Vitamin B-12 combined with Warfarin Sodium

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Urinary Tract Disorder Other Serious 12/1/2005 67 Male 3/29/2006 Physician Norway
Primary
Concomitant
Renal Failure Acute Hospitalization 1/27/2006 70 Male 196 lb 4/20/2006 Pharmacist United States
Primary
Concomitant
Visual Disturbance Other Serious 1/1/2006 62 Female 185 lb 7/5/2006 Consumer United States
Primary
Concomitant
Initial Insomnia 5/15/2006 72 Female 144 lb 7/12/2006 Consumer United States
Primary
Concomitant
International Normalised Ratio Increased Other Serious 6/28/2005 74 Male 181 lb 8/1/2006 Physician United States
Primary
Concomitant
Rectal Haemorrhage Other Serious 1/18/2006 78 Male 9/13/2006 Other Health Professional United States
Primary
Concomitant
Weight Decreased Hospitalization 7/1/2006 76 Male 185 lb 11/8/2006 Consumer United States
Primary
Concomitant
Death Death 10/17/2006 71 Male 11/17/2006 Other Health Professional United States
Primary
Concomitant
White Blood Cell Count Increased Hospitalization 11/27/2005 68 Male 212 lb 12/19/2006 Physician United Kingdom
Primary
Concomitant
Weight Decreased Hospitalization 7/1/2006 76 Male 185 lb 12/5/2006 Consumer United States
Primary
Concomitant
Drug Ineffective 8/1/2006 82 Male 12/28/2006 Consumer United States
Primary
Concomitant
Respiratory Distress Hospitalization 5/10/2005 63 Male 138 lb 1/19/2007 Physician United Kingdom
Primary
Concomitant
Peritonitis Hospitalization 11/27/2005 68 Male 212 lb 3/5/2007 Physician United Kingdom
Primary
Concomitant
Dyspnoea Other Serious 2/6/2007 97 Female 3/6/2007 Consumer Canada
Primary
Concomitant
Pulmonary Embolism Other Serious 3/29/2005 Female 3/28/2007 Physician United States
Primary
Concomitant
Rectal Prolapse Hospitalization 1/1/2006 79 Female 3/26/2007 Consumer United States
Primary
Concomitant
International Normalised Ratio Increased Hospitalization 11/20/2006 65 Male 143 lb 4/12/2007 Pharmacist United States
Primary
Secondary
Concomitant
Pulmonary Hypertension Other Serious Female 5/18/2007 Physician United States
Primary
Concomitant
Somnolence Other Serious 1/1/2006 Female 175 lb 5/23/2007 Consumer United States
Primary
Secondary
Concomitant
Palpitations Other Serious 83 Male 3/19/2007 Consumer United States
Primary
Concomitant
Vomiting Hospitalization 3/8/2007 94 Female 125 lb 4/25/2007 Pharmacist United States
Primary
Concomitant
Tongue Haematoma Hospitalization 6/7/2006 68 Female 8/1/2007 Pharmacist United States
Primary
Secondary
Concomitant
Somnolence Other Serious 1/1/2006 Female 159 lb 8/7/2007 Consumer United States
Primary
Secondary
Concomitant
Tremor Other Serious 1/1/2007 Female 190 lb 9/6/2007 United States
Primary
Secondary
Concomitant
Visual Acuity Reduced Hospitalization 6/21/2007 49 Female 9/7/2007 Other Health Professional United States
Primary
Concomitant
Transient Ischaemic Attack Hospitalization 6/1/2007 86 Female 165 lb 10/2/2007 Consumer United States
Primary
Concomitant
Weight Increased 68 Male 223 lb 10/4/2007 Consumer United States
Primary
Secondary
Concomitant
Palpitations Other Serious 83 Male 9/12/2007 Physician United States
Primary
Concomitant
Pharmaceutical Product Complaint 56 Male 10/25/2007 Consumer United States
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 7/19/2007 49 Female 104 lb 11/13/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Intestinal Perforation Life Threatening 9/26/2007 43 Female 200 lb 11/15/2007 Physician United States
Primary
Secondary
Concomitant
Gynaecomastia 4/1/2007 50 Male 12/20/2007 Consumer United States
Primary
Concomitant
Visual Disturbance 12/26/2007 66 Female 126 lb 2/16/2008 United States
Primary
Concomitant
Visual Disturbance 12/26/2007 66 Female 126 lb 2/27/2008 Other Health Professional United States
Primary
Concomitant
Post Procedural Complication Hospitalization 1/28/2008 86 Female 189 lb 2/22/2008 Other Health Professional United States
Primary
Concomitant
White Blood Cell Count Increased Hospitalization 8/1/2007 78 Male 3/19/2008 Consumer United States
