February 2025: What the FDA Actually Changed on Every Testosterone Label

On 28 February 2025 the FDA informed sponsors of testosterone products about class-wide labeling changes, following its review of the TRAVERSE trial and of required postmarket ambulatory blood pressure monitoring studies.[1] It was widely reported as the removal of a warning. It was four changes, and one of them added a warning that had not been there before.

The four changes

Led by the TRAVERSE results, the FDA recommended:

1. Adding the TRAVERSE results to all testosterone products.
2. Retaining the "Limitation of Use" language for age-related hypogonadism.
3. Removing language from the Boxed Warning related to an increased risk of adverse cardiovascular outcomes, for all testosterone products.[1]

Led by the blood pressure studies, the FDA required:

4. Adding product-specific information on increased blood pressure for testosterone products with completed ABPM studies, and a new warning about increased blood pressure for products that did not already carry one.[1]

Item 3 is the headline. Item 4 is the one that changes what a man should actually watch.

Why a blood pressure warning appeared

This did not come from TRAVERSE. It came from a separate line of evidence that had been running since the middle of the previous decade.

The FDA recommended ABPM studies in 2016 and 2017 as part of premarket development for two different testosterone products, given by two different routes — subcutaneous injection and oral. Consistent results from both premarket studies raised concerns that testosterone products could lead to increased blood pressure, and in March 2018 the FDA issued a postmarket requirement.[1]

Two products, two different routes, consistent findings. That is a stronger evidentiary basis than the one the cardiovascular warning originally rested on — and it arrived with almost no public attention, because it landed on the same day as a removal.

What "retaining the Limitation of Use" meant — and what changed in 2026

In February 2025 the FDA kept the labeling statement that safety and efficacy in men with age-related hypogonadism had not been established.[1] That mattered: it is the sentence separating men with hypogonadism from a known cause from men whose testosterone is simply low with age.

That is no longer the position. Following a further review of new data and a reanalysis of existing evidence including TRAVERSE, the FDA requested prescribing-information updates in June 2026, which included:

Removing the limitation of use stating that the safety and efficacy of testosterone replacement therapy in men with age-related hypogonadism have not been established, and revising safety information related to prostate cancer and benign prostatic hyperplasia.[2]

So the 2025 and 2026 actions point the same way but were separate steps, sixteen months apart. Anyone reading a 2025-vintage summary is reading a superseded position on the limitation of use.

Separately, in April 2026 the FDA began encouraging sponsors to contact the agency about a potential new indication for low libido in men with idiopathic hypogonadism, following a December 2025 expert panel — explicitly noting that any approval would still require substantial evidence of effectiveness and a favourable benefit-risk balance.[3]

What this does and does not mean for a man on testosterone

It does mean the cardiovascular concern that shaped a decade of prescribing was tested in a randomised trial and not confirmed. In TRAVERSE, 7.0% of men on testosterone had a major adverse cardiovascular event versus 7.3% on placebo, and the FDA determined the results did not show a new safety signal.[2]

It does not mean testosterone is now indicated broadly. Testosterone products remain approved for men who lack or have low testosterone in conjunction with an associated medical condition.[2] A label change is not an invitation.

It does mean blood pressure is now an explicit monitoring consideration, which it was not before — and that is a practical change to what belongs on a follow-up visit. What else belongs there is in the 3-month panel.

It does not remove the other boxed warning. Topical gels still carry the secondary-exposure warning about transfer to another person.[4]

It does not change the fracture finding. TRAVERSE's bone sub-study found more clinical fractures on testosterone, not fewer — see TRAVERSE and bone.

Bottom line

February 2025 removed cardiovascular language from the Boxed Warning, added the TRAVERSE results to every label, kept the age-related limitation of use, and introduced a blood pressure warning. June 2026 then removed the limitation of use and revised the prostate cancer and BPH information.

The one-line version — "the FDA removed the black box warning" — is true about one of five changes and silent about a new warning that arrived with it. The fuller history of how the warning got there is in the boxed warning's history.

References

4 sources

1. U.S. Food and Drug Administration. FDA issues class-wide labeling changes for testosterone products. February 28, 2025. fda.gov
2. U.S. Food and Drug Administration. Testosterone Information — postmarket drug safety information for patients and providers, including the TRAVERSE results and the June 2026 requested prescribing-information updates. fda.gov
3. U.S. Food and Drug Administration. FDA Takes Step Forward on Testosterone Therapy for Men. News release, April 16, 2026. fda.gov
4. U.S. Food and Drug Administration. AndroGel (testosterone gel) 1% — prescribing information, including BOXED WARNING: secondary exposure to testosterone. Reference ID 021015s044. 2019. accessdata.fda.gov