XELODA: 1,075 Adverse Event Reports & Safety Profile
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1,075
Total FAERS Reports
424 (39.4%)
Deaths Reported
234
Hospitalizations
1,075
As Primary/Secondary Suspect
33
Life-Threatening
21
Disabilities
First Report: 19980205 · Latest Report: 20140623
What Are the Most Common XELODA Side Effects?
#1 Most Reported
Death
303 reports (28.2%)
#2 Most Reported
Diarrhoea
141 reports (13.1%)
#3 Most Reported
Disease progression
137 reports (12.7%)
All XELODA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Death | 303 | 28.2% | 302 | 13 |
| Diarrhoea | 141 | 13.1% | 31 | 53 |
| Disease progression | 137 | 12.7% | 42 | 13 |
| Nausea | 81 | 7.5% | 19 | 30 |
| Vomiting | 71 | 6.6% | 13 | 41 |
| Palmar-plantar erythrodysaesthesia syndrome | 70 | 6.5% | 5 | 16 |
| Fatigue | 50 | 4.7% | 10 | 12 |
| Malignant neoplasm progression | 45 | 4.2% | 8 | 7 |
| Pain | 37 | 3.4% | 9 | 13 |
| Asthenia | 36 | 3.4% | 9 | 20 |
| Decreased appetite | 32 | 3.0% | 8 | 17 |
| Dehydration | 32 | 3.0% | 10 | 22 |
| Weight decreased | 31 | 2.9% | 3 | 14 |
| Abdominal pain | 29 | 2.7% | 7 | 18 |
| Breast cancer | 29 | 2.7% | 3 | 2 |
| Erythema | 28 | 2.6% | 5 | 9 |
| Neuropathy peripheral | 26 | 2.4% | 7 | 5 |
| Anaemia | 25 | 2.3% | 7 | 11 |
| Paraesthesia | 25 | 2.3% | 4 | 7 |
| Drug ineffective | 24 | 2.2% | 1 | 6 |
Who Reports XELODA Side Effects? Age & Gender Data
Average age: 61.8 years. Most reports from: US. View detailed demographics →
Is XELODA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2004 | 2 | 0 | 0 |
| 2008 | 1 | 0 | 0 |
| 2009 | 15 | 3 | 1 |
| 2010 | 9 | 4 | 3 |
| 2011 | 22 | 5 | 4 |
| 2012 | 44 | 16 | 15 |
| 2013 | 246 | 93 | 89 |
| 2014 | 285 | 143 | 57 |
What Is XELODA Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 215 |
| Colon cancer | 157 |
| Breast cancer | 147 |
| Breast cancer metastatic | 102 |
| Colorectal cancer | 68 |
| Gastric cancer | 56 |
| Rectal cancer | 48 |
| Pancreatic carcinoma | 25 |
| Colorectal cancer metastatic | 23 |
| Colon cancer metastatic | 22 |
XELODA vs Alternatives: Which Is Safer?
XELODA vs XENAZINE
XELODA vs XEPLION
XELODA vs XEROQUEL
XELODA vs XGEVA
XELODA vs XIPAMIDE
XELODA vs XOLAIR
XELODA vs XTANDI
XELODA vs XYLAZINE
XELODA vs XYLOMETAZOLINE
XELODA vs XYREM
Official FDA Label for XELODA
Official prescribing information from the FDA-approved drug label.