Fluorouracil combined with Levoleucovorin Calcium

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Blood Creatinine Increased Hospitalization 5/22/2007 Male 6/6/2007 Consumer United Kingdom
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 5/22/2007 Male 6/11/2007 Consumer United Kingdom
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Death 7/6/2007 55 Male 7/23/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Anaphylactoid Reaction Other Serious 8/19/2008 Male 123 lb 9/26/2008 Physician Japan
Primary
Concomitant
Haematemesis Life Threatening 9/20/2008 Female 10/14/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Generalised Erythema Other Serious 6/20/2008 10/24/2008 Physician Japan
Primary
Concomitant
Duodenal Stenosis Hospitalization 12/21/2007 Male 176 lb 10/30/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Thrombocytopenia Life Threatening 10/9/2008 35 Male 10/30/2008 Other Health Professional France
Primary
Secondary
Gastric Ulcer Life Threatening 9/20/2008 Female 10/31/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Interstitial Lung Disease Other Serious 10/15/2008 Male 132 lb 11/4/2008 Consumer Japan
Primary
Concomitant
Flushing Hospitalization 10/23/2008 Male 123 lb 11/4/2008 Consumer Japan
Primary
Concomitant
Plantar Erythema Other Serious 4/23/2008 Female 11/7/2008 Consumer Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Other Serious 4/2/2008 Male 115 lb 11/11/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Interstitial Lung Disease Life Threatening 12/22/2008 Male 1/30/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Interstitial Lung Disease Life Threatening 12/22/2008 Male 2/17/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Death 1/1/2008 Male 2/20/2009 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Infarction Hospitalization 2/3/2009 Male 141 lb 3/6/2009 Consumer United Kingdom
Primary
Concomitant
White Blood Cell Count Decreased Death 1/1/2008 Male 3/10/2009 Physician Japan
Primary
Secondary
Concomitant
Pancreatitis Acute Hospitalization 2/9/2009 Male 3/12/2009 Physician United Kingdom
Primary
Concomitant
Interstitial Lung Disease Life Threatening 12/22/2008 Male 3/13/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Death 1/1/2008 Male 4/20/2009 Physician Japan
Primary
Secondary
Concomitant
Malignant Neoplasm Progression Other Serious 10/15/2008 Male 132 lb 5/27/2009 Consumer Japan
Primary
Concomitant
Urinary Retention Hospitalization 4/28/2009 Male 6/5/2009 Physician Japan
Primary
Secondary
Concomitant
Pancreatitis Acute Hospitalization 2/9/2009 Male 6/5/2009 Physician United Kingdom
Primary
Concomitant
Humerus Fracture Hospitalization 3/25/2009 79 Female 96 lb 6/26/2009 Consumer United Kingdom
Primary
Concomitant
Renal Failure Acute Life Threatening 3/20/2009 Female 6/26/2009 Consumer United Kingdom
Primary
Concomitant
Urinary Retention Hospitalization 4/28/2009 Male 8/19/2009 Physician Japan
Primary
Secondary
Concomitant
Ileus Other Serious 6/8/2009 Male 8/26/2009 Consumer United Kingdom
Primary
Concomitant
Interstitial Lung Disease Life Threatening 12/22/2008 Male 9/16/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Urinary Retention Hospitalization 4/28/2009 Male 9/22/2009 Physician Japan
Primary
Secondary
Concomitant
Subdural Haematoma Death 4/7/2009 69 Male 10/28/2009 Consumer Japan
Primary
Secondary
Concomitant
Multi-organ Failure Hospitalization 62 Male 11/5/2009 Physician Japan
Primary
Concomitant
Neuropathy Peripheral Other Serious 7/13/2009 Male 11/6/2009 Physician Japan
Primary
Concomitant
Intestinal Obstruction Other Serious 62 Female 12/3/2009 Consumer United Kingdom
Primary
Concomitant
Paraesthesia Hospitalization 1/1/2009 60 Male 5/4/2010 Other Health Professional France
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 10/23/2010 69 Female 95 lb 12/14/2010 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Other Serious 6/1/2009 64 Female 3/2/2011 Physician Japan
