For years the labeling carried a boxed warning about possible cardiovascular risk. Following a large randomized trial and further review, FDA made class-wide labeling changes in 2025 that removed that boxed warning and added information about the potential for increases in blood pressure. The right reading is that cardiovascular safety is better characterized now — not that there is nothing to watch.
On the prostate side, testosterone therapy is not given to men with known prostate cancer, and prostate-specific antigen and examination are used as part of baseline and follow-up assessment based on age, family history and your own preferences after discussion.
In practice, this means blood pressure gets measured, red cell counts get followed, and prostate surveillance is planned deliberately. If you have established heart disease, uncontrolled hypertension or a concerning prostate history, that shapes whether therapy is reasonable at all.
Risks and limitations
- Removal of a boxed warning is not the same as an absence of cardiovascular risk.
- Blood-pressure increases are specifically described in current labeling.
- Testosterone is not appropriate in men with known prostate cancer.
- Individual risk depends on your own cardiac and prostate history.