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      Drugs & Diseases

      fluoxymesterone (Rx)

      Brand and Other Names:Androxy, Halotestin
      • Print

      Dosing & Uses

      AdultPediatric

      Dosage Forms & Strengths

      tablet: Schedule III

      • 2mg
      • 5mg
      • 10mg

      Hypogonadism, Males

      5-20 mg PO qD

      Metastatic Breast Cancer, Females

      Palliative adjunctive therapy: 10-40 mg/day PO in divided doses x3 months or longer

      Other Indications & Uses

      Off-label: prevention of post-partum breast engorgement (historically), angioneurotic edema

      Dosage Forms & Strengths

      tablet: Schedule III

      • 2mg
      • 5mg
      • 10mg

      Delayed Puberty, Males

      2.5-20 mg PO qD x4-6 months

      Hypogonadism, Males

      As adults; 5-20 mg PO qD

      Other Information

      Androgens should be used with extreme caution in children and only by specialists who are aware of the adverse effects of these drugs on bone maturation

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      Interactions

      Interaction Checker

      and fluoxymesterone

      No Results

         activity indicator 
        No Interactions Found
        Interactions Found

        Contraindicated

          Serious - Use Alternative

            Significant - Monitor Closely

              Minor

                All Interactions Sort By:
                 activity indicator 

                Contraindicated (0)

                  Serious - Use Alternative (3)

                  • pexidartinib

                    fluoxymesterone and pexidartinib both increase Other (see comment). Avoid or Use Alternate Drug. Pexidartinib can cause hepatotoxicity. Avoid coadministration of pexidartinib with other products know to cause hepatoxicity.

                  • pretomanid

                    fluoxymesterone, pretomanid. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Pretomanid regimen associated with hepatotoxicity. Avoid alcohol and hepatotoxic agents, including herbal supplements and drugs other than bedaquiline and linezolid.

                  • warfarin

                    fluoxymesterone increases effects of warfarin by anticoagulation. Avoid or Use Alternate Drug.

                  Monitor Closely (1)

                  • carbamazepine

                    fluoxymesterone increases toxicity of carbamazepine by decreasing metabolism. Use Caution/Monitor.

                  Minor (37)

                  • acarbose

                    fluoxymesterone increases effects of acarbose by pharmacodynamic synergism. Minor/Significance Unknown.

                  • androstenedione

                    androstenedione increases effects of fluoxymesterone by pharmacodynamic synergism. Minor/Significance Unknown.

                  • budesonide

                    fluoxymesterone, budesonide. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

                  • chlorpropamide

                    fluoxymesterone increases effects of chlorpropamide by pharmacodynamic synergism. Minor/Significance Unknown.

                  • cortisone

                    fluoxymesterone, cortisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

                  • deflazacort

                    fluoxymesterone, deflazacort. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

                  • dexamethasone

                    fluoxymesterone, dexamethasone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

                  • epoetin alfa

                    fluoxymesterone increases effects of epoetin alfa by pharmacodynamic synergism. Minor/Significance Unknown. Androgens may be used to decrease necessary dose of epoetin alfa.

                  • fludrocortisone

                    fluoxymesterone, fludrocortisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

                  • glimepiride

                    fluoxymesterone increases effects of glimepiride by pharmacodynamic synergism. Minor/Significance Unknown.

                  • glipizide

                    fluoxymesterone increases effects of glipizide by pharmacodynamic synergism. Minor/Significance Unknown.

                  • glyburide

                    fluoxymesterone increases effects of glyburide by pharmacodynamic synergism. Minor/Significance Unknown.

                  • hydrocortisone

                    fluoxymesterone, hydrocortisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

                  • insulin aspart

                    fluoxymesterone increases effects of insulin aspart by pharmacodynamic synergism. Minor/Significance Unknown.

                  • insulin detemir

                    fluoxymesterone increases effects of insulin detemir by pharmacodynamic synergism. Minor/Significance Unknown.

                  • insulin glargine

                    fluoxymesterone increases effects of insulin glargine by pharmacodynamic synergism. Minor/Significance Unknown.

                  • insulin glulisine

                    fluoxymesterone increases effects of insulin glulisine by pharmacodynamic synergism. Minor/Significance Unknown.

                  • insulin lispro

                    fluoxymesterone increases effects of insulin lispro by pharmacodynamic synergism. Minor/Significance Unknown.