Primary
Secondary
Concomitant
Osteonecrosis Of Jaw Other Serious 8/1/2009 64 Female 3/3/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Malaise Hospitalization 12/1/2010 63 Male 3/11/2011 Physician Japan
Primary
Concomitant
Stomatitis Other Serious 8/1/2009 64 Female 3/15/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Osteonecrosis Of Jaw Other Serious 6/1/2009 64 Female 3/18/2011 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Other Serious 8/1/2009 64 Female 3/29/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 12/3/2010 63 Male 3/31/2011 Physician Japan
Primary
Concomitant
Nausea Hospitalization 12/3/2010 63 Male 5/13/2011 Physician Japan
Primary
Concomitant
Stomatitis Other Serious 8/1/2009 64 Female 7/5/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Hypomagnesaemia Hospitalization 9/21/2010 77 Male 146 lb 10/3/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Colorectal Cancer Other Serious 9/21/2010 65 Male 121 lb 10/3/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Dermatitis Acneiform 8/5/2010 59 Male 141 lb 10/3/2011 Physician Japan
Primary
Concomitant
Back Pain Death 10/1/2007 65 Male 10/3/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Ileus Other Serious 7/10/2010 56 Male 146 lb 10/4/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Stomatitis Hospitalization 11/11/2010 58 Male 121 lb 10/5/2011 Physician Japan
Primary
Concomitant
Leukoencephalopathy Hospitalization 9/15/2011 72 Male 10/5/2011 Consumer Japan
Primary
Secondary
Concomitant
Septic Shock Death 8/1/2009 66 Female 83 lb 10/5/2011 Consumer Japan
Primary
Secondary
Concomitant
Colorectal Cancer Death 7/23/2010 59 Male 123 lb 10/6/2011 Physician Japan
Primary
Secondary
Concomitant
Hypocalcaemia Hospitalization 9/13/2010 74 Male 141 lb 10/6/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Transient Ischaemic Attack Hospitalization 8/26/2011 77 Male 121 lb 10/7/2011 Consumer Japan
Primary
Secondary
Concomitant
Skin Fissures Life Threatening 5/7/2011 83 Male 99 lb 10/7/2011 Other Health Professional Japan
Primary
Concomitant
Decreased Appetite Death 9/22/2010 77 Male 121 lb 10/7/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Hepatic Encephalopathy Other Serious 10/2/2010 66 Male 154 lb 10/7/2011 Other Health Professional Japan
Primary
Concomitant
Colorectal Cancer Other Serious 8/9/2010 61 Male 148 lb 10/10/2011 Other Health Professional Japan
Primary
Concomitant
Diarrhoea Hospitalization 2/9/2011 71 Female 123 lb 10/11/2011 Physician Japan
Primary
Concomitant
Dry Skin Hospitalization 10/19/2010 55 Male 108 lb 10/11/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Colorectal Cancer Death 10/18/2010 75 Female 115 lb 10/11/2011 Physician Japan
Primary
Concomitant
Thrombocytopenia Hospitalization 10/29/2010 73 Male 119 lb 10/11/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Rash Maculo-papular Death 10/27/2010 55 Male 119 lb 10/11/2011 Physician Japan
Primary
Concomitant
Haemorrhoids Other Serious 9/17/2010 50 Male 154 lb 10/12/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Stomatitis Disability 1/20/2011 72 Male 152 lb 10/12/2011 Consumer Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Death 71 Male 10/12/2011 Consumer Japan
Primary
Secondary
Concomitant
Decreased Appetite Death 10/24/2010 75 Female 121 lb 10/12/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Neuropathy Peripheral Hospitalization 8/24/2010 75 Male 112 lb 10/13/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Hyperammonaemia Other Serious 1/13/2011 70 Male 121 lb 10/14/2011 Physician Japan
Primary
Concomitant
Cholinergic Syndrome Hospitalization 9/22/2011 62 Male 157 lb 10/14/2011 Physician Japan
Primary
Secondary
Concomitant
Drug Hypersensitivity Other Serious 12/3/2010 66 Male 165 lb 10/14/2011 Physician Japan
Primary
Secondary
Concomitant
Skin Disorder Death 10/14/2010 52 Male 123 lb 10/14/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Drug Hypersensitivity Other Serious 1/1/2009 79 Male 10/18/2011 Other Health Professional Japan
