Index of reports
> Cases with Palmar-Plantar Erythrodysaesthesia Syndrome (231)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Xeloda (Capecitabine) where reactions include palmar-plantar erythrodysaesthesia syndrome. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 231 Next >>
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 male
Reported by a physician from Japan on 2012-08-23
Patient: male, weighing 70.0 kg (154.0 pounds)
Reactions: Ureteric Obstruction, Palmar-Plantar Erythrodysaesthesia Syndrome, Extravasation of Urine
Drug(s) suspected as cause:
Avastin
Dosage: dosage is uncertain.
Indication: Colon Cancer
Start date: 2009-11-24
End date: 2010-03-01
Avastin
Indication: Colon Cancer Recurrent
Start date: 2010-11-22
End date: 2011-08-22
Avastin
Start date: 2011-10-31
End date: 2011-12-12
Xeloda
Administration route: Oral
Start date: 2010-09-27
End date: 2011-08-22
Xeloda
Administration route: Oral
Indication: Colon Cancer Recurrent
Start date: 2010-07-13
End date: 2010-01-01
Other drugs received by patient: Loxoprofen; Loxoprofen; Oxaliplatin; Levoleucovorin Calcium; Fluorouracil; Fluorouracil; Oxycodone HCL; TS-1; Irinotecan HCL; Fluorouracil; Levoleucovorin Calcium; Loxoprofen; Oxaliplatin; Fluorouracil; Oxycodone HCL
Possible Xeloda side effects in 62 year old male
Reported by a physician from Poland on 2012-08-23
Patient: 62 year old male
Reactions: Kwashiorkor, Carcinoembryonic Antigen Increased, Increased Appetite, Nausea, Anaemia, General Physical Health Deterioration, Palmar-Plantar Erythrodysaesthesia Syndrome, Ascites, Apathy, Death, Neutropenia, Thrombocytopenia
Adverse event resulted in: death
Drug(s) suspected as cause:
Cisplatin
Indication: Product Used FOR Unknown Indication
Start date: 2010-12-14
Xeloda
Indication: Product Used FOR Unknown Indication
Start date: 2010-12-14
Other drugs received by patient: Diaprel MR
Possible Xeloda side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21
Patient:
Reactions: Mucosal Inflammation, Diarrhoea, Palmar-Plantar Erythrodysaesthesia Syndrome
Drug(s) suspected as cause:
Xeloda
Possible Xeloda side effects in female
Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-21
Patient: female
Reactions: Defaecation Urgency, Pruritus, Coagulopathy, Central Nervous System Lesion, Palmar-Plantar Erythrodysaesthesia Syndrome, Hypoaesthesia, Neoplasm, Nail Infection, Diarrhoea, Dysphonia, Oral Pain, Skin Lesion, Gastrointestinal Sounds Abnormal, Brain Neoplasm, Eye Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tamoxifen Citrate
Indication: Product Used FOR Unknown Indication
Tykerb
Dosage: 1250mg per day
Administration route: Oral
Indication: Breast Cancer Metastatic
Start date: 2011-10-14
Xeloda
Dosage: 500mg per day
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-14
Possible Xeloda side effects in female
Reported by a physician from Germany on 2012-08-20
Patient: female, weighing 76.3 kg (167.8 pounds)
Reactions: Palmar-Plantar Erythrodysaesthesia Syndrome, Rash
Adverse event resulted in: death
Drug(s) suspected as cause:
Cetuximab and Cetuximab
Dosage: frequency reported as day 1.
Indication: Colorectal Cancer Metastatic
Irinotecan Hydrochloride
Dosage: frequency reported as day 1.
Indication: Colorectal Cancer Metastatic
Xeloda
Administration route: Oral
Indication: Colorectal Cancer Metastatic
Xeloda
Dosage: dose: 3 pills in am and 4 pills in the pm
Administration route: Oral
Other drugs received by patient: Budenofalk; Zofran; Dexamethasone; Mesalamine
Possible Xeloda side effects in 73 year old male
Reported by a pharmacist from Canada on 2012-08-20
Patient: 73 year old male
Reactions: LIP Swelling, Pruritus, Angioedema, Eosinophil Count Abnormal, Urticaria, Palmar-Plantar Erythrodysaesthesia Syndrome, Pyrexia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xeloda
Other drugs received by patient: Insulin; Atacand; Nexium; Carvedilol; Furosemide; Amlodipine; Digoxin; Aspirin; Risedronate Sodium
Possible Xeloda side effects in female
Reported by a consumer/non-health professional from Australia on 2012-08-16
Patient: female
Reactions: Fatigue, Pain in Extremity, Palmar-Plantar Erythrodysaesthesia Syndrome, Impaired Gastric Emptying, Gait Disturbance, Skin Fissures
Drug(s) suspected as cause:
Xeloda
Indication: Product Used FOR Unknown Indication
Xeloda
Possible Xeloda side effects in
Reported by a consumer/non-health professional from Poland on 2012-08-16
Patient:
Reactions: Coagulopathy, Palmar-Plantar Erythrodysaesthesia Syndrome, Thrombocytopenia
Drug(s) suspected as cause:
Xeloda
Possible Xeloda side effects in 35 year old female
Reported by a physician from Poland on 2012-08-14
Patient: 35 year old female
Reactions: Paronychia, Blood Bilirubin Increased, Herpes Zoster Disseminated, Palmar-Plantar Erythrodysaesthesia Syndrome, Metastasis, Diarrhoea, Metastases To Central Nervous System, Neurological Symptom
Drug(s) suspected as cause:
Trastuzumab
Indication: Product Used FOR Unknown Indication
Start date: 2008-09-01
Trastuzumab
Start date: 2008-11-01
End date: 2009-11-01
Xeloda
Administration route: Oral
Start date: 2012-04-01
Xeloda
Dosage: treatment resumed after 3 weeks .
