Fluorouracil combined with Levofolinate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Convulsion Hospitalization 7/4/2006 45 Male 7/12/2006 Physician Portugal
Primary
Concomitant
Convulsion Hospitalization 7/4/2006 45 Male 7/27/2006 Physician Portugal
Primary
Concomitant
Convulsion Hospitalization 7/4/2006 45 Male 10/3/2006 Physician Portugal
Primary
Concomitant
Convulsion Hospitalization 7/4/2006 45 Male 10/18/2006 Physician Portugal
Primary
Concomitant
Vitreous Haemorrhage Other Serious 8/4/2008 Male 9/8/2008 Physician Japan
Primary
Secondary
Concomitant
Large Intestine Perforation Life Threatening 8/6/2008 Male 9/8/2008 Physician Japan
Primary
Secondary
Concomitant
Strabismus Other Serious 9/4/2008 80 Female 10/1/2008 Pharmacist Japan
Primary
Secondary
Concomitant
Disease Progression Death 7/1/2008 Male 146 lb 11/20/2008 Physician Japan
Primary
Secondary
Concomitant
Hepatitis Other Serious 6/11/2008 Female 135 lb 12/16/2008 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Aspiration Other Serious 1/10/2009 Male 90 lb 1/28/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Pulmonary Artery Thrombosis Other Serious 2/20/2008 73 Male 133 lb 2/11/2009 Physician Japan
Primary
Secondary
White Blood Cell Count Decreased Hospitalization 8/6/2008 Female 3/16/2009 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 1/10/2009 Male 90 lb 3/19/2009 Other Health Professional Japan
Primary
Concomitant
White Blood Cell Count Increased Other Serious 1/6/2009 Female 3/23/2009 Physician Japan
Primary
Concomitant
Gastrointestinal Perforation Hospitalization 11/5/2008 68 Male 3/31/2009 Physician Japan
Primary
Secondary
Intestinal Perforation Life Threatening 3/25/2009 41 Male 4/7/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Peritonitis Hospitalization 2/22/2009 Male 132 lb 4/8/2009 Physician Japan
Primary
Secondary
Concomitant
Urticaria Other Serious 2/4/2009 Female 121 lb 4/21/2009 Other Health Professional Japan
Primary
Concomitant
White Blood Cell Count Increased Other Serious 1/7/2009 Female 4/22/2009 Physician Japan
Primary
Secondary
Concomitant
Gastrointestinal Perforation Life Threatening 3/23/2009 Male 123 lb 4/23/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Hospitalization 1/8/2009 Male 143 lb 5/15/2009 Physician
Primary
Secondary
Concomitant
Interstitial Lung Disease Hospitalization 1/6/2009 Male 143 lb 6/10/2009 Physician
Primary
Secondary
Concomitant
Colitis Ischaemic Hospitalization 6/20/2009 Female 130 lb 7/8/2009 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 2/2/2009 Female 7/8/2009 Physician Japan
Primary
Secondary
Colitis Ischaemic Hospitalization 6/20/2009 Female 130 lb 7/17/2009 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 2/2/2009 Female 8/11/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 12/3/2008 Male 146 lb 9/10/2009 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 1/1/2009 Male 9/10/2009 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 8/18/2009 Male 161 lb 9/18/2009 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Embolism Hospitalization 12/13/2007 Male 9/28/2009 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 1/1/2009 Male 10/6/2009 Physician Japan
Primary
Secondary
Concomitant
Shock Life Threatening 9/28/2009 Female 10/23/2009 Other Health Professional Japan
Primary
Concomitant
Varicose Vein Ruptured Other Serious 9/28/2009 Female 11/4/2009 Physician Japan
Primary
Secondary
Ventricular Extrasystoles Life Threatening 9/17/2009 Female 117 lb 12/12/2009 Physician Japan
Primary
Secondary
Concomitant
Aortic Dissection Rupture Death 2/17/2009 Male 119 lb 12/15/2009 Pharmacist Japan
Primary
Concomitant
Nephrotic Syndrome Other Serious 8/10/2009 Male 159 lb 12/16/2009 Physician Japan
Primary
Secondary
Concomitant
Hypersensitivity Hospitalization 60 Female 12/18/2009 Pharmacist Japan
Primary
Concomitant
