United States
Primary
Secondary
Concomitant
Death Death 10/17/2006 71 Male 11/17/2006 Other Health Professional United States
Primary
Concomitant
Melaena Other Serious 3/15/1999 72 Male 169 lb 11/17/2006 Consumer United States
Primary
Secondary
Concomitant
Renal Impairment Disability 4/7/2006 77 Male 128 lb 11/20/2006 Physician Japan
Primary
Concomitant
Swelling Hospitalization 11/13/2006 71 Male 12/1/2006 Pharmacist Japan
Primary
Secondary
Concomitant
Neutropenia Hospitalization 12/4/2006 Female 176 lb 12/5/2006 Pharmacist United States
Primary
Concomitant
Traumatic Haemorrhage Other Serious 12/8/2005 84 Male 11/29/2006 United States
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 59 Male 12/8/2006 Physician Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 60 Male 12/15/2006 Japan
Primary
Secondary
Concomitant
Cerebral Infarction Hospitalization 5/31/2006 74 Female 111 lb 12/27/2006 Physician Japan
Primary
Concomitant
Thrombosis Other Serious 12/8/2005 84 Male 182 lb 1/15/2007 Other Health Professional United States
Primary
Concomitant
Ventricular Tachycardia Life Threatening 12/8/2005 73 Male 1/30/2007 United Kingdom
Primary
Concomitant
Haematoma Hospitalization 10/12/2006 77 Male 2/12/2007 Japan
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Hospitalization 9/13/2006 75 Male 231 lb 2/12/2007 Pharmacist United States
Primary
Concomitant
International Normalised Ratio Increased Other Serious 9/1/2006 46 Male 344 lb 3/27/2007 Physician United Kingdom
Primary
Concomitant
Melaena Hospitalization 1/22/2007 61 Male 3/28/2007 Pharmacist United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 3/15/2007 84 Female 3/30/2007 Physician United States
Primary
Concomitant
Drug Ineffective Hospitalization 3/4/2006 56 Female 120 lb 12/13/2006 Pharmacist United States
Primary
Concomitant
Diverticulum Intestinal Haemorrhagic Hospitalization 2/28/2006 80 Male 12/13/2006 Physician United States
Primary
Concomitant
Thrombocytopenia Hospitalization 78 Male 4/30/2007 Other Health Professional United States
Primary
Concomitant
Tachycardia Other Serious 82 Female 6/14/2007 Other Health Professional United States
Primary
Secondary
Wound Dehiscence Hospitalization 6/4/2007 Male 170 lb 6/7/2007 United States
Primary
Secondary
Concomitant
Therapeutic Product Ineffective Hospitalization 78 Male 198 lb 7/16/2007
Primary
Secondary
Lipids Abnormal Other Serious 6/1/2007 70 Female 121 lb 7/19/2007 Pharmacist United Kingdom
Primary
Concomitant
Haemorrhage Urinary Tract Other Serious 8/1/2006 84 Female 7/9/2007 Physician United States
Primary
Secondary
Concomitant
Drug Interaction Death 83 Male 8/16/2007 Sweden
Primary
Concomitant
Interacting
Oedema Peripheral Other Serious 5/15/2007 Male 8/20/2007 Physician United States
Primary
Secondary
Concomitant
Interacting
Mouth Ulceration Disability 5/8/2007 89 Female 9/10/2007 Other Health Professional United Kingdom
Primary
Concomitant
Myocardial Infarction Other Serious 6/27/2003 Female 228 lb 9/26/2007 Lawyer United States
Primary
Secondary
Concomitant
Head Injury Hospitalization 6/17/2007 Female 120 lb 11/13/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Pyrexia Hospitalization 11/2/2007 11/19/2007 Australia
Primary
Secondary
Concomitant
