HRT for men: testosterone replacement context

FDA says testosterone is approved for men with low or absent testosterone levels together with an associated medical condition. A general anti-aging or performance claim should not be treated as that indication.

In its February 28, 2025 labeling action, FDA called for removal of the boxed-warning language about increased adverse cardiovascular outcomes following review of the TRAVERSE trial. The agency retained limitation-of-use language for age-related hypogonadism.

The same action called for blood-pressure warnings. FDA says completed ambulatory blood-pressure studies confirmed increased blood pressure with testosterone products across the class. Removal of one warning is not a statement that treatment has no risks.

Before arranging care, ask who assesses the diagnosis, which licensed clinician prescribes, which product and route are proposed, and how monitoring, risks, alternatives and costs are discussed. A directory license check does not decide whether treatment is appropriate for you.