Testosterone Enanthate

Status

FDA-approved. Approved labeling exists for testosterone replacement in men with defined hypogonadism, with abuse-potential warnings. In 2025 FDA required class-wide labeling changes for testosterone products that removed boxed cardiovascular-risk language and added or kept blood pressure warnings. The XYOSTED label (checked 11 November 2026) records “Boxed Warnings, Blood Pressure Increases: Removed 03/2025”; its blood pressure warning remains in the Warnings section.

What it is

A long-acting injectable testosterone ester used in prescribed testosterone therapy.

What published research measured

Decades of clinical literature exist on testosterone replacement in hypogonadal men, covering body composition, mood, hematocrit and fertility suppression.

Source

Bhasin S et al. 2005 — Older men are as responsive as young men to the anabolic effects of graded doses of testosterone on the skeletal muscle · Ferrando AA et al. 2002 — Testosterone administration to older men improves muscle function: molecular and physiological mechanisms · Blackman MR et al. 2002 — Growth hormone and sex steroid administration in healthy aged women and men: a randomized controlled trial

Sources

• FDA: class-wide labeling changes for testosterone products
• XYOSTED label (DailyMed)
• Testosterone cypionate label (DailyMed)