Administration route: Oral
Start date: 2011-01-01
End date: 2011-07-01
Xeloda
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-05-07
Xeloda
Dosage: dose reduction by 10 percent
Administration route: Oral
Start date: 2010-07-01
End date: 2011-04-01
Xeloda
Dosage: 50 percent reduced dose
Administration route: Oral
Start date: 2011-10-01
End date: 2011-12-01
Other drugs received by patient: Cytoxan; Paclitaxel; Lapatinib; Adriamycin PFS; Goserelin
Possible Xeloda side effects in 24 year old male
Reported by a physician from Russian Federation on 2012-08-13
Patient: 24 year old male, weighing 49.0 kg (107.8 pounds)
Reactions: Palmar-Plantar Erythrodysaesthesia Syndrome
Drug(s) suspected as cause:
Avastin
Indication: Rectal Cancer
Start date: 2012-05-18
End date: 2012-06-14
Xeloda
Administration route: Oral
Indication: Rectal Cancer
Start date: 2012-06-08
End date: 2012-06-14
Other drugs received by patient: Oxaliplatin
Possible Xeloda side effects in
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-13
Patient:
Reactions: Abdominal Pain, Blood Bilirubin Increased, Thrombosis, Anal Examination Abnormal, Hypokalaemia, Fatigue, Proteinuria, Abdominal Distension, Decreased Appetite, Nausea, Palmar-Plantar Erythrodysaesthesia Syndrome, Hyponatraemia, Small Intestinal Obstruction, Hypophosphataemia, Diarrhoea, Alopecia, Dehydration, Neutropenia, Hypertension, Vascular Access Complication
Adverse event resulted in: death
Drug(s) suspected as cause:
Avastin
Dosage: given on day 1
Indication: Colorectal Cancer Metastatic
Irinotecan Hydrochloride and Irinotecan Hydrochloride
Dosage: given on day 1
Indication: Colorectal Cancer Metastatic
Xeloda
Dosage: 1000 mg/m2 twice daily for age below 65 years,750 mg/m2 twice daily for age above 65 years
Administration route: Oral
Indication: Colorectal Cancer Metastatic
Possible Xeloda side effects in female
Reported by a consumer/non-health professional from Mexico on 2012-08-13
Patient: female, weighing 68.0 kg (149.6 pounds)
Reactions: Hysterectomy, Fatigue, Malaise, Palmar-Plantar Erythrodysaesthesia Syndrome, Musculoskeletal Stiffness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xeloda
Administration route: Oral
Indication: Breast Cancer
Start date: 2012-06-21
End date: 2012-07-05
Xeloda
Administration route: Oral
Start date: 2012-08-06
Possible Xeloda side effects in female
Reported by a physician from Germany on 2012-08-10
Patient: female, weighing 61.0 kg (134.2 pounds)
Reactions: Palmar-Plantar Erythrodysaesthesia Syndrome, Pancytopenia, Febrile Neutropenia, Febrile Infection, Mucosal Inflammation, Agranulocytosis, Diarrhoea, Sepsis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Xeloda
Other drugs received by patient: Herceptin; Carboplatin
Possible Xeloda side effects in female
Reported by a physician from Argentina on 2012-08-10
Patient: female
Reactions: Palmar-Plantar Erythrodysaesthesia Syndrome, Nail Disorder, Disease Progression
Drug(s) suspected as cause:
Xeloda
Other drugs received by patient: Paclitaxel
Possible Xeloda side effects in
Reported by a individual with unspecified qualification from Italy on 2012-08-08
Patient:
Reactions: Stomatitis, Anaemia, Palmar-Plantar Erythrodysaesthesia Syndrome, Rash, Liver Disorder, Mucosal Inflammation, Fatigue, Diarrhoea, Neutropenia, Thrombocytopenia, Leukopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lapatinib
Indication: Breast Cancer Metastatic
Xeloda
Indication: Breast Cancer Metastatic
Possible Xeloda side effects in female
Reported by a physician from United States on 2012-08-07
Patient: female, weighing 72.9 kg (160.4 pounds)
Reactions: Mucosal Inflammation, Blood Bilirubin Increased, Malaise, Dyspnoea, Dehydration, Palmar-Plantar Erythrodysaesthesia Syndrome, Constipation, Ascites
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ramucirumab
