Testosterone's New Label: What TRAVERSE Showed
For about a decade, men considering testosterone therapy heard the same warning: it might raise the risk of heart attack and stroke. That worry came from mixed observational studies, and it shaped testosterone labels starting in 2015.
Then came TRAVERSE, the first large randomized trial built to answer the heart question directly. Its answer was reassuring. On February 28, 2025, the FDA told makers of every testosterone product to update their labels: remove boxed-warning language about adverse cardiovascular outcomes, add the TRAVERSE results, and add or strengthen warnings about blood pressure. In June 2026, the FDA went further and asked manufacturers to drop a long-standing limitation on treating "age-related" low testosterone. That second change is still a request, not a finished label.
Here is what TRAVERSE showed, what it didn't, why blood pressure now gets more attention, and what all of it means if you are on TRT or thinking about it.
Table of Contents
What the FDA changed in 2025
The FDA's February 28, 2025 class-wide labeling changes asked manufacturers of all testosterone products to:
- add the results of the TRAVERSE trial to the label;
- remove language from the boxed warning related to an increased risk of adverse cardiovascular outcomes;
- add product-specific blood pressure data for products that had completed 24-hour ambulatory blood pressure monitoring (ABPM) studies;
- add a new warning about increased blood pressure to products that did not already have one; and
- keep the "Limitation of Use" stating that safety and efficacy in "age-related hypogonadism" have not been established.
A detail most headlines missed: not every testosterone product had a cardiovascular boxed warning to begin with. That boxed language sat mainly on newer products, such as the self-injected Xyosted and the oral capsule Jatenzo, as a blood pressure warning tied to cardiovascular risk. Their current labels now list those boxed warnings as removed. Testosterone gels still carry a separate boxed warning about secondary exposure: children who touch unwashed skin where gel was applied can develop virilization. That one has not changed.
What TRAVERSE was and what it found
TRAVERSE was a randomized, double-blind, placebo-controlled trial published in the New England Journal of Medicine in 2023.
Who was in it: 5,246 men aged 45 to 80 with symptoms of hypogonadism and two fasting testosterone levels below 300 ng/dL. Every participant had existing cardiovascular disease or a high risk of it. Per the label summary, average age was about 63, average BMI was 35, and most had high blood pressure, high cholesterol or diabetes.
What they got: a daily 1.62% testosterone gel, with the dose adjusted to keep testosterone between 350 and 750 ng/dL, or a placebo gel.
What it measured: major adverse cardiovascular events (MACE), meaning cardiovascular death, nonfatal heart attack or nonfatal stroke.
What it found: MACE occurred in 7.0% of men on testosterone and 7.3% on placebo (hazard ratio 0.96). Testosterone met the trial's pre-set definition of "noninferior," meaning it did not raise the risk of major heart events by any meaningful margin. Heart attack, stroke and cardiovascular death, looked at one by one, were also similar between groups.
For men with low testosterone and heart risk factors, this is the most reassuring data we have had. The old fear that properly dosed testosterone causes heart attacks is not supported by the best evidence available.
The findings that got less attention
TRAVERSE did not come back clean on everything. The NEJM paper reported higher rates of several problems in the testosterone group, and the FDA put them on the label:
| Event in TRAVERSE | Testosterone gel | Placebo |
|---|---|---|
| Atrial fibrillation | 3.5% | 2.4% |
| Nonfatal arrhythmias needing intervention | 5.2% | 3.3% |
| Acute kidney injury | 2.3% | 1.5% |
| Pulmonary embolism | 0.9% | 0.5% |
| All venous blood clots (VTE) | 1.7% | 1.2% |
| Bone fracture | 3.5% | 2.5% |
Source: TRAVERSE results as summarized in current FDA-approved testosterone labeling.
Atrial fibrillation is an irregular heart rhythm that raises stroke risk. Acute kidney injury is a sudden drop in kidney function. Pulmonary embolism is a blood clot in the lungs. None of these is common, but each is serious, and each was more frequent with testosterone.
