Is TRT Bad for Your Heart? The FDA’s New Guidance

Testosterone replacement therapy (TRT) has been scrutinized for years, with some studies suggesting it might increase cardiovascular risk. Now, the FDA has recommended updates to the labeling of all testosterone products to reflect the latest clinical trial data. ¹ The key takeaway? The agency is recommending the removal of previous language about an increased risk of major adverse cardiovascular events (MACE)—a category that includes heart attack and stroke—after the largest randomized controlled trial to date found no increased risk in men using TRT for hypogonadism.

As part of these updates, the FDA is recommending:

• Adding results from the TRAVERSE trial ² —a double-blind clinical trial published in 2023—to the labeling of all testosterone products to reflect the latest findings on cardiovascular safety.
• Keeping existing guidance that TRT should not be prescribed solely for age-related testosterone decline.
• Removing prior warnings from the Boxed Warning that suggested TRT increases the risk of serious heart problems.

However, the FDA also recommended a warning about potential blood pressure increases for testosterone products that did not already include one.

So what does this mean for you? Here’s how to assess the risks and benefits of TRT with a longevity-focused approach.

The Research On TRT and Heart Health

The FDA’s recommendation marks a shift in how TRT is viewed in the medical community.

While past concerns about cardiovascular risk led to caution around testosterone therapy, ongoing research has painted a more complex picture. Studies over the years have produced conflicting results. This uncertainty made it difficult for doctors and patients to weigh the risks and benefits of TRT.

Early concerns about TRT and heart health

For years, concerns about cardiovascular risk shaped the conversation around testosterone therapy. Those concerns were amplified in 2010 when a clinical trial on TRT’s effects on muscle deterioration was halted after researchers observed a link between the administered testosterone gel and major cardiovascular events, as well as elevated blood pressure. ³

In 2015, the FDA began requiring testosterone manufacturers to include warning labels that outlined the cardiovascular risk. 

But the latest, more rigorous data challenges those long-standing fears, showing no increased risk of major adverse cardiovascular events (MACE) in men using TRT for hypogonadism.

The TRAVERSE trial—the most definitive study yet

The TRAVERSE study is the largest and most rigorous clinical trial on TRT and cardiovascular risk. Researchers investigated the safety of TRT in men with both hypogonadism—a condition in which your body doesn’t produce adequate levels of testosterone—and a history or risk factors of cardiovascular events. 

Over 5000 men between 45 and 80 years old were divided into two groups: those who were administered a 1.62 percent testosterone gel daily and those who received a placebo gel.

Researchers found that both groups had similar rates (around 7 percent) of major cardiac events like heart attack or nonfatal stroke. This suggests that TRT does not increase the risk of major adverse cardiovascular events (MACE) in men with hypogonadism, including those with preexisting cardiovascular disease.

However, the testosterone group reported higher instances of other side effects like irregular heart rhythm, acute kidney injury, and venous blood clots.

Is TRT Bad for Your Heart?

Previous research has found that TRT may help mitigate other risk factors for cardiovascular disease, like reducing body fat and normalizing blood glucose—two key drivers of heart disease. ^{4 5}

In fact, low testosterone itself may be a risk factor for cardiovascular disease. A 2024 meta-analysis involving 24,000 men across 11 different studies found a concerning link between low testosterone levels and a heightened risk of cardiovascular events. ⁶

Men with extremely low T levels—below 153 ng/dL of total testosterone—were at the highest risk of dying from heart disease.

BOOST YOUR T

I Had a Heart Attack at 42. On TRT, I’m Healthier Than Ever at 62

High Hematocrit on TRT? Here’s How to Reduce It.

Are Anabolic Steroids Bad for Your Heart?

While TRT—prescribed and monitored by a doctor—is safe for your heart, using anabolic steroids can have major cardiovascular health consequences.

Anabolic steroids—unmonitored, high doses of hormones like testosterone or trenbolone—are typically used in bodybuilding to promote muscle growth and to dramatically increase strength. Doses of these steroids can be 10 to 100 times greater than TRT prescribed by a doctor. 

A new study published in the Journal of Physiology found that anabolic steroid abuse is linked to a heart condition called atrial fibrillation, or a rapid and irregular heart rhythm (5). Atrial fibrillation puts you at a higher risk for stroke and heart failure. 

Can I Take TRT After a Heart Attack?

The new research is promising, but men who have “uncontrolled or poorly controlled” congestive heart failure or those who have had a heart attack in the last three to six months may not be a good candidate for TRT, says hormone specialist Jim Staheli, D.O., Chief Medical Officer of Hone Health. And you’ll have to be carefully monitored by your doctor if you decide to take TRT after a major cardiac event. 

If you suspect that you have low T, Hone Health’s at-home testosterone assessment tests eight testosterone biomarkers, including free and total testosterone, SHBG, and prolactin. It also tests cardiac biomarkers including Apo B.  

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