Index of reports
> Life Threatening Events (176)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Xeloda (Capecitabine) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 176 Next >>
Possible Xeloda side effects in 69 year old male
Reported by a physician from Austria on 2012-08-27
Patient: 69 year old male, weighing 79.0 kg (173.8 pounds)
Reactions: Diarrhoea, C-Reactive Protein Increased
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xeloda
Other drugs received by patient: Avastin; Oxaliplatin
Possible Xeloda side effects in female
Reported by a physician from Australia on 2012-08-24
Patient: female, weighing 109.0 kg (239.8 pounds)
Reactions: Nausea, Urinary Tract Infection, Atrial Fibrillation, Pyrexia, Anastomotic Leak, Hypokalaemia, Diarrhoea, Ventricular Tachycardia, Dehydration, Hypoalbuminaemia, Decreased Appetite, Anastomotic Fistula
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Oxaliplatin
Dosage: last dose prior to sae on 21mar 2011 (50 mg/m2 on day1, 8, 15, 21 and 29).
Indication: Rectal Cancer
Start date: 2011-02-21
End date: 2011-08-10
Xeloda
Dosage: last date prior to sae: 26 march 2011 250 mg. (825 mg/m2 bid d1-33 w/o weekends and optional boost),
Administration route: Oral
Indication: Rectal Cancer
Start date: 2011-02-21
End date: 2011-08-10
Other drugs received by patient: Salmeterol; Colecalciferol; Potassium; Aspirin; Fluticasone Propionate; Pantoprazole; Prednisolone; Methotrexate; Acetaminophen; Metoprolol Tartrate; Diclofenac Sodium; Ferrous Sulfate TAB; Olmesartan Medoxomil; Enoxaparin; Folic Acid; Magnesium; Verapamil; Metoclopramide
Possible Xeloda side effects in female
Reported by a physician from Japan on 2012-08-24
Patient: female, weighing 49.0 kg (107.8 pounds)
Reactions: Stomatitis, Disseminated Intravascular Coagulation, Pancytopenia, Palmar-Plantar Erythrodysaesthesia Syndrome, Ketoacidosis, Diarrhoea, Cerebral Infarction, Altered State of Consciousness
Adverse event resulted in: life threatening event, disablity
Drug(s) suspected as cause:
Xeloda
Other drugs received by patient: Tamoxifen Citrate
Possible Xeloda side effects in female
Reported by a physician from Switzerland on 2012-08-22
Patient: female, weighing 62.0 kg (136.4 pounds)
Reactions: Abdominal Pain, Vomiting, Anaemia, Lymphopenia, Pyrexia, Diarrhoea, Small Intestinal Perforation, Sepsis, Hypoalbuminaemia, Neutropenia, Enterocolitis, Infection
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xeloda
Other drugs received by patient: Herceptin
Possible Xeloda side effects in 79 year old male
Reported by a consumer/non-health professional from China on 2012-08-20
Patient: 79 year old male
Reactions: Asthma, Productive Cough, Urinary Incontinence, Bronchial Carcinoma, Aphasia, Rash Pruritic, Off Label Use, Poor Quality Sleep, Death, Oedema Peripheral, Blood Creatinine Increased, Epistaxis, Decreased Appetite, Emphysema, Stomatitis, Vomiting, Pneumonia, Dyspnoea, Blood Urea Increased, Nausea, Rhinorrhoea, Rash, Diarrhoea, Cerebral Infarction, Depressed Level of Consciousness, Metastases To Bone, Asthenia
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Avastin
Dosage: unk
Indication: Rectal Cancer Metastatic
Tarceva
Dosage: 150 mg, uid/qd
Administration route: Oral
Indication: Rectal Cancer Metastatic
Start date: 2012-06-01
End date: 2012-06-09
Xeloda
Dosage: 1.5 df, bid for 2 weeks followed by 7 day rest period
Administration route: Oral
Indication: Rectal Cancer Metastatic
End date: 2012-02-23
Possible Xeloda side effects in 79 year old male
Reported by a consumer/non-health professional from China on 2012-08-20
Patient: 79 year old male
Reactions: Productive Cough, Aphasia, Bronchial Carcinoma, Rash Pruritic, Poor Quality Sleep, Death, Incontinence, Oedema Peripheral, Blood Creatinine Increased, Epistaxis, Decreased Appetite, Emphysema, Dyspnoea, Blood Urea Increased, Stomatitis, Vomiting, Nausea, Rhinorrhoea, Diarrhoea, Cerebral Infarction, Depressed Level of Consciousness, Metastases To Bone, Asthenia
