Oxandrolone

Oxandrolone is a synthetic anabolic steroid taken by mouth. It was approved in the US from 1964, but the FDA withdrew all approvals in 2023 after concluding its risks outweighed unproven benefits.

What it is

Oxandrolone is a synthetic anabolic–androgenic steroid taken as a tablet. In the US it was sold as Oxandrin and as generic tablets. The FDA withdrew approval of all oxandrolone tablets in June 2023 ^[1].

How it works

Like other androgens, oxandrolone binds to androgen receptors inside cells. The receptor moves to the nucleus and switches on genes involved in growth and development ^[6]. Oxandrolone is a 17-alpha-alkylated steroid. This chemical change lets it survive breakdown in the liver so it can be taken by mouth, and steroids of this type can cause cholestatic liver injury ^[6].

Approved medical uses

None currently approved in the UK or US.

In the US, Oxandrin was first approved in 1964. Its labelled uses were as add-on therapy to promote weight gain after weight loss from extensive surgery, chronic infection or severe trauma, to offset protein breakdown during long-term corticosteroid treatment, and to relieve bone pain linked to osteoporosis ^[2].

In 2023 the FDA withdrew approval of the brand and all generic versions ^[1]. The FDA later determined that Oxandrin was withdrawn for reasons of safety or effectiveness. It noted that an FDA advisory committee had concluded unanimously in 1984 that there was no evidence of efficacy for oxandrolone, and that the benefit–risk profile was unfavourable ^[2].

What the research shows

• Severe burns. Oxandrolone has been studied to reduce muscle and weight loss after major burns. A 2025 meta-analysis of 19 randomised trials found that it shortened hospital stay and reduced weight loss, but did not reduce deaths or speed donor-site healing. The trials were small and very varied, some had a high risk of bias, and long-term safety data were limited ^[3].
• Weight loss in HIV. A Cochrane review of anabolic steroids, including oxandrolone, for weight loss in people with HIV found small increases in lean body mass and body weight compared with placebo. Most trials were small and short ^[4].
• Chronic obstructive pulmonary disease (COPD). A 2022 meta-analysis of 8 small trials of anabolic steroids, including oxandrolone, found small increases in body weight and fat-free mass but no improvement in lung function or walking distance ^[5].
• Regulatory view. When withdrawing approval, the FDA concluded that the drug "would not be considered safe and effective" if it were reintroduced to the market today ^[2].

Known risks and side effects

• Liver injury. FDA labelling warned of peliosis hepatis (blood-filled cysts in the liver), sometimes with liver failure or bleeding into the abdomen, liver cell tumours that were sometimes fatal, and cholestatic hepatitis ^[1]. 17-alpha-alkylated steroids are a recognised cause of cholestatic jaundice ^[6].
• Blood fat changes. Oxandrolone causes changes in blood lipids that are known to increase the risk of atherosclerosis ^[1]. High-dose use may affect liver enzymes and lipid metabolism ^[3].
• Other labelled risks include high blood calcium in people with cancer and prostate problems in older men ^[1].
• Effects of anabolic steroid misuse include high blood pressure, heart attack and stroke, reduced sperm count and shrunken testicles in men, and excess body hair and a deeper voice in women ^[7].
• Mental health. Aggression, mood swings and paranoia have been reported with anabolic steroid misuse ^[7].
• Oxandrolone is prohibited at all times in sport under the World Anti-Doping Agency (WADA) Prohibited List ^[8].

Talk to a doctor about any concerns.

Blood tests commonly monitored

There are no current official monitoring guidelines for oxandrolone, because it is no longer an approved medicine in the US. For the closest approved androgen medicines, testosterone injections, labels and guidelines advise monitoring:

• Liver function tests ^[9].
• Cholesterol (lipid profile) ^[9].
• Haemoglobin and haematocrit ^{[9, 10]}.
• PSA (prostate-specific antigen) in men for whom prostate monitoring is appropriate ^[10].

Sources

1. US Food and Drug Administration. Withdrawal of approval of one new drug application (OXANDRIN) and four abbreviated new drug applications for oxandrolone tablets. Federal Register, 28 June 2023. GovInfo
2. US Food and Drug Administration. Determination that OXANDRIN (oxandrolone) tablets were withdrawn from sale for reasons of safety or effectiveness. Federal Register, 13 September 2023. GovInfo
3. Cui S, et al. The efficacy and safety of androgen analog oxandrolone in improving clinical outcomes in burn patients: a systematic review and meta-analysis of randomized controlled trials. Frontiers in Medicine, 2025. Frontiers
4. Cochrane Clinical Answers. In HIV-infected individuals, what are the effects of anabolic steroids for treating weight loss? Based on Johns K, Beddall MJ, Corrin RC, Cochrane Database of Systematic Reviews, 2005. Cochrane Library
5. Liu Y, Huang C, Du J, et al. Anabolic-androgenic steroids for patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis. Frontiers in Medicine, 2022. Frontiers
6. National Library of Medicine. Androgenic Steroids. LiverTox: Clinical and Research Information on Drug-Induced Liver Injury, NCBI Bookshelf, updated 2020. NCBI Bookshelf
7. NHS. Anabolic steroid misuse. NHS
8. World Anti-Doping Agency. The 2026 Prohibited List, International Standard, as published in the Treaty Series of the Kingdom of the Netherlands (Tractatenblad 2026, No. 25). Officielebekendmakingen.nl
9. Pfizer. DEPO-Testosterone (testosterone cypionate) injection: US prescribing information, revised 2025. Pfizer labeling
10. Bhasin S, Brito JP, Cunningham GR, et al. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. Journal of Clinical Endocrinology and Metabolism, 2018. Endocrine Society

Related

Last reviewed 7 October 2026. General information, not medical advice. Found a mistake? Email [email protected].