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Nilotinib Side Effects

For the Consumer

Applies to nilotinib: oral capsule

As well as its needed effects, nilotinib may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking nilotinib, check with your doctor immediately:

More common:
  • Abdominal or stomach pain or tenderness
  • black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • blurred vision
  • bone pain
  • clay colored stools
  • confusion
  • convulsions
  • cough or hoarseness
  • dark urine
  • decreased appetite
  • difficult or labored breathing
  • dry mouth
  • fainting
  • fever or chills
  • flushed, dry skin
  • fruit-like breath odor
  • headache
  • increased hunger
  • increased thirst
  • increased urination
  • irregular heartbeat, recurrent
  • loss of appetite
  • lower back or side pain
  • muscle aches, cramps, or pain
  • nausea and vomiting
  • 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
  • skin rash or itching
  • sore throat
  • stuffy or runny nose
  • sweating
  • swelling of the hands, ankles, feet, or lower legs
  • tightness in the chest
  • trembling
  • troubled breathing with exertion
  • 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:
  • Coma
  • decreased urine output
  • dizziness
  • fast heartbeat
  • 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
  • difficult, burning, or painful urination
  • 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
  • white patches with diaper rash
Incidence not known:
  • Pain or swelling of the treated skin
  • rapid, shallow breathing

Minor Side Effects

Some nilotinib side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

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

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

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Tasigna (nilotinib)." Novartis Pharmaceuticals, East Hanover, NJ.

It is possible that some side effects of nilotinib may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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