May 26, 2017
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(fulvestrant) Injection


FASLODEX is a prescription medicine used to treat:

  • hormone receptor (HR)-positive breast cancer in women who have gone through menopause whose disease has spread after treatment with an antiestrogen medicine, OR
  • HR-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer whose disease has spread to other parts of the body (metastatic) in combination with palbociclib in women with disease progression after hormonal therapy

When FASLODEX is used in combination with palbociclib, please also see the palbociclib Patient Information.

It is not known if FASLODEX is safe and effective in children.

It is not known if FASLODEX is safe and effective in people with severe liver problems.

Who should not receive FASLODEX?

Do not receive FASLODEX if you have had an allergic reaction to any of the ingredients in FASLODEX. See the end of this leaflet for a list of the ingredients in FASLODEX.

Symptoms of an allergic reaction to FASLODEX may include:

  • itching
  • swelling of your face, lips, tongue or throat
  • trouble breathing

What should I tell my healthcare provider before receiving FASLODEX?

Before receiving FASLODEX, tell your healthcare provider about all of your medical conditions, including if you:

  • have a low level of platelets in your blood or bleed easily.
  • have liver problems.
  • are pregnant or plan to become pregnant. FASLODEX can harm your unborn baby.
    • Females who are able to become pregnant should use effective birth control during treatment with FASLODEX and for one year after the last dose of FASLODEX.
    • Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with FASLODEX.
  • are breast-feeding or plan to breast-feed. It is not known if FASLODEX passes into your breast milk. Do not breast-feed during your treatment with FASLODEX and for one year after the last dose of FASLODEX. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription and over the counter medicines, vitamins, and herbal supplements. FASLODEX may affect the way other medicines work, and other medicines may affect how FASLODEX works.

Especially tell your healthcare provider if you take a blood thinner medicine.

How will I receive FASLODEX?

  • Your healthcare provider will give you FASLODEX by injection into the muscle of your buttock.
  • Your healthcare provider may change your dose of FASLODEX if needed.

What are the possible side effects of FASLODEX?

Common side effects of FASLODEX include:

  • injection site pain
  • loss of appetite
  • nausea
  • weakness
  • muscle, joint, and bone pain
  • cough
  • headache
  • shortness of breath
  • tiredness
  • constipation
  • hot flashes
  • increased liver enzymes
  • vomiting

FASLODEX may cause fertility problems in males and females. Talk to your healthcare provider if you plan to become pregnant.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects with FASLODEX. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of FASLODEX

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use FASLODEX for a condition for which it was not prescribed. Do not give FASLODEX to other people, even if they have the same symptoms you have. It may harm them. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about FASLODEX that is written for health professionals.

What are the ingredients in FASLODEX?

Active ingredient: fulvestrant.

Inactive ingredients: alcohol, benzyl alcohol, benzyl benzoate, and castor oil.

Last reviewed on RxList: 3/9/2016
This monograph has been modified to include the generic and brand name in many instances.

Faslodex - User Reviews

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Report Problems to the Food and Drug Administration


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

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