Testosterone therapy in the United States is generally considered safe when prescribed and monitored by a qualified healthcare provider, but it carries potential risks and requires careful management. Testosterone replacement therapy (TRT) is primarily used to treat men diagnosed with hypogonadism, a condition where the body produces insufficient testosterone. The therapy aims to restore testosterone levels to a normal range, helping alleviate symptoms such as low energy, reduced sexual desire, mood changes, and loss of muscle mass.
In the U.S., all forms of testosterone therapy—including injections, gels, patches, and the newer oral formulations—are regulated by the Food and Drug Administration (FDA) as Schedule III controlled substances. This classification reflects the potential for misuse and abuse, particularly because testosterone is an anabolic androgenic steroid that some may use improperly to enhance athletic performance or muscle growth. Because of this, testosterone therapy must be prescribed and supervised by healthcare professionals to ensure safety and effectiveness.
One recent advancement in testosterone therapy is the approval of oral testosterone undecanoate capsules, such as Kyzatrex. This oral form offers a convenient alternative to injections or topical gels, providing steady testosterone levels through an easy-to-take pill. However, despite its convenience, it still requires medical oversight due to the risks associated with testosterone supplementation.
While TRT can be very effective for men with clinically low testosterone, it is not appropriate for everyone. Studies show that only about 2 percent of men aged 40 to 79 actually have a medical need for testosterone therapy, yet prescriptions have surged dramatically, sometimes without proper baseline testing. This overuse and misuse raise safety concerns because testosterone therapy can cause side effects such as reduced sperm count, thickening of the blood, and potentially accelerate undiagnosed prostate cancer. These risks highlight the importance of thorough medical evaluation before starting therapy.
Additionally, many non-FDA-approved testosterone supplements are marketed with exaggerated claims and lack scientific backing. These products can be unsafe and are not recommended as substitutes for prescribed testosterone therapy.
For women, testosterone therapy is less common and currently there are no FDA-approved testosterone medications specifically for women in the U.S. When prescribed off-label, safety and ongoing monitoring are critical due to potential side effects.
In summary, testosterone therapy in the U.S. is safe when used appropriately under medical supervision for men with diagnosed low testosterone. The therapy is regulated to prevent misuse, and new treatment options like oral testosterone are expanding accessibility. However, inappropriate use, lack of proper testing, and unregulated supplements pose significant risks. Patients considering testosterone therapy should undergo comprehensive evaluation and maintain regular follow-up with their healthcare provider to ensure the benefits outweigh the risks.
