Everolimus Side Effects

Common Side Effects

Everolimus has been studied extensively in clinical trials. In these studies, the side effects that occurred in a group of people taking everolimus were carefully documented and compared to the side effects that occurred in a group of people taking a different medication or a placebo (a "sugar pill" that does not contain any active ingredients). As a result, it was possible to see what side effects occurred, how often they appeared, and how they compared to the other groups.
 
In these studies, common side effects of everolimus included:
 
  • Swelling, ulcers, or sores in the mouth -- in up to 86 percent of people
  • Infections, including infections of the urinary tract, respiratory tract, sinuses, and ears -- up to 82 percent
  • A rash -- up to 59 percent
  • Diarrhea -- up to 50 percent
  • Fatigue -- up to 45 percent
  • Swelling of the arms, hands, legs, ankles, feet, or other areas of the body -- up to 45 percent
  • Constipation -- up to 38 percent
  • Abdominal (stomach) pain -- up to 36 percent
  • Weakness -- up to 33 percent
  • Nausea -- up to 32 percent
  • Fever -- up to 32 percent
  • Decreased appetite and weight loss -- up to 30 percent
  • Increased blood pressure (hypertension) -- up to 30 percent
  • Headaches -- up to 30 percent
  • Coughing -- up to 30 percent
  • Vomiting -- up to 29 percent.
 
Other common side effects, occurring in 3 to 26 percent of people, included:
 
  • Low blood cell counts (low red or white blood cells)
  • High lipids in the blood (high cholesterol or triglycerides)
  • Changes in body salts (electrolytes), such as potassium, magnesium, and phosphorus
  • Insomnia
  • Pain at the incision site (the surgical cut) after a kidney transplant
  • High blood sugar (high glucose levels)
  • Blood in the urine
  • Painful urination
  • Pain, such as:
 
    • Back pain
    • Joint pain
    • Pain in the arms and legs
 
 
    • Acne
    • Redness
    • Dry skin
    • Itching
 
  • Stuffy or runny nose
  • Shortness of breath
  • Nosebleeds
  • Changes in personality
  • Nail problems, such as nail infections
  • Changes in taste
  • Inflammation of the digestive tract
  • Dizziness
  • Dry mouth
  • Muscle spasms
  • Abnormal absence of a menstrual period in women.
 
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Everolimus Drug Information

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