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Xeloda Side Effects

Generic name: capecitabine

Medically reviewed by Drugs.com. Last updated on Dec 2, 2023.

Note: This document contains side effect information about capecitabine. Some dosage forms listed on this page may not apply to the brand name Xeloda.

Applies to capecitabine: oral tablet.

Warning

Oral route (Tablet)

Warning: Increased Risk of Bleeding with Concomitant Use of Vitamin K AntagonistsAltered coagulation parameters and/or bleeding, including death, have been reported in patients taking capecitabine 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 capecitabine was introduced. These events occurred within several days and up to several months after initiating capecitabine and, in a few cases, within 1 month after stopping capecitabine. 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.

Serious side effects of Xeloda

Along with its needed effects, capecitabine (the active ingredient contained in Xeloda) 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:

More common

Less common or rare

Incidence not known

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:

Less common

Rare

For Healthcare Professionals

Applies to capecitabine: oral tablet.

Cardiovascular

Very common (10% or more): Thrombosis/embolism, hypertension, lower limb edema

Uncommon (0.1% to 1%): Angina unstable, angina pectoris, myocardial ischemia/infarction, atrial fibrillation, arrhythmia, tachycardia, sinus tachycardia, palpitations, peripheral edema, chest pain, hypertensive crisis

Rare (less than 0.1%): Ventricular fibrillation, QT prolongation, Torsade de pointes, bradycardia, vasospasm[Ref]

Dermatologic

Very common (10% or more): Hand-and-foot syndrome (up to 63%), alopecia (up to 41%), dermatitis (up to 27%), nail disorder (up to 14%)

Common (1% to 10%): Rash, erythema, skin discoloration, dermatitis, onycholysis, pruritus

Uncommon (0.1% to 1%): Blister, skin ulcer, rash, urticaria, photosensitivity reaction, palmar erythema, swelling face, purpura, radiation recall syndrome

Very rare (less than 0.01%): Cutaneous lupus erythematosus, severe skin reactions such as Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis (TEN)[Ref]

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[Ref]

General

The most commonly reported adverse reactions were GI disorders (especially diarrhea, nausea, vomiting, abdominal pain, and stomatitis), hand-foot syndrome (palmar-plantar erythrodysesthesia), fatigue, asthenia, anorexia, cardiotoxicity, increased renal dysfunction in those with preexisting compromised renal function, and thrombosis/embolism.[Ref]

Genitourinary

Uncommon (0.1% to 1%): Urinary tract infection, libido decreased, dysuria

Rare (0.01% to 0.1%): Hydronephrosis, urinary incontinence, hematuria, nocturia, vaginal hemorrhage[Ref]

Hematologic

Very common (10% or more): Anemia (up to 80%), leukopenia, (up to 13%), neutropenia (up to 13%), febrile neutropenia, thrombocytopenia

Common (1% to 10%): Decreased platelets

Uncommon (0.1% to 1%): Granulocytopenia, hemolytic anemia, International Normalized Ratio (INR) increased/Prothrombin time prolonged, phlebitis

Rare (0.01% to 0.1%): Deep vein thrombosis[Ref]

Hepatic

Very common (10% or more): Hyperbilirubinemia (up to 48%)

Common (1% to 10%): Increased ALAT (SGPT)

Uncommon (0.1% to 1%): Jaundice

Very rare (less than 0.01%): Hepatic failure, cholestatic hepatitis[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity[Ref]

Immunologic

Common (1% to 10%): Viral infections, oral candidiasis, herpes viral infection, influenza-like illness

Uncommon (0.1% to 1%): Sepsis, cellulitis[Ref]

Local

Common (1% to 10%): Infusion related reaction, injection site reaction, infusion site pain, injection site pain[Ref]

Metabolic

Very common (10% or more): Anorexia (up to 26%)

Common (1% to 10%): Dehydration, hypokalemia, weight loss, hyponatremia, hypomagnesemia, hypocalcemia, hypercalcemia, hyperglycemia

Uncommon (0.1% to 1%): Diabetes, appetite disorder, malnutrition, hypertriglyceridemia

Rare (0.01% to 0.1%): Blood creatinine increased[Ref]

Musculoskeletal

Very common (10% or more): Back pain (up to 10%), arthralgia, myalgia

Common (1% to 10%): Chest pain (noncardiac), pain in jaw, pain in extremity

Uncommon (0.1% to 1%): Joint swelling, bone pain, facial pain, musculoskeletal stiffness, muscular weakness, muscle spasms[Ref]

Nervous system

Very common (10% or more): Taste disturbance (up to 16%), headache (up to 15%), paresthesia (up to 12%), dizziness (up to 12%), neuropathy (up to 10%), peripheral neuropathy, peripheral sensory neuropathy, dysgeusia, dysesthesia

Common (1% to 10%): Dizziness, hypoesthesia

Rare (0.01% to 0.1%): Aphasia, memory impairment, ataxia, syncope, balance disorder, sensory disorder

Very rare (less than 0.01%): Toxic leukoencephalopathy[Ref]

Ocular

Very common (10% or more): Eye irritation (13%)

Common (1% to 10%): Abnormal vision, lacrimation increased, conjunctivitis

Uncommon (0.1% to 1%): Visual acuity reduced, diplopia, dry eye, eye pain, visual impairment

Rare (0.01% to 0.1%): Lacrimal duct stenosis, corneal disorders, keratitis, punctate keratitis[Ref]

Oncologic

Uncommon (0.1% to 1%): Lipoma[Ref]

Other

Very common (10% or more): Fatigue/weakness (up to 42%), pyrexia (up to 28%), edema (up to 15%), pain (up to 12%), asthenia (up to 26%), lethargy (up to 10%), temperature intolerance, tinnitus, hypoacusis, hot flush, flushing, peripheral coldness

Uncommon (0.1% to 1%): Vertigo, ear pain

Rare (0.01% to 0.1%): Chills, edema, malaise, rigors[Ref]

Psychiatric

Common (1% to 10%): Mood alteration, depression, sleep disorder, insomnia, anxiety

Uncommon (0.1% to 1%): Confusional state, panic attack[Ref]

Renal

Common (1% to 10%): Hematuria, proteinuria, creatinine renal clearance decreased

Rare (0.01% to 0.1%): Acute renal failure secondary to dehydration including fatal outcomes[Ref]

Respiratory

Very common (10% or more): Dyspnea (up to 14%), dysesthesia pharynx, sore throat

Common (1% to 10%): Epistaxis, cough, pharyngeal disorder, dysphonia, rhinorrhea, nasopharyngitis, lower respiratory tract infection, hiccups

Uncommon (0.1% to 1%): Pulmonary embolism, pneumothorax, hemoptysis, asthma, dyspnea exertional[Ref]

Frequently asked questions

References

1. Product Information. Xeloda (capecitabine). Roche Laboratories. 2001;PROD.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Cerner Multum, Inc. Australian Product Information.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.