For US residents only.

Understanding Side Effects

AFINITOR Tablets and AFINITOR DISPERZ 

THE MOST SERIOUS SIDE EFFECTS

AFINITOR® (everolimus) Tablets and AFINITOR DISPERZ™ (everolimus tablets for oral suspension) can cause serious side effects. These serious side effects include:

 

  • You may develop lung or breathing problems. 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

 

  • You may be more likely to develop an infection, such as pneumonia, or a bacterial, fungal, or viral infection. Viral infections may include reactivation of hepatitis B in people who have had hepatitis B in the past. 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, 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, dark urine, yellowing of the skin, pain in the upper right side of the stomach

 

  • Possible increased risk for a type of allergic reaction called angioedema, in people who take an angiotensin-converting enzyme (ACE) inhibitor medicine during treatment with AFINITOR. 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

 

  • You may develop kidney failure. 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 or AFINITOR DISPERZ for a while or use a lower dose. Follow your doctor’s instructions.

COMMON SIDE EFFECTS

Common side effects include mouth ulcers. AFINITOR can cause mouth ulcers and sores. 

Tell your health care provider if you have pain, discomfort, or open sores in your mouth.

  • Your health care provider may tell you to use a special mouthwash or gel that does not contain alcohol, hydrogen peroxide, iodine, or thyme

Other common side effects include:

  • Infections
  • Nausea and vomiting
  • Diarrhea and constipation
  • Swelling of your hands, arms, legs, and feet
  • Joint pain
  • Cough
  • Skin problems (such as rash, acne, or dry skin)
  • Fever
  • Feeling tired
  • Anxiety, aggression, and other abnormal behaviors
  • Low red blood cells, white blood cells, or platelets
  • Increased blood cholesterol level and certain other blood tests
  • Increased blood sugar levels
  • Decreased blood phosphate level 

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.

 

These are not all the possible side effects of AFINITOR or AFINITOR DISPERZ. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects.

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