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Capecitabine

Capecitabine is an oral chemotherapy tablet used to treat colorectal cancer, breast cancer, gastric and esophageal cancers, and pancreatic cancer.

Brand name Xeloda
Drug class Nucleoside Metabolic Inhibitor
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 22 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 6, 2026
Capecitabine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Capecitabine (Xeloda) is an oral chemotherapy the body turns into fluorouracil (5-FU), which blocks an enzyme cancer cells need to make DNA and disrupts their RNA; a mainstay for colorectal and breast cancer, also used for stomach, esophageal and pancreatic cancers, it dates to about 1998 and is available as a generic. Side effects are usually manageable with dose adjustments, but most people notice hand-and-foot syndrome (red, sore or peeling palms and soles) and diarrhea, often with tiredness and nausea. The boxed warning covers severe or fatal reactions in people who completely lack the DPD enzyme (a DPYD gene test is recommended first) and dangerous, sometimes fatal bleeding with blood thinners like warfarin.

Clinical pearls

  • Take each dose within 30 minutes after a meal, morning and evening, swallowed whole with water.
  • Skip folic acid and folate supplements, including multivitamins that contain them, unless your oncologist approves, because they worsen side effects.
  • Tell any prescriber you take capecitabine before starting allopurinol for gout, which may weaken it, or phenytoin, whose levels it raises.
  • Call promptly about severe diarrhea or unusually harsh early side effects; treatment may need pausing, and dehydration can damage kidneys.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

There are two serious, potentially life-threatening warnings for capecitabine.

First: People who completely lack an enzyme called DPD (dihydropyrimidine dehydrogenase) cannot process capecitabine safely. Taking this drug with complete DPD deficiency can cause severe or fatal reactions. Your doctor should test you for a specific gene variant (DPYD) before you start, unless immediate treatment is required. Capecitabine should be avoided in patients confirmed to have complete DPD deficiency.

Second: Taking capecitabine with blood thinners like warfarin can cause dangerous bleeding and has been linked to death. Even patients who have been stable on a blood thinner for a long time can experience a sudden, dangerous rise in their clotting time (INR) once they start capecitabine. This can happen within days of starting treatment or up to a month after stopping. If you take any blood thinner, your INR must be checked much more frequently and your dose adjusted as needed.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet
Earliest FDA record1998
Companies listing it with the FDA19
FDA label last updatedFeb 5, 2026
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Capecitabine, written from its FDA label.

What Capecitabine is used for

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Capecitabine is an oral chemotherapy tablet approved to treat several types of cancer. Specific approvals vary by product.

  • Colorectal cancer: Adjuvant treatment of Stage III colon cancer (as a single agent or part of a combination regimen); perioperative treatment of locally advanced rectal cancer alongside radiation; and treatment of unresectable or metastatic colorectal cancer. Capecitabine 150mg and 500mg tablets are specifically indicated for adjuvant treatment of Dukes' C colon cancer and first-line metastatic colorectal cancer when fluoropyrimidine therapy alone is preferred.
  • Breast cancer: Advanced or metastatic breast cancer as a single agent when anthracycline- or taxane-containing chemotherapy is not appropriate; or in combination with docetaxel after disease progression on prior anthracycline-containing therapy. Capecitabine 150mg and 500mg tablets are also indicated for metastatic breast cancer resistant to paclitaxel and anthracycline regimens.
  • Gastric, esophageal, or gastroesophageal junction cancer: Xeloda and capecitabine tablets are indicated for unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as part of a combination regimen, including for HER2-overexpressing metastatic tumors.
  • Pancreatic cancer: Xeloda and capecitabine tablets are indicated for adjuvant treatment of pancreatic adenocarcinoma as part of a combination chemotherapy regimen.

