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Nilotinib Side Effects

Common Side Effects

Nilotinib has been studied extensively in clinical trials. In these studies, the side effects that occurred in a group of people taking nilotinib were carefully documented and compared to the side effects that occurred in a similar group of people taking a different chemotherapy drug called imatinib (Gleevec®). As a result, it was possible to see what side effects occurred, how often they appeared, and how they compared to the other medicine.
In these studies, the most common nilotinib side effects included:
  • Low blood cell counts (including low red blood cells, white blood cells, and platelets) -- in up to 42 percent of people
  • Nausea -- up to 37 percent
  • A rash -- up to 36 percent
  • Headaches -- up to 35 percent
  • Fatigue -- up to 32 percent
  • Itching -- up to 32 percent
  • Vomiting -- up to 29 percent
  • Fever -- up to 28 percent
  • Diarrhea -- up to 28 percent
  • Coughing -- up to 27 percent
  • Night sweats -- up to 27 percent
  • Joint pain -- up to 26 percent
  • Constipation -- up to 26 percent
  • Symptoms of the common cold, such as a runny nose, sore throat, and congestion -- up to 24 percent.
Other common side effects, occurring in 1 to 20 percent of people, included:
  • Arm and leg pain
  • Muscle pain
  • Back pain
  • Abdominal (stomach) pain
  • Swelling of the arms, hands, legs, ankles, or feet
  • Lack of strength or weakness
  • Shortness of breath
  • Appetite loss
  • Bone pain
  • Muscle spasms
  • Insomnia
  • Coughing
  • Hair loss
  • Mouth pain
  • High blood pressure (hypertension)
  • Heartburn or indigestion
  • Infection of the hair follicles
  • Warts
  • Electrolyte imbalance (high or low body salts, such as potassium, sodium, and magnesium)
  • High blood sugar and diabetes
  • High cholesterol (lipids)
  • Depression
  • Insomnia
  • Dizziness
  • Tingling, pricking, or numbing sensations of the skin
  • Reduced sense of touch
  • Red, dry, or itchy eyes
  • A spinning sensation (vertigo)
  • Chest pain
  • Feelings of a pounding, abnormal, or forcefully beating heart
  • Flushing (sudden redness and warmth of the face, neck, and chest)
  • Nosebleed
  • Hoarseness
  • Abdominal (stomach) bloating and gas
  • Abnormal liver function
  • Bruising
  • Excessive sweating
  • Frequent urination in the daytime
  • General feeling of discomfort
  • General pain
  • Weight loss
  • Swelling of the eyelids
  • Skin problems, such as redness, dryness, hives, and acne.
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