Testosterone Enanthate Medicaid Coverage by State Tier (2026 Guide)

At a glance

  • Product / Intramuscular testosterone enanthate from Eugia and Hikma [1]
  • Controlled substance / Schedule III [2]
  • Label indications / Primary and hypogonadotropic hypogonadism; delayed puberty in selected boys [2]
  • Age-related low testosterone / Label says safety and efficacy are not established [2]
  • Label dose / 50 to 400 mg intramuscularly every 2 to 4 weeks [2]
  • Blood pressure / FDA says monitoring studies confirmed a rise with all testosterone products [3]
  • Contraindications / Breast cancer, prostate cancer, pregnancy [2]

What can be said about state coverage

No state Medicaid preferred drug list or prior authorization document for testosterone enanthate is available to this page, so tier placement, step therapy and copay amounts by state cannot be described.

What the label covers

Testosterone Enanthate Injection, USP is indicated for replacement therapy in men with primary hypogonadism from testicular failure, or hypogonadotropic hypogonadism from gonadotropin or luteinizing hormone-releasing hormone deficiency or pituitary or hypothalamic injury from tumors, trauma or radiation [2]. The label also lists delayed puberty in carefully selected males [2].

The label states that safety and efficacy in men with age-related hypogonadism have not been established [2], while FDA has requested removal of that limitation of use and revision of prostate cancer and benign prostatic hyperplasia safety information [4]. FDA says none of the approved testosterone products is approved for men with low testosterone who lack an associated medical condition [4].

The label lists as contraindications carcinoma of the breast or known or suspected carcinoma of the prostate in men, and women who are or may become pregnant, because androgens cause virilization of the external genitalia of a female fetus [2].

Schedule III, not Schedule II

The label states that testosterone enanthate contains testosterone, a Schedule III controlled substance under the Controlled Substances Act [2]. Its drug abuse and dependence section describes serious cardiovascular and psychiatric adverse reactions reported in people who abuse anabolic androgenic steroids [2].

The dose the label states, and what comes first

For male hypogonadism the label's suggested dose is 50 to 400 mg every 2 to 4 weeks, injected slowly and deeply into the gluteal muscle; total doses above 400 mg per month are generally not required, and injections more often than every 2 weeks are rarely indicated [2]. The label says hypogonadism should be confirmed first with morning serum testosterone on at least two separate days, both below the normal range [2].

What the label says to watch

FDA said in February 2025 that required ambulatory blood pressure studies confirmed a blood pressure increase with all testosterone products, class-wide [3]. The enanthate label warns that testosterone can increase blood pressure, which can increase cardiovascular risk over time, that blood pressure should be monitored periodically, and that testosterone products are not recommended in patients with uncontrolled hypertension [2]. It also says to evaluate leg pain, swelling, warmth and redness for deep vein thrombosis, and acute shortness of breath for pulmonary embolism [2].

Polycythemia is among the label's listed adverse reactions [2]. Across 29 placebo-controlled trials in 3,393 men, intramuscular testosterone enanthate or cypionate raised mean hematocrit by 4.0% (95% CI 2.9 to 5.1) versus placebo [5].

Frequently asked questions

Is testosterone enanthate approved for low testosterone from aging?
The label states that safety and efficacy in men with age-related hypogonadism have not been established [2], and FDA says none of the approved testosterone products is approved for men with low testosterone who lack an associated medical condition [4]. FDA asked in June 2026 for that limitation to be removed [4].
What does the label say to do before a first injection?
The label says to confirm hypogonadism with morning serum testosterone measured on at least two separate days, with concentrations below the normal range [2]. It says to inject slowly and deep into the gluteal muscle [2].
Is testosterone enanthate a controlled substance?
Yes. The label states it contains testosterone, a Schedule III controlled substance under the Controlled Substances Act [2]. It is not Schedule II.
Is Xyosted the same product?
No. Xyosted is a separate testosterone enanthate subcutaneous autoinjector with its own labeling, listed separately from the intramuscular vials in DailyMed [1].

References

  1. DailyMed - Search Results for testosterone enanthate. DailyMed - Search Results for testosterone enanthate
  2. U.S. National Library of Medicine, DailyMed. Testosterone enanthate injection USP intramuscular, Hikma prescribing information. Testosterone enanthate injection USP intramuscular, Hikma label
  3. FDA issues class-wide labeling changes for testosterone products | FDA. FDA issues class-wide labeling changes for testosterone products | FDA
  4. Testosterone Information | FDA. Testosterone Information | FDA
  5. Nackeeran S, Kohn T, Gonzalez D, White J, Ory J, Ramasamy R. The Effect of Route of Testosterone on Changes in Hematocrit: A Systematic Review and Bayesian Network Meta-Analysis of Randomized Trials. J Urol. 2022. The Effect of Route of Testosterone on Changes in Hematocrit: A Systematic Review and Bayesian Network Meta-Analysis of Randomized Trials
Evidence overview for Testosterone Enanthate Medicaid Coverage by State Tier (2026 Guide)