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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, 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 or AFINITOR DISPERZ are at a possible increased risk for a type of allergic reaction called angioedema. Talk with your health care provider before taking AFINITOR or AFINITOR DISPERZ 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 or AFINITOR DISPERZ.

 

Kidney Failure: Patients taking AFINITOR or AFINITOR DISPERZ 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 or AFINITOR DISPERZ.

 

Delayed Wound Healing: AFINITOR or AFINITOR DISPERZ 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 or AFINITOR DISPERZ can cause mouth ulcers and sores. 

 

Other common side effects of AFINITOR or AFINITOR DISPERZ in patients who have angiomyolipoma with TSC include:

  • Infections
  • Feeling weak or tired
  • Cough, shortness of breath
  • Diarrhea and constipation
  • Skin problems (such as rash, acne, dry skin, or 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 or dry mouth
  • Inflammation of the lining of the digestive system
  • Headache
  • Nose bleeds
  • Pain in arms and legs, mouth and throat, back or joints, or stomach area (abdomen)
  • Low red blood cells, white blood cells, or platelets
  • Increased blood cholesterol levels and certain other blood levels
  • Decreased blood phosphate levels
  • Increased blood sugar levels
  • High blood pressure
  • Difficulty sleeping
  • Hair loss
  • Muscle spasms
  • Feeling dizzy
  • Nail disorders
  • Anxiety, aggression, and other abnormal behaviors

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.