Nilotinib Side Effects

Medically reviewed by Drugs.com. Last updated on May 2, 2025.

Applies to nilotinib: oral capsule.

Precautions

If you will be taking this medicine for a long time, it is very important that your doctor check you and your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control during treatment with this medicine and for at least 14 days after the last dose to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine can cause changes in the heart rhythm, including a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Tell your doctor right away if you or your child have a fast, pounding, or irregular heartbeat. Your doctor will check your heartbeat with an ECG test (electrocardiogram) before, during, and 7 days after starting treatment with nilotinib.

After at least 3 years of treatment with this medicine, your doctor may do certain tests to check if you continue to show no symptoms of your cancer (remission) and may let you stop taking it. This is called treatment free remission (TFR). However, you may need to restart treatment, at a later time, if you are no longer in remission.

This medicine may cause heart or blood vessel problems, including decreased blood flow to the legs, heart, or brain. Check with your doctor right away if you or your child have chest pain or discomfort, numbness or weakness, change in the color of the legs, leg pain, or problems with walking or speaking.

Nilotinib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you or your child get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Pancreatitis and other pancreas problems may occur while you are using this medicine. Check with your doctor right away if you or your child have sudden and severe stomach pain with nausea and vomiting.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you or your child a medicine to help prevent this. Call your doctor right away if you or your child have a decrease or change in the amount of your urine, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

This medicine may cause fluid retention (edema). Tell your doctor right away if you or your child have bloating or swelling of the face, arms, hands, lower legs, or feet, rapid weight gain, or trouble breathing.

This medicine may affect your child's growth and development. Talk to your doctor if you have concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

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:

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:

For healthcare professionals

Applies to nilotinib: oral capsule, oral tablet.

General adverse events

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]

Cardiovascular

• 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]

Hematologic

• 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]

Dermatologic

• 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]

Gastrointestinal

• 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]

Musculoskeletal

• 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]

Respiratory

• 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]

Metabolic

• 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]

Genitourinary

• 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]

Other

• 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]

Endocrine

• 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]

Psychiatric

• Very common (10% or more): Insomnia (up to 12%)
• Common (1% to 10%): Depression, anxiety
• Frequency not reported: Disorientation, confusion, amnesia, dysphoria^[Ref]

Hepatic

• 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]

Ocular

• 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]

Renal

• Uncommon (0.1% to 1%): Increased blood urea
• Frequency not reported: Renal failure^[Ref]

Oncologic

• Common (1% to 10%): Skin papilloma
• Frequency not reported: Oral papilloma, paraproteinemia^[Ref]

Hypersensitivity

• Frequency not reported: Hypersensitivity^[Ref]

See also:

Frequently asked questions

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Further information

Nilotinib side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer