Everolimus (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:

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Bloody nose
• Chest pain
• Cough or hoarseness
• Cracked lips
• Decreased weight
• Diarrhea
• Difficult or labored breathing
• Difficulty with swallowing
• Fever or chills
• General feeling of discomfort or illness
• Lower back or side pain
• Painful or difficult urination
• Rapid weight gain
• Shortness of breath
• Sores, ulcers, or white spots on the lips, tongue, or inside the mouth
• Swelling or inflammation of the mouth
• Thickening of bronchial secretions
• Tightness in the chest
• Tingling of the hands or feet

• Bleeding gums
• Bloody urine
• Blurred vision
• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• Coughing up blood
• Decreased urine output
• Dilated neck veins
• Dry mouth
• Extreme fatigue
• Fast, pounding, or irregular heartbeat or pulse
• Flushed, dry skin
• Fruit-like breath odor
• Headache
• Increased hunger
• Increased menstrual flow or vaginal bleeding
• Increased thirst
• Increased urination
• Irregular breathing
• Loss of appetite
• Loss of consciousness
• Nausea
• Nervousness
• Nosebleeds
• Paralysis
• Pounding in the ears
• Prolonged bleeding from cuts
• Red or black, tarry stools
• Red or dark brown urine
• Runny nose
• Slow heartbeat
• Sore throat
• Stomachache
• Sweating
• Uncomfortable swelling around the anus
• Unexplained weight loss
• Unusual tiredness or weakness
• Vomiting
• Weight gain

• Agitation
• Coma
• Confusion
• Depression
• Dizziness
• Hostility
• Irritability
• Lethargy
• Muscle twitching
• Rapid weight gain
• Seizures
• Stupor

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:

• Abdominal or stomach pain
• Change in taste
• Dry skin
• Itching skin
• Lack or loss of strength
• Loss of taste
• Pain in the arms or legs
• Rash
• Unable to sleep

• Back pain
• Blistering, peeling, redness, or swelling of the palms, hands, or bottoms of the feet
• Bumps on the skin
• Burning, dry, or itching eyes
• Discoloration of the fingernails or toenails
• Excess air or gas in the stomach or intestines
• Flushing or redness of the skin
• Full feeling
• Jaw pain
• Numbness, pain, tingling, or unusual sensations in the palms of the hands or bottoms of the feet
• Passing gas
• Redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• Sleepiness or unusual drowsiness
• Unusually warm skin

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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