Capecitabine Side Effects

Some side effects of capecitabine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to capecitabine: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking capecitabine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• nausea, loss of appetite, eating much less than usual, vomiting (more than once in 24 hours);

• severe diarrhea (more than 4 times per day, or during the night);

• bloody, black, or tarry stools;

• coughing up blood or vomit that looks like coffee grounds;

• fever, chills, body aches, flu symptoms, easy bruising or bleeding, white patches or sores inside your mouth or on your lips;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• pain, tenderness, redness, swelling, blistering, or peeling skin on your hands or feet;

• swelling, rapid weight gain; or

• jaundice (yellowing of the skin or eyes).

Common side effects may include:

• stomach pain or upset, constipation;

• tired feeling;

• mild skin rash; or

• numbness or tingling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to capecitabine: oral tablet

Hematologic

Hematologic side effects including lymphopenia (58% to 94%), anemia (44% to 74%), neutropenia (16% to 22%), and thrombocytopenia (15% to 21%) have been reported. Cases of severe hypertriglyceridemia induced by capecitabine have also been reported.

Gastrointestinal

Gastrointestinal side effects including diarrhea (50%), nausea (44%), vomiting (26%), stomatitis (23%), abdominal pain (17%), constipation (9%), and dyspepsia (6%) have been reported. A case of capecitabine-induced pancreatitis has also been reported.

Dermatologic

Dermatologic side effects including hand and foot syndrome (35% to 45%), dermatitis (23% to 31%), nail disorder (4%), alopecia, erythematous rash, pruritus, eruptive multiple lentigo maligna-like lesions, radiation recall dermatitis, pyogenic granulomas, photoeruption, hyperpigmentation, and inflammatory responses in actinic keratosis have been reported. A case of leopard-like vitiligo and a case of subacute cutaneous lupus erythematosus have also been reported.

Hepatic

Hepatic side effects including hyperbilirubinemia (34%) and hepatic failure have been reported.

General

General side effects including fatigue (34%), pyrexia (10%), and limb pain (4%) have been reported.

Metabolic

Metabolic side effects including anorexia (20%) and dehydration (5%) have been reported.

Nervous system

Nervous system side effects including paresthesia (12%), headache (7%), dizziness (5%), and insomnia (3%) have been reported. A case of cerebellar ataxia has also been reported.

Ocular

Ocular side effects including eye irritation (10%) and lacrimal duct stenosis have been reported.

Cardiovascular

Cardiovascular side effects including edema (6%) have been reported. Three cases of severe angina-like chest pain possibly or probably related to capecitabine treatment have been reported. One case of capecitabine-induced coronary vasospasm has also been reported.

Musculoskeletal

Musculoskeletal side effects including myalgia (4%) have been reported.

Other

Other side effects including a case of tumor lysis syndrome have been reported.

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