Applies to nilotinib: oral capsule.

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

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• blurred vision
• bone pain
• chest tightness
• chills
• clay-colored stools
• confusion
• cough
• dark urine
• decreased appetite
• difficult or labored breathing
• dry mouth
• fainting
• fever
• flushed, dry skin
• fruit-like breath odor
• headache
• hoarseness
• increased hunger
• increased thirst
• increased urination
• irregular heartbeat, recurrent
• itching, skin rash
• loss of appetite
• lower back or side pain
• muscle aches, cramps, or pain
• nausea
• no blood pressure
• no breathing
• no pulse
• numbness, tingling, pain, or weakness in the hands or feet
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• seizures
• sore throat
• stomach pain or tenderness
• stuffy or runny nose
• sweating
• swelling of the hands, ankles, feet, or lower legs
• trembling
• trouble breathing
• ulcers, sores, or white spots in the mouth
• unexplained weight loss
• unusual bleeding or bruising
• unusual tiredness or weakness
• weakness and heaviness of the legs
• yellow eyes or skin

Less common

• Decreased urine output
• dizziness
• fast heartbeat
• loss of consciousness
• muscle cramps in the hands, arms, feet, legs, or face
• nervousness
• numbness and tingling around the mouth, fingertips, or lips
• rapid weight gain
• tremor

Less common or rare

• Bladder pain
• bloody or cloudy urine
• body aches or pain
• constipation
• cough producing mucus
• depressed mood
• dry skin and hair
• ear congestion
• feeling cold
• frequent urge to urinate
• hair loss
• loss of voice
• muscle stiffness
• pain or tenderness around the eyes and cheekbones
• sensitivity to heat
• slowed heartbeat
• sneezing
• swelling or puffiness of the face
• tender, swollen glands in the neck
• trouble sleeping
• trouble swallowing
• weight changes
• white patches in the mouth or throat or on the tongue

Incidence not known

• Pain or swelling of the treated skin
• rapid, shallow breathing

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

• Back pain
• burning, itching, and pain in hairy areas
• diarrhea
• difficulty with moving
• joint pain or swelling
• lack or loss of strength
• muscle spasms
• pain in the arms or legs
• pus at the root of the hair

For Healthcare Professionals

Applies to nilotinib: oral capsule.

General

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]