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Avastin
Indication: Rectal Cancer Metastatic
Tarceva
Administration route: Oral
Indication: Rectal Cancer Metastatic
Start date: 2012-06-01
End date: 2012-06-09
Xeloda
Administration route: Oral
Indication: Rectal Cancer Metastatic
End date: 2012-02-23
Possible Xeloda side effects in female
Reported by a physician from Germany on 2012-08-20
Patient: female, weighing 52.0 kg (114.4 pounds)
Reactions: Syncope, Supraventricular Tachycardia, Dehydration, Pulmonary Oedema
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Avastin
Dosage: 1 x 90 minutes. last dose prior to sae was taken on 11/jul/2012
Indication: Colorectal Cancer Metastatic
Start date: 2012-07-11
Irinotecan Hydrochloride
Dosage: 1 x 2 hours
Indication: Colorectal Cancer Metastatic
Irinotecan Hydrochloride
Start date: 2012-08-01
Xeloda
Dosage: 2 tablets in the morning and 2 tablets in the evening.
Administration route: Oral
Start date: 2012-08-01
Xeloda
Dosage: 3 tablets in the morning and 2 tablets in the evening. last dose prior to sae was taken on 24/jul/20
Indication: Colorectal Cancer Metastatic
Start date: 2012-07-11
Possible Xeloda side effects in 60 year old female
Reported by a physician from Canada on 2012-08-20
Patient: 60 year old female
Reactions: Vomiting, Nausea, Diarrhoea, Neoplasm Malignant, Dehydration, Disease Progression, Renal Failure Acute
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Tykerb
Administration route: Oral
Tykerb
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Xeloda
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Hydromorphone Hydrochloride; Retinol; Prevacid; Micardis; Verapamil HCL; Celebrex; Colace; Vitamin D; Antihypertensive Medications; Actonel; Senokot
Possible Xeloda side effects in 50 year old female
Reported by a physician from Japan on 2012-08-13
Patient: 50 year old female, weighing 48.0 kg (105.6 pounds)
Reactions: Renal Impairment, Disease Progression
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Avastin
Indication: Rectal Cancer Metastatic
Start date: 2012-06-01
End date: 2012-06-01
Decadron Phosphate
Indication: Product Used FOR Unknown Indication
Start date: 2012-06-01
End date: 2012-06-01
Decadron Phosphate
Administration route: Oral
Start date: 2012-06-01
End date: 2012-06-03
Oxaliplatin
Indication: Rectal Cancer Metastatic
Start date: 2012-06-01
End date: 2012-06-01
Xeloda
Administration route: Oral
Indication: Rectal Cancer Metastatic
Start date: 2012-06-01
End date: 2012-06-06
Other drugs received by patient: Oxycontin; Aldactone; BIO-Three; Mucosta; Lasix; Prochlorperazine; Magmitt; Loxonin
Possible Xeloda side effects in female
Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-06
Patient: female
Reactions: Dyspnoea, Vomiting, Nausea, Headache, Pericardial Effusion, Dysgeusia, Diarrhoea, Chest Pain, Pulmonary Thrombosis, Decreased Appetite
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Tykerb
Indication: Breast Cancer
Start date: 2012-01-23
End date: 2012-07-01
Xeloda
Indication: Breast Cancer
Start date: 2012-01-23
End date: 2012-07-01
Possible Xeloda side effects in 58 year old male
Reported by a consumer/non-health professional from China on 2012-08-03
Patient: 58 year old male, weighing 60.0 kg (132.0 pounds)
Reactions: Jaundice, Blood Bilirubin Increased, Colorectal Cancer Metastatic, Hypertension, Ascites
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Avastin
Dosage: strength form was 100mg/4ml
Indication: Colorectal Cancer
Start date: 2011-06-24
End date: 2011-08-15
Xeloda
Indication: Colorectal Cancer
Other drugs received by patient: Chemotherapy NOS
Possible Xeloda side effects in 73 year old male
Reported by a health professional (non-physician/pharmacist) from Austria on 2012-08-03
