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What Men 50-Plus Should Know About Testosterone Therapy
Federal health officials are requesting labeling changes that could increase access. Here’s how that could impact you
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Key takeaways
- Federal health officials may remove testosterone therapy product label warnings tied to heart and prostate risks.
- Previous concerns have been debunked by newer studies, which show no higher risk of major heart events or enlarged prostate.
- The labeling changes could boost prescribing, giving more men access to the hormones.
Men with low testosterone may soon have an easier time getting testosterone therapy, as federal health officials consider removing long-standing label warnings about potential heart and prostate risks.
If approved, the change, requested in June by the U.S. Department of Health and Human Services, could make doctors more likely to prescribe the treatment, triggering a “major rebound effect,” says Dr. Michael Miller, a professor of cardiovascular medicine at the Hospital of the University of Pennsylvania.
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Testosterone therapy is the gold-standard treatment for low testosterone, also called low T. Symptoms can include low libido, erection problems, hot flashes, depression, increased body fat and trouble with concentration and memory.
In 2015, the U.S. Food and Drug Administration required testosterone replacement therapy product labeling to include “a limitation of use stating that safety and effectiveness had not been established in men with signs and symptoms associated with idiopathic hypogonadism,” which is a condition that occurs when the body’s sex glands produce little or no testosterone, HHS explained in a news release.
At the time, evidence of the benefit of testosterone therapy was limited, and there were concerns about possible cardiovascular risks. And following that, prescriptions went down by about half, Miller says.
However, in the past decade, new research has emerged, including a 2023 randomized-controlled trial in The New England Journal of Medicine, which found that men who had preexisting or a high risk of cardiovascular disease and were using testosterone gel didn’t have an increased risk of cardiac events such as heart attack and stroke compared with those not taking the therapy.
Revising the labels is welcome news to Dr. Tobias S. Kohler, a professor of urology at Mayo Clinic College of Medicine and Science and president of the Sexual Medicine Society of North America, who testified before the FDA about the therapy. He says the evidence that the FDA used to make the 2015 decision was highly criticized; HHS says new evidence has led the FDA to conclude “that the limitation of use is no longer warranted.”
Health officials are also requesting updates to safety information on prostate health. Current labeling says testosterone therapy should not be used in men with known or suspected prostate cancer. Under the proposed revisions, testosterone therapy would be contraindicated only for men with metastatic prostate cancer.
Clinicians should still be “cautious” recommending therapy for anyone with prostate cancer, Miller says, adding that it can be used after treatment of localized prostate cancer with close monitoring.
A third proposed change is to update the language warning that the medication can make an enlarged prostate worse, since newer research has not found that effect in men with mild to moderate enlarged prostate who took the hormone.
Most urologists are excited about the HHS proposal, says Dr. Justin Dubin, a urologist and director of Men’s Sexual Health at Baptist Health Herbert Wertheim Cancer Institute and Baptist Health Medical Group in Miami. There’s a stigma around treating low T, so clarifying warnings to align with research will help more men receive the therapy, he says.
Know the risks of testosterone therapy
As with any medication, testosterone therapy can come with risks, including:
- Acne
- Enlarged breasts
- Noncancerous prostate growth
- Growth of existing prostate cancer
- Decreased sperm production
- Testicle shrinking
- Increased red blood cell production, which could increase blood clot risk
You shouldn’t use testosterone therapy if you have:
- Untreated obstructive sleep apnea, prostate cancer or heart failure
- Had a stroke or heart attack in the past six months
- A lump on your prostate
- Male breast cancer
- A history of high red blood cell counts
“When you remove those labels, I think people feel more comfortable about talking about these problems,” Dubin says.
The HHS proposal is similar to a recent label change on women’s hormone therapy products. The FDA said in 2025 that the risks of taking those hormones were overstated on previous product packaging.
Who needs testosterone therapy?
Testosterone, a hormone produced mostly in the testicles, supports muscle strength, muscle mass, bone density, mood and red blood cell production.
It declines gradually in your 30s and 40s. And while most men still maintain normal testosterone levels as they age, about 10 to 25 percent have clinically low levels that meet guidelines for treatment. Conditions that can cause low testosterone include obesity, obstructive sleep apnea, stress and taking certain medications such as opioids.
Testosterone therapy in women
The HHS proposal could also affect some women who use testosterone. Women produce much smaller amounts of the hormone than men do, but some may have levels low enough to warrant treatment. Because no testosterone products are FDA-approved for women, doctors prescribe the therapy off-label.
Untreated low T can raise your risk for heart attack, stroke, earlier death, osteoporosis, osteopenia, lower muscle mass, erectile dysfunction, mood changes and obesity, Dubin notes.
Testosterone therapy involves taking testosterone pills or injections or using patches, skin implants or gels.
Unlike some other hormone therapies, testosterone is a scheduled controlled substance because it’s a steroid that’s been abused in the past, particularly for muscle building. That classification can make prescribing it more cumbersome, and some doctors may be reluctant to do so, Kohler says. As a result, men turn to nontraditional outlets to acquire it — a move that can raise the risk of unsafe or unreliable products and leave them without appropriate medical monitoring.
Testosterone therapy is neither recommended nor FDA-approved in men with normal testosterone levels, Miller says. Even still, some doctors prescribe it to men who don’t have low T, since it can improve sexual function.
Diagnosing and treating low T
To diagnose low T, your doctor will review your symptoms and test your blood, Kohler says.
Ideal candidates for testosterone therapy are those with testosterone levels of less than 300 ng/dL and especially under 200 ng/dL, along with symptoms like decreased libido, unexplained anemia and osteoporosis, Miller says.
Generally, Kohler likes to see men who have been diagnosed with low T and who are taking testosterone therapy get to the 400 to 600 ng/dL range, while Dubin says 450 to 600 ng/dL is the sweet spot for most men. Anything over 1,000 ng/dL is often too high, Dubin says.
Testosterone levels vary from person to person, so some men may have results that fall within the normal range but still feel worse as they age if their levels have dropped significantly from their younger baseline.
“There’s this nuance to treating levels,” Kohler explains. “It’s difficult if you try to put exact numbers into this science.”
Whom can you talk to about testosterone therapy?
If you have access to a urologist or an endocrinologist, that’s a good place to talk about symptoms or concerns, Dubin says. Ask your primary care provider if they can help or give you a referral, he notes.
If you’re more comfortable, test testosterone levels using an online service and bring those results to your doctor, Dubin adds.
Updated testosterone therapy guidelines are expected in the next year or two and could shift how doctors diagnose and treat low T.
If you opt for testosterone therapy, you’ll need to stay on it indefinitely to feel your best, and you should have blood work done to monitor your levels every three to six months, Dubin says.
The key takeaways were created with the assistance of generative AI. An AARP editor reviewed and refined the content for accuracy and clarity.
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