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# Labeling Changes for Testosterone Products: FDA
- URL: https://www.fdaweb.com/labeling-changes-for-testosterone-products-fda/
- Published: 2025-02-28T12:00:00.000Z
- Updated: 2026-09-14T14:54:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158747

FDA says it has ordered testosterone product makers to change their drug labeling to remove a warning about risk of adverse cardiovascular outcomes in men using them for hypogonadism. An [agency notice](https://www.fda.gov/drugs/drug-safety-and-availability/fda-issues-class-wide-labeling-changes-testosterone-products?ref=fdaweb.com) says the warning can be removed based on findings from the [Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) clinical trial](https://www.nejm.org/doi/full/10.1056/NEJMoa2215025?ref=fdaweb.com).

Additionally, labeling changes are required on testosterone products based on data from postmarket ambulatory blood pressure (ABPM) studies, including adding product-specific information and a new warning on increased blood pressure for testosterone products which currently do not have such a warning in their labeling, according to the notice.

Testosterone is approved solely for use in men who lack or have low testosterone levels in conjunction with an associated medical condition.