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Nilotinib Side Effects

Medically reviewed by Last updated on Apr 11, 2024.

Applies to nilotinib: oral capsule.


Oral route (Capsule)

Prolongation of the QT interval and sudden death have been reported. Do not use nilotinib in the presence of hypokalemia, hypomagnesemia, or long QT syndrome. Hypokalemia or hypomagnesemia must be corrected prior to nilotinib administration and monitored during treatment. Avoid drugs that prolong the QT interval and strong CYP3A4 inhibitors. Avoid food 2 hours before and 1 hour after taking nilotinib. ECGs should be obtained to monitor the QTc.

Serious side effects of Nilotinib

Along with its needed effects, nilotinib may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking nilotinib:

More common

Less common

Less common or rare

Incidence not known

Other side effects of Nilotinib

Some side effects of nilotinib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

For Healthcare Professionals

Applies to nilotinib: oral capsule.


The most frequently reported side effects included nausea, rash, headache, fatigue, pruritus, vomiting, diarrhea, cough, constipation, arthralgia, nasopharyngitis, pyrexia, night sweats, and myelosuppression (e.g., thrombocytopenia, neutropenia, and anemia).[Ref]


Very common (10% or more): Hypertension (up to 11%)

Common (1% to 10%): Flushing, arrhythmia, angina pectoris, atrioventricular block, cardiac flutter, extrasystoles, atrial fibrillation, tachycardia, bradycardia, palpitations, QT prolongation, peripheral artery stenosis, ischemic heart disease, ischemic cerebrovascular events

Uncommon (0.1% to 1%): Hypertensive crisis, peripheral arterial occlusive disease, intermittent claudication, limb arterial stenosis, hematoma, arteriosclerosis, cardiac failure, myocardial infarction, pericardial effusion, coronary artery stenosis, cardiac murmur, coronary artery disease, cyanosis, cardiomegaly, myocardial ischemia

Frequency not reported: Ventricular dysfunction, pericarditis, decreased ejection fraction, hemorrhagic shock, hypotension, thrombosis, arterial vascular occlusive events, increased troponin[Ref]


Very common (10% or more): Thrombocytopenia (up to 31%), neutropenia (up to 17%), anemia (up to 14%)

Common (1% to 10%): Leukopenia, eosinophilia, febrile neutropenia, pancytopenia, lymphopenia, decreased hemoglobin

Frequency not reported: Thrombocythemia, leukocytosis[Ref]


Very common (10% or more): Rash (up to 39%), pruritus (up to 32%), night sweats (up to 27%), alopecia (up to 14%), dry skin (up to 12%)

Common (1% to 10%): Folliculitis, eczema, urticaria, erythema, hyperhidrosis, contusion, acne, dermatitis (e.g., allergic, exfoliative, and acneiform)

Uncommon (0.1% to 1%): Exfoliative rash, drug eruption, skin pain, ecchymosis, face swelling

Frequency not reported: Psoriasis, erythema multiforme, erythema nodosum, skin ulcer, palmar-plantar erythrodysesthesia syndrome, petechiae, photosensitivity, blister, dermal cyst, sebaceous hyperplasia, skin atrophy, skin discoloration, skin exfoliation, skin hyperpigmentation, skin hypertrophy, hyperkeratosis, subcutaneous abscess, furuncle, tinea pedis[Ref]


Very common (10% or more): Nausea (up to 37%), vomiting (up to 29%), diarrhea (up to 28%), elevated lipase (up to 28%), constipation (up to 26%), upper abdominal pain (up to 18%), abdominal pain (up to 16%), dyspepsia (up to 10%)

Common (1% to 10%): Gastrointestinal (GI) hemorrhage, pancreatitis, abdominal distention, abdominal discomfort, flatulence, gastroenteritis, increased blood amylase

Uncommon (0.1% to 1%): Melena, mouth ulceration, gastroesophageal reflux, stomatitis, esophageal pain, dry mouth, gastritis, sensitivity of teeth

Frequency not reported: GI ulcer perforation, anal abscess, retroperitoneal hemorrhage, hematemesis, rectal hemorrhage, gastric ulcer, esophagitis ulcerative, subileus, enterocolitis, hemorrhoids, hiatus hernia, gingivitis, ascites[Ref]

Nervous system

Very common (10% or more): Headache (up to 35%), dizziness (up to 12%)

Common (1% to 10%): Peripheral neuropathy, hypoesthesia, paresthesia, dysgeusia

Uncommon (0.1% to 1%): Intracranial hemorrhage, ischemic stroke, transient ischemic attack, cerebral infarction, migraine, loss of consciousness/syncope, tremor, disturbance in attention, hyperesthesia, facial paralysis

Frequency not reported: Basilar artery stenosis, brain edema, optic neuritis, lethargy, dysesthesia, restless leg syndrome, cerebrovascular accident

Postmarketing reports: Facial paralysis[Ref]