                  • insulin NPH

                    fluoxymesterone increases effects of insulin NPH by pharmacodynamic synergism. Minor/Significance Unknown.

                  • insulin regular human

                    fluoxymesterone increases effects of insulin regular human by pharmacodynamic synergism. Minor/Significance Unknown.

                  • metformin

                    fluoxymesterone increases effects of metformin by pharmacodynamic synergism. Minor/Significance Unknown.

                  • methylprednisolone

                    fluoxymesterone, methylprednisolone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

                  • miglitol

                    fluoxymesterone increases effects of miglitol by pharmacodynamic synergism. Minor/Significance Unknown.

                  • nateglinide

                    fluoxymesterone increases effects of nateglinide by pharmacodynamic synergism. Minor/Significance Unknown.

                  • pioglitazone

                    fluoxymesterone increases effects of pioglitazone by pharmacodynamic synergism. Minor/Significance Unknown.

                  • prednisolone

                    fluoxymesterone, prednisolone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

                  • prednisone

                    fluoxymesterone, prednisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

                  • repaglinide

                    fluoxymesterone increases effects of repaglinide by pharmacodynamic synergism. Minor/Significance Unknown.

                  • rosiglitazone

                    fluoxymesterone increases effects of rosiglitazone by pharmacodynamic synergism. Minor/Significance Unknown.

                  • saw palmetto

                    saw palmetto decreases effects of fluoxymesterone by pharmacodynamic antagonism. Minor/Significance Unknown.

                  • saxagliptin

                    fluoxymesterone increases effects of saxagliptin by pharmacodynamic synergism. Minor/Significance Unknown.

                  • sitagliptin

                    fluoxymesterone increases effects of sitagliptin by pharmacodynamic synergism. Minor/Significance Unknown.

                  • tacrolimus

                    fluoxymesterone increases effects of tacrolimus by decreasing metabolism. Minor/Significance Unknown.

                  • tolazamide

                    fluoxymesterone increases effects of tolazamide by pharmacodynamic synergism. Minor/Significance Unknown.

                  • tolbutamide

                    fluoxymesterone increases effects of tolbutamide by pharmacodynamic synergism. Minor/Significance Unknown.

                  • triamcinolone acetonide injectable suspension

                    fluoxymesterone, triamcinolone acetonide injectable suspension. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

                  • vildagliptin

                    fluoxymesterone increases effects of vildagliptin by pharmacodynamic synergism. Minor/Significance Unknown.

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                  Adverse Effects

                  >10%

                  Edema

                  Acne

                  Breast soreness

                  Priapism

                  Menstrual irregularities

                  Virilization

                  Frequency Not Defined

                  Gynecomastia

                  Suppression of clotting factors II, V, VII

                  Anaphylaxsis

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                  Warnings

                  Contraindications

                  Severe cardiac, hepatic or renal disease, males with breast or prostate cancer, hypersensitivity

                  Pregnancy

                  Cautions

                  Benign prostatic hypertrophy, males with delayed puberty, geriatric pts, pediatric pts

                  Hypercalcemia may occur in breast CA or immobilized pts

                  Halogenated derivative of testosterone with upto 5 times activity of methyltestosterone

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                  Pregnancy & Lactation

                  Pregnancy Category: X

                  Lactation: excretion in milk unknown; contraindicated

                  Pregnancy Categories

                  A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                  B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                  C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                  D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                  X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                  NA: Information not available.

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                  Pharmacology

                  Half-Life: 9.2 hr, longer t1/2 than natural androgens

                  Bioavailability: PO: rapidly absorbed

                  Protein Bound: 98%

                  Metabolism: liver

                  Excretion: urine (90%)

                  Mechanism of Action

                  Synthetic derivative of testosterone with predominantly androgenic activity; promoting growth and development of male sex organs and maintaining secondary sex characteristics in androgen-deficient males

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                  Images

                  No images available for this drug.
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                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
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                  Formulary

                  FormularyPatient Discounts

                  Adding plans allows you to compare formulary status to other drugs in the same class.

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                  Create Your List of Plans

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                  • Compare formulary status to other drugs in the same class.
                  • Access your plan list on any device – mobile or desktop.

                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  View explanations for tiers and restrictions
                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.
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