Indication: Breast Cancer
Start date: 2012-06-15
Xeloda
Administration route: Oral
Indication: Breast Cancer
Start date: 2012-06-15
Other drugs received by patient: Tramadol HCL; Ativan; Compazine; Lisinopril
Possible Xeloda side effects in
Reported by a physician from Spain on 2012-08-07
Patient:
Reactions: Abdominal Pain, Dyspnoea, Palmar-Plantar Erythrodysaesthesia Syndrome, Rash, Mucosal Inflammation, Death, Fatigue, Diarrhoea, Neutropenia, Hypertension, Asthenia
Adverse event resulted in: death
Drug(s) suspected as cause:
Blinded Sorafenib and Blinded Sorafenib
Administration route: Oral
Indication: Breast Cancer
Xeloda
Dosage: drug was used for 14 days every 21 days.
Administration route: Oral
Indication: Breast Cancer
Possible Xeloda side effects in female
Reported by a consumer/non-health professional from Mexico on 2012-08-06
Patient: female, weighing 46.0 kg (101.2 pounds)
Reactions: Fatigue, Pancreatic Carcinoma, Palmar-Plantar Erythrodysaesthesia Syndrome, Depression
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Xeloda
Administration route: Oral
Indication: Pancreatic Carcinoma
Start date: 2011-10-01
Xeloda
Administration route: Oral
Start date: 2011-11-01
Other drugs received by patient: Gemcitabine Hydrochloride; Cinnarizine; Aspirin; Irbesartan
Possible Xeloda side effects in male
Reported by a physician from Japan on 2012-08-06
Patient: male, weighing 70.0 kg (154.0 pounds)
Reactions: Ureteric Obstruction, Palmar-Plantar Erythrodysaesthesia Syndrome, Extravasation of Urine
Drug(s) suspected as cause:
Avastin
Dosage: dosage is uncertain.
Indication: Colon Cancer Recurrent
Start date: 2009-11-24
End date: 2010-03-01
Avastin
Start date: 2010-11-22
End date: 2011-08-22
Avastin
Start date: 2011-10-31
End date: 2011-12-12
Xeloda
Administration route: Oral
Indication: Colon Cancer Recurrent
Start date: 2010-07-13
End date: 2010-01-01
Xeloda
Administration route: Oral
Start date: 2010-09-27
End date: 2011-08-22
Other drugs received by patient: Levoleucovorin Calcium; Oxycodone HCL; Levoleucovorin Calcium; Oxaliplatin; Loxoprofen; Oxaliplatin; Irinotecan HCL; Fluorouracil; Fluorouracil; Fluorouracil; Loxoprofen; Fluorouracil; Loxoprofen; TS-1; Oxycodone HCL
Possible Xeloda side effects in
Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-08-06
Patient:
Reactions: Vomiting, Anaemia, Pulmonary Embolism, Febrile Neutropenia, Palmar-Plantar Erythrodysaesthesia Syndrome, Peripheral Sensory Neuropathy, Mucosal Inflammation, Diarrhoea, Proteinuria, Neutropenia, Leukopenia
Drug(s) suspected as cause:
Avastin
Dosage: fluorouracil based regimen
Indication: Colorectal Cancer Metastatic
Avastin
Dosage: capecitabine-based regimen
Fluorouracil
Dosage: on day 1
Fluorouracil
Indication: Colorectal Cancer Metastatic
Irinotecan Hydrochloride
Dosage: dose: 150/180 mg/m2 on day 1
Indication: Colorectal Cancer Metastatic
Leucovorin Calcium
Dosage: on day 1
Indication: Colorectal Cancer Metastatic
Oxaliplatin
Dosage: on day 1
Indication: Colorectal Cancer Metastatic
Xeloda
Indication: Colorectal Cancer Metastatic
Possible Xeloda side effects in female
Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-03
Patient: female
Reactions: Central Nervous System Lesion, Palmar-Plantar Erythrodysaesthesia Syndrome, Hypoaesthesia, Nail Infection, Diarrhoea, Oral Pain, Skin Lesion, Eye Disorder, Brain Neoplasm
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tykerb
Administration route: Oral
Indication: Breast Cancer Metastatic
Start date: 2011-10-14
Xeloda
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-14
Possible Xeloda side effects in female
Reported by a physician from United States on 2012-07-31
Patient: female, weighing 59.5 kg (130.8 pounds)
Reactions: Death, Hyperaesthesia, Pain in Extremity, Skin Exfoliation, Palmar-Plantar Erythrodysaesthesia Syndrome