How Capecitabine works

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Capecitabine is a prodrug — it's inactive when you swallow it, and your body converts it into the active cancer-fighting drug fluorouracil (5-FU). Fluorouracil works in two ways: it blocks an enzyme called thymidylate synthase that cancer cells need to build DNA, which stops them from dividing and growing; and it gets mistakenly incorporated into RNA during protein synthesis, disrupting how cancer cells function. Tumor cells tend to activate capecitabine at higher levels than normal tissue, which helps concentrate the effect where it's needed most.

Capecitabine dosage

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Capecitabine tablets are taken by mouth, twice daily (morning and evening), within 30 minutes after a meal, swallowed whole with water. Treatment is given in cycles — most commonly two weeks of active treatment followed by one week off, but the exact schedule depends on the cancer being treated and whether capecitabine is used alone or with other drugs. Your dose is calculated based on your body surface area, and your prescriber may adjust it based on how you tolerate treatment.

  • Always take with food — taking it on an empty stomach significantly reduces absorption
  • Do not adjust your dose or stop treatment without talking to your care team first
  • If a tablet needs to be cut or crushed, only a trained healthcare professional should do this using proper safety equipment

Dosing details from the FDA-approved label

From the Capecitabine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Monotherapy (Metastatic Colorectal Cancer, Adjuvant Colorectal Cancer, Metastatic Breast Cancer)
    • 1250 mg/m2 orally twice daily (morning and evening
    • Equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period, given as 3-week cycles
    • Take swallowed whole with water within 30 minutes after a meal; reduce dose by 25% (to 950 mg/m2 twice daily) in moderate renal impairment (creatinine clearance 30 to 50 mL/min)
  • Adjuvant treatment, Dukes' C colon cancer (capecitabine tablets label)
    • 1250 mg/m2 orally twice daily for 2 weeks followed by a 1-week rest period, given as 3-week cycles for a total of 8 cycles (24 weeks)
    • Maximum: Total of 6 months (8 cycles)
    • Moderate renal impairment: reduce to 75% of starting dose
  • In combination with docetaxel (Metastatic Breast Cancer)
    • Capecitabine 1250 mg/m2 twice daily for 2 weeks followed by a 1-week rest period, combined with docetaxel 75 mg/m2 as a 1-hour intravenous infusion every 3 weeks
    • Moderate renal impairment (creatinine clearance 30 to 50 mL/min): 950 mg/m2 twice daily; start docetaxel pre-medication per docetaxel labeling
  • Xeloda: Adjuvant Treatment of Colon Cancer, single agent
    • 1,250 mg/m2 twice daily orally for the first 14 days of each 21-day cycle
    • Maximum: Maximum of 8 cycles
  • Xeloda: Adjuvant Treatment of Colon Cancer, in combination with oxaliplatin-containing regimens
    • 1,000 mg/m2 orally twice daily for the first 14 days of each 21-day cycle with oxaliplatin 130 mg/m2 intravenously on day 1 of each cycle
    • Maximum: Maximum of 8 cycles
  • Xeloda: Perioperative Treatment of Rectal Cancer
    • With concomitant radiation therapy: 825 mg/m2 orally twice daily
    • Without radiation therapy: 1,250 mg/m2 orally twice daily
  • Xeloda: Unresectable or Metastatic Colorectal Cancer
    • Single agent: 1,250 mg/m2 twice daily orally for the first 14 days of each 21-day cycle
    • In combination with oxaliplatin: 1,000 mg/m2 orally twice daily for the first 14 days of each 21-day cycle with oxaliplatin 130 mg/m2 IV on day 1
    • Maximum: Until disease progression or unacceptable toxicity
  • Xeloda: Advanced or Metastatic Breast Cancer
    • Single agent: 1,000 mg/m2 or 1,250 mg/m2 twice daily orally for the first 14 days of each 21-day cycle
    • With docetaxel: 1,000 mg/m2 or 1,250 mg/m2 orally twice daily for the first 14 days of a 21-day cycle with docetaxel 75 mg/m2 IV on day 1
    • Maximum: Until disease progression or unacceptable toxicity
  • Xeloda: Unresectable or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Cancer
    • 625 mg/m2 orally twice daily on days 1 to 21 of each 21-day cycle with platinum-containing chemotherapy
    • OR 850 mg/m2 or 1,000 mg/m2 orally twice daily for the first 14 days of each 21-day cycle with oxaliplatin 130 mg/m2 IV on day 1
    • Maximum: 625 mg/m2 regimen: maximum of 8 cycles; other regimen: until disease progression or unacceptable toxicity
  • Xeloda: Pancreatic cancer
    • 830 mg/m2 orally twice daily for the first 21 days of each 28-day cycle with gemcitabine 1,000 mg/m2 IV on days 1, 8, and 15 of each cycle
    • Maximum: Maximum of 6 cycles
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Adjuvant Treatment of Colon Cancer Single agent: 1,250 mg/m 2 twice daily orally for the first 14 days of each 21-day cycle for a maximum of 8 cycles. ( 2.1 ) In combination with Oxaliplatin-Containing Regimens: 1,000 mg/m 2 orally twice daily for the first 14 days of each 21-day cycle for a maximum of 8 cycles in combination with oxaliplatin 130 mg/m 2 administered intravenously on day 1 of each cycle. (2.2) Perioperative Treatment of Rectal Cancer With Concomitant Radiation Therapy: 825 mg/m 2 orally twice daily (2.2) Without Radiation Therapy: 1,250 mg/m 2 orally twice daily (2.2) Unresectable or Metastatic Colorectal Cancer: Single agent: 1,250 mg/m 2 twice daily orally for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity. (2.2) In Combination with Oxaliplatin: 1,000 mg/m 2 orally twice daily for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity in combination with oxaliplatin 130 mg/m 2 administered intravenously on day 1 of each cycle. (2.2) Advanced or Metastatic Breast Cancer: Single agent: 1,000 mg/m 2 or 1,250 mg/m 2 twice daily orally for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity. (2.3) In combination with docetaxel: 1,000 mg/m 2 or 1,250 mg/m 2 orally twice daily for the first 14 days of a 21-day cycle, until disease progression or unacceptable toxicity in combination with docetaxel at 75 mg/m 2 administered intravenously on day 1 of each cycle (2.3) Unresectable or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Cancer 625 mg/m 2 orally twice daily on days 1 to 21 of each 21-day cycle for a maximum of 8 cycles in combination with platinum-containing chemotherapy. (2.4) OR 850 mg/m 2 or 1,000 mg/m 2 orally twice daily for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity in combination with oxaliplatin 130 mg/m 2 administered intravenously on day 1 of each cycle. (2.4) HER2-overexpressing metastatic adenocarcinoma of the gastroesophageal junction or stomach 1,000 mg/m 2 orally twice daily for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity in combination with cisplatin and trastuzumab.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Capecitabine side effects

