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Understanding Side Effects

AFINITOR® (everolimus) Tablets

What Are the Side Effects of AFINITOR?

It is important to tell your doctor as soon as possible about any side effects you have while taking AFINITOR® (everolimus) Tablets.


AFINITOR can cause serious side effects that include the following:

In some people lung or breathing problems may be severe, and can even lead to death. Tell your health care provider right away if you have any of these symptoms:

  • New or worsening cough
  • Shortness of breath
  • Chest pain
  • Difficulty breathing or wheezing

Such as pneumonia, or a bacterial, fungal or viral infection. Viral infections may include active hepatitis B in people who have had hepatitis B in the past (reactivation). In some people these infections may be severe, and can even lead to death. You may need to be treated as soon as possible.

Tell your health care provider right away if you have a temperature of 100.5˚F or above, have chills, or do not feel well.

Symptoms of hepatitis B or infection may include the following:

  • Fever
  • Chills
  • Skin rash
  • Joint pain and inflammation
  • Tiredness
  • Loss of appetite
  • Nausea
  • Pale stools or dark urine
  • Yellowing of the skin
  • Pain in the upper right side of the stomach

In people who take an angiotensin-converting enzyme (ACE) inhibitor, a type of blood pressure medication, during treatment with AFINITOR® (everolimus) Tablets. Talk with your health care provider before taking AFINITOR if you are not sure if you take an ACE inhibitor medicine. Get medical help right away if you have trouble breathing or develop swelling of your tongue, mouth, or throat during treatment with AFINITOR.

In some people this may be severe and can even lead to death. Your health care provider should do tests to check your kidney function before and during your treatment with AFINITOR.

If you have any of the serious side effects listed above, you may need to stop taking AFINITOR for a while or use a lower dose. Follow your health care provider’s instructions.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.

Common Side Effects

Common side effects include mouth ulcers. AFINITOR can cause mouth ulcers and sores. When you start treatment with AFINITOR, your healthcare provider may tell you to also start a prescription mouthwash to reduce the likelihood of getting mouth ulcers or sores and to reduce their severity. Follow your healthcare provider’s instructions on how to use this prescription mouthwash. Tell your health care provider if you have pain, discomfort, or open sores in your mouth. Your health care provider may tell you to re-start this mouthwash or to use a special mouthwash or gel that does not contain alcohol, hydrogen peroxide, iodine, or thyme.


Other common side effects include:


  • Infections
  • Diarrhea
  • Swelling of arms, hands, feet, ankles, or other parts of the body
  • Feeling weak or tired
  • Rash, dry skin, and itching
  • Cough, shortness of breath
  • Nausea
  • Fever
  • Weight loss or loss of appetite
  • Vomiting
  • Abnormal taste
  • Nose bleeds
  • High blood glucose


Other side effects that may occur with AFINITOR:


  • Absence of menstrual periods (menstruation). You may miss 1 or more menstrual periods. Tell your health care provider if this happens
  • AFINITOR may affect fertility in females and males, and may affect your ability to become pregnant if you are female or your ability to father a child if you are male. Talk to your health care provider if this is a concern for you

Tell your health care provider if you have any side effect that bothers you or does not go away.