Leucovorin Calcium combined with Xeloda

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Gastrointestinal Stoma Complication Other Serious 2/11/2006 Male 150 lb 2/20/2006 United States
Primary
Secondary
Vomiting Other Serious 2/6/2006 Male 150 lb 2/17/2006 United States
Primary
Secondary
Concomitant
Colon Cancer Death 85 Male 154 lb 6/30/2006 Other Health Professional United States
Primary
Concomitant
Wound Infection Hospitalization 43 Female 200 lb 6/30/2006 United States
Primary
Secondary
Concomitant
Death Death 8/31/2005 66 Female 68 lb 6/30/2006 Other Health Professional United States
Primary
Concomitant
Renal Failure Acute Other Serious 7/18/2006 78 Female 8/25/2006 Pharmacist United States
Primary
Concomitant
Hyponatraemia Hospitalization 10/1/2006 Male 11/8/2006 Consumer United States
Primary
Concomitant
Tooth Extraction Other Serious 52 Female 12/18/2006 United States
Primary
Concomitant
Wheezing Other Serious 12/28/2001 62 Female 140 lb 2/1/2007 United States
Primary
Secondary
Concomitant
Wound Treatment Other Serious 10/1/2001 62 Female 140 lb 2/10/2007 United States
Primary
Secondary
Concomitant
Wound Debridement Other Serious 11/23/2001 52 Female 178 lb 2/10/2007 Lawyer United States
Primary
Concomitant
Urinary Tract Infection Other Serious 1/1/2005 52 Female 3/8/2007 United States
Primary
Concomitant
Wound Debridement Other Serious 11/23/2001 52 Female 178 lb 3/12/2007 Lawyer United States
Primary
Concomitant
Wound Debridement Other Serious 11/23/2001 52 Female 178 lb 3/28/2007 Lawyer United States
Primary
Concomitant
Intestinal Obstruction Hospitalization 65 Male 3/22/2007 Physician United States
Primary
Concomitant
Renal Failure Acute Other Serious 7/18/2006 Female 5/17/2007 United States
Primary
Concomitant
Wound Drainage Other Serious 11/23/2001 52 Female 178 lb 7/12/2007 Lawyer United States
Primary
Concomitant
Urinary Retention Hospitalization 3/11/2005 Male 170 lb 11/30/2007 United States
Primary
Secondary
Urinary Retention Hospitalization 3/11/2005 Male 170 lb 12/12/2007 United States
Primary
Secondary
Concomitant
Wound Drainage Other Serious 11/23/2001 52 Female 178 lb 1/7/2008 Lawyer United States
Primary
Secondary
Concomitant
Weight Decreased Disability 4/24/2007 64 Female 3/28/2008 Consumer United States
Primary
Concomitant
Death Other Serious 9/6/2001 28 Male 195 lb 4/1/2008 Physician United States
Primary
Concomitant
Wound Dehiscence Other Serious 1/9/2007 Male 2/28/2008 Pharmacist United States
Primary
Concomitant
Proteinuria Other Serious 59 2/28/2008 Physician United States
Primary
Concomitant
Nausea Life Threatening 1/4/2006 Male 5/15/2008 Physician United Kingdom
Primary
Secondary
Vomiting Life Threatening 1/4/2006 Male 5/30/2008 Physician United States
Primary
Secondary
Rhinorrhoea Hospitalization 43 Female 200 lb 6/29/2008 United States
Primary
Secondary
Concomitant
Hypersensitivity Other Serious 1/1/2006 8/5/2008 Other Health Professional China
Primary
Concomitant
Urinary Tract Infection Hospitalization 8/14/2008 71 Male 9/5/2008 Physician United Kingdom
Primary
Secondary
Mucosal Inflammation Hospitalization 71 Male 9/5/2008 Physician United Kingdom
Primary
Secondary
Death Death 7/25/2008 32 Female 9/12/2008 Consumer United States
Primary
Concomitant
Urinary Tract Infection Hospitalization 8/14/2008 71 Male 9/18/2008 Physician United Kingdom
Primary
Secondary
Mucosal Inflammation Hospitalization 71 Male 9/18/2008 Physician United Kingdom
Primary
Secondary
Duodenal Ulcer Perforation Hospitalization 9/18/2008 61 Female 11/4/2008 Physician Japan
Primary
Secondary
Concomitant
Rectal Haemorrhage Other Serious 10/1/2008 45 Female 11/5/2008 Physician Russian Federation
Primary
Secondary
Concomitant
Interstitial Lung Disease Hospitalization 11/1/2008 71 Male 12/15/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Nasal Septum Perforation Other Serious 1/12/2008 Female 207 lb 12/31/2008 Consumer United States
Primary
Secondary
Concomitant
