Testosterone

FDA retained the limitation for age-related hypogonadism when updating testosterone labeling in 2025. The update removed the boxed-warning language about increased cardiovascular outcomes and added or strengthened blood-pressure warnings. That is not a statement that testosterone is risk-free. ¹

Kyzatrex is an oral testosterone undecanoate product for specified testosterone-deficiency conditions in adult males. Its label addresses blood pressure, increased red-cell measures, prostate-related assessment and suppression of sperm production. A capsule should not be substituted for an injection or gel by comparing strength numbers. ²

The reviewed Kyzatrex label does not establish use in women. Off-label female use requires a distinct evaluation and product-specific review, including androgenic adverse effects and pregnancy risk. This reference does not establish a female testosterone product, dose or compounded formulation as appropriate. ²

Testosterone therapy is not established by age, fatigue, low mood or one laboratory result alone. Current labeling calls for confirming low morning testosterone on at least two separate days and identifying an associated medical condition before treatment. Acute illness, sleep disruption, obesity, medicines and timing can affect results. The evaluation should also consider fertility goals because external testosterone can suppress sperm production. A normal-aging claim or bodybuilding goal is outside the approved diagnostic framework. ^{1, 2}

Injections, oral capsules, gels, patches, nasal products and pellets have different exposure patterns and instructions. Transdermal products can transfer to another person through skin contact unless application and covering precautions are followed. Oral testosterone undecanoate products have food and blood-pressure considerations specific to their labels. A compounded cream or troche does not inherit the approval of a branded product. Confirm the exact route, concentration and measuring device; do not convert between routes by matching milligrams. ^{1, 2}

Follow-up may include symptoms, testosterone levels timed for the product, blood count, blood pressure and prostate-related assessment when appropriate. Rising hematocrit can increase risk and needs clinical management. Report new leg swelling, chest pain, shortness of breath, neurologic symptoms, severe headache, jaundice, marked urinary change or a prolonged painful erection promptly. Mood or sleep changes also matter. Do not respond to a laboratory value by changing the dose or adding anastrozole without the prescriber's plan. ^{1, 2}

Testosterone is a controlled substance and should be stored securely. Gels and solutions can transfer to children, partners or pets through skin or contaminated surfaces; wash hands, cover the site and follow product-specific contact precautions. Needles and multidose vials also require safe handling. Unexpected virilization, early puberty signs or skin exposure in another household member needs prompt medical advice and a review of application practices. ^{1, 2}