Primary
Concomitant
Leukoencephalopathy Other Serious 9/14/2011 Male 117 lb 10/18/2011 Consumer Japan
Primary
Secondary
Concomitant
Haemorrhage Other Serious 75 Male 10/18/2011 Pharmacist Japan
Primary
Concomitant
Cerebral Infarction Other Serious 8/23/2011 75 Male 10/18/2011 Pharmacist Japan
Primary
Concomitant
Dermatitis Acneiform Hospitalization 9/7/2010 62 Male 95 lb 10/18/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Malaise Other Serious 86 Male 123 lb 10/19/2011 Physician Japan
Primary
Concomitant
Neutropenia Death 10/19/2011 Physician France
Primary
Secondary
Hypomagnesaemia Hospitalization 9/30/2010 59 Male 141 lb 10/19/2011 Other Health Professional Japan
Primary
Secondary
Abscess Other Serious 1/1/2008 69 Male 10/19/2011 Physician Japan
Primary
Concomitant
Haemoptysis Hospitalization 12/1/2010 69 Male 10/19/2011 Physician Japan
Primary
Secondary
Concomitant
Blood Potassium Increased Death 12/7/2010 67 Male 110 lb 10/19/2011 Physician Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Death 9/1/2011 71 Male 10/19/2011 Physician Japan
Primary
Concomitant
Hypersensitivity Other Serious 65 Male 10/20/2011 Other Health Professional Japan
Primary
Secondary
White Blood Cell Count Increased Death 1/27/2011 74 Male 110 lb 10/20/2011 Physician Japan
Primary
Secondary
Concomitant
Paronychia Hospitalization 7/27/2010 61 Female 168 lb 10/21/2011 Physician Japan
Primary
Concomitant
Hyperammonaemia Other Serious 8/26/2011 72 Female 10/21/2011 Physician Japan
Primary
Secondary
Concomitant
Diarrhoea Life Threatening 2/15/2011 66 Male 10/18/2011 Other Health Professional Italy
Primary
Concomitant
Death Death 7/7/2011 73 Male 112 lb 10/24/2011 Other Health Professional Japan
Primary
Secondary
Thrombosis Hospitalization 9/1/2011 76 Female 10/24/2011 Physician Japan
Primary
Concomitant
Blood Pressure Decreased Other Serious 6/30/2008 63 Male 10/24/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Stomatitis Hospitalization 11/11/2010 58 Male 121 lb 10/24/2011 Other Health Professional Japan
Primary
Concomitant
Dyspnoea Other Serious 67 Male 148 lb 10/24/2011 Physician Japan
Primary
Concomitant
Dermatitis Acneiform Death 8/11/2010 60 Male 150 lb 10/24/2011 Other Health Professional Japan
Primary
Concomitant
Condition Aggravated Life Threatening 8/4/2010 81 Male 126 lb 10/24/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Other Serious 8/18/2010 71 Male 10/25/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Neutrophil Count Decreased Other Serious 76 Male 10/25/2011 Japan
Primary
Concomitant
Device Occlusion Other Serious 12/8/2010 56 Male 128 lb 10/25/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Neutrophil Count Decreased Hospitalization 7/21/2010 71 Female 79 lb 10/26/2011 Physician Japan
Primary
Secondary
Concomitant
Fall Other Serious 8/19/2011 58 Female 10/21/2011 Other Health Professional Italy
Primary
Secondary
Concomitant
Mouth Ulceration Hospitalization 8/12/2010 63 Male 126 lb 10/26/2011 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 10/29/2010 70 Male 128 lb 10/26/2011 Physician Japan
Primary
Secondary
Interstitial Lung Disease Death 8/16/2011 65 Male 134 lb 10/27/2011 Physician Japan
Primary
Secondary
Concomitant
Dyschezia Other Serious 11/1/2010 71 Female 10/27/2011 Japan
Primary
Concomitant
Stomatitis Hospitalization 10/13/2010 70 Female 106 lb 10/27/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Stomatitis Hospitalization 8/31/2010 72 Male 176 lb 10/27/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Death 6/29/2011 75 Male 112 lb 10/27/2011 Other Health Professional Japan
Primary
Concomitant
Interstitial Lung Disease Hospitalization 7/29/2010 65 Male 104 lb 10/27/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Lower Gastrointestinal Haemorrhage Death 59 Male 101 lb 10/27/2011 Japan
Primary
Concomitant
Disease Progression Death 10/25/2009 61 Female 10/27/2011 Physician Japan
Primary
Concomitant
Chromaturia Hospitalization 9/1/2011 76 Female 10/27/2011 Physician Japan
Primary
Secondary
Hypocalcaemia Hospitalization 8/20/2010 59 Male 187 lb 10/28/2011 Other Health Professional Japan
Primary
Concomitant
Diarrhoea Life Threatening 9/14/2010 78 Male 137 lb 10/28/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Drug Hypersensitivity Other Serious 12/3/2010 66 Male 165 lb 10/28/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Ileus Hospitalization 7/6/2011 74 Male 10/28/2011 Physician Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 12/3/2010 76 Male 99 lb 10/31/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Glossodynia Death 9/21/2010 65 Male 121 lb 10/31/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Hyperammonaemia Other Serious 78 Male 10/31/2011 Pharmacist Japan
Primary
Secondary
Concomitant
Cardiac Failure Other Serious 9/16/2011 58 Male 11/1/2011 Physician Japan
Primary
Concomitant
Decreased Appetite Death 8/5/2010 70 Male 119 lb 11/1/2011 Physician Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Hospitalization 9/25/2011 72 Male 152 lb 11/2/2011 Physician Japan
Primary
Secondary
Concomitant
Congestive Cardiomyopathy Hospitalization 5/24/2010 68 Male 11/2/2011 Physician Japan
Primary
Secondary
Concomitant
Peptic Ulcer Other Serious 7/31/2010 60 Female 88 lb 11/2/2011 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Death 7/7/2011 73 Male 112 lb 11/3/2011 Physician Japan
Primary
Secondary
Gastrointestinal Anastomotic Leak Hospitalization 1/1/2009 64 Male 84 lb 11/3/2011 Physician Japan
Primary
Secondary
Concomitant
Aortic Dissection Rupture Other Serious 1/1/2011 63 Male 119 lb 11/3/2011 Physician Japan
Primary
Concomitant
Gastric Ulcer Hospitalization 9/22/2011 62 Male 157 lb 11/3/2011 Physician Japan
Primary
Secondary
Concomitant
Dry Skin Death 9/24/2010 64 Male 154 lb 11/4/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Rash Hospitalization 12/20/2010 80 Male 119 lb 11/4/2011 Physician Japan
Primary
Concomitant
Disease Progression Death 9/26/2008 46 Male 108 lb 11/4/2011 Consumer Japan
Primary
Concomitant
Hypoaesthesia Other Serious 2/8/2011 79 Male 165 lb 11/8/2011 Physician Japan
Primary
Concomitant
Neutrophil Count Decreased Hospitalization 4/30/2009 83 Female 134 lb 11/8/2011 Other Health Professional Japan
Primary
Concomitant
Erythema Hospitalization 4/1/2005 29 Female 11/4/2011 Other Health Professional Japan
Primary
Secondary
Dermatitis Acneiform Death 10/5/2010 69 Male 141 lb 11/9/2011 Other Health Professional Japan
Primary
Concomitant
Dry Skin Death 12/1/2010 55 Female 104 lb 11/9/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Colorectal Cancer Hospitalization 9/6/2010 55 Male 137 lb 11/9/2011 Physician Japan
Primary
Secondary
Concomitant
Conjunctivitis 9/17/2010 50 Male 154 lb 11/11/2011 Physician Japan
Primary
Secondary
Concomitant
Hypomagnesaemia Hospitalization 7/26/2010 68 Male 141 lb 11/11/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Enterocolitis Haemorrhagic Hospitalization 10/28/2011 74 Male 132 lb 11/13/2011 Physician Japan
Primary
Secondary
Concomitant
Intestinal Fistula Death 77 Female 11/14/2011 Physician Japan
Primary
Secondary
Angina Pectoris Life Threatening 7/22/2011 Male 139 lb 11/14/2011 Consumer Japan
Primary
Concomitant
Cardiac Failure Other Serious 74 Male 110 lb 11/14/2011 Physician Japan
Primary
Concomitant
Gastrointestinal Perforation Death 10/7/2011 80 Male 99 lb 11/15/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Leukoencephalopathy Hospitalization 55 Male 11/16/2011 Japan
Primary
Secondary
Concomitant
Hyperammonaemia Other Serious 60 Male 11/16/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Dry Skin Death 10/27/2010 55 Male 119 lb 11/16/2011 Other Health Professional Japan
Primary
Concomitant
Haemolytic Uraemic Syndrome Hospitalization 11/1/2011 60 Male 11/16/2011 Physician Japan
Primary
Secondary

Drug Data