Nasal Septum Perforation Other Serious 1/15/2008 Female 207 lb 1/26/2009 Other Health Professional France
Primary
Secondary
Concomitant
Wound Drainage Other Serious 11/23/2001 Female 178 lb 2/13/2009 Lawyer United States
Primary
Secondary
Concomitant
Paraesthesia Other Serious Female 2/25/2009 Consumer United States
Primary
Secondary
Nasal Septum Perforation Other Serious 1/12/2008 Female 207 lb 3/17/2009 Consumer United States
Primary
Secondary
Concomitant
Nasal Septum Perforation Other Serious 1/12/2008 Female 207 lb 5/18/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Tooth Loss Other Serious 10/1/2008 Male 6/29/2009 Consumer Switzerland
Primary
Secondary
Concomitant
Tooth Loss Other Serious 2/1/2009 Male 7/1/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Weight Decreased Required Intervention 91 Male 6/30/2009 Consumer United States
Primary
Secondary
Concomitant
Tooth Loss Other Serious 10/1/2008 Male 170 lb 7/24/2009 Physician Switzerland
Primary
Secondary
Concomitant
Tooth Loss Other Serious 2/1/2009 Male 170 lb 7/29/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Decreased Appetite Hospitalization 7/22/2009 Female 119 lb 8/10/2009 Physician Indonesia
Primary
Secondary
Concomitant
Decreased Appetite Hospitalization 7/22/2009 Female 119 lb 8/11/2009 Physician Indonesia
Primary
Secondary
Concomitant
Decreased Appetite Hospitalization 7/22/2009 Female 119 lb 8/13/2009 Physician Indonesia
Primary
Secondary
Concomitant
Neutropenia Other Serious 8/21/2009 Male 138 lb 9/14/2009 Physician United States
Primary
Secondary
Concomitant
Decreased Appetite Hospitalization 7/22/2009 Female 119 lb 9/17/2009 Physician Indonesia
Primary
Secondary
Concomitant
Gallbladder Disorder 1/1/2006 34 Female 267 lb 9/23/2009 United States
Primary
Concomitant
Decreased Appetite Hospitalization 7/22/2009 Female 119 lb 10/15/2009 Physician Indonesia
Primary
Secondary
Concomitant
Nasal Septum Perforation Other Serious 1/12/2008 54 Female 207 lb 1/13/2009 United States
Primary
Secondary
Concomitant
Stomatitis Other Serious 1/12/2010 59 Male 4/12/2010 Physician Japan
Primary
Secondary
Concomitant
Anaphylactic Shock Life Threatening 4/15/2010 69 Male 4/27/2010 Physician Japan
Primary
Secondary
Concomitant
Subarachnoid Haemorrhage Death 5/11/2010 76 Female 128 lb 5/25/2010 Physician Ecuador
Primary
Secondary
Concomitant
Wound Dehiscence Other Serious 9/1/2007 46 Female 5/28/2010 Consumer United States
Primary
Secondary
Concomitant
Neuropathy Peripheral Life Threatening 12/17/2009 69 Male 128 lb 6/1/2010 Physician Japan
Primary
Secondary
Concomitant
Subarachnoid Haemorrhage Death 5/11/2010 76 Female 128 lb 6/1/2010 Physician Ecuador
Primary
Secondary
Concomitant
Wound Dehiscence Other Serious 9/1/2007 46 Female 6/8/2010 Consumer United States
Primary
Secondary
Concomitant
Small Intestinal Perforation Other Serious 11/1/2008 60 Male 119 lb 6/8/2010 Physician Japan
Primary
Secondary
Concomitant
Liver Abscess Hospitalization 3/19/2010 81 Male 6/17/2010 Physician Japan
Primary
Secondary
Concomitant
Anal Fistula Other Serious 6/24/2010 72 Male 180 lb 7/27/2010 Physician United States
Primary
Secondary
Concomitant
Anal Fistula Other Serious 6/24/2010 72 Male 180 lb 7/27/2010 Physician United States
Primary
Secondary
Concomitant
Somnolence Other Serious 6/1/2010 Male 7/29/2010 Physician China
Primary
Secondary
Concomitant
Skin Laceration Other Serious 3/1/2010 49 Female 8/2/2010 Consumer United States
Primary
Secondary
Wound Dehiscence Other Serious 9/1/2007 46 Female 8/3/2010 Consumer United States
Primary
Secondary
Concomitant
Wound Dehiscence Other Serious 9/1/2007 46 Female 8/5/2010 Consumer United States
Primary
Secondary
Concomitant
Wound Dehiscence Other Serious 9/1/2007 46 Female 8/10/2010 Consumer United States
Primary
Secondary
Concomitant
Wound Dehiscence Other Serious 9/1/2007 46 Female 8/13/2010 Consumer United States
Primary
Secondary
Concomitant
Skin Laceration Other Serious 3/1/2010 49 Female 8/13/2010 Consumer United States
