What the label lists and what reports show
Methyltestosterone side effects
Methyltestosterone's FDA label: “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.” FAERS holds 148 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (23 reports).
- Generic listed
- DEA Schedule III
Check it at the source: the methyltestosterone FDA label on DailyMed (effective May 31, 2025, Amneal Pharmaceuticals of New York LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe 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.
From the label: adverse reactions, continuedEndocrine 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 cause virilization of external genitalia of the female fetus. Male: Gynecomastia, and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages (see CLINICAL PHARMACOLOGY ). Skin and appendages: Hirsutism, male pattern baldness, and acne. Cardiovascular Disorders: myocardial infarction, stroke. Fluid and Electrolyte Disturbances: Retention of sodium, chloride, water, potassium, calcium and inorganic phosphates. Gastrointestinal: Nausea, cholestatic jaundice, alterations in liver function tests, rarely hepatocellular neoplasms and peliosis hepatis (see WARNINGS ). Hematologic: Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy and polycythemia. Nervous System: Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia. Metabolic: Increased serum cholesterol. Vascular Disorders: venous thromboembolism. Miscellaneous: Rarely anaphylactoid reactions. …
Source: FDA drug label, ANDA204851 (Impax Labs Inc), as published by Amneal Pharmaceuticals of New York LLC, effective May 31, 2025 (SPL set 9bed4886-fcd0-4056-be8d-5bb4d15081ce), via openFDA; the full label on DailyMed
What do FAERS reports show?
148 reports list methyltestosterone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 15 are coded as a death and 52 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 2 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Methyltestosterone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions