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Xeloda
Capecitabine
$994.00
500mg · 120 caplets
GenericGeneric medicine· By Roche
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FDA boxed warningSerious 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.
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.
- 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.
Monitor international normalized ratio (INR) more frequently and adjust the dose of the vitamin K antagonist as appropriate.
About Xeloda
Overview
Xeloda contains capecitabine, a prescription chemotherapy medicine supplied as caplets. It treats certain colon, rectal and breast cancers, alone or with other treatments depending on the cancer and treatment setting. It is also used in combination treatment for adults with certain stomach, esophageal or gastroesophageal junction cancers, and after surgery for pancreatic adenocarcinoma. The body converts capecitabine into fluorouracil, which interferes with how cells make DNA and use RNA, helping to inhibit cell division.
What it treats
- Stage III colon cancer, as treatment after surgery, alone or with other chemotherapy. - Locally advanced rectal cancer in adults, with chemotherapy and radiation around the time of surgery. - Colorectal cancer that cannot be removed surgically or has spread, alone or with other chemotherapy. - Advanced or metastatic breast cancer, alone when anthracycline- or taxane-containing chemotherapy is not indicated, or with docetaxel after progression on anthracycline-containing chemotherapy. - Stomach, esophageal or gastroesophageal junction cancer in adults that cannot be removed surgically or has spread, with other chemotherapy. - HER2-overexpressing metastatic stomach or gastroesophageal junction adenocarcinoma in adults who have not previously been treated for metastatic disease, as part of combination treatment. - Pancreatic adenocarcinoma in adults, with other chemotherapy after surgery.
Safety information
Side effects
Common side effects reported with Xeloda include diarrhea, nausea, hand-and-foot syndrome, tiredness, abdominal pain, vomiting, skin inflammation, anemia (low red blood cell counts), low lymphocyte counts (a type of white blood cell), and increased bilirubin levels in the blood. When used with docetaxel, common side effects also include mouth inflammation, hair loss and swelling. Which side effects are most common varies with the cancer being treated and whether Xeloda is used alone or with docetaxel. Serious side effects include heart problems, dehydration, kidney toxicity, severe skin reactions, reduced blood cell production and high bilirubin levels. Heart problems may be more common in people with a history of coronary artery disease. Diarrhea and hand-and-foot syndrome can also be serious. Contact your doctor promptly about these effects, including new or worsening skin reactions. Treatment may need to be interrupted, adjusted or stopped by your prescriber. Blood counts and kidney function require monitoring.
FDA boxed warning
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.
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.
- 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.
Monitor international normalized ratio (INR) more frequently and adjust the dose of the vitamin K antagonist as appropriate.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Do not take Xeloda (capecitabine) if you have had a severe allergic reaction to capecitabine or fluorouracil. Tell your prescriber if you have heart disease, particularly coronary artery disease, kidney problems, liver impairment, diarrhea or dehydration. Xeloda can cause heart problems, kidney toxicity, severe skin reactions, hand-foot syndrome, reduced blood cell counts and raised bilirubin levels. Treatment may need to be paused, changed or stopped if these occur. A severe skin reaction requires permanent discontinuation. Xeloda is not recommended if your neutrophil or platelet counts are too low before treatment. Blood counts should be checked before treatment and before each cycle. Hydration and kidney function also need monitoring. People with liver impairment need closer monitoring for side effects. Xeloda can harm an unborn baby. Tell your prescriber if you are pregnant and use effective contraception during treatment. Do not breastfeed while taking Xeloda.
Interactions
Avoid taking allopurinol with Xeloda. Tell your doctor if you take any of the following: - Leucovorin: close monitoring for toxic effects is needed. - Medicines processed by the enzyme CYP2C9: close monitoring for side effects is needed. - Oral vitamin K antagonist blood thinners: more frequent INR blood tests are needed, and your doctor may adjust your blood thinner treatment. - Phenytoin: close monitoring of phenytoin levels is needed, and your doctor may adjust your treatment. - Medicines that can harm the kidneys: close monitoring for signs of kidney toxicity is needed.
Using Xeloda
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store below 25°C in a dry place, in the original pack, away from direct light and moisture. Do not keep it in a bathroom. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label XELODA (CAPECITABINE) TABLET, FILM COATED [H2-PHARMA, LLC] (DailyMed, retrieved 19 September 2026).
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