Patient: 73 year old male, weighing 94.0 kg (206.8 pounds)
Reactions: Neutropenic Sepsis, Tachycardia, Toxicity To Various Agents, Urinary Hesitation
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Epirubicin Hydrochloride
Dosage: 50 mg/m2 milligram(s)/sq. meter
Indication: Brain Neoplasm Malignant
Start date: 2012-04-24
End date: 2012-05-16
Oxaliplatin
Dosage: 130 mg/m2 milligram(s)/sq. meter intravenous (not otherwise specified)
Indication: Brain Neoplasm Malignant
Start date: 2012-04-24
End date: 2012-05-16
Xeloda
Indication: Brain Neoplasm Malignant
Start date: 2012-04-24
End date: 2012-05-16
Possible Xeloda side effects in female
Reported by a physician from Germany on 2012-07-30
Patient: female, weighing 52.0 kg (114.4 pounds)
Reactions: Syncope, Dehydration, Pulmonary Oedema
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Avastin
Dosage: 1 x 90 minutes
Indication: Colorectal Cancer Metastatic
Irinotecan HCL
Dosage: 1 x 2 hours
Indication: Colorectal Cancer Metastatic
Xeloda
Dosage: 3 tablets in the morning and 2 tablets in the evening
Indication: Colorectal Cancer Metastatic
Start date: 2012-07-11
Possible Xeloda side effects in 73 year old male
Reported by a physician from Austria on 2012-07-27
Patient: 73 year old male, weighing 94.0 kg (206.8 pounds)
Reactions: Atrial Tachycardia, Neutropenic Sepsis, Urinary Hesitation
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Epirubicin Hydrochloride
Dosage: 50 mg/m2, single
Indication: Brain Neoplasm Malignant
Start date: 2012-04-24
End date: 2012-05-16
Oxaliplatin
Dosage: 130 mg/m2, single
Indication: Brain Neoplasm Malignant
Start date: 2012-04-24
End date: 2012-05-16
Xeloda
Dosage: 1250 mg/m2.
Administration route: Oral
Indication: Brain Neoplasm Malignant
Start date: 2012-04-24
End date: 2012-05-21
Possible Xeloda side effects in 73 year old male
Reported by a physician from Austria on 2012-07-25
Patient: 73 year old male, weighing 94.0 kg (206.8 pounds)
Reactions: Atrial Tachycardia, Neutropenic Sepsis, Urinary Hesitation
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Epirubicin Hydrochloride
Indication: Brain Neoplasm Malignant
Start date: 2012-04-24
End date: 2012-05-16
Oxaliplatin
Indication: Brain Neoplasm Malignant
Start date: 2012-04-24
End date: 2012-05-16
Xeloda
Administration route: Oral
Indication: Brain Neoplasm Malignant
Start date: 2012-04-24
End date: 2012-05-21
Possible Xeloda side effects in 50 year old male
Reported by a physician from United States on 2012-07-23
Patient: 50 year old male, weighing 77.3 kg (170.1 pounds)
Reactions: Large Intestine Perforation
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
GDC-0980 (Pi3k / Mtor Inhibitor)
Dosage: cycle 1
Administration route: Oral
Indication: Neoplasm Malignant
Start date: 2011-07-22
End date: 2011-08-03
GDC-0980 (Pi3k / Mtor Inhibitor)
Dosage: cycle 3
Administration route: Oral
Start date: 2011-09-06
End date: 2011-09-19
GDC-0980 (Pi3k / Mtor Inhibitor)
Dosage: cycle 2
Administration route: Oral
Start date: 2011-08-16
End date: 2011-08-29
GDC-0980 (Pi3k / Mtor Inhibitor)
Dosage: cycle 4
Administration route: Oral
Start date: 2011-09-27
End date: 2011-10-10
Simvastatin
Xeloda
Administration route: Oral
Indication: Neoplasm Malignant
Start date: 2011-07-21
End date: 2011-10-10
Other drugs received by patient: Compazine; Imodium
Possible Xeloda side effects in female
Reported by a physician from United States on 2012-07-23
Patient: female
Reactions: Mucosal Inflammation, Oral Mucosal Blistering, Pneumonia, Diarrhoea
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Xeloda
Possible Xeloda side effects in 41 year old female
Reported by a physician from France on 2012-07-20
Patient: 41 year old female, weighing 70.0 kg (154.0 pounds)
Reactions: Large Intestine Perforation, Necrotising Colitis, Rash, Radiation Mucositis, Skin Reaction, Diarrhoea, Bone Marrow Failure, Mucous Membrane Disorder
