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Tasigna Side Effects

Generic Name: nilotinib

Note: This page contains side effects data for the generic drug nilotinib. It is possible that some of the dosage forms included below may not apply to the brand name Tasigna.

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

For the Consumer

Applies to nilotinib: oral capsule

As well as its needed effects, nilotinib (the active ingredient contained in Tasigna) may cause unwanted side effects that require medical attention.

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

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


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.[Ref]


Dermatologic side effects including rash (up to 33%), pruritus (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.[Ref]


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.[Ref]

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.[Ref]


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.[Ref]


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.[Ref]


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, thrombosis, and peripheral arterial occlusive disease have been reported.


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.[Ref]


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.[Ref]


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


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


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


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


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.[Ref]


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.[Ref]


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


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

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. 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.