Adverse event resulted in: death
Drug(s) suspected as cause:
Xeloda
Other drugs received by patient: Allegra; Potassium; Probiotic (Unk Ingredients); Lovenox; Torsemide; Nexium; Diuretic (Unk Ingredients); Valtrex; Lorazepam
Possible Xeloda side effects in female
Reported by a physician from United States on 2012-07-27
Patient: female, weighing 59.5 kg (130.8 pounds)
Reactions: Death, Hyperaesthesia, Skin Exfoliation, Pain in Extremity, Palmar-Plantar Erythrodysaesthesia Syndrome
Adverse event resulted in: death
Drug(s) suspected as cause:
Xeloda
Other drugs received by patient: Probiotic (Unk Ingredients); Lovenox; Diuretic (Unk Ingredients); Allegra; Potassium Chloride; Valtrex; Nexium; Torsemide
Possible Xeloda side effects in 41 year old female
Reported by a pharmacist from Canada on 2012-07-26
Patient: 41 year old female
Reactions: Breast Cancer, Stomatitis, Skin Exfoliation, Metastases To Liver, Palmar-Plantar Erythrodysaesthesia Syndrome, Condition Aggravated, Erythema
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
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: Docusate Sodium; Senokot; Tylenol with Codeine #3 (United States)
Possible Xeloda side effects in
Reported by a health professional (non-physician/pharmacist) from Austria on 2012-07-26
Patient:
Reactions: Neuropathy Peripheral, Embolism, Diarrhoea, Palmar-Plantar Erythrodysaesthesia Syndrome
Drug(s) suspected as cause:
Avastin
Dosage: day 1 of a 2 week cycle for 6 cycles
Indication: Colorectal Cancer Metastatic
Oxaliplatin
Dosage: day 1 of a 2 week cycle for 6 cycles
Indication: Colorectal Cancer Metastatic
Xeloda
Dosage: day 1-7 of a 2 week cycle for 6 cycles
Indication: Colorectal Cancer Metastatic
Possible Xeloda side effects in 46 year old female
Reported by a physician from Canada on 2012-07-26
Patient: 46 year old female
Reactions: Musculoskeletal Disorder, Palmar-Plantar Erythrodysaesthesia Syndrome, DRY Skin, Erythema
Drug(s) suspected as cause:
Tykerb
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Xeloda
Indication: Product Used FOR Unknown Indication
Possible Xeloda side effects in 80 year old female
Reported by a physician from Lebanon on 2012-07-26
Patient: 80 year old female
Reactions: Skin Exfoliation, Pancytopenia, Palmar-Plantar Erythrodysaesthesia Syndrome, Rash, Mucosal Inflammation, Diarrhoea, Skin Discolouration, Neutropenia, Thrombocytopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xeloda
Possible Xeloda side effects in
Reported by a health professional (non-physician/pharmacist) from Austria on 2012-07-25
Patient:
Reactions: Neuropathy Peripheral, Embolism, Diarrhoea, Palmar-Plantar Erythrodysaesthesia Syndrome
Drug(s) suspected as cause:
Avastin
Dosage: day 1 of a 2 week cycle for 6 cycles
Indication: Colorectal Cancer Metastatic
Oxaliplatin
Dosage: day 1 of a 2 week cycle for 6 cycles
Indication: Colorectal Cancer Metastatic
Xeloda
Dosage: day 1-7 of a 2 week cycle for 6 cycles
Indication: Colorectal Cancer Metastatic
Possible Xeloda side effects in 63 year old male
Reported by a consumer/non-health professional from China on 2012-07-25
Patient: 63 year old male, weighing 74.0 kg (162.8 pounds)
Reactions: Productive Cough, Palmar-Plantar Erythrodysaesthesia Syndrome, Immunodeficiency, Oropharyngeal Pain, Rash Macular, Diarrhoea, Skin Discolouration, Ear Pain, Toothache, Asthenia, Metastases To Lung, Lethargy
Drug(s) suspected as cause:
Xeloda
Administration route: Oral
Start date: 2012-03-01
End date: 2012-07-13
Xeloda
Administration route: Oral
Indication: Hepatic Cancer Metastatic
Start date: 2007-11-01
End date: 2008-01-01
Xeloda
Administration route: Oral
Start date: 2010-01-01
Xeloda
Administration route: Oral
Start date: 2009-01-01
Other drugs received by patient: Adefovir Dipivoxil; Lamivudine; Nexavar
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