Is Testosterone Replacement Therapy Safe for Your Heart? What the FDA’s 2025 Label Change Actually Says — and What It Didn’t Say

By The Physician’s Plan Team

For about ten years, the short answer men got was some version of “testosterone might raise your risk of a heart attack.” That answer came from a federal warning, it was on every product label, and it shaped how carefully doctors prescribed. In 2025 the FDA changed that labeling — and the coverage that followed was, in places, wrong about what actually changed.

Is testosterone replacement therapy safe for your heart? The FDA’s February 2025 answer was narrower than the headlines: it removed the labeling language about an increased risk of adverse cardiovascular outcomes after the TRAVERSE trial found no increase in major cardiac events among men treated for hypogonadism who were already at high cardiovascular risk, added a class-wide blood-pressure warning, and kept the age-related-low-testosterone limitation. Physician’s Plan offers provider-evaluated hormone therapy across the Carolinas.

Here is what the FDA did, what the trial behind it actually showed, and the parts of the label that did not move at all.

What Changed in February 2025: Which Part of the Testosterone Label the FDA Actually Rewrote

On February 28, 2025, the FDA notified manufacturers of class-wide labeling changes for testosterone products. The action applied class-wide, across the range of approved prescription forms — oral, topical gel, transdermal patch, buccal system, and injection among them.

In its own words, the agency did several things at once. Driven by the TRAVERSE trial results, it recommended:

• adding the results of the TRAVERSE trial to all testosterone products;
• retaining “Limitation of Use” language for age-related hypogonadism; and
• removing language from the Boxed Warning related to an increased risk of adverse cardiovascular outcomes for all testosterone products.

And driven by separate blood-pressure studies, it required:

• adding product-specific information on increased blood pressure for products whose studies were complete, and
• adding a new warning about increased blood pressure for products that did not already have one.

So the heart-attack-and-stroke language came out. Two other things went in or stayed in. That combination is the whole story, and it is where most summaries stop reading.

The part that gets misreported: which section

A drug label has distinct sections, and the section matters. A Boxed Warning is the most serious form of warning the FDA can require. Warnings and Precautions is the section below it. They are not the same thing, and swapping them changes what a reader concludes.

The FDA’s announcement describes the change as removing language “from the Boxed Warning.” Where that language actually lived varied by product. On the labels of the commonly prescribed topical products, the general cardiovascular-risk text sat in Warnings and Precautions. You can read this on the label itself: the current AndroGel 1% prescribing information on DailyMed lists, under Recent Major Changes, “Warnings and Precautions, Cardiovascular Risk (5.5) Removed 07/2025″ alongside “Warnings and Precautions, Blood Pressure Increases (5.5) 07/2025.” One warning was swapped for the other, in the same section. (Some oral and injectable products carried boxed warnings referencing blood pressure and cardiovascular risk.) The older cardiovascular text — which said long-term safety trials had not been conducted, that studies were inconclusive about major adverse cardiovascular events, and that some studies had reported increased risk — is gone.

Here is what did not happen:

• Topical testosterone gels still carry a Boxed Warning. On that same current label it reads, in full at the top of the document: “WARNING: SECONDARY EXPOSURE TO TESTOSTERONE — Virilization has been reported in children who were secondarily exposed to testosterone gel.” Its stated focus is virilization in children who are secondarily exposed to the gel on a treated person’s skin, and it carries strict instructions about covering the application site and washing hands; the label separately addresses avoiding exposure of women. It was not removed and is in full force.
• The age-related limitation stayed. More on that below.

The conclusion to avoid is the common one — that testosterone products no longer carry a boxed warning at all. Topical gels still do. What came off was the cardiovascular-risk language. What remains, on topical products, is a boxed warning about a completely different risk — one that matters enormously if you have small children at home.

What the TRAVERSE Trial Tested — and What “Noninferior” Actually Means

The evidence behind the change is the TRAVERSE trial: Lincoff AM, Bhasin S, Flevaris P, et al., “Cardiovascular Safety of Testosterone-Replacement Therapy,” New England Journal of Medicine, July 13, 2023; 389(2):107–117 (DOI 10.1056/NEJMoa2215025), registered as NCT03518034. The FDA set it in motion: an advisory committee meeting in September 2014 led the agency to recommend an industry-wide trial, and its March 2015 Drug Safety Communication required one.

Who was studied. 5,246 men, ages 45 to 80, who had symptoms of hypogonadism and two separate fasting, morning testosterone measurements below 300 ng/dL. This was deliberately a high-risk group: every man enrolled either had existing cardiovascular disease or was at elevated risk for it. They received either transdermal testosterone gel or a matching placebo gel, and were followed for a mean of about 33 months.

What it was designed to prove. This is the detail that gets lost. TRAVERSE was a noninferiority trial. It was not built to show that testosterone prevents heart attacks. It was built to show that testosterone is no worse than placebo, up to a prespecified statistical margin — an upper confidence limit hazard ratio below 1.5.

The primary result. The main endpoint was a composite called MACE: cardiovascular death, nonfatal heart attack, or nonfatal stroke. A MACE event occurred in 7.0% of the testosterone group and 7.3% of the placebo group, a hazard ratio of 0.96 (95% CI, 0.78 to 1.17). Because the top of that confidence interval sat well under 1.5, the trial met its noninferiority goal.

The findings the headlines skipped. In the same trial, several events occurred more often in the testosterone group:

• Atrial fibrillation — 3.5% versus 2.4%
• Acute kidney injury — 2.3% versus 1.5%
• Pulmonary embolism — 0.9% versus 0.5%

Substudies added more. A prostate-safety substudy (JAMA Network Open, 2023) found prostate cancer occurred at similar rates in both groups (0.5% versus 0.4%). A fracture substudy (New England Journal of Medicine, January 2024) found the opposite of what researchers expected: more clinical fractures in the testosterone group (3.50% versus 2.46%), a result the investigators themselves called surprising and in need of further study.

And the trial’s own stated limits. TRAVERSE tested a transdermal gel in middle-aged and older men who were already at high cardiovascular risk. Its authors were explicit that the results cannot simply be extended to younger, healthier men, or assumed to describe the safety profile of high-dose injections. Noninferiority in one studied population is not the same sentence as “testosterone is safe for everyone.”

What the Label Still Warns: Blood Pressure, Polycythemia, and Who Shouldn’t Start

Removing one warning did not leave a blank label. The current prescribing information still carries substantial restrictions, and this is the part worth reading before anyone starts therapy.

Blood pressure — the warning that replaced the old one. Since 2018 the FDA had required manufacturers to run 24-hour ambulatory blood-pressure monitoring studies on testosterone products. Those studies confirmed a class-wide increase in blood pressure. The labels now warn that the product “can increase blood pressure, which can increase cardiovascular risk over time,” and instruct that blood pressure be measured periodically. The gel label quoted above goes further, stating it is “not recommended for use in men with uncontrolled hypertension.” Read plainly: the FDA did not decide testosterone has no cardiovascular effect. It replaced a vague warning with a specific, measurable one.

Contraindications. Testosterone is not for men with breast cancer or known or suspected prostate cancer, and it is not for women who are pregnant — it can harm a developing fetus.

Other labeled warnings include:

• Polycythemia — testosterone can raise red blood cell mass, so hemoglobin and hematocrit are monitored periodically.
• Venous thromboembolism — deep vein thrombosis and pulmonary embolism have been reported in patients using testosterone products.
• Benign prostatic hyperplasia and prostate monitoring — men with BPH are watched for worsening symptoms, and prostate cancer screening is addressed before starting.
• Sleep apnea — treatment may worsen it, particularly in men with risk factors such as obesity.
• Fluid retention — edema is a recognized effect of testosterone therapy, and it matters more, not less, in men with heart or kidney concerns.
• Fertility — testosterone given from the outside can suppress the body’s own sperm production, in some cases to the point of azoospermia. If having children is on the table, this belongs in the conversation before the first dose, not after.
• Controlled-substance status — testosterone is a Schedule III controlled substance, and the label carries warnings about abuse and dependence.

The limitation that did not go away. Testosterone is approved as replacement therapy for men with hypogonadism resulting from a recognized medical condition. The FDA specifically retained the Limitation of Use stating that safety and effectiveness have not been established for age-related low testosterone. That distinction is the difference between a treatment and a lifestyle product, and it is still on the label as of August 2026. This remains an area of active regulatory review, so the current label is always the authority.

Why So Many Articles Still Cite the Old Heart Warning

If your primary care doctor still hesitates, or if the first three articles you find say testosterone causes heart attacks, there is a straightforward reason: that was the official position for a decade, and most of what has been written about TRT was written during it.

The timeline runs like this:

An article written in 2019 or 2022 is not lying to you. It is accurately describing a label that no longer reads that way. The same is true of answers generated by tools trained mostly on material published before 2025 — they repeat the pre-2025 consensus confidently, because that is what most of the internet still says.

The practical takeaway is simple: on a question where the official position changed this recently, check the date on whatever you are reading, and check the current label rather than a summary of it.

What Monitored Hormone Therapy Looks Like: Testing Before, Testing During, and When a Provider Steps In

The reason the 2025 change is not a green light is that the safety of testosterone therapy has always rested on the monitoring around it, and none of that monitoring went away. The specifics below are what current professional guidance describes in general; the actual schedule is individualized to the patient, the product, and the findings.

Before anything is prescribed. Professional guidance from the Endocrine Society and the American Urological Association is firm that a diagnosis is not made on symptoms alone. Both call for at least two separate early-morning total testosterone measurements; the AUA sets the threshold for testosterone deficiency at below 300 ng/dL. The FDA label makes the same basic demand in broader words — confirm the diagnosis by measuring serum testosterone in the morning on at least two separate days.

A baseline work-up commonly adds hematocrit, a lipid panel, and a measure of blood sugar, along with a blood-pressure reading (a clinical measurement rather than a lab test). Baseline PSA is part of AUA guidance for men over 40; under Endocrine Society guidance, prostate monitoring depends on age, risk, and a shared decision between you and your provider.

