Key points
- Capecitabine (Xeloda) is chemotherapy in tablet form that the body turns into fluorouracil; it is used for colorectal, breast, stomach, oesophageal and pancreatic cancer [1].
- After bowel cancer surgery, these tablets worked at least as well as chemotherapy by injection and caused fewer side effects [2].
- The most common side effects: hand-foot syndrome (red, sore palms and soles), diarrhoea and nausea [1].
- Before starting, ask about a DPYD gene test; a shortage of this enzyme causes very severe side effects [1, 3].
- If you take warfarin, be sure to say so; there is a risk of severe bleeding [1].
What is this drug and how does it work?
For physicians
Capecitabine (brand name Xeloda) belongs to the fluoropyrimidines and is described in the FDA label as a nucleoside metabolic inhibitor; it was first approved in the United States in 1998 [1].
The drug is inactive itself and is converted in three enzymatic steps (carboxylesterase, cytidine deaminase and finally thymidine phosphorylase) to the active drug fluorouracil. Fluorouracil inhibits thymidylate synthase and so disrupts DNA synthesis, and its misincorporation into RNA also disrupts protein synthesis [1]. In patients given capecitabine for 7 days before surgery, the median fluorouracil concentration in colorectal tumour was 2.9 times that in adjacent healthy tissue [1].
Fluorouracil is broken down mainly by the enzyme DPD (dihydropyrimidine dehydrogenase); this is why people with low levels of this enzyme are at risk of severe toxicity [1].
Which cancers is it used for?
Your doctor may prescribe this drug for:
- Stage 3 colon cancer [1]
- Locally advanced rectal cancer [1]
- Colorectal cancer that cannot be removed by surgery or has spread [1]
- Advanced or spread breast cancer [1]
- Early HER2-negative breast cancer with tumour left after chemotherapy given before surgery [6]
- Cancer of the stomach, oesophagus and the junction between them [1]
- Pancreatic cancer [1]
Whether it suits you depends on the type and stage of your cancer and your test results. Details of each use are in the section for doctors.
For physicians
| Cancer | Setting |
|---|---|
| Stage III colon cancer | Adjuvant treatment after surgery, alone or with oxaliplatin (CAPOX regimen) [1] |
| Locally advanced rectal cancer | Perioperatively, as part of chemoradiotherapy [1] |
| Unresectable or metastatic colorectal cancer | Alone or with oxaliplatin [1] |
| Advanced or metastatic breast cancer | Alone (when an anthracycline or taxane is not suitable) or with docetaxel after an anthracycline [1] |
| Early HER2-negative breast cancer with residual tumour after neoadjuvant chemotherapy | Adjuvant treatment after surgery [6] (this use is not listed in the FDA label) |
| Gastric, oesophageal and gastro-oesophageal junction cancer | Advanced disease with a platinum-containing regimen; in HER2-positive disease with cisplatin and trastuzumab [1] |
| Pancreatic cancer | Adjuvant treatment after surgery with gemcitabine [1] |
| Cancer | Key evidence |
|---|---|
| Stage III colon cancer | X-ACT: 5-year disease-free survival 59% vs 55% with fluorouracil/leucovorin (HR 0.88), non-inferiority shown [1, 2]; NO16968: adding oxaliplatin, HR for disease-free survival 0.80 [4]; IDEA: with CAPOX, 3 months of treatment was non-inferior to 6 months (HR 0.95) [5] |
| Locally advanced rectal cancer | Based on published studies including Rektum-III [1] |
| Unresectable or metastatic colorectal cancer | Two first-line trials: response rates 21% vs 11% and 21% vs 14% with fluorouracil/leucovorin, with similar overall survival [1] |
| Advanced or metastatic breast cancer | SO14999: median overall survival 14.5 vs 11.6 months with docetaxel alone (HR 0.775) [1] |
| Early HER2-negative breast cancer with residual tumour after neoadjuvant chemotherapy | CREATE-X: 5-year disease-free survival 74.1% vs 67.6% (HR 0.70); in the triple-negative subgroup HR 0.58 [6] |
| Gastric, oesophageal and gastro-oesophageal junction cancer | REAL-2: capecitabine vs fluorouracil, HR for death 0.86 (non-inferior) [7]; ToGA: median overall survival 13.8 vs 11.1 months with added trastuzumab (HR 0.74) [8] |
| Pancreatic cancer | ESPAC-4: median overall survival 28.0 vs 25.5 months with gemcitabine alone (HR 0.82) [9] |
HR: hazard ratio; a value below 1 favours the arm receiving the regimen studied.
How it is taken and dosing
Show detailsHide
Treatment regimens and doses: index6 regimens
Capecitabine comes as 150 mg and 500 mg tablets. The dose is calculated from body surface area (height and weight) and the type of cancer, and rounded to the nearest 150 mg [1].
