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TRT Safety: Heart, Prostate and Follow-Up Monitoring

The evidence has moved. Here is where it stands, and what we check after you start.

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Medically reviewed by David A. Robbins, MD — Diplomate, American Board of Urology Last reviewed November 2026

At a glance

In the TRAVERSE trial (NEJM 2023), major cardiac events were no more common on testosterone gel than on placebo: 7.0% versus 7.3%, in 5,246 men aged 45 to 80 with hypogonadism and existing or high cardiovascular risk.
In February 2025 the FDA removed the boxed-warning language about increased cardiovascular risk from testosterone labels and required a blood-pressure warning on every product.
Testosterone can raise blood pressure and red-cell mass, so hematocrit, blood pressure and PSA (in men over 40) are checked before starting and monitored during treatment.
Testosterone levels are checked every 6 to 12 months; if levels normalize but symptoms do not improve after three to six months, stopping is discussed.
Testosterone should not be prescribed to men who are currently trying to conceive, according to the AUA guideline.

Overview

What “is it safe” actually asks

A comprehensive conversation between the doctor and patient is vital in the decision whether or not to start testosterone replacement.

“Is testosterone safe?” is really several separate questions. What does it do to the heart? To blood pressure? To the blood count, and the risk of clots? To the prostate? To sleep? And, for a man who may want children, to his fertility? Each has its own evidence, and the evidence is not equally strong for all of them. This page takes them one at a time and names its sources.

The AUA guideline asks clinicians to tell patients two things at once: that low testosterone is itself a risk factor for cardiovascular disease, and that it cannot be stated definitively whether testosterone therapy increases or decreases the risk of cardiovascular events.

You are reading a page written and reviewed by David Robbins, MD, a board-certified urologist (Diplomate, American Board of Urology) who has practiced in Miami since 2009 at a practice serving South Florida for more than four decades.

David Robbins, MD, board-certified urologist.

What the evidence shows

The heart, the prostate and the blood: what has been shown

TRAVERSE trial · NEJM 2023
Major cardiac events were no more common on testosterone gel than on placebo: 7.0% versus 7.3%.

5,246 men aged 45 to 80 with hypogonadism and existing or high cardiovascular risk; hazard ratio 0.96 (95% CI 0.78 to 1.17), meeting the trial’s non-inferiority test. One trial, one daily gel, men with cardiovascular risk. The trial also reported higher incidences of atrial fibrillation, acute kidney injury and pulmonary embolism in the testosterone group.
FDA class-wide labeling change · 28 Feb 2025
The FDA added the TRAVERSE results to every testosterone label and removed the boxed-warning language about increased cardiovascular risk.

It kept the limitation of use for age-related hypogonadism, and required a blood-pressure warning on every product after studies confirmed an increase in blood pressure class-wide. The label is the regulator’s summary of the evidence, not a promise of safety for you.
Product labels
Testosterone can raise blood pressure and red-cell mass, and blood clots have been reported.

Labels also warn that BPH symptoms can worsen and that sleep apnea may worsen in men with risk factors, and call for evaluation for prostate cancer before and during treatment. These are monitoring instructions, which is why the follow-up section below exists.
AUA guideline · 2018, validity confirmed 2024
Clinicians should inform patients of the absence of evidence linking testosterone therapy to the development of prostate cancer.

PSA is measured before starting in men over 40, to exclude a prostate cancer diagnosis; hemoglobin and hematocrit are measured and the risk of polycythemia explained. Absence of evidence is not evidence of absence, so prostate checks continue during treatment.
AUA guideline
Low testosterone is a risk factor for cardiovascular disease. Whether therapy raises or lowers that risk cannot be stated definitively.

This is the sentence that decides how the conversation goes for a man who already has heart disease.

Sources: Lincoff AM, Bhasin S, Flevaris P, et al. Cardiovascular Safety of Testosterone-Replacement Therapy. N Engl J Med 2023;389:107–117 · U.S. Food and Drug Administration, “FDA issues class-wide labeling changes for testosterone products,” 28 February 2025 · American Urological Association, Evaluation and Management of Testosterone Deficiency (2018; validity confirmed 2024) · FDA prescribing information for testosterone products (2024–2025 versions).

