Testosterone injection, gel and cream deliver the same hormone in different ways, and they are regulated differently. The Depo-Testosterone (testosterone cypionate) label describes an FDA-approved injection into muscle, the AndroGel 1.62% label describes an FDA-approved gel applied daily to the skin, and FDA states compounded drugs are not FDA approved, which includes a compounded cream.
The injection: what the cypionate label says
Testosterone cypionate is an oil-soluble ester of testosterone, and the cypionate label lists it for intramuscular injection. It comes in 100 mg/mL and 200 mg/mL strengths, dissolved in cottonseed oil with benzyl benzoate and benzyl alcohol as a preservative.
The label says the drug is absorbed slowly from the oil, so it can be given every 2 to 4 weeks, and its half-life after injection is about eight days. It is for intramuscular use only, not for use in a vein, and the label says to give it deep in the gluteal muscle. The label lists a dose range of 50 to 400 mg every 2 to 4 weeks, adjusted to the patient's response and side effects. A licensed provider decides whether any dose is right for a given person. Pain at the injection site is among the adverse reactions the label lists.
The gel: daily use and skin transfer
The AndroGel 1.62% label says it is applied once daily in the morning, to the shoulders and upper arms only. Users should avoid swimming, showering or washing the site for at least 2 hours after applying it.
Because it sits on the skin, the gel can pass to other people. The label carries a boxed warning that virilization has been reported in children secondarily exposed to testosterone gel. Reported signs included enlarged penis or clitoris, pubic hair, increased erections and libido, aggressive behavior and advanced bone age. Most regressed after exposure ended, but a few did not fully.
The label's steps to lower this risk are to wash hands with soap and water after applying, cover the site with clothing once dry, and wash the site before expected skin-to-skin contact with another person. Children should avoid contact with unwashed or unclothed application sites.
Compounded cream: how the rules differ
A compounded cream is made by a pharmacy for a specific patient rather than approved as a finished product. FDA says it does not review the safety, effectiveness or quality of compounded drugs before they are marketed.
Under section 503A, compounded drugs are exempt from FDA approval and some other requirements only if conditions are met, one of which is compounding based on valid patient-specific prescriptions. FDA's compounding questions and answers say these pharmacies are not subject to CGMP requirements, unlike 503B outsourcing facilities, and that state boards of pharmacy generally have primary day-to-day oversight.
The same FDA page says compounded drugs should only be used in patients whose needs cannot be met by an FDA-approved drug, and that poor compounding practices can cause contamination or too much or too little active ingredient. It also notes that people buying compounded drugs through online pharmacies or telehealth platforms may not know who the compounder is or whether it meets quality standards.
| Question | What the source says |
|---|---|
| How often is it used? | Cypionate injection: every 2 to 4 weeks. Gel: once daily in the morning. |
| Where does it go? | Injection: deep in the gluteal muscle. Gel: shoulders and upper arms only. |
| Is there a skin transfer warning? | Yes, a boxed warning on the gel label about children exposed to gel. |
| Did FDA review it before sale? | Injection and gel are FDA-approved products. Compounded drugs are not FDA approved. |
Blood counts may differ by form
A network meta-analysis of 29 placebo-controlled trials (3,393 men) found every testosterone form raised mean hematocrit. Intramuscular enanthate or cypionate raised it 4.0% (95% CI 2.9 to 5.1), significantly more than the patch. The cypionate label says hemoglobin and hematocrit should be checked periodically during long-term use.
What this does not tell you
None of these sources tested a compounded testosterone cream. The transfer warnings above come from an FDA-approved gel label, and they do not show how a cream behaves on the skin or how much testosterone it delivers. A compounded cream is not the same as an FDA-approved product. The hematocrit comparison ranked injections against the patch, and it does not tell you how a cream compares. Which form, if any, suits a person is a decision for a licensed provider after reviewing that person's history and lab results.