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Capecitabine commonly causes side effects that your care team will monitor closely throughout treatment.

Common side effects

  • Hand-and-foot syndrome (palmar-plantar erythrodysesthesia) — redness, pain, or peeling on palms and soles
  • Diarrhea
  • Nausea and vomiting
  • Fatigue
  • Mouth sores (stomatitis)
  • Anemia (low red blood cell count)
  • Loss of appetite and abdominal pain
  • Hair loss (alopecia)
  • Hand-and-foot syndrome (palmar-plantar erythrodysesthesia) — redness, pain, swelling, or peeling on the palms and soles; one of the most common reactions
  • Anemia (low red blood cell count) and lymphopenia (low white blood cell count)

When to get medical help

  • Call your doctor immediately if you develop severe or persistent diarrhea — treatment may need to be paused
  • Seek emergency help if you notice unusual bleeding or bruising, especially if you take a blood thinner like warfarin
  • Tell your doctor right away if you develop chest pain, irregular heartbeat, or other heart symptoms
  • Get medical help immediately for signs of severe skin reactions — blistering, peeling, painful rash (could be Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis)
  • Contact your doctor if you become dehydrated (dizziness, very little urine, extreme thirst) — this can lead to kidney failure
  • Report yellowing of the skin or eyes (jaundice/hyperbilirubinemia) promptly
  • Tell your doctor if you experience unusually severe side effects early in treatment — this may signal a rare enzyme deficiency (DPD deficiency) that makes the drug dangerous

