DailyMed NDA 12-535 (oxymetholone label)
FDA Anadrol-50 prescribing information
FDA / Alaven-Meda Pharmaceuticals
EmergingResearch compound
Anadrol (Oxymetholone)
Oxymetholone, 2-hydroxymethylene-17α-methyl-DHT derivative oral AAS. FDA-approved (Anadrol-50) for aplastic and hypoplastic anemia. Classic "wet" bulking steroid; high hepatotoxicity and paradoxical estrogen-like side effects.
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WHAT IS ANADROL (OXYMETHOLONE)?
Detailed overview
Anadrol (Oxymetholone) is a 2-hydroxymethylene-17α-methyl-DHT derivative oral AAS originally synthesized by Syntex in 1960. FDA-approved clinical indications: aplastic anemia, congenital and acquired red cell deficiency anemias (Anadrol-50, now Alaven/Meda Pharmaceuticals). Anabolic:androgenic ratio 320:45 (high anabolic, moderate androgenic). High hepatotoxicity due to 17α-methyl group (one of the highest among AAS). The 2-hydroxymethylene group is NOT a CYP19 substrate (does not aromatize), BUT shows direct ER agonist activity – paradoxical "estrogen-like" side effects (water retention, gynecomastia risk) appear even without aromatization. In bodybuilding context, a "wet" bulking steroid: 10-15 kg weight gain in 4-6 weeks (substantially water + glycogen) documented. WADA-banned year-round.
Mechanism
AR agonist + direct ER agonist (paradoxical)
Anabolic:Androgenic
320:45
Half-life
8-9 hours (oral)
Onset
1-2 h (oral)
Legal status
FDA Rx (Anadrol-50), Schedule III, WADA-banned
Data console
Lab data
/lab/molecular-data.jsonLIVE
> Androgenic:Anabolic320:45
> AR bindingHigh AR affinity + atypical ER activity (Pope-Kanayama 2014…
> Active half-life~16 h (with active metabolites)
> Detection windowOxymetholone metabolites urinary 6-8 weeks (WADA-accredited GC-MS and LC-MS/MS; Schänzer 1996 PMID 8616181).
> AromatizationNot a CYP19 substrate – BUT due to direct ER agonist activity, estrogen-like side effects (water retention, gynecomastia) appear despite anti-aromatase treatment. Only protection: SERM (Nolvadex 20 mg/day or Raloxifene 60 mg/day) (Pope-Kanayama 2014 PMID 24423981)
> HepatotoxicityVery high – 17α-methyl group extreme hepatic first-pass stress, ALT/AST 5-10x rise common, cholestatic jaundice case-reported. Among the highest hepatotoxicity AAS together with Dianabol and Superdrol (Hartgens-Kuipers 2004 PMID 15233599, Pavlatos 2001 PMID 11329221)
Safety
Side effects, stop signs, contraindications
Side effects · 8
- Severe hepatotoxicity: as a 17α-alkylated oral, 5-10x ALT/AST elevation, cholestatic jaundice, rarely peliosis hepatis and liver tumors (adenoma, hepatocellular carcinoma) with prolonged use
- Paradoxical estrogen-like effects without aromatization: direct ER-agonist activity causes water retention, edema, bloated face and gynecomastia; aromatase inhibitors are useless here, only a SERM protects
- Drastic lipid worsening and raised blood pressure: HDL drop up to 60%, rising LDL, water-retention hypertension (often above 140/90), increasing cardiovascular risk
- HPTA suppression: endogenous testosterone production shuts down, testicular atrophy, reduced libido and sperm count; recovery can take months, with prolonged hypogonadism without PCT
- Polycythemia (erythrocytosis): the pronounced erythropoietic effect raises hematocrit and red cell count, increasing the risk of thrombosis, stroke and heart attack
- Androgenic side effects: acne, increased sebum, androgenic hair thinning (in predisposed individuals), prostate enlargement in older men
- Psychiatric effects: marked aggression ("Anadrol rage"), irritability, mood swings and depression; one of the most intense mood-disturbance profiles among AAS
- Virilization in women: deepened voice, facial and body hair, clitoral enlargement, menstrual disruption – develops fast and often irreversibly due to high androgenic activity
Contraindications · 7
- Any pre-existing liver disease or elevated baseline ALT/AST (fatty liver, hepatitis, cholestasis) – absolute contraindication due to the extreme hepatic stress of the 17α-alkylated structure
- Pregnancy and breastfeeding: teratogenic, causes fetal virilization – absolute contraindication
- Existing or suspected prostate or breast carcinoma, or male breast carcinoma – may drive progression of androgen-dependent tumors
- Cardiovascular risk: existing hypertension, ischemic heart disease, dyslipidemia or positive family history – due to HDL crash, raised blood pressure and polycythemia
- Polycythemia or elevated baseline hematocrit, or a history of thrombosis/stroke – the erythropoietic effect raises hematocrit further
- Planned fatherhood / active fertility goals: HPTA suppression can depress sperm production for months to years
- Concurrent hepatotoxic load: alcohol, paracetamol, NSAIDs, other 17α-alkylated oral AAS (Dianabol, Superdrol, Winstrol), or pre-existing psychiatric disorder (depression, bipolar, anxiety)
Related Performance Compounds
Same therapeutic category
Studies
Related research and clinical findings
Endocr Rev. 2014;35(3):341-75.
Adverse health consequences of performance-enhancing drugs: an Endocrine Society scientific statement
Pope HG Jr, Wood RI, Rogol A, Nyberg F, Bowers L, Bhasin S.
PMID: 24423981Open
Sports Med
Effects of androgenic-anabolic steroids in athletes.
Hartgens F, Kuipers H
PMID: 15248788Open
Cureus
Development of Liver Cancers as an Unexpected Consequence of Anabolic Androgenic Steroid Use.
Khalid S, Laput G, Khorfan K, Khan A, Goyal A
PMID: 36874750Open
Int J Mol Sci
Anabolic-Androgenic Steroids Revisited: Structural Biology, Receptor Signaling, and Mechanisms of Anabolic-Androgenic Dissociation.
Wiacek M, Zubrzycki IZ
PMID: 41898445Open
AIDS
Double-blind, randomized, placebo-controlled phase III trial of oxymetholone for the treatment of HIV wasting.
Hengge UR, Stocks K, Wiehler H, Faulkner S, Esser S, Lorenz R, Brockmeyer NH
PMID: 12646793Open
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MolekulaX Editorial Team·Source-verified · PubMed · FDA · EMA
Updated: June 19, 2026
The information here is for educational and scientific purposes only. Performance-enhancing compounds (AAS, prohormones, stimulants, doping agents) are illegal without prescription in Hungary and most of the EU, and carry serious health and legal risks. WADA bans them in competitive sport. This is NOT a usage guide, and we do not encourage any illegal use. If you do use them, medical supervision and regular bloodwork are ESSENTIAL. Severe endocrine, cardiovascular, hepatic and psychiatric side effects are possible.