Drug Safety Information for XELODA (Capecitabine)

Safety-related Labeling Changes for XELODA (CAPECITABINE) Rx Drug: FDA Link

Cerebellar toxicity Evaluating

Adverse Drug Reactions for XELODA* (Capecitabine)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with XELODA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Death5376
2Diarrhoea4953
3Nausea*2547
4Disease progression2525
5Vomiting2447
6Palmar-plantar erythrodysaesthesia syndrome2034
7Fatigue1613
8Neoplasm malignant1505
9Dehydration1488
10Decreased appetite*1192
11Pyrexia1146
12Asthenia1113
13Dyspnoea1084
14Neutropenia975
15Abdominal pain928
16Mucosal inflammation834
17Anaemia791
18Pain*776
19Rash713
20Thrombocytopenia701

* This side effect also appears in "Top 10 Side Effects of XELODA " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking XELODA
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Breast cancer13189
2Product used for unknown indication11860
3Breast cancer metastatic*8287
4Colon cancer7126
5Colorectal cancer5435
6Gastric cancer4731
7Rectal cancer3909
8Colorectal cancer metastatic3842
9Pancreatic carcinoma2042
10Colon cancer metastatic1779

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for XELODA

Total Reports Filed with FDA: 118323


Number of FDA Adverse Event Reports by Patient Age for XELODA

Total Reports Filed with FDA: 118323*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Capecitabine (Capecitabine, Xeloda)

Charts are based on 118323 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and XELODA Reviews and Review Summary .

Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

Visit   DrugInformer.com more on XELODA's side effects.