Very common (10% or more): Arthralgia (up to 26%), pain in extremity (up to 20%), myalgia (up to 19%), back pain (up to 19%), bone pain (up to 15%), muscle spasms (up to 15%), musculoskeletal pain (up to 12%)

Common (1% to 10%): Musculoskeletal chest pain, neck pain, flank pain, muscular weakness

Uncommon (0.1% to 1%): Musculoskeletal stiffness, joint swelling

Frequency not reported: Arthritis[Ref]


Very common (10% or more): Nasopharyngitis (up to 27%), cough (up to 27%), upper respiratory tract infection (up to 17%), dyspnea (up to 15%), influenza (up to 13%), oropharyngeal pain (up to 12%)

Common (1% to 10%): Epistaxis, exertional dyspnea, dysphonia, pharyngitis, rhinitis, pleural effusion

Uncommon (0.1% to 1%): Pneumonia, bronchitis, pulmonary edema, interstitial lung disease, pleuritic pain, pleurisy, pharyngolaryngeal pain, throat irritation

Frequency not reported: Pulmonary hypertension, wheezing[Ref]


Very common (10% or more): Hyperglycemia/increased blood glucose (up to 50%), elevated total cholesterol (up to 28%), decreased appetite/anorexia (up to 17%), elevated triglycerides (up to 12%), increased lipoprotein cholesterol, hypophosphatemia/decreased blood phosphorus

Common (1% to 10%): Electrolyte imbalance, hypomagnesemia, hypocalcemia, decreased albumin, hypokalemia, hyponatremia, hyperkalemia, hypercalcemia, hyperphosphatemia, diabetes mellitus, hypercholesterolemia, increased blood creatinine phosphokinase, increased weight, decreased weight, decreased globulins, hyperlipidemia, hypertriglyceridemia, elevated alkaline phosphatase

Uncommon (0.1% to 1%): Elevated creatinine, gout, dehydration, increased appetite, increased blood lactate dehydrogenase, fluid retention, decreased blood glucose, dyslipidemia

Frequency not reported: Hypoglycemia, hyperuricemia

Postmarketing reports: Tumor lysis syndrome[Ref]


Common (1% to 10%): Pollakiuria

Uncommon (0.1% to 1%): Urinary tract infection, dysuria, micturition urgency, nocturia

Frequency not reported: Hematuria, urinary incontinence, chromaturia[Ref]


Very common (10% or more): Fatigue (up to 32%), pyrexia (up to 28%), asthenia (up to 16%), peripheral edema (up to 15%)

Common (1% to 10%): Vertigo, malaise, chest pain (e.g., non-cardiac), pain, chest discomfort

Uncommon (0.1% to 1%): Candidiasis, herpes virus infection, feeling body temperature change, chills, face edema, gravitational edema, sudden deaths, influenza-like illness

Frequency not reported: Sepsis, hearing impairment, ear pain, tinnitus, localized edema[Ref]


Common (1% to 10%): Increased blood insulin

Uncommon (0.1% to 1%): Hyperthyroidism, hypothyroidism, gynecomastia, erectile dysfunction, breast pain

Frequency not reported: Hyperparathyroidism secondary, thyroiditis, breast induration, nipple swelling, increased blood parathyroid hormone, decreased insulin C-peptide, decreased blood insulin, menorrhagia[Ref]


Very common (10% or more): Insomnia (up to 12%)

Common (1% to 10%): Depression, anxiety

Frequency not reported: Disorientation, confusion, amnesia, dysphoria[Ref]


Very common (10% or more): Increased ALT (up to 72%), hyperbilirubinemia/increased blood bilirubin (up to 59%), increased AST (up to 47%)

Common (1% to 10%): Abnormal hepatic function, increased gamma-glutamyltransferase

Uncommon (0.1% to 1%): Hepatotoxicity, toxic hepatitis, jaundice

Frequency not reported: Cholestasis, hepatomegaly, increased unconjugated blood bilirubin[Ref]


Common (1% to 10%): Eye hemorrhage, eye pruritus, conjunctivitis, dry eye/xerophthalmia, eyelid edema, periorbital edema

Uncommon (0.1% to 1%): Vision impairment, blurred vision, reduced visual acuity, photopsia, eye irritation, conjunctival hemorrhage, hyperemia (e.g., scleral, conjunctival, ocular)

Frequency not reported: Papilledema, diplopia, photophobia, eye swelling, blepharitis, eye pain, chorioretinopathy, allergic conjunctivitis, ocular surface disease[Ref]


Uncommon (0.1% to 1%): Increased blood urea

Frequency not reported: Renal failure[Ref]


Common (1% to 10%): Skin papilloma

Frequency not reported: Oral papilloma, paraproteinemia[Ref]


Frequency not reported: Hypersensitivity[Ref]

Frequently asked questions


1. Cerner Multum, Inc. "UK Summary of Product Characteristics."

2. (2007) "Product Information. Tasigna (nilotinib)." Novartis Pharmaceuticals

3. Cerner Multum, Inc. "Australian Product Information."

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.