Xeloda Side Effects

Generic name: capecitabine

Medically reviewed by Drugs.com. Last updated on Dec 26, 2024.

Note: This document provides detailed information about Xeloda Side Effects associated with capecitabine. Some dosage forms listed on this page may not apply specifically to the brand name Xeloda.

Applies to capecitabine: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Your doctor may request that you have a test to determine if your blood is clotting properly, and may preform this test frequently if you are also taking a blood thinner.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before taking this medicine. Female patients must use effective birth control during treatment and for 6 months after your treatment ends. Male patients with partners of childbearing potential should also use effective contraception during treatment and for 3 months after the last dose. Tell your doctor right away if you think you have become pregnant.

This medicine may increase risk of bleeding when used together with a blood thinner (eg, warfarin). Check with your doctor right away if you have back pain, blood in the eyes, blood in the urine, black, tarry stools, bruising or purple areas on the skin, coughing up blood, decreased alertness, dizziness, headache, joint pain or swelling, or nosebleeds.

This medicine may cause heart problems. Check with your doctor right away if you have chest pain that may spread to your arms, jaw, back, or neck, chest tightness, decreased urine output, dilated neck veins, faintness, nausea, sweating, swelling in your hands, ankles, or feet, trouble breathing, unusual sweating, vomiting.

This medicine may cause kidney problems. Check with your doctor right away if you have agitation, coma, confusion, decreased urine output, depression, dizziness, headache, hostility, irritability, lethargy, muscle twitching, nausea, rapid weight gain, seizures, stupor, swelling of the face, ankles, or hands, or unusual tiredness or weakness.

Check with your doctor right away if any of the following symptoms occur:

• Diarrhea, moderately severe (four to six stools a day more than usual, or during the night).
• Nausea that is severe enough to cause you to eat less than usual.
• Vomiting two or more times in a 24-hour period.
• Pain and redness, swelling, or sores or ulcers in your mouth or on your lips that are severe enough to interfere with eating.

If vomiting occurs less often than mentioned above, or if nausea does not cause you to eat less than usual, it is not necessary for you to stop taking the medicine or to check with your doctor (unless these effects are particularly bothersome). Also, you do not need to stop taking the medicine if diarrhea occurs less often than mentioned above or if the other side effects listed are not severe enough to interfere with eating or other daily activities. However, check with your doctor as soon as possible if they occur.

Check with your doctor right away if you have confusion, decreased urination, dizziness, dry mouth, fainting, increase in heart rate, lightheadedness, rapid breathing, sunken eyes, thirst, unusual tiredness or weakness, or wrinkled skin. These may be symptoms of dehydration.

Serious skin reactions (eg, Stevens-Johnson syndrome and toxic epidermal necrolysis) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, unusual tiredness or weakness, or fever or chills while you are using this medicine.

This medicine may cause a serious skin problem called palmar plantar erythrodysesthesia syndrome. Check with your doctor if you have a rash that does not go away or redness, pain, swelling, or blisters on the palms of your hands or soles of your feet.

While you are being treated with capecitabine (the active ingredient contained in Xeloda) and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Capecitabine may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Capecitabine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Xeloda

Along with its needed effects, capecitabine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking capecitabine:

Other side effects of Xeloda

Some side effects of capecitabine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to capecitabine: oral tablet.

General adverse events

The most commonly reported adverse reactions included gastrointestinal disorders (especially diarrhea, nausea, vomiting, abdominal pain, stomatitis), palmar-plantar erythrodysesthesia (hand-foot syndrome) and other skin disorders, hematologic abnormalities, hyperbilirubinemia, and metabolic alterations.

Reported adverse reactions are compiled from use of this drug as monotherapy or in combination with different chemotherapy regimens in multiple indications. The safety profiles across indications and as monotherapy or in combination are comparable.^[Ref]

Cardiovascular

• Frequency not reported: Venous thrombosis, supraventricular tachycardia, hypotension, venous phlebitis and thrombophlebitis, postural hypotension, flushing, tachycardia, bradycardia, myocarditis, cardiac chest pain including angina, cardiomyopathy, myocardial ischemia/infarction, cardiac failure, cardiac arrest, sudden cardiac death, atrial arrhythmias including atrial fibrillation, ventricular extrasystoles, angina, dysrhythmias, electrocardiographic changes
• Postmarketing reports: Ventricular fibrillation, QT prolongation, torsade de pointes, vasospasm

Dermatologic

• Very common (10% or more): Palmar-plantar erythrodysesthesia syndrome/hand foot syndrome (up to 63%), alopecia (up to 41%), dermatitis (up to 37%), nail disorders (up to 14%)
• Very rare (less than 0.01%): Cutaneous lupus erythematosus
• Frequency not reported: Rash, erythema, skin discoloration, pruritus, onycholysis, increased sweating, photosensitivity reaction, skin ulceration, radiation recall syndrome, skin fissures, exfoliative dermatitis
• Postmarketing reports: Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN), persistent or severe PPES that can eventually lead to loss of fingerprints

