Safety
Boxed warning: secondary exposure. Children have shown signs of early puberty after touching skin where testosterone gel was applied, so wash your hands, cover the site and avoid skin-to-skin contact until it is washed. Gel can also raise blood pressure, worsen an enlarged prostate, cause blood clots and lower sperm counts. Labels call for periodic checks of testosterone, PSA, hemoglobin, hematocrit, liver tests and lipids. Gels are flammable until dry.
Talk to a licensed clinician about your health history and every medication you take before you start.
Legal status
Prescription only; FDA-approved. Testosterone is a Schedule III controlled substance. Prescribing it by telemedicine without an in-person exam relies on the DEA and HHS temporary extension that runs through Dec 31, 2026 (90 FR 61301); without a further extension or a final rule, the in-person requirement returns on Jan 1, 2027. Compounded creams are lawful under section 503A when they differ meaningfully from approved gels, but they are not FDA-approved. Online prescribing needs a live video visit with the prescriber under the DEA’s temporary telemedicine rule, which runs through December 31, 2026.
What testosterone gel or cream is
Testosterone gel or cream is made by Ascend Therapeutics (AndroGel 1.62%), Upsher-Smith (Vogelxo) and generic makers. FDA-approved topical testosterone comes as gels (AndroGel, Vogelxo and generics) and a topical solution. Testosterone creams are prepared by compounding pharmacies and are not FDA-approved. The gel labels carry the same “age-related hypogonadism” limitation as injections.
FDA-approved for
- Primary hypogonadism (congenital or acquired) in adult males
- Hypogonadotropic hypogonadism (congenital or acquired) in adult males
Dosing
Gel or solution rubbed into the skin (FDA-approved), or a compounded cream, in the morning. AndroGel 1.62% starts at 40.5 mg once a day on the shoulders and upper arms, adjusted between 20.25 mg and 81 mg from morning levels taken about 14 and 28 days in. Compounded cream strengths vary by prescription. Your clinician sets the dose for you.
How well it works
In the AndroGel 1.62% label study, 146 of 179 men (81.6%) on treatment had average testosterone in the normal range (300 to 1,000 ng/dL) at day 112. TRAVERSE, the largest heart-safety trial of testosterone, used this gel and found 7.0% major heart events on testosterone vs 7.3% on placebo. Individual results vary.
Testosterone gel or cream cost
Some prices need a membership or a 6-month plan, and most programs we list prescribe a compounded cream rather than an FDA-approved gel. For a full breakdown, read How much does TRT cost online?. For the steps, read How to get TRT online.