Testosterone and Heart Health: The Whole Clinical Picture

The short answer is that in men with hypogonadism and existing cardiovascular disease or high risk of it, testosterone-replacement therapy was non-inferior to placebo for major adverse cardiac events — hazard ratio 0.96, 95% CI 0.78 to 1.17.[1] The longer answer is the one worth having, because the same trial reported a higher incidence of three other things, and because a new blood pressure warning went onto testosterone labels in 2025.

This page is the map. Each section links to the article that covers it properly.

The evidence, in order

Year	Study	What it showed	Weight it carries
2010	TOM	Stopped early: 23 vs 5 cardiovascular adverse events, in 209 frail men[2]	Low — authors said its size and population prevent broader inference
2013	Vigen	Association with mortality, MI and stroke in a VA cohort[3]	Low — observational, confounding by indication
2013	Xu meta-analysis	Pooled placebo-controlled trials[4]	Low — pooled trials designed for other endpoints
2015	Sharma	83,010 veterans: normalisation associated with reduced MI and mortality[5]	Low — observational, but points the opposite way
2023	TRAVERSE	5,246 men, non-inferior for MACE[1]	High — randomised, powered, pre-set margin

The pattern is the point. Everything before 2023 was weak evidence in both directions, and the argument was settled by running the right trial rather than by re-analysing the wrong ones. The design decisions that made it decisive are in why TRAVERSE settled it.

What TRAVERSE found, in full

Primary endpoint. A first cardiovascular event — cardiovascular death, nonfatal MI or nonfatal stroke — occurred in 182 men (7.0%) on testosterone and 190 (7.3%) on placebo. Hazard ratio 0.96 (95% CI 0.78–1.17), P<0.001 for non-inferiority.[1]

The findings that do not make headlines. In the same trial:

A higher incidence of atrial fibrillation, of acute kidney injury, and of pulmonary embolism was observed in the testosterone group.[1]

These are not footnotes. Atrial fibrillation and pulmonary embolism are both clinically consequential, and the clotting question has its own evidence base — see testosterone and blood clots.

"Non-inferior for MACE" is a precise claim about one composite endpoint. It is not a general statement that testosterone has no cardiovascular effects.

Blood pressure is the newer issue

Separately from TRAVERSE, ambulatory blood pressure monitoring studies of two testosterone products — given by two different routes — produced consistent results raising concerns that testosterone could increase blood pressure.[6]

The FDA acted on that in February 2025, requiring product-specific blood pressure information where studies were complete, and a new warning about increased blood pressure for products without one.[6]

So the direction of the regulatory picture is not simply "the warning came off." One warning came off and another went on, the same day. Details in what the 2025 label change did.

Where the label stands now

• February 2025 — TRAVERSE results added to all testosterone products; cardiovascular language removed from the Boxed Warning; the age-related hypogonadism Limitation of Use retained; blood pressure warnings added.[6]
• June 2026 — the FDA requested further updates: removing the age-related hypogonadism limitation of use, and revising safety information on prostate cancer and benign prostatic hyperplasia.[7]

The full history of how the cardiovascular language arrived and departed is in the boxed warning's history.

What this means if you are considering or taking testosterone

1. The heart-attack-and-stroke question is answered for the population TRAVERSE studied — men 45 to 80 with hypogonadism and cardiovascular disease or risk. That is reassuring, and it is population-specific.
2. Blood pressure now belongs on the monitoring list. So does hematocrit, which remains the most common adverse effect of therapy — see polycythemia and hematocrit.
3. Cardiovascular safety is not the same as benefit. The T Trials found moderate benefit for sexual function, some for mood, and none for vitality or walking distance.
4. The other TRAVERSE sub-studies do not all point the same way. Bone found more fractures on treatment — TRAVERSE and bone.
5. A confirmed diagnosis still comes first. Two morning measurements, not one — why one low result isn't enough.

Bottom line

Testosterone therapy does not appear to increase major adverse cardiac events in men with hypogonadism and cardiovascular risk, and that conclusion rests on a properly designed trial rather than on argument.

It is not a clean bill of cardiovascular health. The same trial found more atrial fibrillation, acute kidney injury and pulmonary embolism, and labels now carry a blood pressure warning that did not exist before 2025. A man with atrial fibrillation, a clotting history, or poorly controlled hypertension is having a different conversation from the one the headline suggests — and that conversation belongs with his own clinician.

References

7 sources

1. Lincoff AM, Bhasin S, Flevaris P, et al. Cardiovascular Safety of Testosterone-Replacement Therapy. N Engl J Med. 2023;389(2):107–117. doi:10.1056/NEJMoa2215025 · PMID 37326322
2. Basaria S, Coviello AD, Travison TG, et al. Adverse Events Associated with Testosterone Administration. N Engl J Med. 2010;363(2):109–122. doi:10.1056/NEJMoa1000485 · PMID 20592293
3. Vigen R, O'Donnell CI, Barón AE, et al. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA. 2013;310(17):1829–1836. doi:10.1001/jama.2013.280386 · PMID 24193080
4. Xu L, Freeman G, Cowling BJ, et al. Testosterone therapy and cardiovascular events among men: a systematic review and meta-analysis of placebo-controlled randomized trials. BMC Med. 2013;11:108. doi:10.1186/1741-7015-11-108 · PMID 23597181
5. Sharma R, Oni OA, Gupta K, et al. Normalization of testosterone level is associated with reduced incidence of myocardial infarction and mortality in men. Eur Heart J. 2015;36(40):2706–15. doi:10.1093/eurheartj/ehv346 · PMID 26248567
6. U.S. Food and Drug Administration. FDA issues class-wide labeling changes for testosterone products. February 28, 2025. fda.gov
7. U.S. Food and Drug Administration. Testosterone Information — postmarket drug safety information for patients and providers, including the TRAVERSE results and the June 2026 requested prescribing-information updates. fda.gov