Rectal Perforation Hospitalization 6/18/2009 Male 141 lb 12/21/2009 Physician Japan
Primary
Concomitant
Nephrotic Syndrome Other Serious 8/10/2009 Male 159 lb 12/22/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Disability 10/1/2008 Male 121 lb 12/23/2009 Pharmacist Japan
Primary
Concomitant
Nephrotic Syndrome Other Serious 8/10/2009 Male 159 lb 12/24/2009 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 9/30/2009 Male 12/24/2009 Physician Japan
Primary
Secondary
Concomitant
Nephrotic Syndrome Other Serious 8/10/2009 Male 159 lb 12/30/2009 Physician Japan
Primary
Secondary
Concomitant
Shock Haemorrhagic Life Threatening 7/1/2009 Male 139 lb 12/31/2009 Physician Japan
Primary
Concomitant
Shock Haemorrhagic Life Threatening 7/1/2009 Male 139 lb 1/4/2010 Physician Japan
Primary
Secondary
Pneumonia Aspiration Death Male 1/4/2010 Physician Japan
Primary
Concomitant
Stomatitis Death 11/7/2009 Male 88 lb 1/13/2010 Physician Japan
Primary
Concomitant
Small Intestinal Perforation Hospitalization 1/1/2009 Male 137 lb 2/11/2010 Physician Japan
Primary
Concomitant
Peritonitis Hospitalization 1/1/2009 Male 137 lb 2/16/2010 Physician Japan
Primary
Concomitant
Hyperkalaemia Hospitalization 2/4/2010 Male 2/17/2010 Physician Japan
Primary
Secondary
Hypertension Hospitalization 2/4/2010 Male 2/22/2010 Physician Japan
Primary
Secondary
Hypertension Hospitalization 2/4/2010 Male 106 lb 2/24/2010 Physician Japan
Primary
Secondary
Hypertension Hospitalization 12/9/2009 Male 106 lb 3/11/2010 Physician Japan
Primary
Secondary
Necrotising Fasciitis Other Serious 5/1/2009 65 Male 3/15/2010 Physician Japan
Primary
Concomitant
Dyschezia Other Serious 1/1/2009 64 Male 3/18/2010 Physician Japan
Primary
Concomitant
Pulmonary Oedema Life Threatening 3/2/2010 Female 3/18/2010 Physician Japan
Primary
Secondary
Thrombosis Other Serious 50 Male 3/18/2010 Physician Japan
Primary
Concomitant
Septic Shock Other Serious 9/1/2009 Female 84 lb 3/18/2010 Physician Japan
Primary
Concomitant
Neutrophil Count Decreased Other Serious 10/10/2007 Male 3/22/2010 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Hospitalization 11/26/2007 Male 112 lb 3/23/2010 Physician Japan
Primary
Secondary
Concomitant
Non-cardiogenic Pulmonary Oedema Life Threatening 3/2/2010 Female 95 lb 3/23/2010 Physician Japan
Primary
Secondary
Concomitant
Urinary Tract Infection Other Serious 6/1/2009 Female 104 lb 3/24/2010 Physician Japan
Primary
Secondary
Concomitant
Suture Rupture Hospitalization 1/1/2009 78 Male 82 lb 3/25/2010 Physician Japan
Primary
Concomitant
Sepsis Life Threatening 12/12/2009 Male 121 lb 3/25/2010 Physician Japan
Primary
Concomitant
Pulmonary Thrombosis Life Threatening 1/26/2010 Male 117 lb 3/26/2010 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 2/16/2010 Male 104 lb 3/26/2010 Physician Japan
Primary
Concomitant
Disease Progression Death 55 Female 3/31/2010 Physician Japan
Primary
Concomitant
Septic Shock Other Serious 9/1/2009 66 Female 84 lb 4/2/2010 Physician Japan
Primary
Concomitant
Septic Shock Other Serious 76 Female 4/2/2010 Physician Japan
Primary
Concomitant
Vomiting Other Serious 1/6/2010 56 Male 148 lb 4/5/2010 Physician Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Other Serious 3/31/2009 79 Male 115 lb 11/5/2010 Physician Japan
Primary
Secondary
Concomitant
Volvulus Of Small Bowel Other Serious 1/1/2009 62 Male 148 lb 11/11/2010 Physician Japan
Primary
Secondary
Concomitant
Polymyositis Hospitalization 5/27/2009 57 Male 110 lb 11/22/2010 Physician Japan
Primary
Secondary
Myelodysplastic Syndrome Hospitalization 2/16/2009 55 Male 198 lb 11/29/2010 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Embolism Other Serious 7/8/2009 71 Male 139 lb 11/29/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Increased Death 7/7/2009 70 Male 134 lb 11/29/2010 Physician Japan
Primary
Secondary
Concomitant