Before you start

When we slow down

Some situations call for a closer look before testosterone is started. Each of these comes from the product labels or the AUA guideline:

Uncontrolled high blood pressure. Several labels state their product is not recommended for men with uncontrolled hypertension, and every label now warns that testosterone raises blood pressure.
A high hematocrit. Labels ask for the hematocrit to be checked before treatment begins, because testosterone can raise it further.
A history of blood clots. Clots in the legs and lungs have been reported in men using testosterone products.
Sleep apnea, or the risk factors for it. Labels warn that testosterone may make sleep apnea worse, especially in men with risk factors such as obesity or chronic lung disease.
An abnormal PSA or prostate exam. Labels call for evaluation for prostate cancer before starting, and the AUA guideline asks for a PSA in men over 40.
Trying to conceive now. The AUA guideline says testosterone should not be prescribed to men who are currently trying to conceive. The fertility page explains why, and what can be used instead.

None of these is automatically a no. Each is a reason to look harder first.

Follow-up

Monitoring: what is checked after you start

Guidelines and product labels call for the following. Your own schedule is set with you at the first visit.

Before starting

The baseline

Two early-morning testosterone levels on separate days; hemoglobin and hematocrit; PSA in men over 40; blood pressure; and the fertility conversation. (AUA guideline; product labels)
After starting

A follow-up level

A follow-up total testosterone level “after an appropriate interval.” (AUA statement 29)
Ongoing

Regular checks

Testosterone every 6 to 12 months (AUA statement 30). Hematocrit approximately every 3 months on several labels; others call for a recheck 3 to 6 months after starting, then yearly. Blood pressure measured periodically, and PSA monitored. (Product labels)
Three to six months in

The stop rule

If levels normalize but symptoms do not improve after three to six months, stopping is discussed. (AUA statement 31)

Blood tests are ordered at the visit and drawn at an outside laboratory. Established patients can have follow-up visits by video or phone; whether those are covered depends on your plan, and self-pay is also available.

Sources: American Urological Association, Evaluation and Management of Testosterone Deficiency (2018; validity confirmed 2024), statements 11, 12, 29, 30 and 31; FDA prescribing information for Xyosted (2025), Jatenzo (2025) and testosterone gel 1.62% (2024).

Don’t wait

Call the office the same day if

These are the symptoms the product labels tell patients to report:

Signs of a blood clot: pain, swelling, warmth or redness in a leg; sudden shortness of breath; or chest pain.
If you use a gel: changes in genital size or new pubic hair in a child, or new body hair or a marked increase in acne in a woman, who may have touched the skin where the gel was applied.
Urinary symptoms that get worse: getting up more at night, trouble starting, urgency, a weak stream, or being unable to pass urine.

Call (305) 672-4222. If it feels like an emergency, call 911 first.

Common Questions

Frequently Asked Questions

Does testosterone cause heart attacks?

A large randomized trial (TRAVERSE, 2023) found major cardiac events no more common on testosterone gel than on placebo in men with hypogonadism and cardiovascular risk, and the FDA revised the class labeling in 2025 to reflect it. The same labeling now warns that testosterone raises blood pressure. Your own history still decides.

Does testosterone cause prostate cancer?

The AUA guideline asks clinicians to inform patients of the absence of evidence linking testosterone therapy to the development of prostate cancer. PSA is still checked before starting in men over 40, and monitored during treatment.

Why do you keep checking my blood count?

Testosterone can raise your red-cell mass (polycythemia), which thickens the blood. Labels call for hematocrit checks, and a high value is a reason to adjust or pause therapy.

Can I just stop testosterone?

Stopping is a decision to make with the office, not on your own — your natural production may take time to return, and how that is managed depends on how long you have been on it and why you are stopping. Call us first.

How often will I need to come in?

Guidelines call for a follow-up level after starting and then every six to twelve months, with blood-count and prostate checks alongside; your own schedule is set at the first visit.