Capecitabine monotherapy: Infections and infestations: Herpes simplex, nasopharyngitis, lower respiratory tract infection, sepsis, urinary tract infection, cellulitis, tonsilitis, pharyngitis, oral candidiasis, influenza, gastroenteritis, fungal infection, herpes infection, tooth abscess.
Neoplasm benign, malignant and unspecified: Lipoma.
Blood and lymphatic system disorders: neutropenia, anaemia, febrile neutropenia, pancytopenia, granulocytopenia, thrombocytopenia, leucopenia, haemolytic anaemia.
Immune system disorders: Hypersensitivity.
Metabolism and nutrition disorders: Anorexia, dehydration, decreased appetite, diabetes, hypokalaemia, appetite disorder, malnutrition, hypertriglyceridaemia.
Psychiatric disorders: insomnia, depression, confusional state, panic attack, depressed mood, libido decreased.
Nervous system disorders: Headache, lethargy, dizziness, paresthesia, dysgeusia, aphasia, memory impairment, ataxia, syncope, balance disorder, sensory disorder, neuropathy peripheral.
Eye disorders: Lacrimation increased, conjunctivitis, eye irritation, visual acuity reduced, diplopia.
Ear and labyrinth disorders: Vertigo, ear pain.
Cardiac disorders: Angina unstable, angina pectoris, myocardial ischaemia, atrial fibrillation, arrhythmia, tachycardia, sinus tachycardia, palpitations.
Vascular disorders: thrombophlebitis, deep vein thrombosis, hypertension, petechiae, hypotension, hot flush, peripheral coldness.
Respiratory, thoracic and mediastinal disorders: Dyspnea, epistaxis, cough, rhinorrhea, pulmonary embolism, pneumothorax, haemoptysis, asthma, dyspnea exertional.
Gastrointestinal disorders: Diarrhea, vomiting, nausea, stomatitis, abdominal pain, gastrointestinal haemorrhage, constipation, upper abdominal pain, dyspepsia, flatulence, dry mouth, loose stools, intestinal obstruction, ascites, enteritis, gastritis, dysphagia, abdominal pain lower, esophagitis, abdominal discomfort, gastroesophageal reflux disease, colitis.
Hepatobiliary disorders: Hyperbilirubinemia/blood bilirubin/ blood bilirubin increased, jaundice.
Skin and subcutaneous tissue disorders: Palmar-plantar, erythrodysaesthesia syndrome, rash, alopecia, erythema, dry skin, pruritus, skin hyperpigmentation, rash macular, skin desquamation, dermatitis, pigmentation disorders, nail disorder, skin ulcer, urticaria, photosensitivity reaction, palmar erythema, swelling face, purpura.
Musculoskeletal and connective tissue disorders: Pain in extremity, back pain, arthralgia, joint swelling, bone pain, facial pain, musculoskeletal, stiffness, muscular weakness.
Renal and urinary disorders: Hydronephrosis, urinary incontinence, hematuria, nocturia.
Reproductive system and breast disorders: Vaginal hemorrhage.
General disorders and administration site conditions: Fatigue, asthenia, pyrexia, lethargy, edema peripheral, malaise, non-cardiac chest pain, edema, chills, influenza-like illness, rigors.
Investigations: Weight decreased, liver function tests abnormalities, blood in stool, international normalised ratio increased, blood creatinine increased, body temperature increased.
Injury, poisoning and procedural complications: Blister, overdose.
Laboratory abnormalities observed with Capecitabine monotherapy: Decreased hemoglobin, neutrophils/granulocytes, platelets, lymphocytes, sodium, and potassium.
Increased bilirubin, alkaline phosphatase, SGPT and SGOT.
Increased or decreased calcium.
Capecitabine in combination with Cisplatin: Infections and infestations: Herpes zoster, urinary tract infection.
Neoplasm benign, malignant and unspecified: Aleukaemic leukaemia.
Blood and lymphatic system disorders: Neutropenia, leucopenia, anaemia, thrombocytopenia, bone marrow depression.
Metabolism and nutrition disorders: Hypokalemia, hyponatremia, dehydration, hyperglycemia, decreased appetite.
Psychiatric disorders: Sleep disorder.
Nervous system disorders: Neuropathy, peripheral sensory neuropathy, hypoaesthesia, dizziness.
Ear and labyrinth disorders: Tinnitus, hypoacusis.
Gastrointestinal disorders: Upper gastrointestinal hemorrhage, mouth ulceration, gastritis, constipation, mouth ulceration, abdominal pain.
Hepatobiliary disorders: Hepatic function abnormal.
Skin and subcutaneous tissue disorders: Hyperhidrosis.
Musculoskeletal and connective tissue disorders: Myalgia.
Renal and urinary disorders: renal failure, renal failure acute.
General disorders and administration site conditions: Mucosal inflammation, fatigue, malaise.
Investigations: Creatinine renal clearance decreased.
Capecitabine in combination with Docetaxel: Infections and infestations: Oral candidiasis.
Neoplasm benign, malignant and unspecified: Neutropenic fever.
Metabolism and nutrition disorders: Appetite decreased.
Nervous system disorders: Taste disturbance, paresthesia, peripheral neuropathy, headache.
Eye disorders: Lacrimation increased.
Vascular disorders: Lower limb edema.
Respiratory, thoracic and mediastinal system disorders: Sore throat, epistaxis, cough.
Gastrointestinal disorders: Constipation, dyspepsia.
Skin and subcutaneous tissue disorders: Alopecia, nail disorder, rash erythematous, nail discolouration, onycholysis.
Musculoskeletal and connective tissue disorders: Myalgia, arthralgia.
General disorders and administration site conditions: Pyrexia, weakness, pain in limb, pain.
Capecitabine in combination with Oxaliplatin: Anemia, leukopenia, neutropenia, thrombocytopenia, neuropathy, bleeding.
Capecitabine in combination with Epirubicin and Oxaliplatin: Leukopenia, neutropenia, lethargy, anemia, thrombocytopenia, febrile neutropenia, peripheral neuropathy, infection, fever, thromboembolism.
Capecitabine in combination with Epirubicin and Cisplatin: Leukopenia, neutropenia, anemia, lethargy, thromboembolism, thrombocytopenia, febrile neutropenia, peripheral neuropathy, infection, fever.
Post-marketing: Renal and urinary disorders: Acute renal failure secondary to dehydration.
Nervous system disorders: Toxic leukoencephalopathy.
Hepatobiliary disorders: Hepatic failure, cholestatic hepatitis.
Metabolism and nutrition disorders: Hypertriglyceridemia.
Skin and subcutaneous tissue disorders: Cutaneous lupus erythematosus, severe skin reactions such as Steven-Johnson syndrome and toxic epidermal necrolysis (TEN).
Eye disorders: Lacrimal duct stenosis NOS, corneal disorders including keratitis.