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Xeloda (Capecitabine) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



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: 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 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 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 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 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 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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