The fracture result surprised many clinicians. Testosterone improves bone density, so the expectation was fewer fractures. A dedicated TRAVERSE substudy, published in NEJM in 2024, found the opposite trend: clinical fractures occurred in 3.50% of the testosterone group and 2.46% of the placebo group over a median of about three years. The authors concluded testosterone did not lower fracture risk in these men. Nobody has a settled explanation yet, and this was not the trial's main question. But it means testosterone should not be sold as a fracture-prevention treatment.
Why there is a new blood pressure warning
Testosterone can raise blood pressure. The size of the effect depends on the product.
In TRAVERSE, the gel raised average systolic blood pressure by about 1.5 mm Hg compared with placebo at three years. That is small. Some other products showed larger rises in dedicated 24-hour monitoring studies. For example, the Xyosted label reports an average increase of 3.9/1.5 mm Hg after 12 weeks, and about 10% of men in that study started or changed blood pressure medication during the one-year trial.
A few points of blood pressure may not sound like much. Across a population, and especially in men who already have hypertension, it adds up. That is why the FDA asked for a blood pressure warning on every product that lacked one. Current labels tell prescribers to monitor blood pressure periodically, especially in men with hypertension, and some say the product is not recommended for men with uncontrolled hypertension.
What TRAVERSE did not answer
TRAVERSE is a strong trial. It is not a blank check. Keep these limits in mind:
- It tested one product. Men used a daily transdermal gel. Injections, pellets, orals and compounded products produce different blood levels and peaks. The results do not automatically transfer.
- It used moderate, monitored dosing. Target levels were 350 to 750 ng/dL. The trial says nothing about high-dose or "optimization" protocols that push levels above the normal range.
- Many men stopped treatment. About 61% of participants discontinued gel or placebo during the study, and average treatment lasted about 22 months. That makes long-term effects harder to judge.
- It studied a specific population. Men aged 45 to 80 with heart disease or high cardiovascular risk and clearly low testosterone. It does not tell us about young men, men with normal levels, or bodybuilding doses.
- It was not a benefits trial for most symptoms. TRAVERSE was built to measure heart safety. Whether testosterone helps your energy, mood or sex drive is a separate question with separate evidence.
The 2026 proposal on age-related low testosterone
Since 2015, testosterone labels have said safety and efficacy have not been established for "age-related hypogonadism," meaning low testosterone in older men without a clear structural or genetic cause. According to HHS, as reported by Healio, the FDA added that limitation because evidence of benefit was limited and cardiovascular concerns had been raised.
On June 18, 2026, HHS and the FDA announced they had requested class-wide label updates. FDA's testosterone information page confirms the agency requested updates in June 2026, including removing the age-related hypogonadism limitation of use and revising prostate cancer and benign prostatic hyperplasia (BPH) information. As reported by Urology Times, the requested changes would:
- remove the age-related hypogonadism limitation, citing TRAVERSE;
- narrow the prostate cancer contraindication to men with metastatic prostate cancer, while still recommending risk assessment, screening and monitoring; and
- revise BPH language to say trial data have not shown worsening symptoms in men with mild to moderate BPH, with continued monitoring for severe symptoms.
Status as of October 21, 2026: these are requested changes, not finalized labels. When we checked DailyMed this month, current labels for Xyosted and Jatenzo still included the age-related hypogonadism limitation. Separately, in April 2026 the FDA invited manufacturers to discuss a possible new indication for low libido in men with idiopathic hypogonadism (low testosterone with no identifiable cause). Any new indication would require its own evidence review.
Experts are split. Some endocrinologists quoted by Healio called the change "a major step forward." Others agreed the old restriction was unnecessary but warned that looser criteria could lead to overuse for vague symptoms.
What this means if you are on TRT
If you are already on testosterone, the label change should lower your anxiety about heart attacks. It should not lower your guard. A sensible monitoring plan still includes:
- A confirmed diagnosis. TRAVERSE enrolled men with symptoms and two low fasting morning levels. One random low number is not enough.
