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Understanding Side Effects

AFINITOR Tablets

MOST SERIOUS SIDE EFFECTS

Serious side effects include:

 

Lung or Breathing Problems: In some patients, lung or breathing problems may be severe and can even lead to death. Patients should tell their health care provider right away if they have any of these symptoms: new or worsening cough, shortness of breath, chest pain, difficulty breathing, or wheezing.

 

Infections: AFINITOR or AFINITOR DISPERZ 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 (adults and children), 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.   

 

COMMON SIDE EFFECTS

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

Other side effects that may occur with AFINITOR or AFINITOR DISPERZ:

  • Absence of menstrual periods (menstruation). You may miss 1 or more menstrual periods. Tell your health care provider if this happens
  • AFINITOR or AFINITOR DISPERZ 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.