Primary
Concomitant
White Blood Cell Count Increased Hospitalization 8/1/2007 78 Male 4/2/2008 Consumer United States
Primary
Concomitant
Electrocardiogram Qt Prolonged Other Serious 3/27/2008 76 Female 4/22/2008 Physician Canada
Primary
Concomitant
Electrocardiogram Qt Prolonged Other Serious 3/27/2008 76 Female 5/13/2008 Physician Canada
Primary
Concomitant
Vertigo Other Serious 5/1/2008 Female 5/22/2008 Physician Switzerland
Primary
Concomitant
White Blood Cell Count Increased Other Serious 12/1/2006 Male 6/25/2008 Physician Japan
Primary
Concomitant
Interacting
Blood Pressure Decreased Other Serious 82 Female 236 lb 6/25/2008 Consumer United States
Primary
Concomitant
Vertigo Other Serious 5/1/2008 Female 7/2/2008 Physician Switzerland
Primary
Concomitant
Peritonitis Life Threatening 6/6/2008 Male 7/17/2008 Consumer United States
Primary
Secondary
Concomitant
Peritonitis Life Threatening 6/6/2008 Male 7/25/2008 Consumer United States
Primary
Secondary
Concomitant
International Normalised Ratio Fluctuation 81 Female 172 lb 7/29/2008 Consumer United States
Primary
Secondary
Concomitant
Peritonitis Life Threatening 6/6/2008 Male 8/14/2008 Consumer United States
Primary
Secondary
Concomitant
Pulmonary Embolism Life Threatening 5/1/2008 82 Female 8/21/2008 Consumer Canada
Primary
Concomitant
Peritonitis Life Threatening 6/6/2008 Male 9/16/2008 Consumer United States
Primary
Secondary
Concomitant
Weight Increased Other Serious 1/1/2008 54 Female 9/15/2008 Consumer United States
Primary
Concomitant
Peritonitis Life Threatening 6/6/2008 Male 9/25/2008 Consumer United States
Primary
Secondary
Concomitant
Visual Field Defect Other Serious 6/1/2008 Female 10/7/2008 Physician United States
Primary
Secondary
Concomitant
Interacting
Thrombocytopenia Hospitalization 9/19/2008 Male 184 lb 10/13/2008 Physician United States
Primary
Concomitant
Thrombosis Other Serious 1/1/2001 Male 150 lb 11/24/2008 Consumer United States
Primary
Concomitant
Catheter Related Infection Other Serious 11/11/2008 Female 255 lb 12/12/2008 Other Health Professional United States
Primary
Concomitant
Upper Gastrointestinal Haemorrhage Hospitalization 1/23/2009 85 Male 180 lb 2/4/2009 Pharmacist United States
Primary
Secondary
Concomitant
Muscle Twitching Other Serious 2/18/2009 77 Female 133 lb 3/4/2009 Consumer United States
Primary
Concomitant
Pancytopenia Hospitalization 2/9/2009 Male 3/4/2009 Physician United States
Primary
Concomitant
Upper Gastrointestinal Haemorrhage Hospitalization 2/28/2009 70 Male 201 lb 3/4/2009 Pharmacist United States
Primary
Secondary
Concomitant
Swelling Hospitalization 10/1/2008 71 Male 345 lb 3/11/2009 Consumer United States
Primary
Secondary
Concomitant
Malaise Other Serious 2/6/2009 Female 3/13/2009 Consumer United States
Primary
Concomitant
Staphylococcal Infection Other Serious 2/12/2009 68 Male 3/30/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Somnolence Other Serious 2/6/2009 Female 4/28/2009 Consumer United States
Primary
Concomitant
Pulmonary Hypertension Other Serious 2/1/2009 Male 5/8/2009 Physician United States
Primary
Concomitant
Blood Pressure Increased 4/1/2009 Male 5/4/2009 Consumer United States
Primary
Concomitant
Swelling Hospitalization 10/1/2008 71 Male 345 lb 5/11/2009 Consumer United States
Primary
Secondary
Concomitant
Epilepsy Other Serious 63 5/13/2009 Pharmacist Canada
Primary
Secondary
Concomitant
Muscle Twitching Other Serious 2/18/2009 77 Female 133 lb 5/15/2009 Consumer United States
Primary
Concomitant
Sepsis Death 75 Male 5/19/2009 Consumer United States
Primary
Concomitant
Pulmonary Hypertension Other Serious 10/1/2008 Male 212 lb 5/22/2009 Physician United States
Primary
Concomitant
Pruritus Male 5/27/2009 United States
Primary
Concomitant
Epilepsy Other Serious 5/1/2009 63 6/5/2009 Pharmacist Canada
Primary
Secondary
Concomitant
Dyskinesia 10/2/2008 91 Male 170 lb 6/18/2009 Consumer United Kingdom
Primary
Concomitant
Interacting
Metabolic Encephalopathy Hospitalization 5/9/2009 Male 153 lb 7/7/2009 Pharmacist United States
Primary
Concomitant
Urinary Tract Infection Hospitalization 4/27/2009 Male 7/17/2009 Physician Canada
Primary
Secondary
Concomitant
Type 2 Diabetes Mellitus 1/1/2004 49 Male 144 lb 9/23/2009 United States
Primary
Concomitant
Pancytopenia Hospitalization 9/22/2009 Female 144 lb 10/19/2009 Physician United States
Primary
Concomitant
Myocardial Infarction Hospitalization 1/1/2009 81 Male 132 lb 10/21/2009 Other Health Professional United States
Primary
Concomitant
Weight Increased Other Serious 55 Male 215 lb 11/4/2009 United States
Primary
Concomitant
Urosepsis Other Serious 9/1/2009 Female 11/23/2009 Consumer United States
Primary
Concomitant
Thalassaemia Other Serious 76 Female 11/17/2009 United States
Primary
Concomitant
Weight Increased Other Serious 55 Male 215 lb 11/24/2009 Consumer United States
Primary
Concomitant
Thrombocytopenia Hospitalization 9/19/2008 Male 184 lb 12/1/2009 Physician United States
Primary
Concomitant
Weight Increased Other Serious 1/1/2008 54 Female 12/1/2009 Consumer United States
Primary
Concomitant
Weight Increased Other Serious 55 Male 215 lb 12/23/2009 Lawyer United States
Primary
Concomitant
Vasculitis Other Serious 11/1/2007 63 Male 1/8/2010 Lawyer United States
Primary
Concomitant
Large Intestinal Ulcer Hospitalization 11/18/2009 65 Female 1/15/2010 Consumer United States
Primary
Secondary
Concomitant
Visual Impairment Other Serious 10/30/2009 Female 1/23/2010 Other Health Professional United States
Primary
Secondary
Concomitant
White Blood Cell Count Increased Hospitalization 74 Female 164 lb 1/20/2010 United States
Primary
Concomitant
Vomiting Hospitalization 6/1/2009 Male 330 lb 1/30/2010
Primary
Concomitant
Intestinal Perforation Death Female 124 lb 2/2/2010 Consumer United States
Primary
Concomitant
Catheterisation Cardiac Hospitalization Female 235 lb 2/18/2010 Consumer United States
Primary
Concomitant
Coronary Artery Occlusion Other Serious 1/1/2008 78 Female 135 lb 2/22/2010 Consumer United States
Primary
Concomitant
Pulmonary Embolism Life Threatening 5/1/2008 82 Female 2/23/2010 Other Health Professional Canada
Primary
Concomitant
Wound Dehiscence Other Serious 9/1/2006 31 Female 194 lb 2/17/2010 Lawyer United States
Primary
Secondary
Concomitant
Weight Decreased Other Serious 1/1/2008 Male 179 lb 3/22/2010 Consumer United States
Primary
Concomitant
Pain In Extremity Other Serious 52 Male 3/25/2010 Pharmacist Canada
Primary
Concomitant
Weight Decreased Other Serious 11/1/2009 Female 3/24/2010 Consumer United States
Primary
Concomitant
Vasculitis Other Serious 11/1/2007 63 Male 262 lb 3/31/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Hearing Impaired Other Serious 3/17/2010 82 Male 3/30/2010 United States
Primary
Concomitant
Pneumonia Other Serious 1/22/2010 64 Male 4/7/2010 Physician United States
Primary
Concomitant
Postoperative Wound Infection Hospitalization 3/1/2010 53 Male 143 lb 4/8/2010 Other Health Professional Canada
Primary
Concomitant
Testicular Pain Other Serious 1/1/2007 46 Male 168 lb 4/13/2010 Lawyer United States
Primary
Concomitant
Urine Output Decreased Other Serious 10/1/2007 63 Male 193 lb 5/14/2010 Lawyer United States
Primary
Secondary
Concomitant
Renal Failure Hospitalization 9/3/2009 69 Female 103 lb 5/18/2010 Physician United States
Primary
Secondary
Concomitant
Dyspnoea Hospitalization 5/3/2010 70 Female 132 lb 5/18/2010 Physician United States
Primary
Secondary
Concomitant
Renal Failure Hospitalization 9/3/2009 69 Female 103 lb 5/27/2010 Physician United States
Primary
Secondary
Concomitant
Urine Output Decreased Hospitalization 4/22/2010 84 Male 253 lb 5/27/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Dyspnoea Hospitalization 5/3/2010 70 Female 132 lb 6/4/2010 Physician United States
Primary
Secondary
Concomitant
Pneumonia Other Serious 1/22/2010 64 Male 6/7/2010 Physician United States
Primary
Concomitant
