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XELODA
Generic Name: capecitabine
Brand Name: Xeloda

Last reviewed on RxList: 12/15/2017

 PROFESSIONAL  CONSUMER  SIDE EFFECTS

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Last reviewed on RxList 12/15/2017

Xeloda (capecitabine) is an antineoplastic (anti-cancer) medication used to treat breast cancer and colon or rectum cancer that has spread
Xeloda Drug Imprint
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,
Xeloda 150 mg
dizziness,
oval, pink, imprinted with XELODA, 150
trouble sleeping,

skin darkening,

skin rash, Related Drugs

dry/itchy skin, or Alecensa, Capecitabine Tablets, Docefrez,

Etopophos, Faslodex, Fentora, Fusilev, Halaven,
numbness or tingling in your hands or feet.
Ibrance, Lonsurf, Paclitaxel, Perjeta, Taxol,
Other side effects of Xeloda include temporary hair loss. Normal hair growth should return after treatment with Xeloda has ended. Taxotere, Totect, Tykerb, Vectibix, Xgeva
Temporary nail changes may occur, which may rarely include fungal infections in the nail beds.
Health Resources
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, Breast Cancer, Cancer, Cancer Fatigue
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 Related Supplements
control pills) while taking this medication. Since this drug can be absorbed through the skin, women who are pregnant or who may become Beta-Carotene, Coriolus Mushroom, Folic Acid,
pregnant should not handle this medication. It is not known if this drug passes into breast milk. Because of possible harm to the nursing
Melatonin, Vitamin A
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 XELODA USER REVIEWS
effects to FDA at 1-800-FDA-1088.
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Psoriasis
Xeloda Consumer Information What Does a Psoriasis Rash
Look Like?

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

Call your doctor at once if you have a serious side effect such as:

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);

bloody, black, or tarry stools;

coughing up blood or vomit that looks like coffee grounds;

fever, chills, body aches, u symptoms, easy bruising or bleeding, white patches or sores inside your mouth or on your lips;

pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

pain, tenderness, redness, swelling, blistering, or peeling skin on your hands or feet;
swelling, rapid weight gain; or

jaundice (yellowing of the skin or eyes).

Other 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)

Learn More »

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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 re ect 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)

Adjuvant Treatment for Colon Cancer (N=1969)

Body System/
XELODA (N=995) 5-FU/LV (N=974)
Adverse Event
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 de ne 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 rst 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

XELODA 5-FU/LV
(n=596) (n=593)
Adverse Event
Total Grade Grade Total Grade Grade
% 3% 4% % 3% 4%

Number of Patients
With > One Adverse 96 52 9 94 45 9
Event

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
10 <1 - 7 <1 -
Disorder

  Constipation 14 1 <1 17 1 -

  Oral Discomfort 10 - - 10 - -

  Upper GI In ammatory
8 <1 - 10 1 -
Disorders

  Gastrointestinal
6 1 <1 3 1 -
Hemorrhage

  Ileus 6 4 1 5 2 1

Skin and Subcutaneous

  Hand-and-Foot
54 17 NA 6 1 NA
Syndrome

  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 rst 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 rst 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 modi cation 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

XELODA 1250
mg/m2 /bid With Docetaxel
Docetaxel 100 mg/m2 /3 weeks (n=255)
Adverse Event 75 mg/m2 /3 weeks (n=251)

Total Grade Grade Total Grade Grade

% 3% 4% % 3% 4%

Number of Patients 99 76.5 29.1 97 57.6 31.8

With at Least One
 Adverse Event

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
63 24 NA 8 1 NA
Syndrome

  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 -

  In uenza-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

XELODA 1250 mg/m2 /bid With

Docetaxel 100 mg/m2 /3 weeks
Adverse Event Docetaxel 75 mg/m2 /3 weeks
(n=255)
(n=251)

Body System/ Total Grade 3 Grade 4 Total Grade 3 Grade 4

Adverse Event % % % % % %

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
 Phase 2 Trial in Stage IV Breast
Adverse Event
Cancer (n=162)

Total Grade 3 Grade 4

Body System/ Adverse Event
% % %

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)

abdominal distension, dysphagia, proctalgia, ascites (0.1%), gastric ulcer (0.1%), ileus (0.3%), toxic dilation of
Gastrointestinal:
intestine, gastroenteritis (0.1%)

nail disorder (0.1%), sweating increased (0.1%), photosensitivity reaction (0.1%), skin ulceration, pruritus,
Skin & Subcutan.:
radiation recall syndrome (0.2%)

chest pain (0.2%), in uenza-like illness, hot ushes, pain (0.1%), hoarseness, irritability, dif culty in walking,
General:
thirst, chest mass, collapse, brosis (0.1%), hemorrhage, edema, sedation

insomnia, ataxia (0.5%), tremor, dysphasia, encephalopathy (0.1%), abnormal coordination, dysarthria, loss of
Neurological:
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

tachycardia (0.1%), bradycardia, atrial brillation, ventricular extrasystoles, extrasystoles, myocarditis (0.1%),
Cardiac:
pericardial effusion

laryngitis (1.0%), bronchitis (0.2%), pneumonia (0.2%), bronchopneumonia (0.2%), keratoconjunctivitis, sepsis
Infections: (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%)

hypotension (0.2%), hypertension (0.1%), lymphoedema (0.1%), pulmonary embolism (0.2%), cerebrovascular
Vascular:
accident (0.1%)

Psychiatric: depression, confusion (0.1%)

Renal: renal impairment (0.6%)

Ear: vertigo

Hepatobiliary: hepatic brosis (0.1%), hepatitis (0.1%), cholestatic hepatitis (0.1%), abnormal liver function tests

Immune System: drug hypersensitivity (0.1%)

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
Postmarketing:
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%)

jaundice (0.4%), abnormal liver function tests (0.4%), hepatic failure (0.4%), hepatic coma (0.4%), hepatotoxicity
Hepatobiliary:
(0.4%)

Immune System: hypersensitivity (1.2%)

Read the entire FDA prescribing information for Xeloda (Capecitabine)

Read More »
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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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