Nilotinib Side Effects

Brand Names: Tasigna

Please note - some side effects for Nilotinib 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 Nilotinib - for the Consumer

Nilotinib

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 Nilotinib:

Bone, joint, or muscle aches; constipation; diarrhea; dizziness; flushing; gas; hair loss; headache; loss of appetite; mild itching; mild muscle cramps; nausea; stomach pain or upset; tiredness; trouble sleeping; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; blood in the urine; change in the amount of urine produced; chest pain; confusion; dark urine; fainting; fast or irregular heartbeat; fever or chills; mental or mood changes (eg, anxiety, depression); numbness, tingling, or weakness of an arm or leg; seizure; severe or persistent cough or sore throat; severe or persistent headache, tiredness, or weakness; severe or persistent muscle pain or cramps; severe stomach pain, nausea, or vomiting; shortness of breath; slurred speech; sudden unusual weight gain; swelling of the hands, feet, ankles, or around the eyes; unusual bruising or bleeding; vision changes; vomit that looks like coffee grounds; yellowing of the eyes or skin.

Side Effects by Body System

Hematologic

Hematologic side effects including thrombocytopenia (up to 37%), neutropenia (up to 37%), anemia (up to 23%), febrile neutropenia, pancytopenia, thrombocytosis, and leukocytosis have been reported.

Dermatologic

Dermatologic side effects including rash (up to 33%), pruritis (up to 29%), night sweats, eczema, urticaria, alopecia, erythema, hyperhidrosis, dry skin, exfoliative rash, ecchymosis, swelling face, erythema nodosum, skin ulcer, petechiae, and photosensitivity have been reported.

Gastrointestinal

Gastrointestinal side effects including nausea (up to 31%), diarrhea (up to 22%), constipation (up to 21%), vomiting (up to 21%), abdominal pain (up to 13%), gastroenteritis, abdominal discomfort, dyspepsia, flatulence, pancreatitis, gastrointestinal hemorrhage, melena, abdominal distension, mouth ulceration, gastroesophageal reflux, stomatitis, dry mouth, gastrointestinal ulcer perforation, retroperitoneal hemorrhage, hematemesis, gastric ulcer, esophagitis ulcerative, and near complete obstruction of the intestine have been reported.

Nervous system

Nervous system side effects including headache (up to 31%), dizziness, paresthesia, intracranial hemorrhage, migraine, tremor, hypoesthesia, hyperesthesia, brain edema, loss of consciousness, optic neuritis, and peripheral neuropathy have been reported.

General

General side effects including fatigue (up to 28%), pyrexia (up to 24%), asthenia (up to 14%), peripheral edema (up to 11%), dehydration, decreased appetite, increased appetite, pyrexia, chest pain, face edema, gravitational edema, influenza-like illness, chills, and malaise have been reported.

Musculoskeletal

Musculoskeletal side effects including arthralgia (up to 18%), pain in extremity (up to 16%), myalgia (14%), muscle spasms (up to 14%), bone pain (up to 13%), back pain (up to 12%), musculoskeletal chest pain, musculoskeletal pain, muscular weakness, arthritis, and joint swelling have been reported.

Cardiovascular

Cardiovascular side effects including palpitations, electrocardiogram QT prolonged, cardiac failure, angina pectoris, atrial fibrillation, pericardial effusion, coronary artery disease, cardiomegaly, cardiac murmur, bradycardia, myocardial infarction, ventricular dysfunction, pericarditis, cardiac flutter, extrasystoles, hypertension, flushing, hypertensive crisis, hematoma, hemorrhagic shock, hypotension, and thrombosis have been reported.

Respiratory

Respiratory side effects including cough (up to 17%), nasopharyngitis (up to 16%), dyspnea (up to 11%), pneumonia, pharyngitis, bronchitis, exertional dyspnea, cough, dysphonia, pulmonary edema, pleural effusion, interstitial lung disease, pleuritic pain, pleurisy, epistaxis, pharyngolaryngeal pain, throat irritation, and pulmonary hypertension have been reported.

Metabolic

Metabolic side effects including elevated lipase (up to 17%), hyperglycemia (up to 11%), hypophosphatemia (10%), hypokalemia (up to 5%), hyperkalemia (up to 4%), hypocalcemia (up to 4%), elevated alkaline phosphatase (3%), hyponatremia (3%), decreased albumin (1%), elevated creatinine (less than 1%), hypomagnesemia, hyperkalemia, hyperglycemia, anorexia, hypokalemia, hyponatremia, hypocalcemia, hypophosphatemia, diabetes mellitus, hypercalcemia, hyperphosphatemia, increased blood amylase, increased alanine aminotransferase, increased aspartate aminotransferase, increased blood bilirubin, increased blood alkaline phosphatase, increased gamma-glutamyltransferase, increased blood creatinine phosphokinase, increased blood glucose, decreased weight, increased weight, increased blood lactate dehydrogenase, decreased blood glucose, increased blood creatinine, increased blood urea, increased troponin, decreased blood potassium, and increased unconjugated blood bilirubin have been reported.

Genitourinary

Genitourinary side effects including breast pain, gynecomastia, and erectile dysfunction have been reported.

Other

Other side effects including sepsis, herpes simplex, candidiasis, vertigo, impaired hearing, and ear pain have been reported.

Endocrine

Endocrine side effects including hyperthyroidism, hypothyroidism, and thyroiditis have been reported.

Psychiatric

Psychiatric side effects including insomnia, depression, anxiety, disorientation, and confusional state have been reported.

Hepatic

Hepatic side effects including elevated total bilirubin (up to 10%), elevated SGPT (ALT) (up to 4%), elevated SGOT (AST) (1%), hepatitis, hepatotoxicity, hepatomegaly, and jaundice have been reported.

Ocular

Ocular side effects including eye hemorrhage, visual acuity reduced, periorbital edema, conjunctivitis, eye irritation, dry-eye, papilledema, diplopia, vision blurred, photophobia, eye swelling, blepharitis, and eye pain have been reported.

Renal

Renal side effects including dysuria, micturition urgency, nocturia, pollakiuria, renal failure, hematuria, urinary incontinence, and urinary tract infection have been reported.

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