Nausea Other Serious 2/27/2007 62 Male 11/27/2007 Other Health Professional United Kingdom
Primary
Concomitant
Urinary Tract Infection Hospitalization 11/2/2007 Female 12/5/2007 Australia
Primary
Secondary
Concomitant
Depressed Mood 4/23/2007 Female 12/13/2007 Pharmacist United States
Primary
Concomitant
Death Death 78 Male 165 lb 1/28/2008 Pharmacist United Kingdom
Primary
Concomitant
International Normalised Ratio Decreased Other Serious 11/1/2007 Female 295 lb 1/29/2008 Physician United States
Primary
Concomitant
Interacting
Upper Gastrointestinal Haemorrhage Death 8/1/2002 68 Male 201 lb 2/1/2008 United States
Primary
Concomitant
Urethritis Hospitalization 1/30/2008 63 Male 2/4/2008 Norway
Primary
Concomitant
Polymyositis Hospitalization 12/1/2006 77 Male 2/18/2008 Other Health Professional Norway
Primary
Concomitant
Rhabdomyolysis Hospitalization 1/1/2007 79 Male 2/13/2008 Other Health Professional Israel
Primary
Concomitant
Rhabdomyolysis Hospitalization 1/1/2001 73 Male 3/5/2008 Physician United Kingdom
Primary
Concomitant
Muscle Injury Other Serious 3/20/2008 74 Female 4/2/2008 Consumer United States
Primary
Concomitant
Prothrombin Level Decreased Hospitalization 2/14/2008 67 Female 4/9/2008 Other Health Professional Sweden
Primary
Concomitant
Interacting
Peritonitis Hospitalization 3/15/2008 71 Male 201 lb 4/10/2008 Physician United States
Primary
Concomitant
Respiratory Arrest Other Serious 1/27/2007 71 Male 141 lb 4/14/2008 Japan
Primary
Concomitant
Weight Decreased Hospitalization 3/19/2008 85 Male 146 lb 4/17/2008 Pharmacist United States
Primary
Concomitant
Myocardial Infarction Other Serious 3/16/2002 45 Male 302 lb 4/29/2008 Consumer United States
Primary
Concomitant
Tremor Hospitalization 4/25/2008 Female 113 lb 4/28/2008 Pharmacist United States
Primary
Concomitant
Muscle Injury Other Serious 3/20/2008 74 Female 152 lb 5/2/2008 Consumer United States
Primary
Concomitant
Renal Failure Hospitalization 3/31/2008 80 Male 4/17/2008 United Kingdom
Primary
Concomitant
Tremor Hospitalization 4/20/2008 Female 112 lb 6/9/2008 Pharmacist United States
Primary
Concomitant
Urethritis Hospitalization 1/30/2008 63 Male 6/5/2008 Norway
Primary
Concomitant
Heart Rate Increased Other Serious 5/28/2008 79 Male 6/12/2008 Consumer United States
Primary
Concomitant
Haematuria Other Serious 6/3/2003 Male 7/7/2008 Other Health Professional Sweden
Primary
Concomitant
Interacting
Skin Chapped 1/1/2008 79 Male 7/25/2008 Consumer United States
Primary
Concomitant
International Normalised Ratio Fluctuation 81 Female 172 lb 7/29/2008 Consumer United States
Primary
Secondary
Concomitant
Myocardial Infarction Hospitalization 12/21/2005 82 Female 7/28/2008 Physician Japan
Primary
Concomitant
Rash Macular 7/11/2008 Female 8/29/2008 United States
Primary
Concomitant
Henoch-schonlein Purpura Hospitalization 4/27/2008 Male 8/27/2008 United States
Primary
Secondary
Concomitant
Sciatica Other Serious 8/7/2007 74 Female 198 lb 10/10/2008 Physician Australia
Primary
Concomitant
Myocardial Infarction Other Serious 3/16/2002 45 Male 302 lb 10/14/2008 Consumer United States
Primary
Concomitant
Syncope Hospitalization 6/1/2008 87 135 lb 11/25/2008 Consumer United States
Primary
Concomitant
Haemoglobin Decreased 9/1/2008 Female 250 lb 12/12/2008 United States