Capecitabine warnings and precautions

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  • DPD enzyme deficiency: People with complete absence of the DPD enzyme cannot safely process capecitabine. This can cause life-threatening or fatal toxicity. Genetic testing (DPYD) is recommended before starting treatment. Early, unusually severe side effects may signal this deficiency even in untested patients.
  • Bleeding with blood thinners: Capecitabine dramatically increases bleeding risk in patients taking vitamin K antagonists such as warfarin. Deaths have been reported. INR must be monitored frequently, even in patients previously stable on their blood thinner dose.
  • Severe diarrhea and dehydration: Can lead to acute kidney failure. Treatment must be stopped immediately until diarrhea resolves.
  • Heart problems (cardiotoxicity): More common in patients with a history of coronary artery disease. Report any chest pain or heart symptoms immediately.
  • Severe skin reactions: Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis have been reported and require permanent discontinuation.
  • Embryo-fetal toxicity: Capecitabine can seriously harm an unborn baby. Effective contraception is required during treatment and for 6 months after the last dose for females, and 3 months for males.
  • Hand-and-foot syndrome: Persistent or severe cases can lead to loss of fingerprints. Treatment must be paused until the reaction resolves.

Capecitabine interactions

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Capecitabine has several important drug interactions that can be serious or life-threatening.

  • Warfarin and vitamin K antagonists (blood thinners): capecitabine greatly increases blood-thinning effects, raising the risk of serious or fatal bleeding — INR must be monitored much more closely
  • Allopurinol (gout medication): may reduce the effectiveness of capecitabine — avoid this combination
  • Leucovorin and folic acid/folate supplements: increase fluorouracil toxicity, which can be fatal — do not take without your doctor's explicit instruction
  • Phenytoin (seizure medication): capecitabine can raise phenytoin blood levels, increasing the chance of phenytoin toxicity — levels must be monitored
  • CYP2C9 substrate drugs (including some blood thinners and diabetes medications): capecitabine increases their concentrations, which can lead to adverse effects
  • Nephrotoxic drugs (such as platinum salts, methotrexate, irinotecan, IV bisphosphonates): combining with capecitabine increases the risk of kidney damage

Interactions listed in the FDA-approved label

From the Capecitabine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Allopurinol: Concomitant use may decrease concentration of capecitabine's active metabolites, which may decrease efficacy. Avoid concomitant use of allopurinol with capecitabine.
  • Leucovorin, folic acid, or folate analog products: The concentration of fluorouracil is increased and its toxicity may be enhanced; deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly leucovorin and fluorouracil. Closely monitor for toxicities; instruct patients not to take products containing folic acid or folate analogs unless directed by their healthcare provider.
  • CYP2C9 substrates: Capecitabine increased exposure of CYP2C9 substrates, which may increase the risk of adverse reactions related to these substrates. Closely monitor for adverse reactions of CYP2C9 substrates (e.g., anticoagulants, antidiabetic drugs) where minimal concentration changes may lead to serious adverse reactions.
  • Vitamin K antagonists: Capecitabine increases exposure of vitamin K antagonist, which may alter coagulation parameters and/or bleeding and could result in death; events may occur within days of starting and up to 1 month after discontinuation of capecitabine. Monitor INR more frequently and refer to the vitamin K antagonist prescribing information for dosage adjustment, as appropriate.
  • Phenytoin: Capecitabine may increase exposure of phenytoin, which may increase the risk of adverse reactions related to phenytoin. Closely monitor phenytoin levels and refer to the phenytoin prescribing information for dosage adjustment, as appropriate.
  • Nephrotoxic drugs (e.g., platinum salts, irinotecan, methotrexate, intravenous bisphosphonates): Due to additive pharmacologic effect, concomitant use may increase the risk of renal toxicity. Closely monitor for signs of renal toxicity.
Read the label’s full interactions text