- Blood pressure checks. Especially in the first months and if you already have hypertension. A home cuff helps.
- Hematocrit. Testosterone raises red blood cell mass. Labels advise checking hematocrit before starting and periodically during treatment, approximately every three months for some products.
- Testosterone levels. To keep you in a sensible range rather than above it.
- PSA and lipids, periodically, as labels advise.
- Symptoms to report right away: a racing or irregular heartbeat, sudden shortness of breath, chest pain, or leg swelling and pain.
- Fertility plans. Testosterone can suppress sperm production. If children are in your future, raise it before starting.
For how dose and formulation are individualized, see Testosterone Therapy for Men: How Dosing and Formulation Are Individualized. For what lab testing can and cannot tell you, see Preventive Labs Decoded. And if you are not sure low testosterone explains how you feel, start with What Are the Signs of Hormonal Imbalance in Men and Women?
Frequently asked questions
Does TRT cause heart attacks?
TRAVERSE found no increase in heart attacks, strokes or cardiovascular deaths in men with low testosterone and high heart risk who used a testosterone gel at monitored doses for about two years on average. That is strong evidence against the old fear. It does not cover very high doses or every product.
What did TRAVERSE find besides heart attacks?
More atrial fibrillation, acute kidney injury and pulmonary embolism in the testosterone group, and a fracture substudy that found numerically more fractures with testosterone rather than fewer.
Why is there a new blood pressure warning on testosterone?
Testosterone can raise blood pressure, and some products raised it by several points in 24-hour monitoring studies. The FDA asked for a blood pressure warning on every product that lacked one.
Is testosterone now approved for age-related low T?
Not yet. In June 2026 the FDA requested that manufacturers remove the age-related hypogonadism limitation. As of October 2026, that change has not been finalized across labels.
Does the label change mean I can skip monitoring?
No. Blood pressure, hematocrit, testosterone levels, PSA and symptoms still matter. The label change removed a warning, not the need for follow-up.
The bottom line
TRAVERSE answered the big question well: in men with low testosterone and cardiovascular risk, a monitored testosterone gel did not raise the rate of heart attacks, strokes or cardiovascular death. The FDA was right to take that fear off the top of the label.
But TRAVERSE also found more atrial fibrillation, kidney injury and lung clots, no fracture benefit, and a small rise in blood pressure. Those findings belong in every TRT conversation. And the trial does not cover high-dose regimens, young men with normal levels, or every formulation.
The takeaway: testosterone therapy for a confirmed deficiency looks safer for the heart than many men were told. It still works best with a real diagnosis, sensible dosing and steady monitoring by a licensed provider.
Related reading: Does TRT Cause Infertility? What Men Should Know · HRT Black Box Warning Removed: What It Means for You
Sources
- FDA issues class-wide labeling changes for testosterone products (FDA, Feb. 28, 2025)
- Testosterone Information (FDA; updated June 2026)
- FDA Takes Step Forward on Testosterone Therapy for Men (FDA, Apr. 16, 2026)
- Lincoff AM, et al. Cardiovascular Safety of Testosterone-Replacement Therapy. N Engl J Med. 2023;389(2):107-117. doi:10.1056/NEJMoa2215025
- Snyder PJ, et al. Testosterone Treatment and Fractures in Men with Hypogonadism. N Engl J Med. 2024;390(3):203-211. doi:10.1056/NEJMoa2308836
- DailyMed: Xyosted (testosterone enanthate) prescribing information
- DailyMed: Jatenzo (testosterone undecanoate) prescribing information
- DailyMed: AndroGel 1.62% (testosterone gel) prescribing information
- HHS Requests Testosterone Therapy Label Updates, Citing New Safety Data (Urology Times, June 19, 2026)
- HHS proposes changes to loosen warnings on testosterone therapy (Healio, 2026)
This article is provided for general educational purposes and is not a substitute for individualized medical advice, diagnosis, or treatment. Do not start, stop or change testosterone therapy based on a label change; review your own heart, blood pressure and fertility situation with a qualified healthcare professional.