Label change for testosterone: Implications for urologists, prescribers, and patients

In February 2025, the FDA recommended a removal of the black box warning related to an increased risk of adverse cardiovascular outcomes for all testosterone products. This recommendation has important implications for urologists and the patients they treat.

In February 2025, the labeling requirements for testosterone caught up with what urologists and other prescribers have known for years: testosterone does not increase the risk of adverse cardiovascular outcomes.¹