7 DRUG INTERACTIONS ● Allopurinol: Avoid concomitant use of allopurinol with capecitabine. ( 7.1 ) ● Leucovorin: Closely monitor for toxicities when capecitabine is coadministered with leucovorin. ( 7.1 ) ● CYP2C9 substrates: Closely monitor for adverse reactions when CYP2C9 substrates are coadministered with capecitabine. ( 7.2 ) ● Vitamin K antagonists: Monitor INR more frequently and dose adjust oral vitamin K antagonist as appropriate ● Phenytoin: Closely monitor phenytoin levels in patients taking capecitabine concomitantly with phenytoin and adjust the phenytoin dose as appropriate. ( 7.2 ) ● Nephrotoxic drugs: Closely monitor for signs of renal toxicity when capecitabine is used concomitantly with nephrotoxic drugs. ( 7.3 ) 7.1 Effect of Other Drugs on Capecitabine Allopurinol Concomitant use with allopurinol may decrease concentration of capecitabine’s active metabolites [see Clinical Pharmacology ( 12.3 )], which may decrease efficacy. Avoid concomitant use of allopurinol with capecitabine. Leucovorin The concentration of fluorouracil is increased and its toxicity may be enhanced by leucovorin, folic acid, or folate analog products. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly leucovorin and fluorouracil. Instruct patients not to take products containing folic acid or folate analog products unless directed to do so by their healthcare provider. 7.2 Effect of Capecitabine on Other Drugs CYP2C9 Substrates Capecitabine increased exposure of CYP2C9 substrates [see Clinical Pharmacology ( 12.3 )], which may increase the risk of adverse reactions related to these substrates. Closely monitor for adverse reactions of CYP2C9 substrates where minimal concentration changes may lead to serious adverse reactions when used concomitantly with capecitabine (e.g., anticoagulants, antidiabetic drugs).

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿19 supplements and herbs with documented Capecitabine interactions, ranked by severity Check Capecitabine against a supplement or herb →

Before taking Capecitabine

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  • Severe kidney impairment (creatinine clearance below 30 mL/min): capecitabine is contraindicated — do not use
  • Known allergy to capecitabine or 5-fluorouracil: do not use
  • Complete DPD enzyme deficiency: capecitabine is contraindicated in patients with certain DPYD gene variants causing complete DPD deficiency
  • Moderate kidney impairment: dose reduction is required; close monitoring needed
  • Liver problems: use caution with mild to moderate hepatic impairment due to liver metastases; the effect of severe liver dysfunction is not fully known
  • Pregnancy: capecitabine causes fetal harm — use effective contraception during treatment and for 6 months after the last dose
  • Breastfeeding: do not breastfeed during treatment or for 2 weeks after the final dose
  • Males with partners of reproductive potential: use contraception during treatment and for 3 months after the last dose; capecitabine may impair fertility
  • Older adults: more likely to experience severe side effects — requires careful monitoring throughout treatment
  • Children: safety and effectiveness have not been established in pediatric patients

Capecitabine overdose

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Taking too much capecitabine may cause nausea, vomiting, severe diarrhea, stomach irritation and bleeding, and suppression of the bone marrow (reduced ability to make blood cells). If an overdose is suspected, seek medical care immediately. Dialysis may help remove some of capecitabine's active metabolites from the bloodstream, though clinical experience with this is limited.

What Capecitabine does in the body

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Studies have shown a direct link between higher levels of fluorouracil (capecitabine's active form) in the blood and the risk of severe liver enzyme effects, specifically grade 3–4 hyperbilirubinemia (dangerously high bilirubin levels causing jaundice). This means that as exposure to the drug increases, so does the potential for certain serious toxicities — which is why dose monitoring and adjustment are an important part of treatment.

