Testosterone prescriptions for women are surging, with no FDA-approved product

What happened

Testosterone prescriptions for women have risen sharply in the US, and people trying to fill them are reportedly hitting walls at the pharmacy counter. That is the picture in an analysis Truveta ran for Reuters, as first reported by Healthline News (Healthline News).

The headline number is a 146% increase in prescriptions for females between January 2023 and July 2026. No testosterone product is FDA-approved for women, so clinicians are prescribing products made for men or adapting them.

Per Reuters, via Healthline, nurse practitioners said pharmacies had rejected prescriptions and that many patients struggled to get them filled. Amazon Pharmacy said it does not dispense some testosterone prescriptions that require customized dosing, and that the policy is not specific to testosterone or based on sex or gender identity.

What the numbers actually say

Start with a caution. Healthline says the Truveta results have not been published in a journal, so there is no peer review. We could not access Truveta's write-up or the Reuters story, so we cannot confirm the data source, sample size, age range, or which formulations were counted. The article also gives no absolute prescription counts.

One more wording note: a 146% increase is roughly a 2.5-fold rise, not a tripling.

The direction of the trend does hold up elsewhere. A research letter in JACC: Advances used a large national electronic health record network to track US women prescribed any testosterone-containing product from 2016 to 2025.

That dataset and time frame differ from Truveta's, so the figures cannot be compared directly. What they share is a steep climb since about 2022.

What this does not show

• It does not show benefit or harm. The JACC: Advances paper is descriptive and observational, and its authors frame it around cardiovascular safety questions.
• It does not tell us why prescribing rose, or how many prescriptions were for HSDD versus other reasons.
• It does not quantify the pharmacy problem. The access claims come from nurse practitioners and a company statement relayed through Reuters and Healthline, not from a measured denial rate.
• Healthline's explanation that male-formulated products may need to be divided into lower doses is an inference, not a documented finding.
• We cannot confirm that Truveta's cohort is limited to menopausal women, as Healthline describes it.

What the evidence supports

The 2019 Global Consensus Position Statement, endorsed by the Endocrine Society and 10 other societies, supports testosterone only for postmenopausal women with HSDD (Endocrine Society release; NEJM Journal Watch). It says doses should keep blood levels within the premenopausal range, and that current evidence does not support use for any other symptom or condition.

The Lancet Diabetes & Endocrinology meta-analysis from 2019 pooled blinded randomized trials of at least 12 weeks. Testosterone beat placebo or comparators on sexual desire (standardized mean difference 0.36, 95% CI 0.22–0.50) and on satisfying sexual events (mean difference 0.85, 95% CI 0.52–1.18).

It found no reported effects on body composition, musculoskeletal outcomes or cognition, though few women contributed data on those. Oral testosterone raised LDL cholesterol and lowered HDL; non-oral routes did not. Acne, hair growth and weight gain were more common, and no serious adverse events were recorded. Those safety data come from relatively short trials.

A 2026 narrative review calls HSDD the only evidence-based indication and describes acne and excess hair growth as the most common, dose-dependent side effects. Voice deepening and clitoral enlargement are rare and usually tied to doses above the physiologic range.

Healthline quotes Stephanie Faubion of Mayo Clinic and The Menopause Society, who said testosterone has not been shown to help with fatigue, well-being, bone density, muscle mass or mood. OB/GYN Sherry Ross argues for broader benefits, but the article cites no evidence for that view.

What it means for you

If you are considering testosterone, the first question is what symptom it is meant to treat. Low sexual desire after menopause that bothers you is the one use with trial support. Fatigue, low mood or foggy thinking are not.

• Ask your clinician whether the prescription is off-label, which it will be, and why they chose a specific product and route.
• Ask how your levels will be checked and what target is being used. The consensus aim is the premenopausal range.
• Ask about cholesterol and cardiovascular risk, especially if you are considering an oral form or have risk factors.
• Ask what the plan is if there is no benefit, and when you would stop.
• If a pharmacy refuses a fill, go back to your prescriber rather than switching to a product or dose on your own.

Context: regulators are paying attention

On Sept. 17, 2026, the FDA's Office of Women's Health and its drug center held a public workshop on testosterone use in menopausal women. The background cites growing off-label use and critical knowledge gaps: sexual function, cognition, mood and musculoskeletal effects, how to measure and interpret levels, and missing long-term safety data, especially on cardiovascular and breast cancer risk. The agenda includes sessions on safety, efficacy, dosing and what drug approval would require.

Healthline, citing Reuters, says the agency called for more data and encouraged manufacturers to run studies that could support female-specific products. The FDA event page we read does not state that explicitly, so treat it as reported, not confirmed.