For U.S. residents only.

Understanding Side Effects

AFINITOR Tablets

MOST SERIOUS SIDE EFFECTS

Serious side effects include:

 



Infections: AFINITOR® (everolimus) Tablets may make patients 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. Patients should tell their health care provider right away if they 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 or dark urine, yellowing of the skin, 
or pain in the upper right side of the stomach.


 

Angioedema: 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. 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.

 

Kidney Failure: Patients taking AFINITOR 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.

COMMON SIDE EFFECTS

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

Other common side effects of AFINITOR in patients who have angiomyolipoma with TSC 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 levels  
  • 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. 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.