Safety
No boxed warning since 2025, but oral testosterone can raise blood pressure, which can increase heart risk over time: labels say to measure blood pressure periodically and not to use it with uncontrolled high blood pressure. It can also cause azoospermia (no sperm), blood clots, swelling in people with heart, kidney or liver disease, worse sleep apnea and lipid changes. Schedule III controlled substance.
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. Online prescribing needs a live video visit with the prescriber under the DEA’s temporary telemedicine rule, which runs through December 31, 2026.
What Oral testosterone is
Oral testosterone contains testosterone undecanoate, made by Marius Pharmaceuticals (Kyzatrex), Tolmar (Jatenzo), Verity Pharmaceuticals (Tlando). Kyzatrex, Jatenzo and Tlando are FDA-approved oral testosterone undecanoate capsules with no generic. Their blood pressure boxed warnings were removed in 2025. Compounded oral testosterone capsules and troches sold online are not FDA-approved.
FDA-approved for
- Primary hypogonadism (congenital or acquired) in adult males
- Hypogonadotropic hypogonadism (congenital or acquired) in adult males
Dosing
Capsule, twice a day with food (Kyzatrex can be lowered to once a day). Kyzatrex starts at 200 mg twice a day with food; levels are checked 7 days in, and the dose runs from 100 mg once a day to 400 mg twice a day. Tlando is 225 mg twice a day with food. Your clinician sets the dose for you.
How well it works
In the Kyzatrex label study, 122 of 139 men (88%) had average testosterone in the normal range (222 to 800 ng/dL) at day 90. In the Tlando study, 80% of 95 men reached the normal range (300 to 1,080 ng/dL) at day 24. Individual results vary.
Oral testosterone cost
That range mixes FDA-approved Kyzatrex with compounded troches, and the troche price needs a membership. For a full breakdown, read How much does TRT cost online?. For the steps, read How to get TRT online.