Nilotinib (Oral Route)

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Side Effects

Along with its needed effects, a medicine 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:

• 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
• Itching
• 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
• Shortness of breath
• Skin rash
• 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
• Wheezing
• Yellow eyes or skin

• Coma
• Decreased urine output
• Dizziness
• Fast heartbeat
• Mood or mental changes
• Muscle cramps in the hands, arms, feet, legs, or face
• Nervousness
• Numbness and tingling around the mouth, fingertips, or lips
• Tremor

• 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
• Nasal congestion
• 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 with sleeping
• Trouble with swallowing
• Weight gain
• Weight loss
• White patches in the mouth or throat or on the tongue
• White patches with diaper rash

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

Some side effects 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:

• 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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