Capecitabine: uses, dosing, side effects & brands
Capecitabine is a nucleoside metabolic inhibitor sold in the U.S. under 2 brand and generic names, for breast neoplasms and colorectal neoplasms. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Nucleoside Metabolic Inhibitor
- Treats
- Breast Neoplasms and Colorectal Neoplasms
- Available as
- Tablet
- Sold as
- 2 products — Capecitabine and Xeloda
- Prescription?
- Prescription only
- Generic available?
- Yes
- What the pharmacy pays
- about $14 for a 30-count supply — not your price
- Boxed warning
- Boxed warning
How capecitabine is dosed
From the FDA label for Capecitabine (application ANDA209365). Other capecitabine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Take capecitabine tablets with water within 30 min after a meal ( 2.1 ) Monotherapy: 1,250 mg/m 2 twice daily orally for 2 weeks followed by a one week rest period in 3-week cycles ( 2.2 ) Adjuvant treatment is recommended for a total of 6 months (8 cycles) ( 2.2 ) In combination with docetaxel, the recommended dose of capecitabine tablets is 1,250 mg/m 2 twice daily for 2 weeks followed by a 7-day rest period, combined with docetaxel at 75 mg/m2 as a 1-hour IV infusion every 3 weeks ( 2.2 ) Capecitabine tablets dosage may need to be individualized to optimize patient management ( 2.3 ) Reduce the dose of capecitabine tablets by 25% in patients with moderate renal impairment ( 2.4 ) 2.1 Important Administration Instructions Capecitabine tablets should be swallowed whole with water within 30 minutes after a meal. Capecitabine is a cytotoxic drug. Follow applicable special handling and disposal procedures.1 If capecitabine tablets must be cut or crushed, this should be done by a professional trained in safe handling of cytotoxic drugs using appropriate equipment and safety procedures. Capecitabine dose is calculated according to body surface area. 2.2 Standard Starting Dose Monotherapy (Metastatic Colorectal Cancer, Adjuvant Colorectal Cancer, Metastatic Breast Cancer The recommended dose of capecitabine tablets are 1,250 mg/m 2 administered orally twice daily (morning and…
Capecitabine side effects
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Most common adverse reactions (≥30%) were diarrhea, hand-and-foot syndrome, nausea, vomiting, abdominal pain, fatigue/weakness, and hyperbilirubinemia. Other adverse reactions, including serious adverse reactions, have been reported. ( 6) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Limited, at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Adjuvant Colon Cancer Table 4 shows the adverse reactions occurring in ≥5% of patients from one phase 3 trial in patients with Dukes' C colon cancer who received at least one dose of study medication and had at least one safety assessment. A total of 995 patients were treated with 1,250 mg/m2 twice a day of capecitabine administered for 2 weeks followed by a 1-week rest period, and 974 patients were administered 5-FU and leucovorin (20 mg/m2 leucovorin IV followed by 425 mg/m2 IV bolus 5- FU on days 1-5 every 28 days). The median duration of treatment was 164 days for capecitabine- treated patients and 145 days for 5-FU/LV-treated patients. A total of 112 (11%) and 73 (7%) capecitabine and 5-FU/LV-treated patients, respectively, discontinued treatment…
Who shouldn’t take capecitabine
Severe Renal Impairment ( 4.1 ) Hypersensitivity ( 4.2 ) 4.1 Severe Renal Impairment Capecitabine is contraindicated in patients with severe renal impairment (creatinine clearance below 30 mL/min [Cockroft and Gault]) [ see Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3 ) ]. 4.2 Hypersensitivity Capecitabine is contraindicated in patients with known hypersensitivity to capecitabine or to any of its components. Capecitabine is contraindicated in patients who have a known hypersensitivity to 5-fluorouracil.