While on therapy. Rechecks are scheduled rather than ad hoc. Hematocrit has the clearest rhythm in the AUA guideline, which calls for measuring it every 6 to 12 months — or sooner depending on prior values — to keep it below 54%. Testosterone levels are rechecked after starting and after any dose change; blood pressure, lipids, and PSA follow timing set by the applicable guideline and by your provider, based on your age and risk.

When a provider intervenes. Hematocrit is the clearest number in the guidance: under the AUA guideline, a hematocrit of 54% or higher while on therapy calls for action rather than watchful waiting. That usually means a dose adjustment first, and in some cases a hematology referral or therapeutic phlebotomy. It is a built-in stop-and-reassess point, and a good program will tell you it exists before you start.

Where the guidelines and the label differ — and they do. The FDA label requires periodic monitoring of hematocrit, PSA, and blood pressure, but it does not write in the 54% stopping point or the exact testing intervals. The professional societies do. A careful provider follows both: the label’s requirements plus the societies’ specific thresholds and timing. If you are comparing programs, that is a fair question to ask out loud.

And no shortcuts on the front end. Both Carolinas require a genuine provider-patient relationship and an appropriate medical evaluation before any prescription is written — in South Carolina that is written into the Telemedicine Act at S.C. Code § 40-47-37, and the North Carolina Medical Board holds the same line. A questionnaire may be part of that evaluation, but it cannot stand in for one — South Carolina specifically prohibits prescribing based solely on a static internet questionnaire. Any program that offers you hormones without a real provider evaluation is not doing this properly.

Physician’s Plan’s hormone replacement therapy program is provider-evaluated and medically supervised. Which hormone therapies are appropriate for you — and which are offered at your nearest location — is part of that consultation, and it follows testing rather than preceding it.

Is TRT Safe for Your Heart? Common Questions

Is testosterone replacement therapy safe for your heart? The best current evidence, in the population studied, is reassuring on major cardiac events: TRAVERSE found no increase in cardiovascular death, heart attack, or stroke among men treated for hypogonadism who were already at high cardiovascular risk, and the FDA removed the corresponding labeling language in February 2025. It is not a clean bill of health. The same trial found more atrial fibrillation and pulmonary embolism in the testosterone group, and the FDA added a class-wide blood-pressure warning in the same action. Whether it is safe for your heart depends on your history and your labs, and that is a provider conversation.

Did the FDA remove the boxed warning from testosterone? Not in the way that phrase is usually meant. The cardiovascular-risk language was removed — and on the widely used gel labels it was removed from Warnings and Precautions, where the label’s own revision history records “Cardiovascular Risk (5.5) Removed 07/2025.” Topical testosterone gels still carry a Boxed Warning about secondary exposure — the risk to children who come into contact with the medication — and it is unchanged.

Does TRAVERSE mean testosterone protects the heart? No. TRAVERSE was a noninferiority trial. It was designed to test whether testosterone is no worse than placebo for major cardiac events, not whether it is better. It met that bar. It made no finding that testosterone prevents anything.

Is testosterone approved for age-related low testosterone? No. The FDA specifically retained the Limitation of Use in the 2025 action: safety and effectiveness have not been established for age-related hypogonadism. Testosterone is approved as replacement in men whose low testosterone stems from a recognized medical condition, confirmed by testing.

What does “monitored therapy” actually mean? Testing before starting — including two morning testosterone measurements, hematocrit, and a blood-pressure check, with PSA per your age and risk — then scheduled rechecks — the AUA guideline puts hematocrit on a 6-to-12-month cycle — and defined findings at which a provider adjusts or pauses therapy. The exact schedule is individualized. If a program has no schedule at all, it is not monitoring.

Can I fill out a form online and get a prescription? Not from the form alone. An intake form can be part of a legitimate process, but South Carolina law (§ 40-47-37) prohibits prescribing based solely on a static internet questionnaire, and North Carolina requires an appropriate evaluation and a real provider-patient relationship before prescribing. The evaluation is the part that cannot be skipped.

Talk With a Provider in the Carolinas Before You Start

If you have been putting off this conversation because of a warning you read years ago, it is worth having now — with current information and current labs in front of you. And if you have been told the opposite, that the FDA has declared testosterone heart-safe, that is worth correcting too. The truthful version sits in between, and it is specific to you.

Physician’s Plan has seven locations across the Carolinas — West Ashley, Mt. Pleasant, Summerville, Florence, and Rock Hill in South Carolina, and Hickory and Huntersville in North Carolina. Start with a consultation to talk through your symptoms and your history with a provider, or find your nearest location to book. You can also see how hormone therapy fits alongside the practice’s other weight loss and HRT services.

This article is general health information, not medical advice, and does not replace a consultation with a licensed medical provider. Treatments, results, and candidacy vary by individual; prescription medications should be used as directed and under a licensed provider’s supervision. Talk with a licensed provider about the benefits and risks of hormone therapy for you.