What Is Testosterone?
Testosterone (Test) is an androgen hormone. The US Drug Enforcement Administration (DEA) also includes testosterone and several of its esters among prescribed anabolic steroids. AndroGel label; DEA overview.
The US AndroGel 1.62% label describes replacement therapy for males whose bodies produce too little or no testosterone because of primary or hypogonadotropic hypogonadism. Before treatment, the label calls for low morning serum testosterone to be confirmed on at least two separate days. US AndroGel label, sections 1–2.
Medical Use and Anabolic-Steroid Misuse
The AndroGel label separately addresses abuse of anabolic-androgenic steroids. It reports serious cardiovascular and psychiatric adverse reactions in people abusing these drugs. Keep that warning separate from an account of prescribed replacement therapy: do not use a medical indication as reassurance about non-medical use. US AndroGel label, section 9.2.
What Changed in FDA Safety Information?
In February 2025, after reviewing the TRAVERSE trial, the US Food and Drug Administration (FDA) recommended removing boxed-warning language about increased adverse cardiovascular outcomes from testosterone product labeling. In the same communication, FDA reported that completed blood-pressure studies confirmed an increase in blood pressure across testosterone products and required related warning information. Removing one warning therefore should not be read as removing the blood-pressure concern. FDA's February 2025 communication.
In June 2026, FDA requested removal of the limitation of use concerning age-related hypogonadism. It also requested revisions to safety information about prostate cancer and benign prostatic hyperplasia. These are requested labeling changes. When comparing older and newer descriptions, preserve that distinction rather than assuming every product label already contains the requested wording. FDA Testosterone Information.
Important AndroGel Warnings
AndroGel 1.62% has a boxed warning about secondary testosterone exposure, including reports of virilization in children who were exposed. This is a different issue from the cardiovascular boxed-warning language addressed by FDA in 2025. US AndroGel boxed warning; FDA 2025 update.
The AndroGel label also warns about increased hematocrit and calls for hematocrit monitoring. FDA's blood-pressure warning adds another distinct safety issue. Bring the exact product name to a medical discussion of its hematocrit and blood-pressure warnings. US AndroGel label, section 5.2; FDA blood-pressure findings.
Related Pages
Continue with the trenbolone guide or return to the anabolics overview. For another compound, use the research index.