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 67%), stomatitis (up to 67%), nausea (up to 45%), vomiting (up to 35%), abdominal pain (up to 35%), constipation, (up to 20%), GI motility disorder (up to 10%), dyspepsia
• Common (1% to 10%): Upper abdominal pain, lower abdominal pain, upper GI inflammatory disorders, upper GI hemorrhage, ileus, dry mouth, mouth ulceration, gastritis, abdominal distension, gastroesophageal reflux disease, oral pain, dysphagia, rectal hemorrhage, oral dysesthesia, oral paresthesia, oral hypoesthesia
• Uncommon (0.1% to 1%): Tonsillitis, oral candidiasis, gastroenteritis, tooth abscess
• Rare (0.01% to 0.1%): Intestinal obstruction, ascites, enteritis, esophagitis, colitis

Genitourinary

• Uncommon (0.1% to 1%): Urinary incontinence
• Frequency not reported: Urinary tract infection, vaginal hemorrhage

Hematologic

• Very common (10% or more): Lymphocytopenia (up to 99%), leukopenia (up to 91%), neutropenia (up to 86%), anemia (up to 80%), thrombocytopenia (up to 41%), neutropenic fever (up to 16%), decreased lymphocytes (up to 13%)
• Common (1% to 10%): Decrease neutrophils/granulocytes, decreased hemoglobin, decreased platelets
• Frequency not reported: Agranulocytosis, decreased prothrombin, coagulation disorder, bone marrow depression, pancytopenia, hemorrhage, increased prothrombin time, increased INR

Hepatic

• Very common (10% or more): Hyperbilirubinemia (up to 48%)
• Common (1% to 10%): Increased ALT
• Very rare (less than 0.01%): Cholestatic hepatitis, hepatic failure
• Frequency not reported: Jaundice, abnormal liver function tests, hepatic coma, hepatotoxicity, hepatic fibrosis, hepatitis
• Postmarketing reports: Hepatic failure

Hypersensitivity

• Common (1% to 10%): Hypersensitivity
• Postmarketing reports: Angioedema

Metabolic

• Very common (10% or more): Anorexia (up to 23%), dehydration (up to 10%)
• Common (1% to 10%): Decreased calcium, increased calcium
• Frequency not reported: Hyperglycemia, decreased weight, cachexia, hypertriglyceridemia, hypokalemia, hypomagnesemia

Musculoskeletal

• Very common (10% or more): Arthralgia (up to 15%), myalgia (up to 15%), back pain (up to 12%)
• Frequency not reported: Bone pain

Nervous system

• Very common (10% or more): Paresthesia (up to 21%), taste disturbance (up to 16%), headache (up to 15%), dizziness (up to 12%), peripheral sensory neuropathy (up to 10%)
• Frequency not reported: Dizziness, dysgeusia, ataxia, syncope, taste loss, polyneuropathy, migraine, vertigo, tremor, dysphasia, encephalopathy, dysarthria, impaired balance, impaired memory
• Postmarketing reports: Toxic leukoencephalopathy

Ocular

• Very common (10% or more): Eye irritation (up to 15%), increased lacrimation (up to 12%)
• Very rare (less than 0.01%): Lacrimal duct stenosis
• Frequency not reported: Conjunctivitis, abnormal vision, keratoconjunctivitis
• Postmarketing reports: Lacrimal duct stenosis, corneal disorders including keratitis

Oncologic

• Frequency not reported: Lipoma

Other

• Very common (10% or more): Fatigue (up to 41%), edema (up to 33%), pyrexia (up to 28%), asthenia (up to 26%), decreased appetite (up to 26%), weakness (up to 16%), pain in limb (up to 13%), pain (up to 12%), lethargy (up to 10%)
• Common (1% to 10%): Herpes zoster infection
• Frequency not reported: Chest pain, viral infections, influenza-like illness, hypoesthesia, neutropenic sepsis, sepsis, thirst, fibrosis, temperature intolerance, lower limb edema, rigors, malaise, ear pain

Psychiatric

• Frequency not reported: Insomnia, mood alteration, depression, depressed mood, confusion, panic attack, decreased libido

Renal

• Uncommon (0.1% to 1%): Hydronephrosis
• Frequency not reported: Renal failure, renal impairment, increased serum creatinine
• Postmarketing reports: Acute renal failure secondary to dehydration (including fatal outcome)

Respiratory

• Very common (10% or more): Dyspnea (up to 14%), cough (up to 13%), sore throat (up to 12%)
• Common (1% to 10%): Nasopharyngitis, lower respiratory tract infection
• Frequency not reported: Pharyngeal disorder, bronchopneumonia, upper respiratory tract infection, pleural effusion, epistaxis, rhinorrhea, bronchitis, pneumonia, pulmonary embolism

See also:

Frequently asked questions

• What is the CAPOX chemotherapy regimen?
• Why do you need to take Xeloda with food?

Further information

Xeloda side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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