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Xeloda
Administration route: Oral
Indication: Rectal Cancer
Start date: 2012-04-05
End date: 2012-04-16
Xeloda
Administration route: Oral
Start date: 2012-04-10
End date: 2012-04-13
Possible Xeloda side effects in male
Reported by a physician from France on 2012-07-19
Patient: male
Reactions: Cardio-Respiratory Arrest, Chest Pain
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Xeloda
Other drugs received by patient: Atorvastatin
Possible Xeloda side effects in male
Reported by a physician from Japan on 2012-07-18
Patient: male, weighing 58.0 kg (127.6 pounds)
Reactions: Electrocardiogram ST Segment Depression, Leukoencephalopathy, Cardiomyopathy
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Xeloda
Other drugs received by patient: Enalapril Maleate; Norvasc; Famotidine; Basen
Possible Xeloda side effects in male
Reported by a physician from Germany on 2012-07-12
Patient: male, weighing 73.5 kg (161.7 pounds)
Reactions: Allergic Oedema
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Oxaliplatin
Dosage: last dose prior to sae: 18 april 2011
Indication: Colorectal Cancer
Xeloda
Start date: 2011-04-19
Xeloda
Dosage: date of lst dose prior to sae : 22/may/2011
Start date: 2011-05-09
Xeloda
Dosage: last dose prior to sae :
Administration route: Oral
Indication: Colon Cancer
Start date: 2010-12-02
Other drugs received by patient: Dexamethasone Sodium Posphate; Granisetron; Novalgin; Heparin
Possible Xeloda side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-11
Patient: female
Reactions: Oral Mucosal Blistering, Mucosal Inflammation, Pneumonia, Diarrhoea
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Xeloda
Possible Xeloda side effects in 41 year old female
Reported by a physician from France on 2012-07-11
Patient: 41 year old female, weighing 70.0 kg (154.0 pounds)
Reactions: Large Intestine Perforation, Necrotising Colitis, Radiation Mucositis, Rash, Skin Reaction, Diarrhoea, Bone Marrow Failure, Mucous Membrane Disorder
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Xeloda
Possible Xeloda side effects in male
Reported by a physician from Germany on 2012-07-10
Patient: male
Reactions: Multi-Organ Failure, Haemoglobin Decreased, Splenic Lesion, Acute Abdomen
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Oxaliplatin
Dosage: last dose prior to sae: 14/mar/2011
Indication: Rectal Cancer
Start date: 2011-02-14
Xeloda
Dosage: last dose prior to sae: 23/mar/2011
Administration route: Oral
Indication: Rectal Cancer
Start date: 2011-02-14
Possible Xeloda side effects in male
Reported by a individual with unspecified qualification from Japan on 2012-07-06
Patient: male, weighing 58.0 kg (127.6 pounds)
Reactions: Ventricular Hypokinesia, Leukoencephalopathy, Cardiomyopathy, Blood Pressure Decreased, Electrocardiogram ST Segment Elevation
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Xeloda
Other drugs received by patient: Norvasc; Famotidine; Enalapril Maleate; Basen
Possible Xeloda side effects in male
Reported by a physician from Japan on 2012-07-05
Patient: male, weighing 60.0 kg (132.0 pounds)
Reactions: Dyschezia, Device Related Infection, Constipation, Portal Vein Pressure Increased, Gastric Varices Haemorrhage, Insomnia, Platelet Count Decreased, Catheter Site Pain
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Avastin
Start date: 2011-06-30
End date: 2011-11-01
Avastin
Indication: Colorectal Cancer Metastatic
Start date: 2010-08-03
End date: 2011-05-19
Kytril
Indication: Prophylaxis
Start date: 2010-08-03
End date: 2011-05-19
Motilium
Administration route: Oral
Indication: Prophylaxis
Start date: 2010-08-03
End date: 2010-11-10
Motilium
Administration route: Oral
Indication: Prophylaxis of Nausea and Vomiting
Start date: 2011-10-25
End date: 2011-11-14
Xeloda
Dosage: it is one administering weekly holiday medicine for two weeks.
