What the label lists and what reports show
Capecitabine side effects
Capecitabine's FDA label: “Most common adverse reactions in patients who received XELODA as a single agent for the adjuvant treatment for colon cancer (≥30%) were palmar-plantar erythrodysesthesia syndrome, diarrhea, and nausea.” FAERS holds 90,997 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (13,623 reports).
- Generic listed
- Boxed warning
Check it at the source: the capecitabine FDA label on DailyMed (effective February 5, 2026, H2-Pharma, LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of XELODA?XELODA can cause serious side effects including: See " What is the most important information I should know about XELODA? " Heart problems. XELODA can cause heart problems including: heart attack and decreased blood flow to the heart, chest pain, irregular heartbeats, changes in the electrical activity of your heart seen on an electrocardiogram (ECG), problems with your heart muscle, heart failure, and sudden death. You may have an increased risk of heart problems with XELODA if you have a history of narrowing or blockage of the coronary arteries (coronary artery disease). Stop taking XELODA and call your healthcare provider or go to the nearest hospital emergency room right away if you get any new symptoms of a heart problem including: chest pain shortness of breath dizziness lightheadedness Diarrhea. Diarrhea is common with XELODA and can sometimes be severe. […]
Source: FDA drug label, NDA020896 (Cheplapharm), as published by H2-Pharma, LLC, effective February 5, 2026 (SPL set e702d84d-7162-4751-bf37-d724cc7e45a5), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions in patients who received XELODA as a single agent for the adjuvant treatment for colon cancer (≥30%) were palmar-plantar erythrodysesthesia syndrome, diarrhea, and nausea.
Table 5 Adverse Reactions (≥10%) in Patients Who Received XELODA with Docetaxel for Metastatic Breast Cancer in Study SO14999
| Reaction | All Grades (%) | Grade 3 (%) | Grade 4 (%) | All Grades (%) | Grade 3 (%) | Grade 4 (%) |
|---|---|---|---|---|---|---|
| Diarrhea | 67 | 14 | <1 | 48 | 5 | <1 |
| Stomatitis | 67 | 17 | <1 | 43 | 5 | – |
| Nausea | 45 | 7 | – | 36 | 2 | – |
| Vomiting | 35 | 4 | 1 | 24 | 2 | – |
| Abdominal pain | 30 | 3 | <1 | 24 | 2 | – |
| Constipation | 20 | 2 | – | 18 | – | – |
| Dyspepsia | 14 | – | – | 8 | 1 | – |
| Palmar-plantar erythrodysesthesia syndrome | 63 | 24 | NA | 8 | 1 | NA |
| Alopecia | 41 | 6 | – | 42 | 7 | – |
| Nail disorder | 14 | 2 | – | 15 | – | – |
| Edema | 33 | <2 | – | 34 | <3 | 1 |
| Pyrexia | 28 | 2 | – | 34 | 2 | – |
| Asthenia | 26 | 4 | <1 | 25 | 6 | – |
| Fatigue | 22 | 4 | – | 27 | 6 | – |
| Weakness | 16 | 2 | – | 11 | 2 | – |
| Pain in Limb | 13 | <1 | – | 13 | 2 | – |
| Neutropenic fever | 16 | 3 | 13 | 21 | 5 | 16 |
| Taste disturbance | 16 | <1 | – | 14 | <1 | – |
| Headache | 15 | 3 | – | 15 | 2 | – |
| Paresthesia | 12 | <1 | – | 16 | 1 | – |
| Dizziness | 12 | – | – | 8 | <1 | – |
| Arthralgia | 15 | 2 | – | 24 | 3 | – |
| Myalgia | 15 | 2 | – | 25 | 2 | – |
| Back Pain | 12 | <1 | – | 11 | 3 | – |
| Dyspnea | 14 | 2 | <1 | 16 | 2 | – |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Cardiotoxicity [see Warnings and Precautions (5.3) ] Diarrhea [see Warnings and Precautions (5.4) ] Dehydration [see Warnings and Precautions (5.5) ] Renal Toxicity [see Warnings and Precautions (5.6) ] Serious Skin Toxicities [see Warnings and Precautions (5.7) ] Palmar-Plantar Erythrodysesthesia Syndrome [see Warnings and Precautions (5.8) ] Myelosuppression [see Warnings and Precautions (5.9) ] Hyperbilirubinemia [see Warnings and Precautions (5.10) ] Most common adverse reactions in patients who received XELODA as a single agent for the adjuvant treatment for colon cancer (≥30%) were palmar-plantar erythrodysesthesia syndrome, diarrhea, and nausea. ( 6.1 ) Most common adverse reactions (≥30%) in patients with metastatic colorectal cancer who received XELODA as a single agent were anemia, diarrhea, palmar-plantar erythrodysesthesia syndrome, hyperbilirubinemia, nausea, fatigue, and abdominal pain. ( 6.1 ) Most common adverse reactions (≥30%) in patients with metastatic breast cancer who received XELODA with docetaxel were diarrhea, stomatitis, palmar-plantar erythrodysesthesia syndrome, nausea, alopecia, vomiting, edema, and abdominal pain. …
Source: FDA drug label, NDA020896 (Cheplapharm), as published by H2-Pharma, LLC, effective February 5, 2026 (SPL set e702d84d-7162-4751-bf37-d724cc7e45a5), via openFDA; the full label on DailyMed
What do FAERS reports show?
90,997 reports list capecitabine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 18,292 are coded as a death and 28,846 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 17 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Capecitabine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions