Anavar

FDA withdrew Oxandrin approval effective June 28, 2023, and in a September 2023 determination notice concluded that its tablets were withdrawn for reasons of safety or effectiveness, citing labeled risks including peliosis hepatis, liver-cell tumors, adverse lipid changes, cholestatic hepatitis and an unfavorable benefit-risk profile without substantial evidence of effectiveness. Presenting Anavar/oxandrolone as a currently FDA-approved drug without that history is misleading.^[3]

Jurisdiction

United States

Product

Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg (NDA 013718, held by Gemini Laboratories LLC)

Indication

Originally approved as adjunctive therapy for weight gain after severe weight loss, corticosteroid-related protein catabolism and osteoporosis-related bone pain; FDA withdrew approval effective June 28, 2023, and on September 8, 2023 determined under 21 CFR 314.161 that the product was withdrawn for reasons of safety or effectiveness

Record date

2026-09-08 · Approved 1964-07-21

• US Oxandrin determination; foreign status and individual compounded products require separate review.

In a 9-month randomized, placebo-controlled trial comparing testosterone enanthate, an oral-anabolic-steroid arm and placebo in 30 obese men aged 40-60 undergoing dietary weight loss, oral oxandrolone lowered HDL and raised LDL cholesterol; investigators switched that treatment arm to parenteral nandrolone decanoate after three months because of the lipid changes.^[1]

• Small selected population and treatment switch; does not quantify cardiovascular events or safety in other populations.
• Abstract-checked; no qualified clinical review.
• The abstract does not report how the 30 participants were divided among the three arms.

LiverTox's Androgenic Steroids chapter individually names methandrostenolone (Dianabol), oxymetholone (Anadrol), fluoxymesterone (Halotestin), stanozolol (Winstrol) and oxandrolone (Anavar) among the C-17-alpha-alkylated steroids it says "have all been implicated in cases of liver injury, including prolonged cholestasis, peliosis hepatis, nodular regeneration, hepatic adenomas and hepatocellular carcinoma," and estimates that acute cholestasis occurs in roughly 1% of patients treated specifically with methyltestosterone, danazol, stanozolol or oxymetholone. Methasterone (Superdrol) is not named in that class-level narrative; LiverTox links it to liver injury only through separately cited case-report literature. This class context does not establish an equal, quantified risk for every one of these six compounds, formulations or exposures.^[4]

• Class-level synthesis; no product-specific event rate and no evidence that supplements prevent injury.
• The approximate 1% acute-cholestasis estimate applies only to methyltestosterone, danazol, stanozolol and oxymetholone; it is not stated for methandrostenolone, fluoxymesterone, oxandrolone or methasterone.
• Methasterone/Superdrol's connection to this LiverTox chapter runs through cited case-report literature (including the same methasterone case series relied on elsewhere in this dossier), not the chapter's own class-level narrative naming used for the other five compounds.

A study of male weightlifters associated long-term mixed AAS exposure with lower left-ventricular function and greater coronary plaque volume than in non-users. The observational design cannot isolate an individual steroid or prove a precise risk of heart attack.^[5]

• Class-context evidence from selected male weightlifters; residual confounding and uncertain historical exposures remain.
• This finding and the interaction file's "safety-aas-cardiovascular" note rest on the same single study, held under two source records. Seeing both is not two studies agreeing.

The HAARLEM echocardiography cohort found increased left-ventricular mass and reduced function during mixed AAS use. Left-ventricular mass and the E/A ratio returned to baseline at follow-up, when only 25 of 31 participants had recovery imaging. These group findings cannot promise that every person or repeated exposure recovers.^[6]

• Small cohort, coexposures and missing follow-up; no clinical-event or molecule-specific risk estimate.

A cross-sectional study of male weightlifters associated long-term illicit AAS use with impaired cardiac function and more coronary plaque. The study cannot establish the risk from one particular compound, dose or combination.^[5]

• This note and the compound records' "general-anadrol-safety-86" finding rest on the same single study, held under two source records. Seeing both is not two studies agreeing.
• Observational evidence, self-reported mixed exposures and potential confounding; not a comparison of medically indicated testosterone treatment.
• This is the same underlying study cited at full-text scope elsewhere in the site (content/evidence/general.ts "general-aas-cardiovascular-full"); it is one single source, not independent corroboration.

FDA reports serious liver injury and other serious reactions involving steroid or steroid-like bodybuilding products. It advises immediately consulting a healthcare professional, including before abrupt cessation, because of dangerous withdrawal problems that can arise from quickly stopping such products.^[7]

• General product safety communication, not an incidence estimate for every listed steroid.

In the HAARLEM cohort of men using mixed anabolic-androgenic steroids, testosterone and sperm recovery differed. The final visit was one year after cycle start, not one year after cessation, and some abnormal final results were already present at baseline. The study did not measure pregnancy or live birth and does not provide a universal recovery deadline.^[2]

• Class-context evidence: mixed exposures cannot isolate any individual molecule or ester, and follow-up was too short to characterize all recovery.
• Final hormone and semen denominators differ; attrition and resumed use limit recovery inference.

Long-term illicit AAS exposure was associated with myocardial dysfunction and greater coronary plaque in male weightlifters. Concern about combining AAS follows from this class evidence; the incremental risk of any two steroids was not measured, and the paper does not name or compare specific steroid combinations.^[5]

• Observational, mixed self-reported exposure; no pair-specific causal estimate.
• This is the same underlying study cited at full-text scope elsewhere in the site (general.ts "general-aas-cardiovascular-full"); it is one single source, not independent corroboration.

FDA warns that people who “stack” steroid-like bodybuilding products with other products, including stimulants, may be at greater risk for serious and life-threatening reactions. This broad warning does not establish the effect or severity of an individual compound pair.^[7]

• This evidence does not establish the magnitude or frequency of harm from the selected combination.

Methasteron case reports and an oxymetholone trial document liver injury or liver-test abnormalities with individual oral steroids. Added liver risk from combining two 17-alpha-alkylated steroids is a concern, but these studies do not measure or prove a multiplying effect.^[8][9]

• This evidence does not establish the magnitude or frequency of harm from the selected combination.

Liver injury reports involving oral methasteron and products labeled RAD-140/LGD-4033 motivate a possible overlapping liver concern. The additional risk when these agents are combined is unknown; this evidence does not identify YK-11 toxicity.^[8][10]

• This evidence does not establish the magnitude or frequency of harm from the selected combination.

A review of testosterone-treatment studies found increased hemoglobin and hematocrit. Extrapolating to combined anabolic steroids suggests a possible overlapping effect, but the review did not establish pair-specific thrombosis risk.^[11]

• This evidence does not establish the magnitude or frequency of harm from the selected combination.

Testosterone-related hematocrit increases and tamoxifen/raloxifene thromboembolic findings come from different study populations. They motivate a possible overlapping concern, not evidence of a measured thrombosis increase from the selected pair.^[11][12]

• This evidence does not establish the magnitude or frequency of harm from the selected combination.

A controlled study in men given goserelin, testosterone gel and anastrozole linked estrogen deficiency to increased body fat and a contribution to reduced sexual function. Only anastrozole was studied; it does not establish the outcome of combining aromatase inhibitors generally, or of adding anastrozole specifically to a particular anabolic steroid.^[13]

• This evidence does not establish the magnitude or frequency of harm from the selected combination.
• Exemestane and letrozole were not administered in this trial and do not inherit this observation; the compound scope and the corresponding rule's applicable IDs are narrowed to anastrozole (see interactionsFileNotes).