Summary

Commonly reported side effects of capecitabine include: anemia, diarrhea, hyperbilirubinemia, increased serum alkaline phosphatase, increased serum transaminases, nausea, neutropenia, palmar-plantar erythrodysesthesia, paresthesia, stomatitis, thrombocytopenia, and vomiting. Other side effects include: erythema of skin. Continue reading for a comprehensive list of adverse effects.

Applies to capecitabine: oral tablet.

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

• 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

• 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

• 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

• 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.

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]