Prescription medicine
Capecitabine Brand names: Xeloda
Capecitabine (Xeloda) is a prescription medicine with an FDA approval on record since 1998. FDA's NDC Directory lists it from 18 generic labelers, and pharmacies paid $0.456 per capecitabine 500 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the capecitabine FDA label on DailyMed (effective February 5, 2026, H2-Pharma, LLC); the NDA 20896 record on Drugs@FDA; every capecitabine label on DailyMed.
Highlights of the record
FDA label of February 5, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SERIOUS ADVERSE REACTIONS OR DEATH IN PATIENTS WITH COMPLETE DPD.
DEFICIENCY and INCREASED RISK OF BLEEDING WITH CONCOMITANT USE OF VITAMIN K ANTAGONISTS Increased risk of serious adverse reactions or death in patients with complete DPD deficiency
Test patients for genetic variants of DPYD prior to initiating XELODA unless immediate treatment is necessary. Avoid use of XELODA in patients with certain homozygous or compound heterozygous DPYD variants that result in complete DPD deficiency [see Warnings and Precautions (5.1) ]. Increased risk of bleeding with concomitant use of Vitamin K antagonists
Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking XELODA concomitantly with oral vitamin K antagonists, such as warfarin [see Warnings and Precautions (5.2), Drug Interactions (7.2) ].
Clinically significant increases in prothrombin time (PT) and international normalized ratio (INR) have been reported in patients who were on stable doses of a vitamin K antagonist at the time XELODA was introduced. These events occurred in patients with and without liver metastases.
Monitor INR more frequently and adjust the dose of the vitamin K antagonist as appropriate [see Drug Interactions (7.2) ]. […]
Used for
From the label: indications and usageXELODA (capecitabine) is a nucleoside metabolic inhibitor indicated for: Colorectal Cancer adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen.
Forms and strengths
- 150 mg
- 500 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- April 30, 1998 Xeloda, Cheplapharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 14 first September 16, 2013; 11 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 19 of which 18 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.456 per tablet Capecitabine 500 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2015 0 Class I among all firms' recalls; latest April 3, 2018
- FAERS reports
- 90,997 through July 30, 2026
What is capecitabine used for?
From the label: indications and usageXELODA (capecitabine) is a nucleoside metabolic inhibitor indicated for: Colorectal Cancer adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. ( 1.1 ) perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. ( 1.1 ) treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. ( 1.1 ) Breast Cancer treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline- or taxane-containing chemotherapy is not indicated. […]
Conditions named in the indications of capecitabine's FDA labels, with every medicine labeled for each:
From other capecitabine labelsColorectal cancer: Colorectal Cancer XELODA is indicated for the: adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. …
Breast cancer: Metastatic Breast Cancer (1.2) – In combination with docetaxel after failure of prior anthracycline containing therapy – As monotherapy in patients resistant to both paclitaxel and an anthracycline-containing regimen
FDA pharmacologic class: Nucleoside Metabolic Inhibitor.
Source: FDA drug label (XELODA), 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 patient leaflet for capecitabine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about XELODA?XELODA can cause serious side effects, including: Serious side effects or death in people with dihydropyrimidine dehydrogenase (DPD) enzyme deficiency. People with certain changes in a gene called DPYD may have a deficiency of the DPD enzyme. People who do not have any DPD enzyme are at increased risk of sudden side effects that come on early during treatment with XELODA and can be serious, and sometimes lead to death. People who have some DPD enzyme may have an increased risk of serious side effects or death with XELODA treatment. Your healthcare provider will test you for DPYD before starting treatment with XELODA, unless you need treatment right away. […] Tell your healthcare provider right away if you develop any signs or symptoms of bleeding. See " What are the possible side effects of XELODA? " for more information about side effects. […]
From the patient leaflet: How should I store XELODA?Store XELODA at room temperature between 68°F to 77°F (20°C to 25°C). Keep XELODA in a tightly closed container. Ask your healthcare provider or pharmacist how to safely throw away any unused XELODA. Keep XELODA and all medicines out of the reach of children.
