The U.S. Food and Drug Administration has substantially rewritten the risk labeling shared by all approved testosterone products in two stages. On 28 February 2025 the agency directed sponsors to implement class-wide changes: remove the boxed-warning language about an increased risk of adverse cardiovascular outcomes, and add the results of the TRAVERSE cardiovascular-outcomes trial to every label. The boxed warning had constrained prescribing since 2015.
TRAVERSE was a randomized, placebo-controlled trial of more than 5,200 middle-aged and older men with low testosterone and either established cardiovascular disease or high cardiovascular risk, followed for a mean of about 33 months. It found no meaningful difference in major adverse cardiovascular events (MACE) between the testosterone-gel and placebo groups — roughly 7.0% versus 7.3% — and no increased risk of prostate cancer. Those data undercut the rationale for the 2015 cardiovascular warning.
Removing one warning surfaced another. Completed ambulatory blood-pressure monitoring (ABPM) studies, required by the FDA as postmarketing commitments, showed that testosterone products raise blood pressure class-wide. The relabeling therefore adds product-specific blood-pressure information where ABPM data exist and a new blood-pressure warning for products that previously lacked one. Elevated blood pressure is now described as the most concrete class-wide safety signal for the drug class.
In June 2026 the FDA requested a further round of updates. Under the proposals, the 'Limitation of Use' stating that TRT's safety and effectiveness in men with age-related hypogonadism have not been established would be removed, and the prostate-cancer contraindication would be narrowed to apply only to men with metastatic prostate cancer, reflecting accumulating evidence that testosterone therapy does not generally increase prostate-cancer risk.
The direction of travel is a regulator loosening restrictions it imposed a decade ago as the supporting evidence has shifted. The changes concern approved, prescribed testosterone products and their prescribing information; they do not address non-prescription or illicit anabolic-androgenic steroid use, and the blood-pressure signal is a reminder that even physiologic replacement carries measurable cardiovascular effects.