"Potential drug treatments are tested on paper, in laboratories and eventually in thousands of people. But every drug that goes through this cycle â€“ every drug that FDA approves â€“ carries some risk. One of the first lines of defense against "...
Halotestin Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Halotestin (fluoxymesterone) is a male hormone (androgen) used in men as replacement therapy in conditions associated with symptoms of deficiency or absence of endogenous testosterone, and in delayed puberty. It may also be used in some women for palliation of androgen-responsive recurrent breast cancer. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include nausea, vomiting, headache, skin color changes, increased/decreased sexual interest, oily skin, hair loss, and acne.
The dosage of Halotestin varies depending upon the individual, the condition being treated, and its severity. The total daily oral dose may be administered singly or in divided (three or four) doses. Halotestin may interact with blood thinners, or corticosteroids. Tell your doctor all medications and supplements you use. Halotestin must not be used during pregnancy. It may harm a fetus. Discuss birth control with your doctor. It is recommended that women using this medication use 2 forms of birth control (such as condoms and birth control pills) while taking this medication. It is unknown if this drug passes into breast milk. It may affect milk production and it may harm a nursing infant. Breastfeeding while using this drug is not recommended.
Our Halotestin (fluoxymesterone) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Halotestin Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects when it is used at normal doses.
Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as anxiety, depression, increased anger), trouble sleeping/snoring.
If you are male, tell your doctor immediately if any of these unlikely but serious side effects occur: trouble urinating, breast swelling/tenderness, too frequent/prolonged erections.
Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and seek immediate medical attention, or permanent problems could occur.
This medication can decrease sperm production, an effect that may lower male fertility. Consult your doctor for more details.
If you are female, tell your doctor immediately if any of these unlikely but serious side effects occur: deepening of the voice, hoarseness, unusual facial/body hair growth, enlarged clitoris, irregular menstrual periods.
This medication can cause your body to hold on to extra body water (edema). This can increase your risk of heart failure. Tell your doctor immediately if any of these unlikely but serious signs of water retention or heart failure occur: decreased exercise ability, hands/ankles/feet swelling, unusual tiredness, shortness of breath while lying down.
Tell your doctor immediately if any of these rare but very serious side effects occur: signs of serious liver disease (such as persistent abdominal pain/nausea, unusual tiredness, yellowing eyes/skin, dark urine).
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Halotestin (Fluoxymesterone)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Halotestin FDA Prescribing Information: Side Effects
Endocrine and urogenital
Female: the most common side effects of androgen therapy are amenorrhea and other menstrual irregularities; inhibition of gonadotropin secretion; and virilization, including deepening of the voice and clitoral enlargement. The latter usually is not reversible after androgens are discontinued. When administered to a pregnant woman, androgens can cause virilization of external genitalia of the female fetus.
Skin and appendages
Fluid and electrolyte disturbances
Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia.
Hypersensitivity, including skin manifestations and anaphylactoid reactions.
Drug Abuse And Dependence
Controlled Substance Class: Fluoxymesterone is a controlled substance under the Anabolic Steroids Control Act, and HALOTESTIN (fluoxymesterone) Tablets has been assigned to Schedule III.
Read the entire FDA prescribing information for Halotestin (Fluoxymesterone)
Additional Halotestin Information
- Halotestin Drug Interactions Center: fluoxymesterone oral
- Halotestin Side Effects Center
- Halotestin Overview including Precautions
- Halotestin FDA Approved Prescribing Information including Dosage
Halotestin - User Reviews
Halotestin User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
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.
Find out what women really need.