How your body processes Capecitabine

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After you take capecitabine by mouth, it is absorbed quickly and converted by the liver and other tissues into its active form, fluorouracil (5-FU), reaching peak blood levels within about 1.5–2 hours. Eating a meal before taking it reduces and slightly delays absorption, which is why it must be taken within 30 minutes after eating. Both capecitabine and fluorouracil have short half-lives of about 45 minutes, meaning they clear the body relatively quickly. The drug and its breakdown products are eliminated mainly through urine — about 96% is recovered in urine — with very little passing through the stool. In patients with moderate kidney impairment, exposure to some metabolites is significantly increased, which is why a dose reduction is required for those patients.

How to store Capecitabine

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Store capecitabine tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

19

Supplements & herbs that interact with Capecitabine

19 supplements and herbal products have documented interactions with Capecitabine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 8
  • Minor · 10
ACTIVATED CHARCOAL Major COFFEE CHARCOAL Moderate EUROPEAN MANDRAKE Moderate FOLIC ACID Moderate GLUCOMANNAN Moderate GUAR GUM Moderate GUM ARABIC Moderate SLIPPERY ELM Moderate +11 more
Every supplement checked against Capecitabine — ranked by severity The full interaction hub: 1 major · 8 moderate · 10 minor · every one linked to its full report. Check Capecitabine against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Capecitabine has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

MAGNESIUM Moderate Depletion
See the full Capecitabine nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Capecitabine: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Capecitabine — the kind of thing our pharmacy team would talk through with you at the counter.

What kinds of cancer does capecitabine treat?

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Capecitabine is used for several types of cancer — most commonly colorectal (colon and rectal) cancer, advanced or metastatic breast cancer, and, depending on the product, cancers of the stomach, esophagus, or gastroesophageal junction, and pancreatic cancer. Sometimes it's given alone, and sometimes as part of a combination with other chemotherapy drugs. Your oncologist will explain the exact role it plays in your treatment plan.

Does it matter if I take it with food?

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Yes — this one really matters. You should take capecitabine within 30 minutes after eating a meal, and swallow the tablets whole with water. Taking it on an empty stomach significantly reduces how much of the drug your body absorbs. Building it into your morning and evening meal routine is the best way to stay consistent.

What side effects should I expect, and which ones should I call my doctor about right away?

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The most common side effects are hand-and-foot syndrome (redness, soreness, or peeling on your palms and soles), diarrhea, nausea, fatigue, and mouth sores. Many of these can be managed, but some are signals to call your care team immediately — especially severe or persistent diarrhea, any signs of bleeding, chest pain, yellowing of your skin or eyes, or a severe rash with blistering or peeling. Don't try to push through those on your own.

I take warfarin. Is that a problem?

▾
This is a serious interaction and one of the most important things to tell your prescriber. Capecitabine can dramatically increase the blood-thinning effect of warfarin, which can lead to dangerous — even life-threatening — bleeding. If you're on warfarin or any other blood thinner, your INR (a measure of how quickly your blood clots) will need to be checked much more often, and your warfarin dose will likely need to be adjusted. Make sure all of your doctors know you're on both medications.

Is capecitabine safe to take during pregnancy or while breastfeeding?

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No — capecitabine is not safe during pregnancy. It can cause serious harm to an unborn baby. If you could become pregnant, you need to use effective contraception while on treatment and for 6 months after your last dose. If you're male and your partner could become pregnant, you also need contraception for 3 months after your last dose. Breastfeeding should be stopped during treatment and for at least 2 weeks after your final dose. Always talk to your oncologist if you have questions about family planning.

I heard something about a genetic test before starting this medication — what's that about?