Vomiting Other Serious 10/16/2002 75 Female 135 lb 6/22/2010 United States
Primary
Secondary
Concomitant
Pain In Extremity 10/1/2007 67 Female 190 lb 6/29/2010 Consumer United States
Primary
Concomitant
Vomiting Other Serious 10/16/2002 75 Female 135 lb 7/5/2010 United States
Primary
Secondary
Concomitant
Vitamin K Increased 1/1/2007 67 Female 157 lb 7/7/2010 Consumer United States
Primary
Secondary
Concomitant
Sleep Disorder Other Serious 1/1/2007 63 Male 181 lb 7/9/2010 Other Health Professional United States
Primary
Concomitant
Weight Decreased Other Serious 10/16/2002 75 Female 135 lb 7/19/2010 United States
Primary
Secondary
Concomitant
Medication Residue 4/1/2009 81 Male 244 lb 7/31/2010 Physician United States
Primary
Concomitant
Cerebral Infarction Other Serious Male 8/3/2010 Physician Japan
Primary
Concomitant
Drug Ineffective Male 155 lb 8/6/2010 Consumer United States
Primary
Concomitant
Weight Decreased Other Serious 10/16/2002 75 Female 135 lb 8/9/2010 United States
Primary
Secondary
Concomitant
Nausea Required Intervention 5/1/2008 63 Female 7/29/2010 United States
Primary
Concomitant
Thrombosis Other Serious 1/1/2010 62 Male 8/17/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Upper Limb Fracture Hospitalization 8/1/2010 73 Female 8/27/2010 Physician Canada
Primary
Concomitant
Muscle Spasms 5/1/2009 75 Female 150 lb 8/28/2010 United States
Primary
Concomitant
Flushing Male 200 lb 8/28/2010 United States
Primary
Concomitant
Paraesthesia 1/1/2010 73 Female 240 lb 8/28/2010 United States
Primary
Concomitant
Pruritus 2/1/2010 50 Female 185 lb 8/28/2010 United States
Primary
Concomitant
Anaemia Hospitalization 8/3/2010 57 Male 222 lb 8/31/2010 Physician United States
Primary
Secondary
Concomitant
Cerebral Infarction Other Serious Male 9/3/2010 Physician Japan
Primary
Concomitant
Microangiopathic Haemolytic Anaemia Hospitalization 8/3/2010 57 Male 223 lb 9/6/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Anaemia Hospitalization Male 222 lb 9/7/2010 Physician United States
Primary
Secondary
Concomitant
Skin Ulcer Hospitalization 63 Female 9/7/2010 Other Health Professional United States
Primary
Concomitant
Vision Blurred Required Intervention 3/1/2007 78 Male 178 lb 8/31/2010 United States
Primary
Concomitant
Cellulitis Other Serious 63 Female 9/9/2010 Consumer United States
Primary
Concomitant
Off Label Use Other Serious 5/25/2010 73 Female 130 lb 9/13/2010 Consumer United States
Primary
Concomitant
Wound Dehiscence Other Serious 9/1/2006 31 Female 194 lb 9/16/2010 Lawyer United States
Primary
Secondary
Concomitant
Vision Blurred Required Intervention 3/1/2008 78 Male 178 lb 9/16/2010 Consumer United States
Primary
Concomitant
Off Label Use Other Serious 5/25/2010 73 Female 130 lb 9/30/2010 Consumer United States
Primary
Concomitant
Catheterisation Cardiac Hospitalization Female 235 lb 10/6/2010 Physician United States
Primary
Concomitant
Vasculitis Other Serious 11/1/2007 63 Male 262 lb 10/12/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Urine Analysis Abnormal Other Serious 8/28/2006 66 Female 10/12/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Cerebral Artery Embolism Death 7/22/2010 Male 10/14/2010 Physician Japan
Primary
Concomitant
Weight Decreased Other Serious 10/16/2002 75 Female 134 lb 10/19/2010 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
Visual Impairment Other Serious 10/30/2009 84 Female 10/25/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Shock Other Serious Male 172 lb 10/25/2010 Physician Canada
Primary
Concomitant
Skin Cancer Other Serious Male 180 lb 10/27/2010 Other Health Professional Canada
Primary
Concomitant
White Blood Cell Count Increased Hospitalization 9/1/2010 53 Male 11/12/2010 Other Health Professional United States
Primary
Concomitant
Upper Limb Fracture Hospitalization 8/1/2010 73 Female 11/18/2010 Other Health Professional Canada
Primary
Concomitant
Gynaecomastia 79 Male 177 lb 11/16/2010 Consumer United States
Primary
Concomitant

Drug Data