Primary
Secondary
Wound Dehiscence Other Serious 9/1/2007 46 Female 8/13/2010 Consumer United States
Primary
Secondary
Concomitant
Wound Dehiscence Other Serious 9/1/2007 46 Female 8/19/2010 Consumer United States
Primary
Secondary
Concomitant
Liver Abscess Hospitalization 2/11/2010 81 Male 141 lb 8/19/2010 Physician Japan
Primary
Secondary
Concomitant
Liver Abscess Hospitalization 2/11/2010 81 Male 8/30/2010 Physician Japan
Primary
Secondary
Concomitant
Wound Dehiscence Other Serious 9/1/2007 46 Female 9/8/2010 Consumer United States
Primary
Secondary
Concomitant
Wound Dehiscence Other Serious 9/1/2007 46 Female 9/9/2010 Consumer United States
Primary
Secondary
Concomitant
Ovarian Torsion Other Serious 10/2/2008 41 Female 119 lb 9/9/2010 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 5/7/2010 49 Female 9/17/2010 Consumer United States
Primary
Secondary
Concomitant
Wound Dehiscence Other Serious 9/1/2007 46 Female 70 lb 9/22/2010 Consumer United States
Primary
Secondary
Concomitant
Wound Dehiscence Other Serious 9/1/2007 46 Female 10/4/2010 Consumer United States
Primary
Secondary
Concomitant
Wound Dehiscence Other Serious 9/1/2007 46 Female 10/6/2010 Consumer United States
Primary
Secondary
Concomitant
Wound Dehiscence Other Serious 9/1/2007 46 Female 10/18/2010 Physician United States
Primary
Secondary
Concomitant
Decreased Appetite Other Serious 2/22/2010 72 Male 123 lb 1/18/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Diarrhoea Other Serious 2/24/2011 58 Female 3/9/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Hyperlipidaemia Other Serious Male 247 lb 3/15/2011 Physician Turkey
Primary
Concomitant
Diarrhoea Other Serious 2/24/2011 58 Female 4/4/2011 Physician Japan
Primary
Secondary
Concomitant
Diarrhoea Life Threatening 12/30/2010 72 Male 5/10/2011 Other Health Professional France
Primary
Secondary
Concomitant
Insomnia Death 2/26/2011 76 Female 99 lb 5/17/2011 Physician Japan
Primary
Secondary
Concomitant
Mouth Haemorrhage Death 10/21/2010 84 Female 103 lb 5/19/2011 Physician Ecuador
Primary
Secondary
Concomitant
Neuropathy Peripheral Death 2/24/2011 76 Female 99 lb 5/26/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Duodenal Ulcer Other Serious 12/18/2009 56 Female 117 lb 5/27/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Cardiac Failure Hospitalization 12/30/2010 72 Male 5/31/2011 Other Health Professional France
Primary
Secondary
Concomitant
Diarrhoea Other Serious 11/1/2010 58 Female 126 lb 5/31/2011 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Embolism Hospitalization 6/12/2010 52 Female 112 lb 6/3/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Ileus Death 2/26/2011 76 Female 99 lb 6/8/2011 Physician Japan
Primary
Secondary
Concomitant
Diarrhoea Death 1/1/2010 56 Female 104 lb 6/10/2011 Physician Japan
Primary
Secondary
Malaise Death 1/1/2010 56 Female 6/17/2011 Consumer Japan
Primary
Secondary
Thyroid Atrophy Hospitalization 7/13/2010 57 Female 126 lb 6/24/2011 Physician Japan
Primary
Secondary
Concomitant
Fatigue Hospitalization 3/1/2007 76 Male 6/30/2011 Physician Israel
Primary
Secondary
Concomitant
Urticaria Hospitalization 7/14/2009 47 Male 183 lb 7/8/2011 Physician Japan
Primary
Secondary
Concomitant
Neutrophil Count Decreased Other Serious 7/1/2010 34 Female 130 lb 7/12/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Diarrhoea Other Serious 6/27/2011 74 Male 7/14/2011 Consumer Costa Rica
Primary
Secondary
Concomitant
Pulmonary Embolism Hospitalization 3/1/2007 76 Male 170 lb 7/15/2011 Physician Israel
Primary
Secondary
Concomitant
Cardio-respiratory Arrest Life Threatening 1/1/2010 56 Female 104 lb 7/21/2011 Other Health Professional Japan
Primary
Secondary
Neutrophil Count Decreased Other Serious 7/1/2010 34 Female 7/25/2011 Consumer Japan
Primary
Secondary
Concomitant
Neutrophil Count Decreased Hospitalization 1/1/2010 57 Female 7/26/2011 Consumer Japan
Primary
Secondary
