Prescription medicine
Methyltestosterone Brand names: Methitest
Methyltestosterone (Methitest) is a prescription medicine. FDA's NDC Directory lists it from 2 generic labelers.
- 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); every methyltestosterone label on DailyMed.
Highlights of the record
FDA label of May 31, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageMales Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) – testicular failure due to cryptorchidism, bilateral torsions, orchitis, vanishing testis syndrome;
Forms and strengths
- 10 mg
Capsule; tablet.
On the market
- Generic approvals
- 19 first December 22, 1971; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 2 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 148 through July 30, 2026
What is methyltestosterone used for?
From the label: indications and usageMales Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) – testicular failure due to cryptorchidism, bilateral torsions, orchitis, vanishing testis syndrome; or orchidectomy. Hypogonadotropic hypogonadism (congenital or acquired) – gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary hypothalamic injury from tumors, trauma, or radiation. […]
Conditions named in the indications of methyltestosterone's FDA labels, with every medicine labeled for each:
From other methyltestosterone labelsBreast cancer: This treatment has also been used in premenopausal women with breast cancer who have benefitted from oophorectomy and are considered to have a hormone-responsive tumor.
FDA pharmacologic class: Androgen.
Source: FDA drug label (MethylTESTOSTERone), 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
Is there a generic for methyltestosterone (Methitest)?
The FDA approved the first generic methyltestosterone on December 22, 1971. 19 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists methyltestosterone from 2 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the methyltestosterone label say about other medicines?
The methyltestosterone label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 1 other medicine name methyltestosterone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Testosterone | drug interactions | Anticoagulants: C-17 substituted derivatives of testosterone, such as methandrostenolone, have been reported to decrease the anticoagulant requirements of patients receiving oral anticoagulants. |
Source: FDA drug label (MethylTESTOSTERone), 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 for methyltestosterone?
The FDA Adverse Event Reporting System holds 148 reports that list methyltestosterone among the medicines taken, through July 30, 2026, 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as methyltestosterone?
17 other medicines are given the same way (oral) and in the same FDA class as methyltestosterone or labeled mainly for the same use (breast cancer), the same class first. Breast cancer lists all 44 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Everolimus | Breast cancer | 14 labelers | $26.32 per tablet 10 mg tablet | A presentation being discontinued |
| Anastrozole | Breast cancer | 24 labelers | $0.142 per tablet 1 mg tablet | No current entry |
| Letrozole | Breast cancer | 19 labelers | $0.145 per tablet 2.5 mg tablet | No current entry |
| Tamoxifen | Breast cancer | 10 labelers | $0.277 per tablet 20 mg tablet | No current entry |
| Exemestane | Breast cancer | 10 labelers | $0.748 per tablet 25 mg tablet | No current entry |
| Talazoparib | Breast cancer | none listed | n/a | No current entry |
| Palbociclib | Breast cancer | none listed | n/a | A presentation being discontinued |
| Abemaciclib | Breast cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as methyltestosterone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to methyltestosterone
- 17 medicines for the same use
- Other androgens
- the pharmacologic class, with prices and generics
- Methyltestosterone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other