Testosterone prescriptions climb past their old peak after FDA drops heart warning

The share of American men with an active testosterone prescription has climbed back past its prior peak, an Epic Research analysis of 109 million patients finds, tracking almost exactly to the FDA's February 2025 decision to remove the boxed cardiovascular warning from every testosterone product on the market.

By mid-2026, 0.95% of men aged 18 and older in the Epic Cosmos dataset had an active testosterone prescription, up from a 2021 low of 0.64% and above the 0.83% peak set in 2013, the year the boxed warning was first added. The rebound crosses the previous high in every age band Epic tracked, with one exception.

Men aged 50 to 64 still carry the highest prevalence, reaching 1.57% in 2025 against a prior 1.30% peak in 2013. Men aged 30 to 39 (0.57% in 2025), 40 to 49 (1.35%), 65 to 74 (1.06%), and 75 and older (0.57%) all cleared their own early-2010s highs. The 18-to-29 band stayed flat at 0.10% to 0.15%, a reminder that younger men were not driving the rebound.

The proximate cause is the FDA's February 2025 decision to drop the boxed warning after the 2023 TRAVERSE trial found no increased risk of major adverse cardiac events in men with hypogonadism and elevated cardiovascular risk. The label change did not endorse broader use, but it removed a regulator-imposed ceiling that had shaped a decade of cautious prescribing.

The 2015 warning arrived after the early-2010s "low T" direct-to-consumer expansion, when prescription rates had climbed on marketing rather than tight diagnosis. The label pulled those rates down, but it also made some clinicians reluctant to treat men with genuinely low testosterone, who can experience fatigue, reduced bone density, and loss of muscle mass. The February 2025 reversal gives those clinicians a more permissive evidence base, and the data shows how quickly that permissiveness translates into prescriptions.

Two parallel forces also feed the rebound. Telehealth platforms and direct-to-consumer men's health services have grown rapidly since the pandemic, making the prescribing pathway faster and often cash-pay, and Epic's article does not separate their contribution from the post-2022 recovery. The Cosmos dataset is U.S.-dominant (with Canada, Lebanon, and Saudi Arabia), so the rebound reflects large health systems more than a complete census of American prescribing, and "active prescription" is a prescription-on-file metric, not a measured adherence or exposure rate.

The same direct-to-consumer channels that raised awareness of low T during the early 2010s also drove the overprescription that prompted the FDA's warning in the first place. That history is worth keeping in view as the numbers climb again.

Cleveland Clinic's commentary on the label change frames it as vindication of TRAVERSE's cardiovascular safety finding when testosterone is used as indicated, while still cautioning that a single trial is not a final word on a therapy that has had two decades of contested evidence behind it. Older cardiovascular signals from earlier observational studies are not necessarily extinguished by one large randomized result.

The next thing to watch is whether the rebound stabilizes around the new 0.95% level or continues climbing into 2027, and whether the 30-to-49 bands widen the gap with the 50-to-64 cohort, the way DTC and telehealth channels would predict. Epic Research plans to refresh the Cosmos numbers as the dataset grows, and the FDA's label change remains a public data point any prescriber, payer, or patient can point back to when the conversation gets hard.