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Xeloda

Last reviewed on RxList: 4/25/2019
Xeloda Side Effects Center

Last reviewed on RxList 4/25/2019

Xeloda (capecitabine) is an antineoplastic (anti-cancer) medication used to treat breast cancer and colon or rectum cancer that has spread to other parts of the body. Common side effects of Xeloda include:

  • severe nausea or vomiting (may be severe),
  • stomach pain or upset,
  • loss of appetite,
  • constipation,
  • tiredness,
  • weakness,
  • back/joint/muscle pain,
  • headache,
  • dizziness,
  • trouble sleeping,
  • skin darkening,
  • skin rash,
  • dry/itchy skin, or
  • numbness or tingling in your hands or feet.

Other side effects of Xeloda include temporary hair loss. Normal hair growth should return after treatment with Xeloda has ended. Temporary nail changes may occur, which may rarely include fungal infections in the nail beds.

Dose of Xeloda is calculated according to body surface area. Xeloda tablets are swallowed whole with water within 30 minutes after a meal. Xeloda may adversely interact with folic acid (including multivitamins with folic acid), blood thinners, leucovorin, metronidazole, tinidazole, fosphenytoin, and phenytoin. Discuss all medications you are taking with your doctor. This drug is not recommended for use during pregnancy. It may harm a fetus. It is recommended that men and women use two effective forms of birth control (e.g., condoms and birth control pills) while taking this medication. Since this drug can be absorbed through the skin, women who are pregnant or who may become pregnant should not handle this medication. It is not known if this drug passes into breast milk. Because of possible harm to the nursing infant, breastfeeding while using this drug is not recommended. Consult your doctor before breastfeeding.

Our Xeloda Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

What are risk factors for developing colon cancer? See Answer
Xeloda Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • fever above 100.5 degrees;
  • nausea, loss of appetite, eating much less than usual, vomiting (more than once in 24 hours);
  • severe diarrhea (more than 4 times per day, or during the night);
  • blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
  • pain, tenderness, redness, swelling, blistering, or peeling skin on your hands or feet;
  • dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
  • heart problems--chest pain or pressure, uneven heartbeats, shortness of breath (even with mild exertion), swelling or rapid weight gain;
  • kidney problems--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath;
  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • low blood cell counts--fever or other flu symptoms, cough, skin sores, pale skin, easy bruising, unusual bleeding, feeling light-headed, rapid heart rate; or
  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • stomach pain or upset, constipation;
  • tired feeling;
  • mild skin rash; or
  • numbness or tingling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Xeloda (Capecitabine)

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow
Xeloda Professional Information

SIDE EFFECTS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adjuvant Colon Cancer

Table 4 shows the adverse reactions occurring in =5% of patients from one phase 3 trial in patients with Dukes' C colon cancer who received at least one dose of study medication and had at least one safety assessment. A total of 995 patients were treated with 1250 mg/m2 twice a day of XELODA administered for 2 weeks followed by a 1-week rest period, and 974 patients were administered 5-FU and leucovorin (20 mg/m2 leucovorin IV followed by 425 mg/m2 IV bolus 5-FU on days 1-5 every 28 days). The median duration of treatment was 164 days for capecitabine-treated patients and 145 days for 5-FU/LV-treated patients. A total of 112 (11%) and 73 (7%) capecitabine and 5-FU/LV-treated patients, respectively, discontinued treatment because of adverse reactions. A total of 18 deaths due to all causes occurred either on study or within 28 days of receiving study drug: 8 (0.8%) patients randomized to XELODA and 10 (1.0%) randomized to 5-FU/LV.

Table 5 shows grade 3/4 laboratory abnormalities occurring in =1% of patients from one phase 3 trial in patients with Dukes' C colon cancer who received at least one dose of study medication and had at least one safety assessment.

Table 4 Percent Incidence of Adverse Reactions Reported in =5% of Patients Treated With XELODA or 5-FU/LV for Colon Cancer in the Adjuvant Setting (Safety Population)

Body System/
Adverse Event
Adjuvant Treatment for Colon Cancer (N=1969)
XELODA (N=995) 5-FU/LV (N=974)
All Grades Grade 3/4 All Grades Grade 3/4
Gastrointestinal Disorders
  Diarrhea 47 12 65 14
  Nausea 34 2 47 2
  Stomatitis 22 2 60 14
  Vomiting 15 2 21 2
  Abdominal Pain 14 3 16 2
  Constipation 9 - 11 <1
  Upper Abdominal Pain 7 <1 7 <1
  Dyspepsia 6 <1 5 -
Skin and Subcutaneous Tissue Disorders
  Hand-and-Foot Syndrome 60 17 9 <1
  Alopecia 6 - 22 <1
  Rash 7 - 8 -
  Erythema 6 1 5 <1
General Disorders and Administration Site Conditions
  Fatigue 16 <1 16 1
  Pyrexia 7 <1 9 <1
  Asthenia 10 <1 10 1
  Lethargy 10 <1 9 <1
Nervous System Disorders
  Dizziness 6 <1 6 -
  Headache 5 <1 6 <1
  Dysgeusia 6 - 9 -
Metabolism and Nutrition Disorders
  Anorexia 9 <1 11 <1
  Eye Disorders        
  Conjunctivitis 5 <1 6 <1
Blood and Lymphatic System Disorders
  Neutropenia 2 <1 8 5
Respiratory Thoracic and Mediastinal Disorders
  Epistaxis 2 - 5 -

Table 5 Percent Incidence of Grade 3/4 Laboratory Abnormalities Reported in =1% of Patients Receiving XELODA Monotherapy for Adjuvant Treatment of Colon Cancer (Safety Population)

Advers e Event XELODA (n=995) Grade 3/4 % IV 5-FU/LV (n=974) Grade 3/4 %
  Increased ALAT (SGPT) 1.6 0.6
  Increased calcium 1.1 0.7
  Decreased calcium 2.3 2.2
  Decreased hemoglobin 1.0 1.2
  Decreased lymphocytes 13.0 13.0
  Decreased neutrophils* 2.2 26.2
  Decreased neutrophils/granulocytes 2.4 26.4
  Decreased platelets 1.0 0.7
  Increased bilirubin 20 6.3
*The incidence of grade 3/4 white blood cell abnormalities was 1.3% in the XELODA arm and 4 .9% in the IV 5-FU/LV arm. It should be noted that grading was according to NCIC CTC Version 1 (May, 1994 ). In the NCIC-CTC Version 1, hyperbilirubinemia grade 3 indicates a bilirubin value of 1.5 to 3.0 x upper limit of normal (ULN) range, and grade 4 a value of > 3.0 x ULN. The NCI CTC Version 2 and above define a grade 3 bilirubin value of>3.0 to 10.0 x ULN, and grade 4 values >10.0 x ULN.

Metastatic Colorectal Cancer

Monotherapy

Table 6 shows the adverse reactions occurring in =5% of patients from pooling the two phase 3 trials in first line metastatic colorectal cancer. A total of 596 patients with metastatic colorectal cancer were treated with 1250 mg/m2 twice a day of XELODA administered for 2 weeks followed by a 1-week rest period, and 593 patients were administered 5-FU and leucovorin in the Mayo regimen (20 mg/m2 leucovorin IV followed by 425 mg/m2 IV bolus 5-FU, on days 1-5, every 28 days). In the pooled colorectal database the median duration of treatment was 139 days for capecitabine-treated patients and 140 days for 5-FU/LV-treated patients. A total of 78 (13%) and 63 (11%) capecitabine and 5-FU/LVtreated patients, respectively, discontinued treatment because of adverse reactions/intercurrent illness. A total of 82 deaths due to all causes occurred either on study or within 28 days of receiving study drug: 50 (8.4%) patients randomized to XELODA and 32 (5.4%) randomized to 5-FU/LV.

Table 6 Pooled Phase 3 Colorectal Trials : Percent Incidence of Adverse Reactions in =5% of Patients

