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AFINITOR Side Effects
Understanding possible reactions to AFINITOR
AFINITOR® (everolimus) Tablets may cause side effects in some individuals and every patient's experience with AFINITOR will be different. Some people will experience more side effects than other people. Remember to talk to your doctor about any side effects that may appear. So that together you can work to find a way to manage them.
Serious side effects have been reported with AFINITOR:
- 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. Patients 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:
- Skin rash
- Joint pain and inflammation
- Loss of appetite
- 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.
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.
Common AFINITOR side effects
Common side effects of AFINITOR in people with advanced pancreatic neuroendocrine tumors 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.
- Rash, dry skin, and itching
- Feeling weak or tired
- Swelling of arms, hands, feet, ankles, face, or other parts of the body
- Stomach pain
- Loss of appetite, weight loss
- Cough, shortness of breath
- Nose bleed
- Nail disorders
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 www.fda.gov/medwatch or call 1-800-FDA-1088.
Important Safety Information
AFINITOR® (everolimus) Tablets can cause serious side effects, including lung or breathing problems, infections, and kidney failure, which can lead to death. Patients who take an angiotensin-converting enzyme (ACE) inhibitor medicine during treatment with AFINITOR are at a possible increased risk for a type of allergic reaction called angioedema. AFINITOR can cause incisions to heal slowly or not heal well. Mouth ulcers and mouth sores are common side effects, occurring in up to 86% of patients taking AFINITOR. AFINITOR can affect blood cell counts, kidney and liver function, and blood sugar and cholesterol levels. Regular blood tests should be performed before starting AFINITOR and as needed during treatment to check blood cell count, kidney and liver function, and blood sugar and cholesterol levels.
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