- Take the tablets twice a day, about 12 hours apart, at the same times every day [1].
- Swallow the tablets whole with water within 30 minutes after a meal; do not chew, split or crush them [1].
- In most regimens the drug is taken for 14 days and then stopped for 7 days (a 21-day cycle); some regimens (for example with radiotherapy or gemcitabine) use a different schedule [1].
- If you miss a dose or vomit after taking a tablet, do not take an extra dose; take the next one as planned [1].
- Do not change the dose yourself or stop treatment without talking to your doctor; but if one of the side effects under “When should I call my doctor?” happens, stop taking it as the drug label advises and contact your treatment team straight away [1].
- DPYD testing: test for DPYD variants before starting unless treatment is urgent (no FDA-approved test is currently available). Avoid use in complete DPD deficiency; no dose has been shown to be safe. In partial deficiency, individualise the dose; CPIC recommends a 50% reduction of the starting dose with later titration for a gene activity score of 1 [1, 3]. Severe toxicity can occur even without a variant [1].
- Conditions to start: not recommended with baseline neutrophils below 1500 or platelets below 100,000 per µL; optimise hydration before starting [1].
- Monitoring: CBC at baseline and before each cycle; renal function and hydration at baseline and as needed; frequent PT/INR with warfarin; phenytoin levels; hepatic impairment: closer monitoring for toxicity [1].
- Dose modification for toxicity (percentage of the current dose): grade 2: hold until grade 0–1, then 100% (first occurrence), 75% (second), 50% (third), discontinue permanently (fourth). Grade 3: hold until grade 0–1, then 75%, then 50%, discontinue permanently at the third occurrence. Grade 4: discontinue permanently, or hold until grade 0–1 and resume at 50% [1].
- Grade 3–4 hyperbilirubinaemia: resume once grade ≤2 (below 3 times the upper limit) at the percentage in the scheme above. Cardiotoxicity: withhold (the safety of resuming has not been established). Severe skin reaction: discontinue permanently [1].
- Renal impairment: CLcr 30 to 50 mL/min (Cockcroft-Gault): reduce the dose by 25%; CLcr below 30: no dose has been established [1].
- Overdose: uridine triacetate within 96 hours [1].
For physicians
Standard dosing and regimens (FDA label)
Stage III colon cancer, adjuvant
Monotherapy or with oxaliplatin (CAPOX/XELOX)Cycle length: Every 21 days
Monotherapy or with oxaliplatin (CAPOX/XELOX)
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Monotherapy | |||
| Capecitabine | 1250 mg/m² twice daily | Oral, within 30 minutes after a meal | Days 1 to 14 |
| Or CAPOX | |||
| Capecitabine | 1000 mg/m² twice daily | Oral, within 30 minutes after a meal | Days 1 to 14 |
| CAPOX | |||
| Oxaliplatin | 130 mg/m² | IV | Day 1 |
Dosing as per the FDA label [1].
Locally advanced rectal cancer, perioperative
Part of chemoradiotherapy or a perioperative combination regimen
Part of chemoradiotherapy or a perioperative combination regimen
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| With radiotherapy | |||
| Capecitabine | 825 mg/m² twice daily | Oral, within 30 minutes after a meal | |
| Without radiotherapy | |||
| Capecitabine | 1250 mg/m² twice daily | Oral, within 30 minutes after a meal | |
Dosing as per the FDA label [1].
Unresectable or metastatic colorectal cancer
Monotherapy or with oxaliplatinCycle length: Every 21 days
Monotherapy or with oxaliplatin
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Monotherapy | |||
| Capecitabine | 1250 mg/m² twice daily | Oral, within 30 minutes after a meal | Days 1 to 14 |
| Or with oxaliplatin | |||
| Capecitabine | 1000 mg/m² twice daily | Oral, within 30 minutes after a meal | Days 1 to 14 |
| Oxaliplatin | 130 mg/m² | IV | Day 1 |
Dosing as per the FDA label [1].
Advanced or metastatic breast cancer
Monotherapy when an anthracycline- or taxane-containing regimen is not suitable; or with docetaxel after progression on an anthracyclineCycle length: Every 21 days
Monotherapy when an anthracycline- or taxane-containing regimen is not suitable; or with docetaxel after progression on an anthracycline
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Capecitabine | 1000 or 1250 mg/m² twice daily | Oral, within 30 minutes after a meal | Days 1 to 14 |
| In combination | |||
| Docetaxel | 75 mg/m² | IV | Day 1 |
Individualise the dose according to risk factors and toxicity. In combination with docetaxel, both drugs are withheld until the conditions for resuming both are met [1].
Gastric, oesophageal or gastro-oesophageal junction cancer
Unresectable or metastatic, as part of a combination regimen; untreated HER2-positive metastatic disease with cisplatin and trastuzumabCycle length: Every 21 days
Unresectable or metastatic, as part of a combination regimen; untreated HER2-positive metastatic disease with cisplatin and trastuzumab
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| With a platinum-containing regimen | |||
| Capecitabine | 625 mg/m² twice daily | Oral, within 30 minutes after a meal | Days 1 to 21 (continuous) |
| Or with oxaliplatin | |||
| Capecitabine | 850 or 1000 mg/m² twice daily | Oral, within 30 minutes after a meal | Days 1 to 14 |
| Oxaliplatin | 130 mg/m² | IV | Day 1 |
| HER2-positive | |||
| Capecitabine | 1000 mg/m² twice daily (with cisplatin and trastuzumab) | Oral, within 30 minutes after a meal | Days 1 to 14 |
Doses of the partner drugs as per their own labels [1].
Pancreatic cancer, adjuvant (with gemcitabine)
Pancreatic adenocarcinoma after surgeryCycle length: Every 28 days
Pancreatic adenocarcinoma after surgery
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Capecitabine | 830 mg/m² twice daily | Oral, within 30 minutes after a meal | Days 1 to 21 |
| Gemcitabine | 1000 mg/m² | IV | Days 1, 8 and 15 |
Dosing as per the FDA label [1].
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Side effects
The most common side effects:
For physicians
| Adverse reaction | All grades | Grade 3 or 4 |
|---|---|---|
| Hand-foot syndrome (red, swollen and painful palms and soles) | 60% | 17% |
| Diarrhoea | 47% | 12% |
| Nausea | 34% | 2% |
| Stomatitis | 22% | 2% |
| Fatigue | 16% | Less than 1% |
| Vomiting | 15% | 2% |
| Abdominal pain | 14% | 3% |
| Raised bilirubin (blood test) | — | 20% |
Source: FDA label for Xeloda [1]. With oxaliplatin the adverse reactions are similar, but sensory nerve damage is more common [1]. Hair loss was reported in fewer than 10% of patients [1].
Hand-foot syndrome is the most important everyday adverse reaction to capecitabine; in metastatic patients it appeared at a median of about 2.6 months after starting treatment, and in severe or prolonged cases it can lead to loss of fingerprints [1]. In the CREATE-X trial it occurred in 73.4% of breast cancer patients [6]. Early symptomatic treatment is recommended [1].
Serious side effects
These are less common but serious; tell your team early if you notice any sign of them:
- Inherited DPD enzyme deficiency: a small number of people have low levels of this enzyme, and the drug causes very severe side effects from the first weeks (severe mouth sores, severe diarrhoea, infection). Talk to your doctor about a DPYD gene test before starting [1].
- With warfarin: the risk of severe bleeding goes up; be sure to say that you take warfarin [1].
- Severe diarrhoea and dehydration, which can damage the kidneys: report diarrhoea more than 4 times a day or at night straight away, and do not take the tablets until you have spoken to your doctor [1].
- Heart problems: chest pain, palpitations or shortness of breath [1].
- Fever or chills, severe skin reactions (blisters, mouth sores) and harm to an unborn baby [1].
For physicians
The FDA label for Xeloda has two boxed warnings [1]:
- DPD deficiency: patients with complete DPD deficiency (two non-functional DPYD variants) are at risk of early, severe and sometimes fatal toxicity (severe mucositis, diarrhoea, neutropenia and neurotoxicity). About 3 to 5% of the white population have partial and about 0.2% complete deficiency. Severe toxicity can occur even with a negative test [1].
- Bleeding with warfarin: raised INR and bleeding, including deaths, have been reported with concomitant vitamin K antagonist anticoagulants [1].
Other important warnings [1]:
- Cardiotoxicity: myocardial infarction, angina, arrhythmias, heart failure and sudden death; more common with a history of coronary artery disease.
- Severe diarrhoea and dehydration, which can lead to renal failure (sometimes fatal); the median time to grade 2 to 4 diarrhoea was about 34 days.
- Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
- Myelosuppression: as a single agent, grade 3–4 neutropenia in 3.2%; with docetaxel in 68% of patients. Necrotising enterocolitis (typhlitis) has also been reported.
- Hyperbilirubinaemia: grade 3 in 15% and grade 4 in 3.9% of patients with metastatic breast and colorectal cancer.
- Embryo-fetal toxicity if used in pregnancy.
When should I call my doctor?