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Before starting capecitabine, your doctor may order a genetic test to check for a variant in the DPYD gene. This gene controls how your body breaks down capecitabine's active ingredient. A small number of people have a deficiency in this enzyme (called DPD deficiency), which means they can't process the drug safely — leading to potentially severe or life-threatening side effects even at standard doses. The test helps your team know if capecitabine is safe for you or if your dose needs adjustment. If the test can't be done before treatment starts, your team will watch you very closely for any unusually severe early side effects.

Is Capecitabine available over the counter?

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No. Capecitabine is a prescription medicine: every Capecitabine product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Capecitabine first available?

▾
The earliest FDA record we hold for Capecitabine is from 1998: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Capecitabine was first used.

Who makes Capecitabine?

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19 companies currently list Capecitabine products in the FDA's NDC Directory, including BluePoint Laboratories, Accord Healthcare Inc., Armas Pharmaceuticals Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Capecitabine on HelloPharmacist

📊Capecitabine supplement interactions19 checked — ranked by severity 🌿Drug & Supplement CheckerCapecitabine vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Capecitabine NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Capecitabine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Capecitabine forms and strengths (how it comes)

Capecitabine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Capecitabine inactive ingredients by manufacturer.

Tablet

By mouth
Brands Xeloda
How this form is used
What it may be used for
  • Xeloda is indicated for colorectal cancer (adjuvant Stage III colon cancer, perioperative locally advanced rectal cancer, and unresectable or metastatic colorectal cancer), breast cancer, gastric/esophageal/gastroesophageal junction cancer, and adjuvant pancreatic adenocarcinoma
  • Capecitabine 150mg and Capecitabine 500mg tablets are indicated for adjuvant treatment of Dukes' C colon cancer and first-line metastatic colorectal cancer (as single agent when fluoropyrimidine therapy alone is preferred), and for metastatic breast cancer
  • Capecitabine tablets are indicated for advanced or metastatic breast cancer — alone when anthracycline- or taxane-containing therapy is not indicated, or combined with docetaxel after prior anthracycline-containing treatment
  • Capecitabine tablets are indicated for unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer, including HER2-overexpressing tumors, and for adjuvant pancreatic adenocarcinoma as part of a combination regimen
Important instructions
  • Swallow capecitabine tablets whole with water within 30 minutes after a meal
  • Capecitabine 150mg and Capecitabine 500mg tablets: if a tablet must be cut or crushed, this must be done by a trained professional using appropriate safety equipment for cytotoxic drugs
  • Capecitabine tablets are taken twice daily (morning and evening) in treatment cycles; your prescriber will set the exact schedule based on your cancer type and regimen
  • Dose is calculated based on body surface area — follow your prescriber's instructions exactly; do not adjust your dose without guidance
Available strengths 2 strengths
150 mg 500 mg
78 FDA-listed product records ⓘ

Capecitabine on the U.S. market: products, makers and brands

How Capecitabine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

19 companies list 36 Capecitabine product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 1998. Brand names on the directory include Xeloda; the rest are generics.

1
Dose forms ⓘ
19
Labelers (makers, repackagers, distributors)
4
Brand names
36
FDA-listed product records ⓘ
1998
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (17) · Crystal (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

BluePoint Laboratories11%
Accord Healthcare Inc.6%
Armas Pharmaceuticals Inc.6%
Ascend Laboratories, LLC6%
Aurobindo Pharma Limited6%
Camber Pharmaceuticals, Inc.6%
Other makers61%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Capecitabine is used (Medicaid data)

A general measure of how commonly Capecitabine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Capecitabine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

29,934
Medicaid prescriptions filled (Q1–Q4 2025)
$5.6M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Capecitabine prescribed? Of the 1,601 medications we measure, Capecitabine ranks #740 by Medicaid prescriptions — more than 54% of them.

