Testosterone Information
Testosterone is a hormone essential to the development of male growth and male characteristics. Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition). Examples of these conditions include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy. Other examples include problems with brain structures, called the hypothalamus and pituitary, that control the production of testosterone by the testicles.
None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition. FDA-approved testosterone formulations include the topical gel, transdermal patch, buccal system (applied to upper gum or inner cheek), and injection.
To assess the cardiovascular safety of testosterone therapy, an industry consortium led by manufacturers of AndroGel and Androderm (testosterone replacement products) conducted an FDA-required postmarketing safety trial, the Testosterone Replacement Therapy for Assessment of Longterm Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) trial. The trial tracked serious major adverse cardiovascular outcomes, such as death from cardiovascular events, nonfatal heart attacks, and nonfatal stroke, in more than 5,200 men receiving at least one dose of AndroGel 1.62%. The results, published in June 2023, showed no meaningful difference in serious cardiovascular events between men who received AndroGel and those who received a placebo, with 7.0% of men in the AndroGel group reporting a major adverse cardiovascular event compared with 7.3% of men in the placebo group. After reviewing these results, FDA determined that the results of TRAVERSE did not demonstrate a new safety signal or trend in adverse cardiovascular outcomes with testosterone use.
Following a rigorous review of new data and reanalysis of existing evidence, including the TRAVERSE trial, FDA requested updates to testosterone prescribing information in June 2026. These updates included:
- Removing the limitation of use stating the safety and efficacy of testosterone replacement therapy in men with age-related hypogonadism (certain signs and symptoms associated with low blood testosterone levels without a clear cause) have not been established
- Revising safety information related to prostate cancer and benign prostatic hyperplasia (noncancerous enlarged prostate)