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Xeloda (Capecitabine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Xeloda (Capecitabine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (3065)
Death (1169)
Life Threatening Events (176)
Disability (76)

Reports by Reaction Type

Death (706)Diarrhoea (464)Palmar-Plantar Erythrodysaesthesia Syndrome (231)Nausea (202)Disease Progression (200)Vomiting (177)Dehydration (150)Fatigue (140)Decreased Appetite (116)Mucosal Inflammation (94)Neutropenia (91)Stomatitis (82)

Below are a few examples of reports where side effects / adverse reactions may be related to Xeloda (Capecitabine). For a complete list or a specific selection of reports, please use the links above.

Possible Xeloda side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male, weighing 101.7 kg (223.7 pounds)

Reactions: Death, Fatigue, Vomiting

Adverse event resulted in: death

Drug(s) suspected as cause:
Xeloda

Xeloda
    Administration route: Oral
    Indication: Bile Duct Cancer
    Start date: 2012-02-06

Other drugs received by patient: Prochlorperazine; Prochlorperazine



Possible Xeloda side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Xeloda



Possible Xeloda side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Xeloda



Possible Xeloda side effects in 62 year old female

Reported by a physician from United States on 2012-08-27

Patient: 62 year old female

Reactions: Mucosal Inflammation, Fatigue, Diarrhoea, Mental Status Changes, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xeloda
    Indication: Colorectal Cancer Metastatic

Avastin
    Indication: Colorectal Cancer Metastatic



Possible Xeloda side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Xeloda
    Indication: Malignant Melanoma

Tarceva
    Indication: Malignant Melanoma



Possible Xeloda side effects in male

Reported by a physician from Netherlands on 2012-08-27

Patient: male

Reactions: Dyspnoea, Respiratory Failure, Cardiac Arrest

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Avastin
    Indication: Colorectal Cancer
    Start date: 2010-12-06

Oxaliplatin
    Indication: Colorectal Cancer
    Start date: 2010-12-06

Xeloda
    Administration route: Oral
    Indication: Colorectal Cancer
    Start date: 2010-12-06

Other drugs received by patient: Glyburide; Rosuvastatin; Augmentin '500'; Telmisartan



Possible Xeloda side effects in 69 year old female

Reported by a consumer/non-health professional from Canada on 2012-08-27

Patient: 69 year old female

Reactions: Phlebitis, Breast Cancer, Fatigue, Diarrhoea, Decreased Appetite, Disease Progression

Drug(s) suspected as cause:
Xeloda
    Indication: Product Used FOR Unknown Indication

Tykerb
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Xeloda side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Xeloda



Possible Xeloda side effects in male

Reported by a consumer/non-health professional from Chile on 2012-08-27

Patient: male, weighing 65.0 kg (143.0 pounds)

Reactions: Oesophageal Stenosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Chemotherapy (Unk Ingredients)
    Indication: Gastric Cancer
    Start date: 2012-05-11
    End date: 2012-08-14

Xeloda
    Dosage: 1000 mg in the morning and 1000 mg at night
    Administration route: Oral
    Indication: Gastric Cancer
    Start date: 2012-05-11
    End date: 2012-08-14

Other drugs received by patient: Metformin HCL



Possible Xeloda side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female, weighing 57.2 kg (125.8 pounds)

Reactions: Nausea, Platelet Count Decreased, Abdominal Cavity Drainage, Abdominal Pain Upper, Decreased Appetite

Drug(s) suspected as cause:
Xeloda

Other drugs received by patient: Marinol (United States)



Possible Xeloda side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Xeloda



Possible Xeloda side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Xeloda



Possible Xeloda side effects in female

Reported by a consumer/non-health professional from Mexico on 2012-08-27

Patient: female, weighing 43.0 kg (94.6 pounds)

Reactions: Thrombosis, Vomiting, Monoplegia, Nausea, Diarrhoea, Oedema Peripheral, Headache

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Xeloda



Possible Xeloda side effects in 54 year old male

Reported by a physician from Brazil on 2012-08-27

Patient: 54 year old male

Reactions: Disease Progression

Adverse event resulted in: death

Drug(s) suspected as cause:
Xeloda
    Indication: Metastatic Gastric Cancer
    Start date: 2009-03-18

Herceptin
    Indication: Metastatic Gastric Cancer

Oxaliplatin
    Indication: Metastatic Gastric Cancer
    Start date: 2009-03-18



Possible Xeloda side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Xeloda
    Indication: Gastric Cancer

Tarceva
    Indication: Product Used FOR Unknown Indication



Possible Xeloda side effects in 60 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 60 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Xeloda



Possible Xeloda side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Xeloda



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 51 year old female

Reported by a physician from Canada on 2012-08-27

Patient: 51 year old female

Reactions: Breast Cancer Metastatic, Neoplasm Malignant

Drug(s) suspected as cause:
Xeloda
    Indication: Product Used FOR Unknown Indication

Tykerb
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Oxycontin; Percocet



Possible Xeloda side effects in 79 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 79 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Xeloda



Possible Xeloda side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: male

Reactions: Drug Ineffective, Colorectal Cancer Metastatic

Adverse event resulted in: death

Drug(s) suspected as cause:
Xeloda



Possible Xeloda side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Sepsis

Adverse event resulted in: death

Drug(s) suspected as cause:
Xeloda

Other drugs received by patient: Ixempra KIT



Possible Xeloda side effects in 63 year old female

Reported by a physician from Canada on 2012-08-27

Patient: 63 year old female

Reactions: Paronychia, Skin Chapped, Stomatitis, Haemorrhage, Diarrhoea

Drug(s) suspected as cause:
Xeloda
    Indication: Product Used FOR Unknown Indication

Tykerb
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Amitriptyline Hydrochloride; Atorvastatin Calcium; Lansoprazole; Metformin HCL



Possible Xeloda side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Xeloda



Possible Xeloda side effects in 66 year old male

Reported by a pharmacist from Spain on 2012-08-27

Patient: 66 year old male

Reactions: Pancreatitis Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xeloda



Possible Xeloda side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male, weighing 67.2 kg (147.8 pounds)

Reactions: Death, Insomnia, Hyperchlorhydria

Adverse event resulted in: death

Drug(s) suspected as cause:
Xeloda



Possible Xeloda side effects in

Reported by a physician from Japan on 2012-08-27

Patient:

Reactions: Cerebral Infarction

Drug(s) suspected as cause:
Xeloda
    Dosage: dosage is uncertain.
    Administration route: Oral
    Indication: Large Intestine Carcinoma

Oxaliplatin
    Dosage: dosage is uncertain.
    Indication: Large Intestine Carcinoma

Avastin
    Indication: Large Intestine Carcinoma



Possible Xeloda side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Xeloda



Possible Xeloda side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Disease Progression

Adverse event resulted in: death

Drug(s) suspected as cause:
Avastin
    Indication: Pancreatic Carcinoma

Xeloda
    Indication: Pancreatic Carcinoma

Tarceva
    Indication: Pancreatic Carcinoma



Possible Xeloda side effects in

Reported by a consumer/non-health professional from United States on 2012-08-25

Patient:

Reactions: Death, Ill-Defined Disorder

Adverse event resulted in: death, disablity

Drug(s) suspected as cause:
Tarceva
    Indication: Brain Neoplasm Malignant

Tarceva

Xeloda
    Indication: Brain Neoplasm Malignant

Xeloda

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