Stop taking the tablets and contact your doctor or treatment team straight away if you have [1]:
- Diarrhoea with 4 to 6 more bowel movements a day than usual, or diarrhoea at night; or bloody diarrhoea with severe abdominal pain and fever
- A temperature of 38 °C or higher or any sign of infection
- Chest pain, shortness of breath, dizziness or light-headedness (go to the emergency department)
- Vomiting 2 to 5 times in 24 hours, or nausea that has clearly reduced how much you eat
- Painful sores in the mouth or on the tongue, or redness, swelling and pain of the palms and soles that interferes with daily activities
- Yellow skin or eyes, passing less urine or signs of dehydration
- A rash, blisters or peeling skin; hives or swelling of the face, lips, tongue or throat that makes swallowing or breathing difficult
- Any sign of bleeding, especially if you take warfarin
Interactions, pregnancy and precautions
- Other medicines: give your doctor a list of all your medicines, vitamins and herbal remedies. Capecitabine increases the effect of the blood thinner warfarin, the epilepsy drug phenytoin and some diabetes medicines; its effect on warfarin may last up to 1 month after stopping capecitabine. Do not take the gout medicine allopurinol with it, because it may reduce the effect of capecitabine [1].
- Folic acid: supplements containing folic acid or leucovorin increase fluorouracil toxicity; take them only if your doctor tells you to [1].
- Kidneys: use with drugs that can harm the kidneys (such as platinum drugs, methotrexate and intravenous bisphosphonates) needs monitoring; drink enough fluids before starting treatment [1].
- Pregnancy and contraception: pregnancy is checked before starting. Women should use effective contraception for 6 months, and men with a partner who could become pregnant for 3 months, after the last dose. The drug may reduce fertility [1].
- Breastfeeding: do not breastfeed during treatment and for 1 week after the last dose [1].
- Older adults have more gastrointestinal side effects and need closer follow-up [1].
- Family safety: capecitabine is a hazardous (cytotoxic) drug; do not crush the tablets, because contact with the powder has caused eye irritation, rash and other effects [1].
Frequently asked questions
Is capecitabine chemotherapy too?
Yes. Capecitabine is an oral prodrug of fluorouracil and is turned into the same active drug in the body [1]. As adjuvant treatment of colon cancer, it worked at least as well as the injected fluorouracil and leucovorin regimen [2].
Why is a DPYD test needed before treatment?
What should I do if I forget a dose or vomit after taking a tablet?
Do not make up a missed or vomited dose; take the next dose at the usual time [1].
What should I do about red, sore palms and soles?
Tell your treatment team; early symptomatic treatment is recommended. If the pain and swelling interfere with daily activities, stop taking the tablets and call your doctor; once it improves, treatment usually continues at the same or a lower dose [1].
Will capecitabine make my hair fall out?
I take warfarin; is that a problem?
Be sure to tell your doctor. Capecitabine increases the effect of warfarin and carries a risk of serious bleeding; INR should be checked often, even up to a month after stopping capecitabine [1].
Scientific evidence
Show detailsHide
Key studies
13 itemsDuration of Adjuvant Chemotherapy for Stage III Colon Cancer
Comparison of adjuvant gemcitabine and capecitabine with gemcitabine monotherapy in patients with resected pancreatic cancer (ESPAC-4): a multicentre, open-label, randomised, phase 3 trial
Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial
Short-course radiotherapy followed by chemotherapy before total mesorectal excision (TME) versus preoperative chemoradiotherapy, TME, and optional adjuvant chemotherapy in locally advanced rectal cancer (RAPIDO): a randomised, open-label, phase 3 trial
Localised colon cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up
Localised rectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up
Gastric cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up
Pancreatic cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up
Breast Cancer, Version 4.2026, NCCN Clinical Practice Guidelines In Oncology
Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial
Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer (KEYNOTE-859): a multicentre, randomised, double-blind, phase 3 trial
Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23): a multicentre, randomised, open-label, phase 3 trial
First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial
Related cancer types
Treatment regimens (physicians)
References
9 referencesShow all references, 8 with a study cardClose the reference list
Numbers in the text, such as [1], refer to these sources. Sources with a “Study card” button are summarised in the site’s evidence library.
- 1XELODA (capecitabine) tablets, for oral use — Prescribing Information
- 2
- 3
- 4Capecitabine Plus Oxaliplatin Compared With Fluorouracil and Folinic Acid As Adjuvant Therapy for Stage III Colon Cancer
- 5Duration of Adjuvant Chemotherapy for Stage III Colon Cancer
- 6
- 7Capecitabine and Oxaliplatin for Advanced Esophagogastric Cancer
- 8Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial
- 9Comparison of adjuvant gemcitabine and capecitabine with gemcitabine monotherapy in patients with resected pancreatic cancer (ESPAC-4): a multicentre, open-label, randomised, phase 3 trial
This page is based on reputable scientific sources and was last updated on 27 October 2026. The content of this website is for educational and informational purposes only and does not replace consultation, diagnosis or treatment by a specialist physician. Consult your treating physician about any treatment decision.
Printed from the website; the full and up-to-date version: https://drdabiri.com/en/drugs/capecitabine/