Xeloda Side Effects
Generic name: capecitabine
Medically reviewed by Drugs.com. Last updated on Jul 12, 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
- 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 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
- 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.
General
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
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References
1. (2022) "Product Information. Xeloda (capecitabine)." Genentech
2. (2022) "Product Information. Xelabine (capecitabine)." Aspen Pharma Pty Ltd
3. (2022) "Product Information. Capecitabine (Sandoz) (capecitabine)." Sandoz Pty Ltd
4. (2022) "Product Information. Capecitabine (DRLA) (capecitabine)." Dr Reddy's Laboratories Australia Pty Ltd
5. (2022) "Product Information. Capecitabine (capecitabine)." Amarox Ltd
6. (2021) "Product Information. Capecitabine (capecitabine)." Glenmark Pharmaceuticals Europe Ltd
7. (2023) "Product Information. Capecitabine (capecitabine)." Dr Reddy's Laboratories (UK) Ltd
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.