Where Capecitabine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #740 of 1,601
#735 Cobicistat / Darunavir... 30,573 Rx #736 Chlorzoxazone 30,247 Rx #737 Fluorouracil Topical 30,176 Rx #738 Febuxostat 30,153 Rx #739 Isoniazid 30,009 Rx #740 Capecitabine 29,934 Rx #741 Thiamine (Vitamin B<su... 29,550 Rx #742 Empagliflozin / Linagl... 29,523 Rx #743 Rituximab Injection 29,521 Rx #744 Mesalamine Rectal 29,129 Rx #745 Magnesium Citrate 28,753 Rx

Utilization by Capecitabine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 500 mg oral tablet is the most-dispensed Capecitabine product — about 92% of these Medicaid prescriptions.

capecitabine 500 MG Oral Tablet Most dispensed

27,556 Medicaid prescriptions (Q1–Q4 2025) 92% of Capecitabine prescriptions shown $5.5M gross reimbursement (before rebates) ≈ $198 per prescription (gross)

Summed across the 12 of 47 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 200328

capecitabine 150 MG Oral Tablet

2,378 Medicaid prescriptions (Q1–Q4 2025) 8% of Capecitabine prescriptions shown $128,422 gross reimbursement (before rebates) ≈ $54 per prescription (gross)

Summed across the 7 of 36 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 200327

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Capecitabine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 19 of 83 listed Capecitabine NDCs with Medicaid activity.

Compare Capecitabine products

A representative set of FDA-listed product records for Capecitabine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 36 of 36 products — FDA National Drug Code Directory. See every product, package size and price: browse all 36 Capecitabine NDCs →

Capecitabine recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Capecitabine recalls since July 2021.

✅No Capecitabine recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Capecitabine RxCUI 194000 1 dose form · 2 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 371250 In current FDA listings
    Clinical drug / strength (SCD) 150 MG RxCUI 200327 500 MG RxCUI 200328

Look up RxCUI 194000 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Capecitabine costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated · Oral 500 mg $0.456 per tablet NDC details & price history
Tablet, Film Coated · Oral 150 mg $0.362 per tablet NDC details & price history
Tablet · Oral 500 mg $0.456 per tablet NDC details & price history
Tablet · Oral 150 mg $0.362 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Capecitabine brand names

Capecitabine is sold under one brand name in the FDA directory — Xeloda. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Xeloda

Who makes Capecitabine: manufacturers and labelers

19 companies list Capecitabine products with the FDA. By number of product records, the largest are BluePoint Laboratories, Accord Healthcare Inc., Armas Pharmaceuticals Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

BluePoint Laboratories 4 Accord Healthcare Inc. 2 Armas Pharmaceuticals Inc. 2 Ascend Laboratories, LLC 2 Aurobindo Pharma Limited 2 Camber Pharmaceuticals, Inc. 2 Cipla USA Inc. 2 CivicaScript LLC 2 Dr. Reddy's Laboratories Limited 2 Golden State Medical Supply, Inc. 2 Lifestar Pharma LLC 2 Novadoz Pharmaceuticals LLC 2 Sun Pharmaceutical Industries, Inc. 2 Teva Pharmaceuticals USA, Inc. 2 Teyro Labs Private Limited 2 American Health Packaging 1 H2-Pharma, LLC 1 NorthStar RxLLC 1 Quallent Pharmaceuticals Health LLC 1

Capecitabine drug class (RxNorm)

Capecitabine belongs to the Nucleoside Metabolic Inhibitor class.

Pharmacologic class Nucleoside Metabolic Inhibitor
Drug family (ATC) Pyrimidine analogues
How it works Nucleic Acid Synthesis Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Capecitabine page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Feb 5, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Capecitabine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Capecitabine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
22
Finished products in the current FDA directory
36
Companies listing them (makers, repackagers, distributors)
19
FDA labeler codes behind them ⓘ
19
Linked representative label ⓘ
H2-Pharma, LLC
Linked label effective
Feb 5, 2026
Composite sections available
25
Linked SPL Set ID
e702d84d-7162-4751-bf37-d724cc7e45a5
Linked SPL Document ID
32dd0155-c5cb-49c2-9b74-74f40df22df7
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. H2-Pharma, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →