Medical Editor: John P. Cunha, DO, FACOEP
What Is Xeloda?
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.
What Are Side Effects of Xeloda?
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.
Dosage for Xeloda
Dose of Xeloda is calculated according to body surface area. Xeloda tablets are swallowed whole with water within 30 minutes after a meal.
What Drugs, Substances, or Supplements Interact with Xeloda?
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.
Xeloda During Pregnancy and Breastfeeding
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.
Additional Information
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.
SLIDESHOW
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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)
QUESTION
What are risk factors for developing colon cancer? See AnswerSIDE 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)
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