Capecitabine Side Effects

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

Applies to capecitabine: oral tablet.

Important warnings This medicine can cause some serious health issues

Oral route (tablet)

Warning: 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 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 capecitabine

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:

More common side effects

• diarrhea
• loss of fingerprints
• nausea
• numbness, pain, tingling, or other unusual sensations in the palms of the hands or bottoms of the feet
• pain, blistering, peeling, redness, or swelling of the palms of the hands or bottoms of the feet
• pain, redness, swelling, sores, or ulcers in your mouth or on your lips
• stomach pain
• unusual tiredness or weakness
• vomiting

Less common or rare side effects

• agitation
• back pain
• bleeding and bruising
• bleeding gums
• blood in the urine or stools
• bloody nose
• bloody or black, tarry stools
• blurred vision
• burning, dry, or itching eyes
• chest pain or tightness
• chills
• clumsiness or unsteadiness
• cold
• collapse
• coma
• confusion
• constipation
• cough or hoarseness (accompanied by fever or chills)
• cough producing mucus
• coughing or spitting up blood
• dark urine
• decreased frequency or amount of urine
• difficulty with breathing
• difficulty with swallowing or pain in the back of throat or chest when swallowing
• discharge from the eyes
• drowsiness
• dry mouth
• excessive tearing
• extra heartbeats
• eye redness, irritation, or pain
• fainting
• fast or irregular heartbeat
• fever or chills
• flu-like symptoms
• hallucinations
• headache, sudden and severe
• heavier menstrual periods
• high fever
• hot, red skin on the feet or legs
• inability to speak
• increased menstrual flow or vaginal bleeding
• increased thirst
• irritability
• itching in the genital or other skin areas
• lightheadedness
• light-colored stools
• loss of consciousness
• lower back or side pain (accompanied by fever or chills)
• muscle aches, cramps, or spasms
• nosebleeds
• numbness or tingling in the hands, feet, or lips
• painful or difficult urination (accompanied by fever or chills)
• painful, swollen feet or legs
• pain, tenderness, or swelling in the upper abdominal or stomach area
• pale skin
• paralysis
• pinpoint red spots on the skin
• problems with coordination
• prolonged bleeding from cuts
• rapid, shallow breathing
• red or dark brown urine
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• scaling
• seizures
• severe constipation
• skin rash or itching
• slow or irregular heartbeat
• slurred speech
• sneezing
• sores, ulcers, or white spots on the lips or in the mouth
• sore throat
• stiff neck
• stomach bloating, burning, or cramping
• stuffy nose
• swelling of the face, fingers, feet, or lower legs
• swelling of the lymph nodes
• swollen glands
• temporary blindness
• trouble with speaking
• trouble breathing
• unexplained nosebleeds
• unusual bleeding or bruising
• unusual lump or swelling in the chest
• unusual tiredness or weakness
• vomiting blood or material that looks like coffee grounds
• weakness in the arm or leg on one side of the body, sudden and severe
• weight gain or loss
• white patches in the mouth or throat or on the tongue
• white patches with diaper rash
• yellow eyes or skin

Incidence not known

• blistering, peeling, or loosening of the skin
• chest discomfort or heaviness
• dilated neck veins
• dizziness
• eye irritation or pain
• irregular breathing
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• no blood pressure or pulse
• pain or discomfort in the arms, jaw, back, or neck
• red irritated eyes
• red skin lesion, often with a purple center
• stopping of heart
• sweating
• unconsciousness
• weight gain

Other side effects of capecitabine

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 side effects

• burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
• changes or discoloration in the fingernails or toenails
• difficulty with moving
• discouragement
• headache
• heartburn
• increased sensitivity of the skin to sunlight
• muscle pain
• pain
• pain and redness of the skin at the place of x-ray treatment
• pain in the joints or limbs
• red, sore eyes
• sunken eyes
• thirst
• trouble sleeping
• weakness
• wrinkled skin

Rare side effects

• bone pain
• change in color of treated skin
• difficulty with walking
• discouragement
• feeling of constant movement of self or surroundings
• feeling sad or empty
• full or bloated feeling or pressure in the stomach
• general feeling of discomfort or illness
• hot flushes
• impaired balance
• increased sweating
• joint pain
• lack of appetite
• loss of interest or pleasure
• muscle weakness
• noisy breathing
• pain in the rectum
• pain, swelling, or redness in the joints
• passing less gas
• rough, scratchy sound to voice
• runny nose
• sensation of spinning
• shakiness in the legs, arms, hands, or feet
• shivering
• sores on the skin
• swelling of the stomach area
• tremor or shaking of the hands or feet
• trouble concentrating
• voice changes

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

Frequently asked questions

• Why do you need to take Xeloda with food?

Further information

Capecitabine 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.

Medical Disclaimer