Women’s Testosterone Prescriptions Rise 146%, FDA Review Planned

The FDA is reviewing the evidence behind the rising off-label use of testosterone in menopausal women, amid concerns about safety, effectiveness and appropriate dosing. No testosterone product is FDA-approved specifically for women, and medical organizations generally support its use only for persistent low sexual desire associated with menopause, the condition with the strongest evidence. Some clinicians prescribe it for fatigue, muscle loss, mood and other symptoms, but experts say there is insufficient evidence to support those uses or show benefits for muscle mass, bone density or overall well-being. Prescriptions increased sharply from 2023 to 2026, while patients have reported pharmacy delays, denials and limited insurance coverage. Supporters cite improvements in libido and quality of life, but researchers and regulators say longer-term data are needed to assess risks, including potential cancer concerns, and to establish standardized treatment guidelines.