Testosterone Enanthate and Autoimmune Disease: What Clinicians and Patients Need to Know

At a glance

  • Approved use / Replacement in men with primary or hypogonadotropic hypogonadism [2]
  • Hematocrit / Intramuscular enanthate or cypionate raised mean hematocrit by 4.0% over placebo across 29 trials [3]
  • Clots / Venous thromboembolism reported with testosterone products; the label says to discontinue and evaluate if suspected [2]
  • Corticosteroids / The label lists an enhanced tendency toward edema when given with ACTH or corticosteroids [2]
  • Oral anticoagulants / The label says patients need close monitoring, especially when an androgen is started or stopped [2]

Does testosterone enanthate treat autoimmune disease?

No. Testosterone enanthate injection is labeled for replacement in men with primary or hypogonadotropic hypogonadism [2], and none of the FDA-approved testosterone products are approved for men with low testosterone who lack an associated medical condition [1]. A 2014 review lists hypoandrogenemia among the hormonal changes that accompany chronic inflammatory disease [4]; that describes a hormonal pattern in disease and is not evidence that enanthate treats it.

What the label warns about

These label warnings apply to any man given enanthate, including men who also have an autoimmune condition. In a network meta-analysis of 29 placebo-controlled randomized trials in 3,393 men, intramuscular enanthate or cypionate raised mean hematocrit by 4.0% over placebo (95% CI 2.9 to 5.1) [3]. The label lists polycythemia as a reaction. It also reports venous thromboembolism, including deep vein thrombosis and pulmonary embolism, with testosterone products, and says to discontinue treatment and begin a workup if one is suspected [2].

The label also lists sodium and water retention and warns that edema, with or without congestive heart failure, can be a serious complication in patients with preexisting cardiac, renal or hepatic disease [2]. It says ACTH and corticosteroids show an enhanced tendency toward edema and that caution is needed when they are given together [2]. The label states that testosterone can increase blood pressure and that testosterone products are not recommended in uncontrolled hypertension [2]. FDA said in February 2025 that ambulatory blood pressure studies confirmed a blood pressure increase with all testosterone products [5].

Is there any autoimmune evidence for testosterone?

One pilot crossover study gave 10 men with relapsing-remitting multiple sclerosis 12 months of daily testosterone gel (10 g containing 100 mg) after a 6-month pretreatment period. Brain atrophy slowed (P<.001) and cognitive performance improved (P=.008), with no significant effect on gadolinium-enhancing lesion numbers (P=.31) or volumes (P=.94) [6]. That was gel, not enanthate, and the authors called the findings exploratory.

What the label requires before treatment

The label directs that hypogonadism be confirmed with morning serum testosterone measured on at least two separate days and below the normal range before starting, and gives 50 to 400 mg every 2 to 4 weeks for male hypogonadism [2]. The 2018 Endocrine Society guideline recommends against starting testosterone therapy in men with elevated hematocrit [7].

Frequently asked questions

Can you take testosterone enanthate if you have an autoimmune disease?
Autoimmune disease is neither an approved use nor a listed contraindication; the label's contraindications are breast cancer, known or suspected prostate cancer, pregnancy and hypersensitivity to a component [2]. Label warnings that may matter include polycythemia, venous thromboembolism, fluid retention with corticosteroids or ACTH, and anticoagulant monitoring [2].
Does testosterone enanthate raise the risk of blood clots?
Venous thromboembolism, including deep vein thrombosis and pulmonary embolism, has been reported with testosterone products, and the label says to discontinue treatment and begin a workup if one is suspected [2]. Intramuscular enanthate or cypionate raised mean hematocrit by 4.0% over placebo in 29 randomized trials [3].
Can testosterone help multiple sclerosis?
In a pilot crossover study of 10 men with relapsing-remitting MS, 12 months of testosterone gel slowed brain atrophy (P<.001) and improved cognition (P=.008), with no significant effect on gadolinium-enhancing lesions [6]. The authors called the results exploratory, and the study used gel rather than enanthate.

References

  1. Testosterone Information | FDA. Testosterone Information | FDA
  2. U.S. National Library of Medicine, DailyMed. Testosterone enanthate injection USP intramuscular, Hikma prescribing information. Testosterone enanthate injection USP intramuscular, Hikma label
  3. 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;207(1):44-51. The Effect of Route of Testosterone on Changes in Hematocrit: A Systematic Review and Bayesian Network Meta-Analysis of Randomized Trials
  4. Straub RH. Interaction of the endocrine system with inflammation: a function of energy and volume regulation. Arthritis Res Ther. 2014;16(1):203. Interaction of the endocrine system with inflammation: a function of energy and volume regulation
  5. FDA issues class-wide labeling changes for testosterone products | FDA. FDA issues class-wide labeling changes for testosterone products | FDA
  6. Sicotte NL, Giesser BS, Tandon V, Klutch R, Steiner B, Drain AE, et al. Testosterone treatment in multiple sclerosis: a pilot study. Arch Neurol. 2007;64(5):683-8. Testosterone treatment in multiple sclerosis: a pilot study
  7. Bhasin S, Brito JP, Cunningham GR, Hayes FJ, Hodis HN, Matsumoto AM, et al. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2018;103(5):1715-1744. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline
Evidence overview for Testosterone Enanthate and Autoimmune Disease: What Clinicians and Patients Need to Know