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Capecitabine Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 12, 2023.

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 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

Less common or rare

Incidence not known

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

Rare

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

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.