Primary
Secondary
Concomitant
Syncope Hospitalization 11/1/2008 75 Female 12/17/2008 Consumer United States
Primary
Concomitant
Product Quality Issue Death 4/7/2007 72 Male 170 lb 12/19/2008 Consumer United States
Primary
Concomitant
Product Quality Issue Hospitalization 8/6/2008 73 Male 205 lb 12/23/2008 Consumer United States
Primary
Concomitant
Pain Hospitalization 11/1/2008 74 Female 1/14/2009 Consumer United Kingdom
Primary
Secondary
Toxic Skin Eruption Hospitalization 11/14/2008 67 Male 1/29/2009 Consumer Japan
Primary
Concomitant
Myocardial Infarction Other Serious 1/1/2004 Male 209 lb 2/13/2009 Consumer United States
Primary
Concomitant
Sudden Death Death 12/7/2008 72 Male 2/13/2009 Physician United Kingdom
Primary
Concomitant
Pemphigoid Other Serious 12/12/2008 Female 3/5/2009 Physician United Kingdom
Primary
Concomitant
Sudden Death Death 1/6/2009 Male 220 lb 3/6/2009 United States
Primary
Concomitant
Pain In Extremity Hospitalization 9/21/2008 70 Male 3/23/2009 Slovakia (Slovak Republic)
Primary
Concomitant
Sudden Death Death 12/7/2008 Male 245 lb 3/30/2009 Physician United Kingdom
Primary
Concomitant
Vomiting Hospitalization 4/1/2005 69 Male 12/4/2008 United States
Primary
Secondary
Concomitant
Rhabdomyolysis Other Serious 1/1/2008 86 Female 4/20/2009 Physician Finland
Primary
Secondary
Concomitant
Lung Neoplasm Malignant Other Serious 12/1/2008 Male 4/21/2009 Consumer Switzerland
Primary
Concomitant
Rhabdomyolysis Other Serious 1/1/2008 86 Female 5/1/2009 Physician Finland
Primary
Secondary
Concomitant
Rhabdomyolysis Other Serious 1/1/2008 86 Female 5/13/2009 Physician Finland
Primary
Secondary
Concomitant
Swelling Face 1/1/2007 Female 120 lb 5/22/2009 United States
Primary
Concomitant
Syncope Death 1/6/2009 79 Female 5/18/2009 United Kingdom
Primary
Secondary
Concomitant
International Normalised Ratio Increased 4/14/2009 73 Male 167 lb 5/14/2009 Other Health Professional United States
Primary
Secondary
Concomitant
International Normalised Ratio Increased Life Threatening 5/12/2009 80 Female 75 lb 5/29/2009 Physician Japan
Primary
Concomitant
Interacting
Product Quality Issue Other Serious 3/11/2009 Male 159 lb 6/3/2009 Pharmacist United Kingdom
Primary
Concomitant
International Normalised Ratio Increased Life Threatening 5/12/2009 80 Female 75 lb 6/9/2009 Physician Japan
Primary
Concomitant
Interacting
Small Intestinal Haemorrhage Hospitalization 1/19/2009 76 Male 6/15/2009 Pharmacist United States
Primary
Concomitant
International Normalised Ratio Increased Hospitalization 5/27/2009 74 Male 157 lb 6/26/2009 Other Health Professional United Kingdom
Primary
Concomitant
Interacting
Hand Deformity Other Serious 4/1/2009 Male 7/30/2009 Other Health Professional United Kingdom
Primary
Concomitant
Atrial Fibrillation Other Serious 10/1/2008 Male 7/31/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Hand Deformity Other Serious 4/1/2009 76 Male 8/6/2009 United Kingdom
Primary
Concomitant
Flushing 7/1/2008 Male 8/21/2009 United States
Primary
Concomitant
Vitreous Haemorrhage Other Serious 6/20/2009 Male 9/3/2009 Physician Switzerland
Primary
Secondary
Concomitant
Rash Pruritic 1/1/2008 75 Female 203 lb 9/3/2009 Lawyer United States
Primary
Concomitant

Drug Data