Administration route: Oral
Start date: 2010-09-14
End date: 2010-10-25
Xeloda
Dosage: it is one administering weekly holiday medicine for two weeks.
Administration route: Oral
Start date: 2010-10-26
End date: 2011-01-18
Xeloda
Dosage: it is one administering weekly holiday medicine for two weeks.
Administration route: Oral
Indication: Colorectal Cancer Metastatic
Start date: 2010-08-03
End date: 2010-09-13
Xeloda
Dosage: it is one administering weekly holiday medicine for two weeks.
Administration route: Oral
Start date: 2011-02-17
End date: 2011-05-19
Other drugs received by patient: Irinotecan HCL; Oxaliplatin; Tramadol Hydrochloride; Prochlorperazine; Viagra; Fluorouracil; Pydoxal; Mucosta; Tramadol Hydrochloride; Fluorouracil; Irinotecan HCL; Fluorouracil; Loxonin; Oxaliplatin; Levoleucovorin Calcium; Decadron; Aloxi; Tramadol Hydrochloride; Prochlorperazine
Possible Xeloda side effects in 65 year old
Reported by a individual with unspecified qualification from Japan on 2012-06-29
Patient: 65 year old
Reactions: Cerebral Infarction
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Xeloda
Other drugs received by patient: Cisplatin
Possible Xeloda side effects in male
Reported by a pharmacist from Japan on 2012-06-29
Patient: male, weighing 49.0 kg (107.8 pounds)
Reactions: Disseminated Intravascular Coagulation, Pancytopenia, Palmar-Plantar Erythrodysaesthesia Syndrome, Ketoacidosis, Cerebral Infarction, Diarrhoea, Oral Mucosa Erosion, Altered State of Consciousness
Adverse event resulted in: life threatening event, disablity
Drug(s) suspected as cause:
Xeloda
Other drugs received by patient: Tamoxifen Citrate
Possible Xeloda side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-29
Patient: male, weighing 93.2 kg (205.0 pounds)
Reactions: Dyspnoea, Disease Recurrence, Ejection Fraction Decreased, Cardiomyopathy, Cardiac Failure Congestive, Disease Progression
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Avastin
Indication: Colorectal Cancer
Start date: 2011-04-01
End date: 2011-12-01
Xeloda
Indication: Colorectal Cancer
Other drugs received by patient: Fluorouracil; Furosemide; Levothyroxine; Hycodan; Coumadin; Metoprolol Succinate; Benadryl; Amaryl; Aldactone; Lisinopril; Warfarin Sodium; Vitamin D; Ascorbic Acid; Selenium; Wellbutrin; Fluticasone Propionate; Wellbutrin SR; Lovaza; Prilosec; Irinotecan HCL; Toprol-XL; Zocor; Insulin; Prilosec; Glimepiride
Possible Xeloda side effects in female
Reported by a physician from Australia on 2012-06-26
Patient: female, weighing 109.0 kg (239.8 pounds)
Reactions: Nausea, Urinary Tract Infection, Atrial Fibrillation, Pyrexia, Anastomotic Leak, Hypokalaemia, Diarrhoea, Dehydration, Ventricular Tachycardia, Hypoalbuminaemia, Decreased Appetite, Anastomotic Fistula
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Oxaliplatin
Dosage: last dose prior to sae on 21mar 2011 (50 mg/m2 on day1, 8, 15, 21 and 29).
Indication: Rectal Cancer
Start date: 2011-02-21
End date: 2011-08-10
Xeloda
Dosage: last date prior to sae: 26 march 2011 250 mg. (825 mg/m2 bid d1-33 w/o weekends and optional boost),
Administration route: Oral
Indication: Rectal Cancer
Start date: 2011-02-21
End date: 2011-08-10
Other drugs received by patient: Olmesartan Medoxomil; Salmeterol; Prednisolone; Folic Acid; Aspirin; Ferrous Sulfate TAB; Fluticasone; Colecalciferol; Potassium Acetate; Magnesium Sulfate; Verapamil; Diclofenac Sodium; Methotrexate; Pantoprazole; Metoclopramide; Metoprolol Tartrate; Acetaminophen; Enoxaparin
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