For US residents only.

Understanding Side Effects


Understanding Possible Side Effects of AFINITOR When Treating Your Advanced PNET

It is important to tell your health care provider as soon as possible about any side effects you have while taking AFINITOR® (everolimus) Tablets for advanced pancreatic neuroendocrine tumors (PNET).

AFINITOR can cause serious side effects that include the following:

You may develop lung or breathing problems. In some patients, 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, have chills, or do not feel well.

Symptoms of hepatitis B or infection may include:

  • 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

If you take an ACE inhibitor medicine during treatment with AFINITOR, you are at a possible increased risk for a type of an allergic reaction called angioedema. Talk with your health care provider before taking AFINITOR if you are not sure if you take an angiotensin-converting enzyme (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. Patients should have tests to check their kidney function before and during their treatment with AFINITOR.

Delayed wound healing. AFINITOR can cause incisions to heal slowly or not heal well. Call your health care provider right away if your incision is red, warm, or painful; if you have blood, fluid, or pus in your incision; if your incision opens up; or if your incision swells.

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.

Learn About Mouth Sores, the Most Common Side Effect of AFINITOR When Used for Your Advanced PNET

Different people react differently to AFINITOR and its possible side effects. It's good to know that your doctor can help you take a proactive role in managing a common side effect called stomatitis, or mouth ulcers and sores.

Mouth sores can cause oral pain, redness, and changes in taste. They can sometimes be severe and can appear as early as within the first 8 weeks of treatment, or they can occur at any time. Stay on the lookout for these signs:

AFINITOR and Mouth Sores or Ulcers


Other common side effects of AFINITOR include the following:

  • Infections
  • Feeling weak or tired
  • Cough, shortness of breath
  • Diarrhea and constipation
  • Rash, dry skin, and itching
  • Nausea and vomiting
  • Fever
  • Loss of appetite, weight loss
  • Swelling of arms, hands, feet, ankles, face, or other parts of the body
  • Abnormal taste
  • Dry mouth
  • Inflammation of the lining of the digestive system
  • Headache
  • Nose bleeds
  • Pain in arms and legs, mouth and throat, back or joints
  • High blood glucose
  • High blood pressure
  • Difficulty sleeping
  • Hair loss
  • Muscle spasms
  • Feeling dizzy
  • Nail disorders

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. For more information, ask your health care provider or pharmacist.

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