Adverse Event XELODA
(n=596)
5-FU/LV
(n=593)
Total
%
Grade
3%
Grade
4%
Total
%
Grade
3%
Grade
4%
Number of Patients
With > One Adverse
Event
96 52 9 94 45 9
Body System/Adverse Event
GI            
  Diarrhea 55 13 2 61 10 2
  Nausea 43 4 - 51 3 <1
  Vomiting 27 4 <1 30 4 <1
  Stomatitis 25 2 <1 62 14 1
  Abdominal Pain 35 9 <1 31 5 -
  Gastrointestinal Motility
Disorder
10 <1 - 7 <1 -
  Constipation 14 1 <1 17 1 -
  Oral Discomfort 10 - - 10 - -
  Upper GI Inflammatory
Disorders
8 <1 - 10 1 -
  Gastrointestinal
Hemorrhage
6 1 <1 3 1 -
  Ileus 6 4 1 5 2 1
Skin and Subcutaneous
  Hand-and-Foot
Syndrome
54 17 NA 6 1 NA
  Dermatitis 27 1 - 26 1 -
  Skin Discoloration 7 <1 - 5 - -
  Alopecia 6 - - 21 <1 -
General            
  Fatigue/Weakness 42 4 - 46 4 -
  Pyrexia 18 1 - 21 2 -
  Edema 15 1 - 9 1 -
  Pain 12 1 - 10 1 -
  Chest Pain 6 1 - 6 1 <1
Neurological
  Peripheral Sensory Neuropathy 10 - - 4 - -
  Headache 10 1 - 7 - -
  Dizziness* 8 <1 - 8 <1 -
  Insomnia 7 - - 7 - -
  Taste Disturbance 6 1 - 11 <1 1
Metabolism
  Appetite Decreased 26 3 <1 31 2 <1
  Dehydration 7 2 <1 8 3 1
Eye
  Eye Irritation 13 - - 10 <1 -
  Vision Abnormal 5 - - 2 - -
Respiratory
  Dyspnea 14 1 - 10 <1 1
  Cough 7 <1 1 8 - -
  Pharyngeal Disorder 5 - - 5 - -
  Epistaxis 3 <1 - 6 - -
  Sore Throat 2 - - 6 - -
Musculoskeletal
  Back Pain 10 2 - 9 <1 -
  Arthralgia 8 1 - 6 1 -
Vascular
  Venous Thrombosis 8 3 <1 6 2 -
Psychiatric
  Mood Alteration 5 - - 6 <1 -
  Depression 5 - - 4 <1 -
Infections
  Viral 5 <1 - 5 <1 -
Blood and Lymphatic
  Anemia 80 2 <1 79 1 <1
  Neutropenia 13 1 2 46 8 13
Hepatobiliary
  Hyperbilirubinemia 48 18 5 17 3 3
–Not observed
NA = Not Applicable
*Excluding vertigo

Breast Cancer

In Combination With Docetaxel

The following data are shown for the combination study with XELODA and docetaxel in patients with metastatic breast cancer in Table 7 and Table 8. In the XELODA and docetaxel combination arm the treatment was XELODA administered orally 1250 mg/m2 twice daily as intermittent therapy (2 weeks of treatment followed by 1 week without treatment) for at least 6 weeks and docetaxel administered as a 1- hour intravenous infusion at a dose of 75 mg/m2 on the first day of each 3-week cycle for at least 6 weeks. In the monotherapy arm docetaxel was administered as a 1-hour intravenous infusion at a dose of 100 mg/m2 on the first day of each 3-week cycle for at least 6 weeks. The mean duration of treatment was 129 days in the combination arm and 98 days in the monotherapy arm. A total of 66 patients (26%) in the combination arm and 49 (19%) in the monotherapy arm withdrew from the study because of adverse reactions. The percentage of patients requiring dose reductions due to adverse reactions was 65% in the combination arm and 36% in the monotherapy arm. The percentage of patients requiring treatment interruptions due to adverse reactions in the combination arm was 79%. Treatment interruptions were part of the dose modification scheme for the combination therapy arm but not for the docetaxel monotherapy-treated patients.

Table 7 Percent Incidence of Adverse Events Considered Related or Unrelated to Treatment in =5% of Patients Participating in the XELODA and Docetaxel Combination vs Docetaxel Monotherapy Study

Adverse Event XELODA 1250
mg/m2 /bid With
Docetaxel
75 mg/m2 /3 weeks (n=251)
Docetaxel
100 mg/m2 /3 weeks (n=255)
Total
%
Grade
3%
Grade
4%
Total
%
Grade
3%
Grade
4%
Number of Patients
With at Least One
Adverse Event
99 76.5 29.1 97 57.6 31.8
Body System/Adverse Event
GI
  Diarrhea 67 14 <1 48 5 <1
  Stomatitis 67 17 <1 43 5 -
  Nausea 45 7 - 36 2 -
  Vomiting 35 4 1 24 2 -
  Constipation 20 2 - 18 - -
  Abdominal Pain 30 <3 <1 24 2 -
  Dyspepsia 14 - - 8 1 -
  Dry Mouth 6 <1 - 5 - -
Skin and Subcutaneous
  Hand-and-Foot
Syndrome
63 24 NA 8 1 NA
  Alopecia 41 6 - 42 7 -
  Nail Disorder 14 2 - 15 - -
  Dermatitis 8 - - 11 1 -
  Rash Erythematous 9 <1 - 5 - -
  Nail Discoloration 6 - - 4 <1 -
  Onycholysis 5 1 - 5 1 -
  Pruritus 4 - - 5 - -
General
  Pyrexia 28 2 - 34 2 -
  Asthenia 26 4 <1 25 6 -
  Fatigue 22 4 - 27 6 -
  Weakness 16 2 - 11 2 -
  Pain in Limb 13 <1 - 13 2 -
  Lethargy 7 - - 6 2 -
  Pain 7 <1 - 5 1 -
  Chest Pain (non-cardiac) 4 <1 - 6 2 -
  Influenza-like Illness 5 - - 5 - -
Neurological
  Taste Disturbance 16 <1 - 14 <1 -
  Headache 15 3 - 15 2 -
  Paresthesia 12 <1 - 16 1 -
  Dizziness 12 - - 8 <1 -
  Insomnia 8 - - 10 <1 -
  Peripheral Neuropathy 6 - - 10 1 -
  Hypoaesthesia 4 <1 - 8 <1 -
Metabolism
  Anorexia 13 1 - 11 <1 -
  Appetite Decreased 10 - - 5 - -
  Weight Decreased 7 - - 5 - -
  Dehydration 10 2 - 7 <1 <1
Eye
  Lacrimation Increased 12 - - 7 <1 -
  Conjunctivitis 5 - - 4 - -
  Eye Irritation 5 - - 1 - -
Musculoskeletal
  Arthralgia 15 2 - 24 3 -
  Myalgia 15 2 - 25 2 -
  Back Pain 12 <1 - 11 3 -
  Bone Pain 8 <1 - 10 2 -
Cardiac
  Edema 33 <2 - 34 <3 1
Blood
  Neutropenic Fever 16 3 13 21 5 16
Respiratory
  Dyspnea 14 2 <1 16 2 -
  Cough 13 1 - 22 <1 -
  Sore Throat 12 2 - 11 <1 -
  Epistaxis 7 <1 - 6 - -
  Rhinorrhea 5 - - 3 - -
  Pleural Effusion 2 1 - 7 4 -
Infections
  Oral Candidiasis 7 <1 - 8 <1 -
  Urinary Tract Infection 6 <1 - 4 - -
  Upper Respiratory Tract 4 - - 5 1 -
Vascular
  Flushing 5 - - 5 - -
  Lymphoedema 3 <1 - 5 - -
Psychiatric
  Depression 5 - - 5 1 -
–Not observed
NA = Not Applicable

Table 8 Percent of Patients With Laboratory Abnormalities Participating in the XELODA and Docetaxel Combination vs Docetaxel Monotherapy Study

Adverse Event XELODA 1250 mg/m2 /bid With
Docetaxel 75 mg/m2 /3 weeks
(n=251)
Docetaxel 100 mg/m2 /3 weeks
(n=255)
Body System/
Adverse Event
Total
%
Grade 3
%
Grade 4
%
Total
%
Grade 3
%
Grade 4
%
Hematologic            
  Leukopenia 91 37 24 88 42 33
  Neutropenia/ Granulocytopenia 86 20 49 87 10 66
  Thrombocytopenia 41 2 1 23 1 2
  Anemia 80 7 3 83 5 <1
  Lymphocytopenia 99 48 41 98 44 40
Hepatobiliary            
  Hyperbilirubinemia 20 7 2 6 2 2

Monotherapy

The following data are shown for the study in stage IV breast cancer patients who received a dose of 1250 mg/m2 administered twice daily for 2 weeks followed by a 1-week rest period. The mean duration of treatment was 114 days. A total of 13 out of 162 patients (8%) discontinued treatment because of adverse reactions/intercurrent illness.

Table 9 Percent Incidence of Adverse Reactions Considered Remotely, Possibly or Probably Related to Treatment in =5% of Patients Participating in the Single Arm Trial in Stage IV Breast Cancer

Adverse Event Phase 2 Trial in Stage IV Breast
Cancer (n=162)
Body System/ Adverse Event Total
%
Grade 3
%
Grade 4
%
GI
Diarrhea 57 12 3
Nausea 53 4 -
Vomiting 37 4 -
Stomatitis 24 7 -
Abdominal Pain 20 4 -
Constipation 15 1 -
Dyspepsia 8 - -
Skin and Subcutaneous
Hand-and-Foot Syndrome 57 11 NA
Dermatitis 37 1 -
Nail Disorder 7 - -
General
Fatigue 41 8 -
Pyrexia 12 1 -
Pain in Limb 6 1 -
Neurological
Paresthesia 21 1 -
Headache 9 1 -
Dizziness 8 - -
Insomnia 8 - -
Metabolism
Anorexia 23 3 -
Dehydration 7 4 1
Eye
Eye Irritation 15 - -
Musculoskeletal
Myalgia 9 - -
Cardiac      
Edema 9 1 -
Blood
Neutropenia 26 2 2
Thrombocytopenia 24 3 1
Anemia 72 3 1
Lymphopenia 94 44 15
Hepatobiliary
Hyperbilirubinemia 22 9 2
– Not observed
NA = Not Applicable

Clinically Relevant Adverse Events In <5% Of Patients

Clinically relevant adverse events reported in <5% of patients treated with XELODA either as monotherapy or in combination with docetaxel that were considered at least remotely related to treatment are shown below; occurrences of each grade 3 and 4 adverse event are provided in parentheses.

Monotherapy (Metastatic Colorectal Cancer, Adjuvant Colorectal Cancer, Metastatic Breast Cancer)

Gastrointestinal: abdominal distension, dysphagia, proctalgia, ascites (0.1%), gastric ulcer (0.1%), ileus (0.3%), toxic dilation of intestine, gastroenteritis (0.1%)
Skin & Subcutan.: nail disorder (0.1%), sweating increased (0.1%), photosensitivity reaction (0.1%), skin ulceration, pruritus, radiation recall syndrome (0.2%)
General: chest pain (0.2%), influenza-like illness, hot flushes, pain (0.1%), hoarseness, irritability, difficulty in walking, thirst, chest mass, collapse, fibrosis (0.1%), hemorrhage, edema, sedation
Neurological: insomnia, ataxia (0.5%), tremor, dysphasia, encephalopathy (0.1%), abnormal coordination, dysarthria, loss of consciousness (0.2%), impaired balance
Metabolism: increased weight, cachexia (0.4%), hypertriglyceridemia (0.1%), hypokalemia, hypomagnesemia
Eye: conjunctivitis
Respiratory: cough (0.1%), epistaxis (0.1%), asthma (0.2%), hemoptysis, respiratory distress (0.1%), dyspnea
Cardiac: tachycardia (0.1%), bradycardia, atrial fibrillation, ventricular extrasystoles, extrasystoles, myocarditis (0.1%), pericardial effusion
Infections: laryngitis (1.0%), bronchitis (0.2%), pneumonia (0.2%), bronchopneumonia (0.2%), keratoconjunctivitis, sepsis (0.3%), fungal
infections (including candidiasis) (0.2%)
Musculoskeletal: myalgia, bone pain (0.1%), arthritis (0.1%), muscle weakness
Blood & Lymphatic: leukopenia (0.2%), coagulation disorder (0.1%), bone marrow depression (0.1%), idiopathic thrombocytopenia purpura (1.0%), pancytopenia (0.1%)
Vascular: hypotension (0.2%), hypertension (0.1%), lymphoedema (0.1%), pulmonary embolism (0.2%), cerebrovascular accident (0.1%)
Psychiatric: depression, confusion (0.1%)
Renal: renal impairment (0.6%)
Ear: vertigo
Hepatobiliary: hepatic fibrosis (0.1%), hepatitis (0.1%), cholestatic hepatitis (0.1%), abnormal liver function tests
Immune System: drug hypersensitivity (0.1%)
Postmarketing: hepatic failure, lacrimal duct stenosis, acute renal failure secondary to dehydration including fatal outcome [see WARNINGS AND PRECAUTIONS], cutaneous lupus erythematosus, corneal disorders including keratitis, toxic leukoencephalopathy, severe skin reactions such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (TEN) [see WARNINGS AND PRECAUTIONS]

XELODA In Combination With Docetaxel (Metastatic Breast Cancer)

Gastrointestinal: ileus (0.4%), necrotizing enterocolitis (0.4%), esophageal ulcer (0.4%), hemorrhagic diarrhea (0.8%)
Neurological: ataxia (0.4%), syncope (1.2%), taste loss (0.8%), polyneuropathy (0.4%), migraine (0.4%)
Cardiac: supraventricular tachycardia (0.4%)
Infection: neutropenic sepsis (2.4%), sepsis (0.4%), bronchopneumonia (0.4%)
Blood & Lymphatic: agranulocytosis (0.4%), prothrombin decreased (0.4%)
Vascular: hypotension (1.2%), venous phlebitis and thrombophlebitis (0.4%), postural hypotension (0.8%)
Renal: renal failure (0.4%)
Hepatobiliary: jaundice (0.4%), abnormal liver function tests (0.4%), hepatic failure (0.4%), hepatic coma (0.4%), hepatotoxicity (0.4%)
Immune System: hypersensitivity (1.2%)

Read the entire FDA prescribing information for Xeloda (Capecitabine)

Related Resources for Xeloda

Read the Xeloda User Reviews »

© Xeloda Patient Information is supplied by Cerner Multum, Inc. and Xeloda Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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