The United States is giving testosterone therapy labels their biggest update in a decade. In June 2026, HHS and the FDA proposed updates to testosterone replacement therapy warnings. The proposal follows new research, including a large randomized trial and a broad 2026 review of dozens of studies. That evidence found less cardiovascular and prostate-cancer risk than regulators assumed when they added the original warnings in 2015. The change doesn’t mean testosterone therapy is risk-free; it means the label is finally catching up to the science.
The rise in popularity of testosterone supplements
Millions of American men take testosterone replacement therapy for low testosterone, a condition doctors call hypogonadism. Doctors usually diagnose it when blood testosterone stays low. The threshold is generally below 300 nanograms per deciliter, confirmed on two separate morning blood draws. A man also needs symptoms like low sex drive, fatigue, erectile trouble, low mood, or muscle loss.
Prescribing of testosterone has swung wildly over the past two decades, according to an analysis from Epic Research. Direct-to-consumer “Low T” marketing and easy topical gels fueled a sharp rise in testosterone replacement therapy. Prescribing climbed through the 2000s and early 2010s. By 2013, 0.83% of male patients nationwide had an active prescription. In 2015, the FDA required testosterone products to carry new restrictions and warnings amid limited evidence of benefit and concerns about cardiovascular risk. Prescribing fell to 0.64% by 2021. Since a major 2023 trial and a 2025 warning update, prescribing has climbed back up. It reached 0.95% of male patients by mid-2026. Men ages 50 to 64 have the highest rate: 1.57% in 2025.
Prescribing of testosterone has swung wildly over the past two decades.
Testosterone Prescription Prevalence Over Time by Age Group
The percentage of male patients with a healthcare encounter who had at least one active testosterone prescription each year from 2012 through mid-2026, overall and by age group.
Why medical professionals are concerned
That rebound in testosterone prescriptions worries some physicians. Testosterone replacement therapy is meant for men with both symptoms of deficiency and consistently low blood testosterone — not simply men seeking more energy, muscle, sexual performance, or protection against aging. Physicians caution against using it as a general anti-aging supplement.
Regulators are now revisiting the old warnings. In June 2026, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) requested updates to testosterone replacement therapy labels. The request follows a comprehensive review of new clinical data. Some of that data targets the exact concerns that shaped the original warnings a decade ago.
Three changes on the table
The FDA’s requested changes target three areas of the label:
- First, the agency wants to remove a limitation on age-related hypogonadism. Current FDA labeling limits approval of testosterone products for the treatment of low testosterone to men with a specific medical condition, citing a lack of data on safety and effectiveness in men with low testosterone due to aging. The change will remove the limitation.
- Second, the FDA wants to narrow the prostate cancer warning. Current labels advise against use in men with known or suspected prostate cancer. Under the proposed change, the warning would only apply to men whose prostate cancer has already spread. That doesn’t mean the FDA has declared testosterone safe for men with localized prostate cancer. The new labeling would still call for risk assessment, screening, and monitoring.
- Third, the FDA wants to soften warnings about benign prostatic hyperplasia (BPH), or enlarged prostate. Current labels warn that treatment may worsen BPH symptoms. The requested revision would drop that warning for mild-to-moderate cases. Doctors would still monitor men with severe symptoms.
“By updating testosterone therapy labels to reflect current evidence, we are giving patients and physicians clearer information,” HHS Secretary Robert F. Kennedy Jr. said in the announcement.
What the evidence shows about heart risk
The TRAVERSE trial and its companion prostate-safety study provide some of the most important new evidence behind the proposed changes.
Concerns about heart risk triggered the original 2015 warning. A small earlier trial had been stopped early after researchers spotted more heart problems in men taking testosterone. Later studies gave conflicting results — some found increased risk, others found none. So the FDA required manufacturers to conduct a large trial designed to answer the question.
That trial, called TRAVERSE, appeared in the New England Journal of Medicine in 2023. Researchers followed 5,246 men ages 45 to 80 who had heart disease or a high risk of it. They randomly assigned each man to testosterone gel or a placebo gel. Treatment lasted an average of 22 months. A major cardiac event — death from cardiovascular causes, heart attack, or stroke — occurred in 7.0% of men on testosterone. The placebo group’s rate was similar at 7.3%. The trial did find more cases of irregular heart rhythm, pulmonary embolism (blood clots in the lungs), and acute kidney injury among men taking testosterone. The HHS announcement doesn’t emphasize that nuance, but it matters for anyone weighing treatment.
What the evidence shows about prostate cancer risk
The prostate cancer and BPH revisions draw from a companion study. Researchers built it into the same trial and published it separately in JAMA Network Open. They tracked prostate outcomes in the same group of men, who had already been screened to exclude those at elevated prostate-cancer risk — including anyone with a prior cancer diagnosis, a high PSA level, or a suspicious prostate exam. Prostate cancer occurred in 0.46% of the testosterone group. It occurred in 0.42% of the placebo group — not a statistically meaningful difference. More aggressive, high-grade prostate cancer occurred in 0.19% of testosterone patients versus 0.12% of placebo patients. That gap wasn’t significant either, though the small case count leaves uncertainty. Enlarged-prostate symptoms and urinary scores rose at similar rates in both groups. The number of men needing new BPH treatment did not vary between groups.
A broader 2026 systematic review adds further support, on both heart risk and prostate cancer risk. Researchers pooled data from 41 randomized trials and more than 11,000 men total. They found no statistically meaningful increase in major cardiovascular events among men taking testosterone. They found no statistically significant increase in prostate cancer either, including clinically significant cases. But the review flagged an important limitation: most trials followed men for months, not years or decades. Long-term risk, especially for a slow-developing disease like prostate cancer, isn’t fully settled.
What doctors are saying
Physicians largely welcome the proposed changes. Several told Healthline and CNN that the original warnings overstated the cardiovascular and prostate cancer risks. More than one expert pushed back on the idea that testosterone causes prostate cancer. Prostate tumors are often androgen-sensitive, though, meaning testosterone can still speed the growth of an existing, undetected tumor. That’s a different claim than causing a tumor to form in the first place.
Nearly every physician quoted added a caveat, though. Dr. Jamin Brahmbhatt, a urologist at Orlando Health, put it plainly: “Taking a warning off a label isn’t the same as saying every man should be on it. Testosterone is still a medical therapy, not a wellness drug.” He and others stressed that treatment still needs a confirmed diagnosis. Dosing should stay within a normal physiologic range. Ongoing monitoring, including bloodwork and prostate screening, still matters.
When will the labelling change take effect?
Testosterone therapy labels haven’t changed yet. The FDA has asked manufacturers to submit labeling supplements that reflect the new evidence. The FDA must then review and approve those supplements. Only then does any change take legal effect. No firm deadline has been set for this round, but the previous labelling changes took about 19 months to complete. The vocal backing from groups like the American Urological Association makes eventual approval likely, even without a clear timeline.
For now, the practical takeaway hasn’t changed. Anyone considering testosterone replacement therapy should talk with a doctor first. Ask about confirmed bloodwork, your specific symptoms, and a monitoring plan — regardless of what the label says this year.