Vomiting Hospitalization 7/13/2010 57 Female 126 lb 7/26/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Alopecia Other Serious 1/1/2008 75 Female 7/27/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Diarrhoea 1/1/2008 75 Female 8/5/2011 Physician Japan
Primary
Secondary
Concomitant
Duodenal Ulcer Other Serious 12/18/2009 56 Female 117 lb 8/17/2011 Physician Japan
Primary
Secondary
Concomitant
Haematuria Life Threatening 7/8/2010 62 Female 106 lb 8/17/2011 Physician Japan
Primary
Secondary
Concomitant
Urticaria Hospitalization 9/27/2010 83 Female 99 lb 8/31/2011 Physician Japan
Primary
Secondary
Concomitant
Colitis Life Threatening 61 Male 9/2/2011 Consumer Japan
Primary
Secondary
Concomitant
Drug Interaction Hospitalization 8/1/2011 82 Male 9/7/2011 Other Health Professional United States
Primary
Concomitant
Interacting
Death Death 9/8/2011 9/20/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Other Serious 1/1/2011 70 Male 9/20/2011 Physician Japan
Primary
Secondary
Concomitant
Dermatitis Acneiform Other Serious 12/8/2010 56 Male 128 lb 9/26/2011 Physician Japan
Primary
Secondary
Concomitant
Left Atrial Dilatation Other Serious 11/23/2001 52 Female 178 lb 10/17/2011 Lawyer United States
Primary
Secondary
Concomitant
Cerebrovascular Accident Hospitalization 8/29/2010 56 Female 108 lb 11/7/2011 France
Primary
Secondary
Concomitant
Plasma Protein Metabolism Disorder Other Serious Male 11/24/2011 Physician United States
Primary
Secondary
Concomitant
Pelvic Sepsis Death 9/24/2009 53 Male 163 lb 12/2/2011 Physician France
Primary
Secondary
Dyspnoea Hospitalization 10/4/2011 47 Female 163 lb 12/7/2011 Consumer France
Primary
Concomitant
Angiopathy Other Serious 11/23/2001 52 Female 178 lb 12/8/2011 Lawyer United States
Primary
Secondary
Concomitant
Blindness Hospitalization 12/8/2011 Lawyer United States
Primary
Secondary
Concomitant
Peripheral Sensory Neuropathy Other Serious 1/27/2012 Other Health Professional Korea, Republic Of
Primary
Secondary
Disease Progression Death Female 2/7/2012 Consumer United States
Primary
Secondary
Concomitant
Hypomagnesaemia Other Serious 11/25/2008 56 Male 3/22/2012 Other Health Professional United States
Primary
Secondary
Mental Status Changes Death Female 140 lb 3/30/2012 Consumer United States
Primary
Secondary
Concomitant
Renal Failure Other Serious 4/19/2012 Italy
Primary
Secondary
Aortic Dissection Other Serious Male 4/30/2012 Physician Taiwan, Province Of China
Primary
Secondary
Neoplasm Progression Death Male 5/2/2012 Physician Germany
Primary
Secondary
Coronary Artery Disease Death Female 140 lb 5/7/2012 Consumer United States
Primary
Secondary
Concomitant
Neoplasm Progression Death Male 5/16/2012 Germany
Primary
Secondary
Cerebral Haemorrhage Hospitalization 10/1/2010 75 Male 143 lb 5/16/2012 Physician United States
Primary
Secondary
Hypertension Death 5/24/2012 Physician Greece
Primary
Secondary
Death Death Male 134 lb 5/29/2012 Physician Germany
Primary
Secondary
Leukopenia Death Male 134 lb 6/7/2012 Physician Germany
Primary
Secondary
Gastrointestinal Perforation Other Serious 65 Male 7/9/2012 Physician Australia
Primary
Secondary
Concomitant
Postoperative Wound Infection Other Serious 1/1/2011 72 Female 7/12/2012 Japan
Primary
Secondary
Surgery Other Serious Male 7/30/2012 Other Health Professional Australia
Primary
Secondary
Concomitant
Antibiotic Resistant Staphylococcus Test Positive Other Serious 1/1/2011 72 Female 8/2/2012 Physician Japan
Primary
Secondary
Disease Progression Death Male 8/3/2012 Physician France
Primary
Concomitant
Mucosal Inflammation Other Serious 8/6/2012 Other Health Professional Korea, Republic Of
Primary
Secondary
Disease Progression Death Male 8/8/2012 Physician France
Primary
Concomitant
Anaemia Death Female 8/9/2012 Physician France
Primary
Secondary
Concomitant
Vomiting Other Serious 5/2011 62 Female 117 lb 9/27/2012 Physician Be
Primary
Secondary
Vomiting Hospitalization 11/11/2012 73 Female 158 lb 1/24/2013 Other Health Professional Us
Primary
Concomitant

Drug Data