Source: FDA drug label (XELODA), 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
Is there a generic for capecitabine (Xeloda)?
The FDA approved the first generic capecitabine on September 16, 2013. 14 generic applications are approved; 11 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists capecitabine from 18 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1998 earliest approval on file
- 2013 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for capecitabine (Xeloda)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.456 per Capecitabine 500 mg tablet, down 7% from $0.490 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Capecitabine 500 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Capecitabine 150 mg tablet | Generic | $0.362 per tablet | $10.85 | -10% |
| Capecitabine 500 mg tablet | Generic | $0.456 per tablet | $13.67 | -7% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has capecitabine been recalled?
The FDA's Enforcement Report lists 4 recalls naming capecitabine since 2015: 0 Class I (the most serious), 4 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 3, 2018 | Class II | Kroger Specialty Pharmacy, Inc. | Lack of Processing Controls. |
| December 21, 2015 | Class II | Teva North America | Failed Dissolution Specifications: low test results at the 18 month time-point |
| June 30, 2015 | Class II | Mylan Pharmaceuticals Inc | Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the capecitabine label say about other medicines?
The capecitabine label names 8 other medicines in its interaction, contraindication or warning sections. The labels of 9 other medicines name capecitabine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Allopurinol | drug interactions | DRUG INTERACTIONS Allopurinol: Avoid concomitant use of allopurinol with XELODA. |
| Docetaxel | warnings and precautions | In the 251 patients with metastatic breast cancer who received XELODA with docetaxel, 68% had grade 3 or 4 neutropenia, 2.8% had grade 3 or 4 thrombocytopenia, and 10% had grade 3 or 4 anemia. |
| Fluorouracil | contraindications | CONTRAINDICATIONS XELODA is contraindicated in patients with history of severe hypersensitivity reaction to fluorouracil or capecitabine [see Adverse Reactions (6.1) ]. |
| Irinotecan | drug interactions | Closely monitor for signs of renal toxicity when XELODA is used concomitantly with nephrotoxic drugs (e.g. platinum salts, irinotecan, methotrexate, intravenous bisphosphonates). |
| Leucovorin | drug interactions | Closely monitor for toxicities when XELODA is coadministered with leucovorin. ( 7.1 ) CYP2C9 substrates: |
| Methotrexate | drug interactions | Closely monitor for signs of renal toxicity when XELODA is used concomitantly with nephrotoxic drugs (e.g. platinum salts, irinotecan, methotrexate, intravenous bisphosphonates). |
| Phenytoin | drug interactions | Monitor INR more frequently and dose adjust oral vitamin K antagonist as appropriate Phenytoin: |
| Warfarin | boxed warning | Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking XELODA concomitantly with oral vitamin K antagonists, such as warfarin [see Warnings and Precautions (5.2), Drug Interactions (7.2) ]. |
Other labels that name capecitabine
Source: FDA drug label (XELODA), 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 for capecitabine?
The FDA Adverse Event Reporting System holds 90,997 reports that list capecitabine among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as capecitabine?
5 other medicines are given the same way (oral) and in the same FDA class as capecitabine or labeled mainly for the same use (colorectal cancer), the same class first. Colorectal cancer lists all 23 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Tipiracil and trifluridine | Colorectal cancer | none listed | n/a | No current entry |
| Tucatinib | Breast cancer, Colorectal cancer | none listed | n/a | No current entry |
| Fruquintinib | Colorectal cancer | none listed | n/a | No current entry |
| Encorafenib | Colorectal cancer | none listed | n/a | No current entry |
| Regorafenib | Colorectal cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as capecitabine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to capecitabine
- 5 medicines for the same use
- Other nucleoside metabolic inhibitors
- the pharmacologic class, with prices and generics
- Capecitabine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other