Capecitabine drug interactions
Anticoagulants: Monitor anticoagulant response (INR or prothrombin time) frequently in order to adjust the anticoagulant dose as needed.( 5.2 , 7.1 ) Phenytoin: Monitor phenytoin levels in patients taking capecitabine concomitantly with phenytoin. The phenytoin dose may need to be reduced. ( 7.1 ) Leucovorin: The concentration of 5-fluorouracil is increased and its toxicity may be enhanced by leucovorin. ( 7.1 ) CYP2C9 substrates: Care should be exercised when capecitabine is coadministered with CYP2C9 substrates. ( 7.1 ) Allopurinol: Avoid the use of allopurinol during treatment with capecitabine. Food reduced both the rate and extent of absorption of capecitabine. ( 2 , 7.2 , 12.3 ) 7.1 Drug-Drug Interactions Anticoagulants Altered coagulation parameters and/or bleeding have been reported in patients taking capecitabine concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon [see Boxed Warning ] . These events occurred within several days and up to several months after initiating capecitabine therapy and, in a few cases, within 1 month after stopping capecitabine. These events occurred in patients with and without liver metastases. In a drug interaction study with single-dose warfarin administration, there was a significant increase in the mean AUC of S-warfarin [see Clinical Pharmacology ( 12.3 )] . The maximum observed INR value increased by 91%. This interaction is probably due to an inhibition of cytochrome P450 2C9 by capecitabine and/or its metabolites. Phenytoin The level of phenytoin should be carefully monitored in patients taking capecitabine and phenytoin dose may need to be reduced [see Dosage and Administration ( 2.3 )] . Postmarketing reports indicate that some patients receiving capecitabine and phenytoin had toxicity associated with elevated phenytoin levels. Formal drug-drug interaction studies with phenytoin have not been conducted, but the mechanism of interaction is presumed to be inhibition of the CYP2C9 isoenzyme by capecitabine and/or its metabolites. Leucovorin The concentration of 5-fluorouracil is increased and its toxicity may be enhanced by leucovorin. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly leucovorin and fluorouracil. CYP2C9 substrates Other than warfarin, no formal drug-drug interaction studies between capecitabine and other CYP2C9 substrates have been conducted. Care should be exercised when capecitabine is coadministered with CYP2C9 substrates. Allopurinol Concomitant use with allopurinol may decrease concentration of capecitabine's active metabolites [see Clinical Pharmacology ( 12.3 )] , which may decrease capecitabine efficacy. Avoid the use of allopurinol during treatment with capecitabine. 7.2 Drug-Food Interaction Food was shown to reduce both the rate and extent of absorption of capecitabine [see Clinical Pharmacology ( 12.3 )] . In all clinical trials, patients were instructed to administer capecitabine within 30 minutes after a meal. It is recommended that capecitabine be administered with food [see Dosage and Administration ( 2 )].
Every capecitabine product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Tablet | Generic | $14 | View → | |
| 2 | Not yet rated | Prescription | Tablet | Generic | $14 | View → |
What capecitabine pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Can you crush or split capecitabine?
At least one capecitabineproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each capecitabine label says about crushing, splitting and chewingHow long capecitabine keeps
No capecitabine label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does capecitabine expire? The in-use limits and storage rules from its labelsCapecitabine and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for capecitabine: levels in milk, effects in breastfed infants, and the drugs it would consider insteadMost sources consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy. It might be possible to breastfeed safely during intermittent therapy with an appropriate period of breastfeeding abstinence. some have suggested a period of 24 hours before resuming nursing, although the manufacturer recommends an abstinence period of 2 weeks. Capecitabine is metabolized to fluorouracil. Limited information indicates that a maternal continuous intravenous fluorouracil infusion at a dose of 200 mg/square meter daily produces undetectable levels in milk. If capecitabine use is undertaken, monitoring of the infant's complete blood count and differential is advisable. Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk. Women who receive chemotherapy during pregnancy are more likely to have difficulty nursing their infant.
National Institute of Child Health and Human Development, record revised August 16, 2021. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about capecitabine
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 61,725 reports naming capecitabine, and the FDA flagged 82% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- diarrhoea8,659 reports
- nausea5,402 reports
- palmar-plantar erythrodysaesthesia syndrome4,344 reports
- vomiting4,161 reports
- fatigue4,029 reports
- malignant neoplasm progression2,848 reports
- neutropenia2,517 reports
- asthenia2,240 reports
Read these as a signal, not a rate. A report does not mean capecitabine caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is capecitabine?
Capecitabine is a nucleoside metabolic inhibitor used to treat Breast Neoplasms, Colorectal Neoplasms.
What kind of drug is capecitabine?
The FDA classifies capecitabine as a nucleoside metabolic inhibitor. Nucleoside metabolic inhibitors are fake DNA building blocks that fast-dividing cancer cells mistake for the real thing. Once inside, they get incorporated into the cell's DNA and also block enzymes such as ribonucleotide reductase, which together halt DNA copying and cause the cancer cell to die. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take capecitabine with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run capecitabine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is capecitabine sold under?
We track 2 capecitabine-containing products in the U.S.: Capecitabine and Xeloda. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does capecitabine come in?
Across the brands we track, capecitabine is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic capecitabine?
Yes. Our catalog lists 1 generic capecitabine product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Capecitabine: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/capecitabine
- MLA
- “Capecitabine: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/capecitabine.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for capecitabine on DailyMed (NIH) ↗ — including its boxed warning in full.