Anaphylactic Shock Other Serious 8/2/2010 60 Female 86 lb 11/29/2010 Pharmacist Japan
Primary
Secondary
Concomitant
Anaphylactic Shock Other Serious 8/2/2010 60 Female 86 lb 11/29/2010 Pharmacist Japan
Primary
Secondary
Concomitant
Peritonitis Other Serious 51 Female 11/29/2010 Physician Japan
Primary
Concomitant
Cataract Hospitalization 1/1/2010 Male 121 lb 11/30/2010 Physician Japan
Primary
Concomitant
Varicose Vein Ruptured Other Serious 11/1/2010 55 Female 12/3/2010 Physician Japan
Primary
Concomitant
Shock Other Serious 7/7/2009 70 Male 134 lb 12/10/2010 Physician Japan
Primary
Secondary
Concomitant
Large Intestinal Ulcer Other Serious 65 Female 12/14/2010 Physician Japan
Primary
Concomitant
Sepsis Death 1/1/2008 77 Female 79 lb 12/16/2010 Physician Japan
Primary
Concomitant
Large Intestine Perforation Hospitalization 10/1/2009 67 Male 168 lb 12/16/2010 Physician Japan
Primary
Concomitant
Decreased Appetite Death 6/1/2010 70 Male 12/17/2010 Physician Japan
Primary
Concomitant
Tachycardia Death 8/1/2009 52 Male 150 lb 12/17/2010 Physician Japan
Primary
Secondary
Concomitant
Urinary Tract Infection Death 1/6/2009 78 Male 12/20/2010 Pharmacist Japan
Primary
Concomitant
Cardio-respiratory Arrest Death 12/10/2010 70 Male 12/20/2010 Physician Japan
Primary
Secondary
Interstitial Lung Disease Other Serious 12/14/2010 77 Male 12/23/2010 Other Health Professional Japan
Primary
Secondary
Congestive Cardiomyopathy Hospitalization 5/24/2010 68 Male 12/23/2010 Physician Japan
Primary
Secondary
Concomitant
Peritonitis Other Serious 11/11/2009 43 Female 134 lb 12/27/2010 Physician Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 11/1/2010 65 Male 12/30/2010 Physician Japan
Primary
Concomitant
Large Intestine Perforation Life Threatening 6/25/2010 72 Male 139 lb 12/30/2010 Other Health Professional Japan
Primary
Concomitant
Femoral Neck Fracture Other Serious 68 Male 12/30/2010 Pharmacist Japan
Primary
Concomitant
Malaise Other Serious 61 Female 12/30/2010 Physician Japan
Primary
Secondary
Concomitant
Pyothorax Hospitalization 6/18/2010 74 Female 121 lb 1/3/2011 Other Health Professional Japan
Primary
Concomitant
Peritonitis Life Threatening 6/24/2010 66 Male 104 lb 1/3/2011 Physician Japan
Primary
Concomitant
Chills Other Serious 6/18/2010 59 Female 132 lb 1/3/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Cytomegalovirus Gastrointestinal Infection Death 6/1/2010 70 Male 1/3/2011 Other Health Professional Japan
Primary
Concomitant
Hypoaesthesia Death 9/1/2009 75 Male 1/3/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Small Intestinal Perforation Hospitalization 12/2/2010 65 Male 1/20/2011 Physician Japan
Primary
Secondary
Interstitial Lung Disease Other Serious 12/20/2010 78 Female 2/4/2011 Other Health Professional Japan
Primary
Secondary
Interstitial Lung Disease Life Threatening 1/5/2011 59 Male 159 lb 2/16/2011 Other Health Professional Japan
Primary
Concomitant
Carotid Artery Occlusion Life Threatening 11/1/2010 50 Male 176 lb 2/16/2011 Other Health Professional Japan
Primary
Concomitant
Gastrointestinal Perforation Death 11/20/2007 69 Female 101 lb 2/16/2011 Physician Japan
Primary
Concomitant
Loss Of Consciousness Other Serious 9/17/2010 75 Male 132 lb 2/18/2011 Physician Japan
Primary
Concomitant
Rectal Perforation Other Serious 12/13/2010 45 Male 172 lb 2/18/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Other Serious 9/1/2010 78 Female 88 lb 2/21/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Delirium Other Serious 8/1/2009 52 Male 150 lb 2/22/2011 Physician Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Other Serious 3/18/2011 Male 3/30/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Diabetic Gangrene Other Serious 1/1/2009 71 Male 3/30/2011 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Infection Life Threatening 11/26/2010 77 Male 141 lb 4/1/2011 Physician Japan
Primary
Secondary
Concomitant
Jaundice Hospitalization 12/16/2010 4/1/2011 Physician Japan
Primary
Concomitant
Abscess Intestinal Life Threatening 12/1/2010 65 Male 141 lb 4/4/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Disability 6/2/2010 61 Female 75 lb 4/6/2011 Physician Japan
Primary
Concomitant
Short-bowel Syndrome Death 7/21/2010 58 Female 121 lb 4/11/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Ventricular Fibrillation Life Threatening 10/1/2010 72 Male 126 lb 4/12/2011 Physician Japan
Primary
Secondary
Concomitant
Abdominal Pain Upper Other Serious 3/12/2011 63 Male 4/14/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombosis Hospitalization 1/24/2011 63 Female 110 lb 4/14/2011 Other Health Professional Japan
Primary
Concomitant
Diarrhoea Other Serious 4/9/2011 Male 4/18/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Gastric Ulcer Hospitalization 1/13/2010 74 Female 108 lb 4/18/2011 Physician Japan
Primary
Secondary
Concomitant
Jaundice Hospitalization 12/16/2010 67 Male 4/20/2011 Physician Japan
Primary
Secondary
Concomitant
Dehydration Hospitalization Male 4/20/2011 Physician Japan
Primary
Secondary
Pulmonary Fibrosis Other Serious Male 4/21/2011 Other Health Professional Japan
Primary
Concomitant
Interstitial Lung Disease Life Threatening 1/5/2011 59 Male 159 lb 4/21/2011 Physician Japan
Primary
Concomitant
Erythema Hospitalization 11/1/2009 77 Female 4/25/2011 Physician Japan
Primary
Concomitant
Neuropathy Peripheral Hospitalization 71 Female 4/25/2011 Other Health Professional Japan
Primary
Concomitant
White Blood Cell Count Abnormal Hospitalization 3/12/2011 63 Male 4/26/2011 Physician Japan
Primary
Secondary
Concomitant
Disease Progression Hospitalization 10/1/2009 67 Male 168 lb 4/29/2011 Other Health Professional Japan
Primary
Concomitant
Septic Shock Death 60 Female 168 lb 4/29/2011 Physician Japan
Primary
Concomitant
Rash Hospitalization 12/20/2010 80 Male 119 lb 5/2/2011 Other Health Professional Japan
Primary
Concomitant
Disease Progression Death 12/26/2009 58 Male 5/3/2011 Physician Japan
Primary
Concomitant
Carotid Arterial Embolus Life Threatening 11/1/2010 50 Male 176 lb 5/4/2011 Other Health Professional Japan
Primary
Concomitant
Pulmonary Embolism Hospitalization 6/12/2010 52 Female 112 lb 5/19/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Drug Hypersensitivity Other Serious 10/11/2010 54 Male 128 lb 5/19/2011 Physician Japan
Primary
Secondary
Concomitant
Disease Progression Death 4/4/2011 58 Male 185 lb 5/19/2011 Other Health Professional Japan
Primary
Concomitant
Pneumonia Other Serious 8/30/2010 67 Male 5/23/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Intestinal Fistula Death 65 Male 3/21/2012 Physician Japan
Primary
Concomitant
Haematochezia Death 7/1/2010 46 Male 146 lb 3/21/2012 Other Health Professional Japan
Primary
Secondary
Concomitant
Altered State Of Consciousness Life Threatening 6/3/2011 79 Female 88 lb 3/21/2012 Physician Japan
Primary
Secondary
Concomitant
Small Intestinal Perforation Other Serious 57 Female 3/22/2012 Japan
Primary
Concomitant
Adverse Reaction Other Serious 1/1/2010 62 Male 3/22/2012 Japan
Primary
Concomitant
Thrombosis Other Serious 62 Male 3/22/2012 Japan
Primary
Concomitant
Psoas Abscess Other Serious 50 Male 3/22/2012 Japan
Primary
Concomitant
Interstitial Lung Disease Life Threatening 12/24/2010 58 Male 159 lb 3/23/2012 Other Health Professional Japan
Primary
Secondary
Concomitant
Rectal Cancer Metastatic Death 65 Male 3/28/2012 Physician Japan
Primary
Concomitant
Alanine Aminotransferase Increased Other Serious 3/14/2012 55 Male 3/28/2012 Physician Japan
Primary
Secondary
Concomitant
Abscess Intestinal Hospitalization 64 Male 3/28/2012 Japan
Primary
Concomitant
Gastrointestinal Perforation Other Serious 62 Male 3/28/2012 Physician Japan
Primary
Concomitant

Drug Data