Compare online TRT. Find your clinic.

Our own count · Labels counted 2026-08-26

Most testosterone labels have not caught up with the evidence yet

If you start TRT this month, the prescribing information that comes with your vial may still describe the evidence as it stood in 2015. We counted. On 2026-08-26 we pulled every testosterone label in the FDA's openFDA index, 120 posted labels in all, and checked each one against the two federal labeling actions that are supposed to have changed it. Only 19 of 120 mention the trial that settled the cardiovascular question, and 82 of 120 still carry the limitation FDA has asked sponsors to remove.

What the trial actually found, since the labels will not tell you

The sentence still printed on 66 of these labels reads: “Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use.” That is a verbatim quote from a document that has not been revised, and it is no longer the state of the evidence. The long-term trial was conducted. TRAVERSE randomised 5,246 men aged 45 to 80 with cardiovascular disease or high risk of it, reported in 2023, and found a first event of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke in 7 percent on testosterone against 7.3 percent on placebo, hazard ratio 0.96 (95% CI 0.78 to 1.17). FDA reviewed it and acted on it. Read the label sentence as an artefact of a document nobody has updated, not as an open question.

The part that gets dropped from summaries belongs here too: atrial fibrillation, acute kidney injury, pulmonary embolism were each more frequent in the testosterone arm. The trial cleared the headline cardiovascular question. It did not clear everything. Full breakdown of what the four labels warn about.

Whether your label is current depends on which formulation you got

The 19 labels that did adopt the changes are branded products with modern prescribing information and active sponsors. Jatenzo and Xyosted, whose own RECENT MAJOR CHANGES tables record the 03/2025 removals record those removals in their own change tables. The labels that have not moved are overwhelmingly the older-format generic injectable testosterone cypionate labels, which is what most online TRT clinics actually prescribe. The flagship injectable label, Depo-Testosterone, was reposted as recently as 2026-08-21 as version 26, and we searched that document: it contains no mention of TRAVERSE and still prints both the age-related limitation and the sentence above.

None of this is a reason to avoid TRT, and none of it is a reason to start. It is a reason to be careful about what your paperwork proves. A prescribing information sheet is a regulatory document on a sponsor's republication schedule, not a summary of current science, and the two have been out of step for eighteen months.