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Xeloda Side Effects

Generic Name: capecitabine

Note: This page contains side effects data for the generic drug capecitabine. It is possible that some of the dosage forms included below may not apply to the brand name Xeloda.

In Summary

Common side effects of Xeloda include: diarrhea, stomatitis, paresthesia, neutropenia, thrombocytopenia, anemia, nausea, vomiting, increased serum alkaline phosphatase, hyperbilirubinemia, increased serum transaminases, and palmar-plantar erythrodysesthesia. Other side effects include: erythema. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to capecitabine: oral tablet

As well as its needed effects, capecitabine (the active ingredient contained in Xeloda) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking capecitabine, check with your doctor immediately:

More common:
  • Abdominal or stomach pain
  • diarrhea
  • 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
  • unusual tiredness or weakness
  • vomiting
Less common or rare:
  • Abdominal or stomach cramping or pain (severe)
  • 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
  • chills
  • clumsiness or unsteadiness
  • cold
  • collapse
  • coma
  • confusion
  • constipation
  • convulsions
  • 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 or cramps
  • muscle 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, sore throat, or stuffy nose
  • sores, ulcers, or white spots on the lips or in the mouth
  • stiff neck
  • stomach bloating, burning, or cramping
  • swelling of the face, fingers, feet, or lower legs
  • swelling of the lymph nodes
  • swollen glands
  • temporary blindness
  • tiredness or weakness
  • trouble with speaking
  • troubled breathing or tightness in the chest
  • unexplained nosebleeds
  • unusual bleeding or bruising
  • unusual lump or swelling in the chest
  • 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

Minor Side Effects

Some capecitabine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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
  • dizziness
  • 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 abdominal or 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]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Xeloda (capecitabine)." Roche Laboratories, Nutley, NJ.

It is possible that some side effects of Xeloda may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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