Surging Off-Label Testosterone Demand for Women Creates Pharmacy Bottlenecks

A surge in women seeking testosterone therapy for menopause symptoms is encountering significant hurdles at the pharmacy counter, including prescription denials and delays. This growing demand is for off-label use, as there is currently no testosterone product approved by the U.S. Food and Drug Administration (FDA) specifically for women.

A Spike in Off-Label Use

An exclusive data analysis conducted for Reuters by healthcare analytics firm Truveta revealed that the rate of women receiving a testosterone prescription jumped 146%, nearly tripling, between January 2023 and July 2026. This trend is occurring alongside a broader increase in hormone therapy for menopause.

Medical guidelines from The Menopause Society and other organizations currently only support testosterone use for one condition in menopausal women: hypoactive sexual desire disorder. However, some clinicians are also prescribing it for other symptoms like fatigue and loss of muscle strength, a practice not supported by current clinical data. "We do not have any evidence in women that it will improve muscle mass or bone density or mood or well-being or really any other metric," said Dr. Stephanie Faubion, medical director of The Menopause Society and director of the Mayo Clinic’s Center for Women’s Health.

Pharmacy Pushback and Patient Costs

Because no female-dosed product exists, women are prescribed testosterone gels designed for men, requiring them to divide packaged doses. This has led to fulfillment issues at major retailers. Clinicians reported that Amazon Pharmacy began rejecting such prescriptions this year, citing a new policy. Amazon stated it does not dispense certain prescriptions that require dose customization to ensure safety and refers customers to compounding pharmacies.

Ad

Practitioners also reported that over a third of their patients have faced issues at pharmacies including CVS and Walgreens. These challenges can force patients to use compounding pharmacies, which can be significantly more expensive—approximately $100 for a three-month supply compared to as little as $30 for a 10-month supply at a commercial pharmacy with discounts, according to one practitioner. Most insurers do not cover testosterone for women, placing the full cost burden on the patient.

Regulatory and Industry Outlook

The FDA has scheduled a public workshop to review evidence for testosterone use in menopausal women. An FDA spokesperson noted that off-label uses have not been evaluated by the agency for safety, efficacy, or proper dosing. Pharmacists have raised concerns about dosing accuracy, medication stability, and contamination when single-use packaging is reused.

Meanwhile, the pharmaceutical industry is taking notice, with over 30 clinical trials underway or planned to study testosterone use in women. Companies including Marius Pharmaceuticals and Aviva Bio are developing products specifically for this market. Existing testosterone products used off-label include AbbVie’s AndroGel and Upsher-Smith’s Vogelxo, though the companies have not commented on plans for women-specific formulations.