Xeloda Side Effects
Generic Name: capecitabine
Please note - some side effects for Xeloda may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Side Effects of Xeloda - for the Consumer
Xeloda
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Xeloda:
Seek medical attention right away if any of these SEVERE side effects occur when using Xeloda:Back, joint, or muscle pain; constipation; dizziness; eye irritation; fatigue; headache; itchy or dry skin; loss of appetite; mild nausea, vomiting, or diarrhea; stomach pain; taste changes; tiredness; trouble sleeping; upset stomach; vomiting; weakness.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; bloody diarrhea; chest pain; decreased amount of urine; dry mouth; fast or irregular heartbeat; fever higher than 100.5 degrees F, chills, or sore throat; hair loss; leg pain or swelling; moderate to severe nausea, vomiting, or diarrhea; mood or mental changes; numbness, pain, tingling, blistering, swelling, or redness in the palms of the hands or soles of the feet; pain, redness, swelling, or sores in the mouth or throat; unusual bleeding or bruising; unusual tiredness; vision changes; yellowing of the eyes or skin.
Xeloda Side Effects - for the Professional
Xeloda
Adjuvant Colon Cancer
Table 11 shows the adverse events 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 events. 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 12 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.
| Adjuvant Treatment for Colon Cancer (N=1969) | ||||
|---|---|---|---|---|
| Xeloda (N=995) |
5-FU/LV (N=974) |
|||
| Body System/ 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 | - |
| Adverse Event | Xeloda (n=995) |
IV 5-FU/LV (n=974) |
|---|---|---|
| Grade 3/4 % | 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 |
Metastatic Colorectal Cancer
Table 13 shows the adverse events 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/LV-treated patients, respectively, discontinued treatment because of adverse events/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.
| Adverse Event | Xeloda (n=596) |
5-FU/LV (n=593) |
||||
|---|---|---|---|---|---|---|
| Total % |
Grade 3 % |
Grade 4 % |
Total % |
Grade 3 % |
Grade 4 % |
|
| – Not observed | ||||||
| NA = Not Applicable | ||||||
|
||||||
| 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 |
Breast Cancer Combination
The following data are shown for the combination study with Xeloda and docetaxel in patients with metastatic breast cancer in Table 14 and Table 15. 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 events. The percentage of patients requiring dose reductions due to adverse events was 65% in the combination arm and 36% in the monotherapy arm. The percentage of patients requiring treatment interruptions due to adverse events 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.
| 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 % |
|
| – Not observed | ||||||
| NA = Not Applicable | ||||||
| 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 | – |
| Infection | ||||||
| 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 | 1 | – |
| Psychiatric | ||||||
| Depression | 5 | – | – | 5 | 1 | – |
| 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 |
Breast Cancer Xeloda 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 events/intercurrent illness.
| Adverse Event | Phase 2 Trial in Stage IV Breast Cancer (n=162) |
|||||
|---|---|---|---|---|---|---|
| Body System/Adverse Event | Total % |
Grade 3 % |
Grade 4 % |
|||
| – Not observed | ||||||
| NA = Not Applicable | ||||||
| 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 | |||
Xeloda and Docetaxel in Combination
Shown below by body system are the clinically relevant adverse events in <5% of patients in the overall clinical trial safety database of 251 patients (Study Details) reported as related to the administration of Xeloda in combination with docetaxel and that were clinically at least remotely relevant. In parentheses is the incidence of grade 3 and 4 occurrences of each adverse event.
It is anticipated that the same types of adverse events observed in the Xeloda monotherapy studies may be observed in patients treated with the combination of Xeloda plus docetaxel.
Gastrointestinal: ileus (0.39), necrotizing enterocolitis (0.39), esophageal ulcer (0.39), hemorrhagic diarrhea (0.80)
Neurological: ataxia (0.39), syncope (1.20), taste loss (0.80), polyneuropathy (0.39), migraine (0.39)
Cardiac: supraventricular tachycardia (0.39)
Infection: neutropenic sepsis (2.39), sepsis (0.39), bronchopneumonia (0.39)
Blood and Lymphatic: agranulocytosis (0.39), prothrombin decreased (0.39)
Vascular: hypotension (1.20), venous phlebitis and thrombophlebitis (0.39), postural hypotension (0.80)
Renal: renal failure (0.39)
Hepatobiliary: jaundice (0.39), abnormal liver function tests (0.39), hepatic failure (0.39), hepatic coma (0.39), hepatotoxicity (0.39)
Immune System: hypersensitivity (1.20)
Xeloda Monotherapy Metastatic Breast and Colorectal Cancer
Shown below by body system are the clinically relevant adverse events in <5% of patients in the overall clinical trial safety database of 875 patients (phase 3 colorectal studies — 596 patients, phase 2 colorectal study — 34 patients, phase 2 breast cancer studies — 245 patients) reported as related to the administration of Xeloda and that were clinically at least remotely relevant. In parentheses is the incidence of grade 3 or 4 occurrences of each adverse event.
Gastrointestinal: abdominal distension, dysphagia, proctalgia, ascites (0.1), gastric ulcer (0.1), ileus (0.3), toxic dilation of intestine, gastroenteritis (0.1)
Skin and Subcutaneous: 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 and 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
TopSide Effects by Body System
Hematologic
Hematologic side effects including lymphopenia (58% to 94%), anemia (44% to 74%), neutropenia (16% to 22%), and thrombocytopenia (15% to 21%) have been reported. Cases of severe hypertriglyceridemia induced by capecitabine have also been reported.
Gastrointestinal
Gastrointestinal side effects including diarrhea (50%), nausea (44%), vomiting (26%), stomatitis (23%), abdominal pain (17%), constipation (9%), and dyspepsia (6%) have been reported. A case of capecitabine-induced pancreatitis has also been reported.
Dermatologic
Dermatologic side effects including hand and foot syndrome (35% to 45%), dermatitis (23% to 31%), nail disorder (4%), alopecia, erythematous rash, pruritus, eruptive multiple lentigo maligna-like lesions, radiation recall dermatitis, pyogenic granulomas, photoeruption, hyperpigmentation, and inflammatory responses in actinic keratosis have been reported. A case of leopard-like vitiligo has also been reported.
Hepatic
Hepatic side effects including hyperbilirubinemia (34%) and hepatic failure have been reported.
General
General side effects including fatigue (34%), pyrexia (10%), and limb pain (4%) have been reported.
Metabolic
Metabolic side effects including anorexia (20%) and dehydration (5%) have been reported.
Nervous system
Nervous system side effects including paresthesia (12%), headache (7%), dizziness (5%), and insomnia (3%) have been reported.
Ocular
Ocular side effects including eye irritation (10%) and lacrimal duct stenosis have been reported.
Cardiovascular
Cardiovascular side effects including edema (6%) have been reported. Three cases of severe angina-like chest pain possibly or probably related to capecitabine treatment have been reported. One case of capecitabine-induced coronary vasospasm has also been reported.
Musculoskeletal
Musculoskeletal side effects including myalgia (4%) have been reported.
Other
Other side effects including a case of tumor lysis syndrome have been reported.
Top
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