Testosterone therapy without evidence of deficiency may boost heart risk
News briefs
- Reviewed by Robert H. Shmerling, MD, Senior Faculty Editor, Harvard Health Publishing; Editorial Advisory Board Member, Harvard Health Publishing
The FDA’s proposed label changes to testosterone therapy may widen access to this popular hormone treatment. But some men who are considering (or currently using) the drug should be cautious. A recent study found that men who use testosterone without evidence of low testosterone (hypogonadism) face a higher risk of serious cardiovascular problems and death from all causes than men who use testosterone replacement therapy (TRT) for documented hypogonadism.
Researchers used data from electronic health records from 123 health care organizations throughout the world to identify men ages 30 to 75 using testosterone. Of the nearly 359,000 men taking the hormone, about a third had no evidence of hypogonadism. The researchers compared men who were prescribed TRT for hypogonadism with those using testosterone who did not have hypogonadism but otherwise had similar traits (such as age and overall health).
Over 10 years of follow-up, men on testosterone who did not have hypogonadism had a roughly 50% higher risk of serious heart problems (including heart attack, stroke, and cardiac arrest) compared with men prescribed TRT for hypogonadism. In addition, the risk of death from any cause was nearly twice as high among testosterone users without versus with hypogonadism.
Earlier research looking at whether testosterone use raises heart risk overall has been mixed. The new findings, published in the August 2026 issue of eBioMedicine, extend and add nuance to the existing evidence. However, they don’t prove that testosterone, even in men without hypogonadism, is responsible for the elevated heart risks, because other unmeasured differences between the two groups of men could be at play.
Still, men who are considering testosterone for any reason should have a full clinical evaluation before starting, the authors advise. For example, testosterone use has been linked to an increased risk of developing a high red blood cell count, which can increase the risk of blood clots in leg veins and the lungs.
Image: © ljubaphoto/Getty Images
About the Author
Julie Corliss, Executive Editor, Harvard Heart Letter
About the Reviewer
Robert H. Shmerling, MD, Senior Faculty Editor, Harvard Health Publishing; Editorial Advisory Board Member, Harvard Health Publishing
Disclaimer:
As a service to our readers, Harvard Health Publishing provides access to our library of archived content. Please note the date of last review or update on all articles.
No content on this site, regardless of date, should ever be used as a substitute for direct medical advice from your doctor or other qualified clinician.
