Does Testosterone Therapy Increase My Risk of a Heart Attack or Stroke?
Quick Answer
The best current evidence says no. A large randomized trial published in 2023, called TRAVERSE, followed over 5,000 men with hypogonadism and existing or high risk of heart disease for an average of nearly three years and found no difference in cardiovascular death, heart attack, or stroke between men on testosterone and men on placebo. That evidence was strong enough that the FDA removed its 2015 boxed warning about cardiovascular risk from testosterone product labels in February 2025.
The original warning did not come from nowhere. Two earlier studies, one a small trial stopped early and one a large observational study, genuinely raised the concern that TRAVERSE was designed to answer. The honest short version: on appropriately monitored therapy, the data no longer support the old blanket warning about heart attacks and strokes.
Where the Original Warning Came From
The concern that testosterone might harm the cardiovascular system did not start as a hypothetical. In 2010, a placebo-controlled trial of testosterone gel in 209 older men with mobility limitations and a high burden of hypertension, diabetes, and obesity was stopped early by its own safety monitoring board after the testosterone group had a clearly higher rate of cardiovascular adverse events than placebo, 23 events versus 5 (Basaria et al., 2010). The trial's own authors were careful to note that its small size and the frailty of its specific population meant the finding could not be generalized to testosterone therapy broadly, but it was enough to put the question on the table.
Three years later, a retrospective study of nearly 8,700 male veterans who had undergone coronary angiography and had low testosterone levels found that the roughly 1,200 men who went on to receive testosterone therapy had a higher three-year rate of death, heart attack, or stroke than those who did not, 25.7% versus 19.9% (Vigen et al., 2013). This was an observational study, not a randomized trial, so it could not rule out the possibility that sicker men were simply more likely to be prescribed testosterone in the first place, and the methodology was challenged by other researchers in the years that followed. But between this study and the earlier trial, the FDA required a class-wide boxed warning on testosterone products in 2015, stating that they may increase the risk of heart attacks and strokes, and restricted the approved use of testosterone to men with a confirmed medical cause of hypogonadism rather than age-related decline alone.
What the Definitive Trial Actually Found
The FDA's 2015 action came with a requirement attached: manufacturers had to fund a trial large enough and long enough to actually answer the question the earlier studies could only raise. That trial, TRAVERSE, enrolled 5,246 men between the ages of 45 and 80 who had symptoms of hypogonadism, two separate testosterone levels below 300 ng/dL, and either existing cardiovascular disease or a high risk of developing it, precisely the population most likely to be harmed if the original concern were correct (Lincoff et al., 2023). Men were randomized to daily transdermal testosterone gel, dosed to a target range of 350 to 750 ng/dL, or placebo gel, and followed for an average of 33 months.
The result was unambiguous on the specific question it was designed to answer. A first cardiovascular event, defined as the combination of cardiovascular death, nonfatal heart attack, or nonfatal stroke, occurred in 7.0% of the testosterone group and 7.3% of the placebo group, meeting the trial's prespecified criteria for noninferiority. This is the largest and most rigorous trial ever conducted on this question, and because it deliberately enrolled higher-risk men rather than excluding them, a null result here carries real weight rather than reflecting a study that was too healthy a population to find anything.
What Changed at the FDA
On February 28, 2025, the FDA announced class-wide labeling changes for all testosterone products, removing the language warning of a possible increased risk of heart attack and stroke, based directly on the TRAVERSE results. The FDA kept its existing use restriction in place and added a new warning about blood pressure elevation, based on ambulatory blood pressure monitoring the agency had separately required as part of the same post-marketing commitment. Blood pressure is worth naming here rather than treating as a footnote, since it's a direct driver of the same two outcomes this question is actually about; a therapy that measurably raises blood pressure over time isn't fully cleared of cardiovascular relevance just because a three-year trial didn't capture enough events to move the needle on heart attacks and strokes specifically.
Does Having Low Testosterone Itself Carry Cardiovascular Risk?
There's a separate, and separately important, body of evidence here that shouldn't get folded into the therapy question, because it answers a different one. A large pooled analysis of individual data from nine cohort studies, covering more than 255,000 participant-years, found that men whose own naturally occurring testosterone fell below roughly 213 ng/dL had higher all-cause mortality, and men below about 153 ng/dL had a higher risk of cardiovascular death specifically (Yeap et al., 2024).
This is worth stating carefully rather than turning into more than it is. It is an association between a man's own baseline testosterone level and his future risk, observed in cohort studies, not a trial showing that raising a low level with therapy lowers that risk. Low testosterone in these cohorts could easily be a marker of underlying illness rather than an independent cause of it; men who are already sicker, from causes unrelated to their hormones, often have lower testosterone as a downstream effect. TRAVERSE is the trial that actually tested whether correcting the level changes hard outcomes, and it answered the heart attack and stroke question specifically. It did not test, and this association data does not establish, that testosterone therapy extends life or prevents death from other causes.
What This Means in Practice
Put together, the evidence supports a specific, bounded claim rather than a sweeping one. In men with hypogonadism, appropriately dosed and monitored testosterone therapy does not appear, based on the best trial evidence available, to increase the risk of heart attack, stroke, or cardiovascular death, even in men who already have heart disease or a high risk of it. Blood pressure is still worth checking before starting therapy and rechecking periodically afterward.
Curious whether testosterone therapy is appropriate and safe for you? Let's talk it through at your next visit.
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References
- Basaria S, Coviello AD, Travison TG, et al. Adverse events associated with testosterone administration. N Engl J Med. 2010;363(2):109–122. PMID: 20592293.
- 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. PMID: 24193080.
- Lincoff AM, Bhasin S, Flevaris P, et al. Cardiovascular safety of testosterone-replacement therapy. N Engl J Med. 2023;389(2):107–117. PMID: 37326322.
- Yeap BB, Marriott RJ, Dwivedi G, et al. Associations of testosterone and related hormones with all-cause and cardiovascular mortality and incident cardiovascular disease in men: individual participant data meta-analyses. Ann Intern Med. 2024;177(6):768–781. PMID: 38739921.
- U.S. Food and Drug Administration. FDA Issues Class-Wide Labeling Changes for Testosterone Products. February 28, 2025. View announcement.
This content is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Testosterone therapy carries real risks and requires appropriate laboratory evaluation and ongoing monitoring. Testing and treatment decisions should be based on a clinician's review of the complete medical history, examination, laboratory pattern, medications, and individual risk factors. Do not start, stop, or adjust any prescription medication without guidance from your treating clinician. Dr. Wilcox is licensed to practice in multiple states. See About for current licensure.