The most common adverse effects that were reported with capecitabine use are diarrhea, nausea, vomiting, abdominal pain, stomatitis, hand-and-foot syndrome, fatigue, asthenia, anorexia, cardiotoxicity, increased renal dysfunction on those with preexisting compromised renal function and thrombosis or embolism. Other adverse effects of capecitabine used both as monotherapy or in combination with other chemotherapy regimens are: Infections and infestations:
Herpes viral infection, nasopharyngitis, lower respiratory tract infection, upper respiratory tract infection, sepsis, urinary tract infection, cellulitis, tonsillitis, pharyngitis, oral candidiasis, oral herpes, influenza, gastroenteritis, fungal infection, infection, tooth abscess, rhinitis, viral infection, bronchitis, bronchopneumonia, pneumonia, otitis media, superinfection.
Neoplasms benign, malignant and unspecified:
Lipoma, solar keratoses.
Blood and lymphatic system disorders:
Neutropenia, anemia, febrile neutropenia, pancytopenia, granulocytopenia, thrombocytopenia, leucopenia, hemolytic anemia, international normalized ratio (INR) increased, prothrombin time prolonged, bone marrow depression, hyperbilirubinemia, jaundice, lymphoedema, lymphopenia, coagulopathy, neutropenic sepsis, agranulocytosis.
Immune system disorders:
Hypersensitivity, asthma, urticaria, swelling face, Stevens-Johnson syndrome, drug hypersensitivity, face edema, skin reaction, bronchospasm, food allergy.
Metabolism and nutrition disorders:
Anorexia, edema, dehydration, decreased appetite, weight increased/decreased, diabetes, hypokalemia, appetite disorder, malnutrition, hypertriglyceridemia, hypokalemia, hyponatremia, hypomagnesemia, hypocalcemia, hyperglycemia, lower limb edema, peripheral edema, thirst, fluid retention, food intolerance, diabetes control impaired.
Insomnia, depression, confusional state, panic attack, depressed mood, libido decreased, sleep disorder, anxiety, dysphonia, mood alteration, irritability, aphasia, dysarthria, mental impairment, psychiatric symptom, psychogenic disorder.
Nervous system disorders:
Headache, lethargy, dizziness, paresthesia, dysesthesia, dysgeusia, ageusia, aphasia, memory impairment, ataxia, syncope, balance disorder, sensory disorder, peripheral neuropathy, peripheral sensory neuropathy, neurotoxicity, tremor, neuralgia, hypoesthesia, visual acuity reduced, diplopia, blurred vision, oral dysesthesia, oral paresthesia, oral hypoesthesia, muscular weakness, trismus, gait disturbance, sedation, encephalopathy, abnormal coordination, balance disorder, cerebrovascular accident, polyneuropathy, migraine, hepatic coma, facial palsy, myoclonus, peroneal nerve palsy, amnesia, personality change.
Lacrimation increased, conjunctivitis, eye irritation, visual disorders, dry eye, eye pain, visual impairment, keratoconjunctivitis, lacrimal duct stenosis, cataract, corneal disorder, keratitis, punctuate keratitis.
Ear and labyrinth disorders:
Vertigo, ear pain, tinnitus, hypoacusis, deafness, ear discomfort Cardiac disorders: Angina unstable, angina pectoris, myocardial ischemia, atrial fibrillation, arrhythmia, tachycardia, sinus tachycardia, palpitation, dyspnea, exertional dyspnea, chest pain, bradycardia, ventricular extrasystoles, extrasystoles, myocarditis, pericardial effusion, supraventricular tachycardia, chest discomfort, orthopnea, cardiomyopathy, ventricular fibrillation, QT prolongation, Torsades de pointes.
Thrombophlebitis, deep vein thrombosis, hypertension, hypotension, hot flush, flushing, peripheral coldness, embolism, thrombosis, epistaxis, hemoptysis, rectal hemorrhage, skin ulcer, venous thrombosis, hemorrhage, hemorrhagic diarrhea, venous phlebitis, thrombophlebitis, orthostatic hypotension, hemorrhoids, hematoma, varicose vein, transient ischemic attack, cushingoid, vasospasm.
Respiratory, thoracic and mediastinal disorders:
Cough, rhinorrhea, pulmonary embolism, pneumothorax, pharynx dysesthesia, pharyngolaryngeal pain, pharyngeal disorder, non-cardiac chest pain, pleural effusion, respiratory distress, laryngitis, increased sputum production, nasal ulcer, pleural disorder, sneezing.
Sore throat, hiccup, gastrointestinal hemorrhage, constipation, upper/lower abdominal pain, dyspepsia, flatulence, dry mouth, intestinal obstruction, enteritis, gastritis, dysphagia, esophagitis, abdominal discomfort, gastroesophageal reflux disease, colitis, blood in stool, upper gastrointestinal hemorrhage, mouth ulceration, abdominal distention, oral pain, gastrointestinal motility disorder, oral discomfort, upper gastrointestinal inflammatory disorders, ileus, proctalgia, gastric ulcer, toxic dilatation of intestine, gastroenteritis, necrotizing enterocolitis, esophageal ulcer, fecal abnormality, tongue disorder, incisional hernia, painful swallowing, melena.
Ascites, abnormal hepatic function, hepatic fibrosis, hepatitis, hepatic failure, hepatotoxicity, hepatomegaly, hepatic pain, fatty liver, bile duct stone, hepatitis cholestatic.
Skin and subcutaneous tissue disorders:
Petechiae, rash, alopecia, erythema, dry skin, pruritus, skin hyperpigmentation, rash macular, skin desquamation, dermatitis, pigmentation disorder, nail disorder, photosensitivity reaction, palmar erythema, purpura, skin discoloration, rash erythematous, nail discoloration, onycholysis, idiopathic thrombocytopenia purpura, skin lesion, ecchymoses, hyperkeratosis, intertrigo, rosacea, scab, skin exfoliation, skin fissures, solar keratosis.
Musculoskeletal and connective tissue disorders:
Pain in extremity, back pain, arthralgia, joint swelling, bone pain, musculoskeletal stiffness, myalgia, pain in jaw, muscle spasms, chills, arthritis, neck pain, calcaneal spur, cutaneous lupus erythematosus.
Renal and urinary disorders:
Hydronephrosis, urinary incontinence, hematuria, nocturia, proteinuria, dysuria, renal impairment, acute renal failure, urinary tract disorder, chromaturia, urinary retention, polyuria.
Reproductive system and breast disorders:
Genital pruritus, intermenstrual bleeding, balanoposthitis, vaginal pain, nipple disorder, premenstrual tension syndrome, vaginal hemorrhage.
General disorders and administration site conditions:
Pain, facial pain, pyrexia, lethargy, malaise, influenza-like illness, temperature intolerance, mucosal inflammation, infusion related reaction, hyperhidrosis, collapse, mass, fibrosis, cachexia, sudden death unexplained, crackles.
Blood creatinine increased, creatinine renal clearance decreased, body temperature increased, prothrombin level decreased, blood pressure increased.
Injury, poisoning and procedural complications:
Phlebitis, injection site reaction, infusion site pain, injection site pain, blister, overdose, radiation recall syndrome, toxic epidermal necrolysis, injection site infection, contusion, scratch.
Surgical and medical procedures:
paronychia drainage, postoperative complications, wound drainage increased.