Methyltestosterone

FDA label, Amneal Pharmaceuticals of New York LLC, oral, effective 2025-05-31. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Handling and access

NIOSH hazardous drug

Table 2

NIOSH lists methyltestosterone as a hazardous drug. AHFS class: 68:08 androgens.

  • Meets the NIOSH definition of a hazardous drug (carcinogenicity, developmental or reproductive toxicity, organ toxicity at low doses, or genotoxicity) without MSHI or a Group 1 or 2A carcinogen classification.
  • Only a developmental and/or reproductive hazard: precautions matter most for workers who are pregnant, breastfeeding, or trying to conceive.

Handle with the precautions your facility uses for hazardous drugs (USP <800>). NIOSH's Managing Hazardous Drug Exposures lists controls by drug form and activity.

Source: NIOSH List of Hazardous Drugs in Healthcare Settings, 2024December 2024, updates through Jul 17, 2025

Androgen

Dosing in kidney impairment

Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events. Edema with or without congestive heart failure may be a serious complication in patients with pre-existing cardiac, renal or hepatic disease.

Drug interactions

Check methyltestosterone against a medication list
Label text (2 paragraphs)

Drug Interactions 1. Anticoagulants: C-17 substituted derivatives of testosterone, such as methandrostenolone have been reported to decrease the anticoagulant requirements of patients receiving oral anticoagulants. Patients receiving anticoagulant therapy require close monitoring, especially when androgens are started or stopped. 2. Oxyphenbutazone: Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone. 3. Insulin: In diabetic patients, metabolic effects of androgens may decrease blood glucose and insulin requirements.

Drug/Laboratory Test Interference Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

Contraindications

CONTRAINDICATIONS METHITEST™ (methyltestosterone) tablets are contraindicated in men with carcinomas of the breast or with known or suspected carcinomas of the prostate, and in women who are or may become pregnant. When administered to pregnant women, androgens cause virilization of the external genitalia of the female fetus. This virilization includes clitoromegaly, abnormal vaginal development, and fusion of genital folds to form a scrotal-like structure. The degree of masculinization is related to the amount of drug given and age of the fetus, and is most likely to occur in the female fetus when the drugs are given in the first trimester.

If the patient becomes pregnant while taking these drugs, she should be apprised of the potential hazard to the fetus.

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for methyltestosterone. Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

Pregnancy: Teratogenic Effects Pregnancy Category X (see CONTRAINDICATIONS )

Lactation

Nursing Mothers It is not known whether androgens are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from androgens, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

Drug shortage status

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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Price ladder

Not the price at the counter
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These are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.

Products and NDCs

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Recruiting clinical trials

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