The Study
Off-label testosterone therapy is associated with higher long-term cardiovascular risk in men
This study looked at men who got testosterone pills and noticed that those without a clear medical reason for it had more heart problems later. But it didn’t randomly assign who got it — so we can’t say the pills caused the problems. Maybe those men were sicker or took higher doses, and we just don’t know.
Analysis score
Maximum 72 for a cohort study.
Where the score came from
Some men get testosterone shots even when their bodies aren't low in testosterone. This study looked at what happened to them over 10 years compared to men who got it because they truly needed it.
Where does this study sit?
Reviews of RCTs (Meta-analyses)
Max 100Randomized Trials
Max 90Reviews of Cohort Studies
Max 85Cohort Studies
Max 72Reviews of Case-Control Studies
Max 63Case-Control Studies
Max 58Cross-Sectional & Case Series
Max 50Expert Opinion
Max 567 / 100
Quality score
Groups of people are followed over time to see who develops an outcome. Strong for identifying risk factors and associations, but cannot prove causation as firmly as RCTs.
Key takeaways
Summary
Based on the study abstract and findings.
- 1These are big increases — for every 100 men treated without a clear medical reason, about 5 more will have a major heart event or die over 10 years compared to those treated with a confirmed diagnosis.
- 2Men without documented low testosterone had a 51% higher chance of heart problems, 90% higher chance of dying, 23% higher chance of stroke, 32% higher chance of heart failure, and 41% higher chance of cardiac arrest.
Score breakdown, methodology, conflicts of interest, evidence analysis & raw study data
Publication
Journal
eBioMedicine
Year
2026
Authors
Hatim Kerniss, P. Curman, Henning Olbrich, K. Kridin, R. Francis, David M. Leistner, U. Alam, R. J. Ludwig
Related Content
Claims (7)
People who start testosterone therapy without a diagnosed low testosterone level have a 32% higher chance of developing heart failure over 10 years compared to those who start therapy after a diagnosed low testosterone level.
People who start testosterone therapy without a diagnosed low testosterone level have a 41% higher rate of cardiac arrest over 10 years than those who start therapy with a diagnosed low testosterone level.
Among men aged 30–75, those prescribed testosterone therapy without confirmed low testosterone levels have a 51% higher rate of serious heart problems over 10 years than those prescribed testosterone therapy with confirmed low testosterone levels.
Among men aged 30 to 75, those prescribed testosterone therapy without a diagnosis of hypogonadism have a 90% higher rate of death from any cause over 10 years than those prescribed testosterone therapy with a diagnosis of hypogonadism.
People who start testosterone therapy without a diagnosed low testosterone level have a 23% higher chance of having an ischemic stroke within 10 years compared to those who start therapy after a documented diagnosis of hypogonadism.
Among men receiving testosterone therapy without a diagnosis of low testosterone, Asian men have higher rates of heart problems and death compared to other racial and ethnic groups.
Not medical advice. For informational purposes only. Always consult a qualified healthcare professional before making health decisions.