Brand Name(s):

  • Halotestin®

WHY is this medicine prescribed?

Fluoxymesterone, an androgenic hormone, is similar to the male hormone testosterone. It is prescribed for males when this hormone is absent or low or to treat delayed onset of puberty in males. It is also used in females with certain kinds of breast cancer.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Fluoxymesterone comes as a tablet to take by mouth. It usually is taken once a day or three or four times a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take fluoxymesterone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take fluoxymesterone even if you feel well. Do not stop taking fluoxymesterone without talking to your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before taking fluoxymesterone,

  • tell your doctor and pharmacist if you are allergic to fluoxymesterone, tartrazine (a yellow dye in some processed foods and drugs), or any other drugs.
  • tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially anticoagulants ('blood thinners') such as warfarin (Coumadin), diabetes medications such as insulin, and vitamins.
  • tell your doctor if you have or have ever had diabetes; migraine headaches; heart, liver, or kidney disease; high blood cholesterol or fats; cancer of the breast; depression; enlarged prostate or prostate cancer; or any blood disorder.
  • tell your doctor if you are pregnant, plan to become pregnant or are breast-feeding. If you become pregnant while taking fluoxymesterone, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Fluoxymesterone may cause an upset stomach. Take fluoxymesterone with food or milk.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Call your doctor for directions if you miss more than one dose.

What SIDE EFFECTS can this medicine cause?

Fluoxymesterone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • acne
  • enlargement of the breast
  • swelling or fluid retention
  • absence of menstrual periods
  • deepening of the voice or hoarseness
  • facial hair growth
  • headache
  • anxiety
  • depression
  • tingling, prickling, burning, or tight sensations
  • upset stomach
  • vomiting
  • increased number and/or duration of penile erections
  • decreased sperm production
  • increased blood cholesterol
  • increased blood calcium

If you experience any of the following symptoms, call your doctor immediately:

  • skin rash, itching, or hives
  • difficulty breathing
  • yellowing of the skin or eyes
  • unusual or excessive bleeding
  • severe swelling or fluid retention
  • difficulty urinating (males)

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to fluoxymesterone.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Last Reviewed: September 1, 2010.