Testosterone

The selected U.S. products treat testosterone deficiency associated with primary or hypogonadotropic hypogonadism. Confirm low morning testosterone on at least two separate days before starting. They are not approved simply to improve performance, appearance, or nonspecific symptoms without the associated diagnostic condition.

In June 2026 FDA requested removal of the age-related limitation, a prostate-cancer contraindication limited to metastatic disease, and revised BPH warnings. These proposed changes still require baseline assessment and monitoring; long-term prostate-risk uncertainty remains. Those requests do not by themselves rewrite an individual product label. All six retrieved labels still say safety/efficacy in age-related hypogonadism are unestablished and still contraindicate known or suspected prostate cancer. Follow the current dispensed-product label and reassess when its revision is issued. Aveed is additionally reserved for patients whose benefits outweigh its serious injection risks. This profile covers these six products; other gels, oral brands, implants, nasal/buccal products, patches, and gender-affirming regimens require separate product or guideline review.

For replacement in hypogonadal males, the label specifies 50–400 mg every 2–4 weeks, individualized to clinical response and adverse effects. Inject deep into the gluteal muscle; never intravenously. This is not a subcutaneous-autoinjector regimen. Pubertal induction is individualized using chronological and skeletal age; no universal pediatric dose is established here. Inspect for particles/discoloration before administration. Label instructions allow warming and shaking to redissolve crystals caused by low-temperature storage.

Start 40.5 mg once each morning (two pump actuations). Adjust within 20.25–81 mg/day using predose morning testosterone about days 14 and 28 after initiation or a dose change, then periodically. Each actuation delivers 20.25 mg. Prime a new pump with three discarded actuations. Do not apply to the abdomen or genitals. Avoid washing the application site, swimming, or showering for at least 2 hours.

Start 50 mg each morning (four pump actuations, two 25-mg packets, or one 50-mg packet). Apply to shoulders/upper arms and/or abdomen, never genitals. Each actuation delivers 12.5 mg; prime a new pump with three discarded actuations. Follow serum testosterone and response; the label allows escalation to 75 then 100 mg/day for low concentrations. Stop if testosterone remains above the normal range even on 50 mg/day. Wait at least 5 hours before swimming or showering. The 1% and 1.62% regimens are not interchangeable.

Start 237 mg twice daily with food, morning and evening. Titrate in equal twice-daily steps of 158, 198, 237, 316 (two 158-mg capsules), or 396 mg (two 198-mg capsules). Measure serum testosterone 6 hours after the morning dose after at least 7 days on the starting or adjusted regimen. Use the specified plain serum tube and allow clotting at room temperature for 30 minutes before centrifugation to avoid misleading results. A level below 425 ng/dL calls for the next higher step; 425–970 maintains the dose; above 970 calls for the next lower step. Stop if above 970 at 158 mg twice daily. This algorithm applies to Jatenzo, not other oral undecanoate products.

Start 75 mg subcutaneously in the abdomen once weekly. Do not inject into muscle or a blood vessel. After 6 weeks of treatment or a dose change, obtain a trough testosterone level 7 days after the last injection. If below 350 ng/dL increase by 25 mg; if at least 650 decrease by 25 mg; maintain if at least 350 but below 650. Available weekly doses are 50, 75, and 100 mg. Follow the autoinjector instructions rather than adapting a vial/syringe technique.

Give 750 mg (3 mL) deep intramuscularly in the gluteal muscle initially, again after 4 weeks, then every 10 weeks. It has no labeled dose titration. A trained healthcare professional administers it slowly over 60–90 seconds while avoiding intravascular delivery. Observe on site for at least 30 minutes after every injection, with treatment available for pulmonary oil microembolism or anaphylaxis. Only certified providers and facilities in the Aveed REMS may administer it. Do not substitute a non-U.S. 1,000-mg undecanoate regimen or oral undecanoate.

All selected labels contraindicate male breast cancer, known or suspected prostate cancer, pregnancy, and hypersensitivity to that product’s components. Depo-Testosterone additionally contraindicates serious cardiac, hepatic, or renal disease. Xyosted contains sesame oil; Aveed contains refined castor oil and benzyl benzoate. Do not generalize Depo’s formal organ-disease contraindication to every formulation or treat other products’ fluid-retention precautions as a guarantee of safety.

AndroGel 1% and 1.62% carry boxed warnings for secondary testosterone exposure, including virilization in children. Wash hands after application, let skin dry, cover the site, and wash it before anticipated skin contact; wash another person’s exposed skin promptly. Aveed carries a boxed warning for serious pulmonary oil microembolism and anaphylaxis and requires REMS certification and observation after every injection. The retrieved Depo-Testosterone, Jatenzo, and Xyosted labels have no boxed warning; all still have substantial precautions.

Reported effects vary by formulation and include acne, application/injection-site reactions, increased hematocrit, increased blood pressure, edema, gynecomastia, and altered libido. Serious reports include thromboembolism and hypersensitivity; spontaneous reports cannot determine frequency or causality. Excess dosing or misuse can cause endocrine, cardiovascular, and psychiatric harm. Seek urgent assessment for severe symptoms; treatment is supportive and product-specific, including stopping exposure and washing off gel when relevant. Withdrawal after supratherapeutic misuse can include depression, fatigue, insomnia, and craving.

Androgens can reduce glucose and insulin requirements; follow glucose and adjust diabetes treatment clinically. Testosterone can alter oral anticoagulant effects. Monitor INR/prothrombin time more frequently when initiating, changing, or stopping testosterone in a patient receiving warfarin or a similar vitamin K antagonist. Do not invent a fixed warfarin adjustment.

ACTH or corticosteroids can add fluid retention, especially with cardiac, renal, or hepatic disease. Jatenzo/Xyosted specifically caution that other medicines raising blood pressure, including some OTC cold or pain medicines, can add to the effect; review them and monitor pressure. Androgens can lower thyroid-binding globulin and total T4 without necessarily changing free thyroid hormone or causing clinical thyroid dysfunction.

These products are not indicated for women and are contraindicated during pregnancy because fetal androgen exposure can cause virilization. Prevent pregnant people’s skin contact with unwashed gel sites. Milk/infant-effect information is insufficient to establish lactation safety; avoid treating the adult male indication as a breastfeeding recommendation. Exogenous testosterone can suppress spermatogenesis and cause oligospermia or azoospermia; discuss fertility plans before treatment.

The selected gels, Jatenzo, Xyosted, and Aveed do not establish safety/efficacy below age 18. Depo-Testosterone does not establish safety/efficacy below age 12; its individualized pubertal-use discussion is distinct from those adult-only labels. Pediatric androgen exposure can accelerate bone maturation and compromise height; Depo calls for hand/wrist bone-age assessment every 6 months when treating children. Older adults have limited product trial data and require monitoring for hematocrit, prostate symptoms, edema, and cardiovascular risks.

No validated universal renal/hepatic dose-conversion table exists for these products. Depo formally contraindicates serious cardiac, hepatic, or renal disease. The other selected labels warn about edema with preexisting cardiac/renal/hepatic disease; the gels and Aveed expressly lack renal/hepatic-impairment studies. Separate hepatic effects associated with older orally active 17-alpha-alkylated androgens from the selected testosterone preparations; a formulation distinction does not negate monitoring or contraindications.

Testosterone supports androgen-dependent sexual development and maintenance. External testosterone suppresses pituitary gonadotropin signaling and can reduce sperm production. Therapeutic concentrations do not guarantee preserved fertility. Replacement does not establish a benefit for performance enhancement or symptoms without confirmed hypogonadism.

Cypionate/enanthate and undecanoate esters are converted to testosterone after administration, but release depends on the ester, vehicle, and route. Gel absorption depends on the concentration, application site, and washing interval. Jatenzo is an oral undecanoate formulation requiring food; Aveed is a long-acting oil depot, not an oral equivalent. Use each product’s sample timing and titration algorithm; an injection trough, predose gel sample, and 6-hour oral sample answer different dosing questions.

Confirm the diagnosis and cause; assess prostate/breast disease, fertility goals, blood pressure, hematocrit, and interacting medicines. Recheck testosterone at the product-specific interval, monitor pressure periodically, and review symptoms and adverse effects. Jatenzo/Xyosted call for hematocrit about every 3 months and stopping for elevations; their labels specify permanent discontinuation if elevation recurs after restarting. The gels/Aveed call for baseline hematocrit, reassessment at 3–6 months, then annually, with stopping for elevated values. Depo requires periodic hemoglobin/hematocrit assessment. Review PSA/prostate symptoms, edema, sleep apnea, and lipids as directed and clinically appropriate; assess calcium in cancer patients at risk of hypercalcemia.

Explain the exact route, dose, timing, and blood-test schedule. Gel users must wash hands, dry and cover sites, wash before direct contact, and protect children and pregnant people; keep alcohol-based gel away from fire until dry. Aveed requires on-site observation after every injection. Seek urgent help for breathing difficulty, chest pain, severe allergy, signs of a clot, or suicidal thoughts. Report urinary changes, edema, sleep-apnea symptoms, persistent erections, or signs of androgen exposure in a child. Do not share a Schedule III medicine or alter dosing for bodybuilding.

Examples from the selected labels: Depo-Testosterone 200 mg/mL, 1-mL vial (NDC 0009-0417-01); AndroGel 1.62% metered pump (NDC 17139-562-88), 20.25 mg per actuation; AndroGel 1% pump (source package NDC 17139-501-02), 12.5 mg per actuation; Jatenzo 237-mg orange/white capsule marked 237, 120-count bottle (NDC 69087-237-12); Xyosted 75 mg/0.5 mL, four autoinjectors (NDC 54436-275-04); Aveed 750 mg/3 mL single-use vial (NDC 67979-511-43). Verify the actual label and any repackager identity rather than identifying medicine by appearance alone.

Depo: 100 and 200 mg/mL intramuscular solutions. AndroGel 1.62%: 20.25-mg pump actuations and 20.25-/40.5-mg packets; 1%: 12.5-mg pump actuations and 25-/50-mg packets. Jatenzo: 158-, 198-, and 237-mg oral capsules. Xyosted: 50-, 75-, and 100-mg/0.5-mL subcutaneous autoinjectors. Aveed: 750 mg/3 mL intramuscular single-use vial. No cross-product mg-for-mg conversion is provided.

Follow the dispensed package: Depo, AndroGel 1.62%, Jatenzo, and Xyosted specify 20–25°C; AndroGel 1% and Aveed specify 25°C. Labeled excursions of 15–30°C apply where specified. Protect Depo from light; keep Aveed in its carton and discard unused vial contents. Keep Xyosted in its carton away from light, do not refrigerate or freeze, and use at room temperature. Keep Jatenzo dry. Secure all products from children; discard pumps/packets safely because residual gel can expose others, and dispose of injection devices in sharps containers.