What changed in February 2025
On February 28, 2025, the FDA announced class-wide labeling changes for testosterone products. Every testosterone label, whether injection, gel, capsule or pellet, was required to make four changes:
- Add the results of the TRAVERSE trial, the large cardiovascular safety study completed in 2023.
- Remove the boxed warning language about increased risk of adverse cardiovascular outcomes.
- Add blood pressure information. Products with completed ambulatory blood pressure studies add their own product-specific data; products without a blood pressure warning gain one.
- Keep the “limitation of use” stating that safety and effectiveness in age-related low testosterone have not been established.
For men already on testosterone, the practical message is mixed in a useful way. The biggest historical fear, heart attacks and strokes, was eased by a large trial. At the same time, blood pressure moved from a concern on a few products to a warning on all of them.
Why the cardiovascular warning came off
The warning had a history. In 2014 the FDA issued a safety communication after reports of stroke, heart attack and death in men using testosterone, and in 2015 it required labels to describe a possible increased cardiovascular risk and urged caution in men whose low testosterone was attributed to aging alone. The agency also asked manufacturers to run a proper trial.
That trial was TRAVERSE. It randomized more than 5,200 men aged 45 to 80 with existing heart disease or high cardiovascular risk to daily testosterone gel or placebo. According to the FDA’s testosterone information page, a major adverse cardiovascular event occurred in 7.0% of the testosterone group and 7.3% of the placebo group, and the FDA concluded the results showed no new safety signal for those outcomes. The published trial also reported more atrial fibrillation, acute kidney injury and pulmonary embolism with testosterone. Those findings now appear on the labels, and our article on the TRAVERSE trial walks through each one.
The blood pressure warning now covers every product
Blood pressure is the part of the change that affects monitoring most directly. The FDA explains that it first asked for 24-hour ambulatory blood pressure studies during the development of two newer products in 2016 and 2017, and their consistent results raised concern. In March 2018 it required those studies for all testosterone products, and the completed studies confirmed blood pressure increases across the class.
Current labels reflect that. The Kyzatrex label, for example, says testosterone can raise blood pressure and increase cardiovascular risk over time, tells clinicians to measure blood pressure periodically, and says it is not recommended in men with uncontrolled hypertension. Its TRAVERSE section reports that mean systolic pressure rose 1.0 mm Hg over 36 months with testosterone gel while it fell 0.5 mm Hg with placebo.
A 1.5 mm Hg average gap sounds small, and for many men it is. Averages hide individuals, though, and men who already run high deserve closer attention. Our article on whether TRT raises blood pressure explains home readings and when a number is an emergency.
The age-related low T limitation: kept in 2025, now under revision
In 2025 the FDA chose to keep the statement that testosterone’s safety and effectiveness in men with “age-related hypogonadism” had not been established. Its testosterone information page still explains that testosterone products are approved for men who lack or have low testosterone in conjunction with an associated medical condition, such as testicular failure or a pituitary problem.
That position has since moved. In June 2026 the FDA requested further label updates, including removal of the age-related limitation of use and revised wording on prostate cancer and benign prostate enlargement. Label revisions take time: as of early October 2026, current labels on DailyMed, including Kyzatrex’s, still showed the older limitation wording. Separately, an April 2026 Federal Register notice invited manufacturers to seek a new indication for low libido in men with idiopathic hypogonadism.
None of this changes how a careful diagnosis is made. Two low early-morning tests and symptoms that fit are still the foundation, as our answer on whether TRT is FDA-approved for age-related low testosterone explains.
What did not change
Several warnings were untouched by the 2025 action, and they remain part of every responsible plan:
| Warning | Why it still matters |
|---|---|
| Venous blood clots | Added to all labels in 2014 and reinforced by TRAVERSE data |
| Higher red blood cell counts | Hematocrit is checked before and during treatment |
| Prostate monitoring | PSA before starting and during treatment |
| Reduced sperm production | Testosterone can suppress fertility |
| Abuse at high doses | Testosterone remains a Schedule III controlled substance |
Our article on testosterone and blood clots explains how the clot warning differs from the red blood cell concern.
What this means for you
If you are considering testosterone, the 2025 changes are good news on the question most men ask first, and a reminder about a question many forget. Bring a few recent blood pressure readings to your first visit. Expect your clinician to check blood pressure, hematocrit and PSA, and to ask about palpitations, clots and kidney problems. If you are already on testosterone, ask whether your monitoring plan reflects the current label.
One wrinkle applies to compounded testosterone, such as some creams and pellets. A compounded product is not FDA-approved, so it has no FDA label of its own. The class-wide warnings still describe what testosterone does in the body, and a careful clinician applies them to compounded products the same way.
How Ultimate Male applies the current label
At our San Gabriel and Downey clinics, blood pressure is measured at the evaluation and at follow-ups, and labs are drawn on site with results in 24 to 48 hours. Your PA-C or MD reviews your cardiovascular history, current medicines and baseline labs before recommending any route. Because the label advises against testosterone with uncontrolled hypertension, getting blood pressure under control comes first.
The goal is a plan that matches what the label now says, not what it said a decade ago. When you are ready, book the free 10-minute call, or read about testosterone therapy at Ultimate Male and how men on blood pressure medicines are evaluated.
