Oxymetholone
Oxymetholone increased lean mass in human trials, and those same trials recorded liver toxicity and lower HDL cholesterol. The Anadrol-50 product is listed as discontinued in the US.
Oral anabolic-androgenic steroid
- Also called Anadrol
- Historical anemia medicine
What is oxymetholone used for?
Oxymetholone is an oral anabolic steroid historically sold as Anadrol-50 for anemias caused by inadequate red-cell production.
It also has controlled human studies of lean mass and weight gain. That does not make it an established or safe treatment for an otherwise healthy person seeking more muscle.
Anadrol label · anemia and safety
Historical FDA label
FDA, NDA 016848, 2004.
The label describes treatment of anemias caused by deficient red-cell production. Warnings include serious liver injury, adverse lipids, fluid retention, androgenic effects and fertility impairment.
This is a historical label for a product currently listed as discontinued.
Read the original sourceOlder-men trial · lean mass and cholesterol
Randomized trial
American journal of physiology. Endocrinology and metabolism. PMID 12388137.
In 31 men aged 65 to 80, 12-week lean-mass changes were 0.0 kg with placebo, 3.3 kg with 50 mg daily and 4.2 kg with 100 mg daily. Strength improved, HDL fell in both active groups and ALT rose substantially in the higher-dose group.
The study measured lean mass, not exclusively new muscle protein, and did not assess long-term safety.
Read the original sourceWhere does the 4.2 kg lean-mass result come from?
It comes from a 31-man study in people aged 65 to 80, not a bodybuilding trial. After 12 weeks, the higher-dose group gained 4.2 kg of lean mass.
| Measure | Placebo | 50 mg/day | 100 mg/day |
|---|---|---|---|
| Lean-mass change | 0.0 kg | +3.3 kg | +4.2 kg |
| HDL change | Comparator | −19 mg/dL | −23 mg/dL |
The higher-dose group’s ALT increased by 72 U/L on average. These exposures identify the study, not a recommended regimen.
Upper-body strength improved too. Lean mass includes water and other nonfat tissue; the number cannot be read as 4.2 kg of pure muscle.
Older-men trial · lean mass and cholesterol
Randomized trial
American journal of physiology. Endocrinology and metabolism. PMID 12388137.
In 31 men aged 65 to 80, 12-week lean-mass changes were 0.0 kg with placebo, 3.3 kg with 50 mg daily and 4.2 kg with 100 mg daily. Strength improved, HDL fell in both active groups and ALT rose substantially in the higher-dose group.
The study measured lean mass, not exclusively new muscle protein, and did not assess long-term safety.
Read the original sourceHow serious is the liver risk?
Human trials recorded substantial liver toxicity at the studied exposures. This is not a concern inferred only from animal experiments.
| HIV-wasting trial group | Participants affected |
|---|---|
| Placebo | 8% |
| 50 mg twice daily | 25% |
| 50 mg three times daily | 43% |
89 participants studied for 16 weeks. The threshold concerned ALT, AST or gamma-GT.
HIV-wasting trial · liver toxicity
Randomized placebo-controlled trial
HIV clinical trials. PMID 12815555.
In 89 participants, weight increased by 3.5 kg with twice-daily treatment, 3.0 kg with three-times-daily treatment and 1.0 kg with placebo. Liver enzymes exceeded five times baseline in 25%, 43% and 8%, respectively.
- Participants / model
- Men and women with HIV-associated wasting and normal gonadal status.
- Treatment
- 50 mg per administration for 16 weeks.
The higher exposure did not produce a greater weight gain but had more liver toxicity. These are study regimens, not treatment advice.
Read the original sourceThe historical label also warns about cholestatic jaundice, blood-filled liver lesions and liver tumors. Yellow skin or eyes, severe itching, abdominal pain or swelling require prompt medical assessment.
Anadrol label · anemia and safety
Historical FDA label
FDA, NDA 016848, 2004.
The label describes treatment of anemias caused by deficient red-cell production. Warnings include serious liver injury, adverse lipids, fluid retention, androgenic effects and fertility impairment.
This is a historical label for a product currently listed as discontinued.
Read the original sourceWhat do the rat cancer findings mean?
The NTP program found liver tumors in female rats. That supports a toxicology hazard, but it cannot supply a human cancer probability. Human liver warnings and the trial enzyme findings are already sufficient reasons to take the risk seriously.
NTP study · chronic animal toxicity
Government animal toxicology study
National Toxicology Program technical report series. PMID 12571678.
NTP found clear evidence of carcinogenic activity in female rats, including liver tumors, and equivocal evidence in males after two years of exposure.
This is animal hazard evidence, not a numerical estimate of human cancer risk.
Read the original sourceAnadrol label · anemia and safety
Historical FDA label
FDA, NDA 016848, 2004.
The label describes treatment of anemias caused by deficient red-cell production. Warnings include serious liver injury, adverse lipids, fluid retention, androgenic effects and fertility impairment.
This is a historical label for a product currently listed as discontinued.
Read the original sourceWhat did the HIV-wasting study show?
Participants on oxymetholone gained more weight than those on placebo, but the higher exposure produced more liver toxicity without a larger weight gain.
This trial treated involuntary wasting in people with HIV. Healthy performance users were not studied.
HIV-wasting trial · liver toxicity
Randomized placebo-controlled trial
HIV clinical trials. PMID 12815555.
In 89 participants, weight increased by 3.5 kg with twice-daily treatment, 3.0 kg with three-times-daily treatment and 1.0 kg with placebo. Liver enzymes exceeded five times baseline in 25%, 43% and 8%, respectively.
- Participants / model
- Men and women with HIV-associated wasting and normal gonadal status.
- Treatment
- 50 mg per administration for 16 weeks.
The higher exposure did not produce a greater weight gain but had more liver toxicity. These are study regimens, not treatment advice.
Read the original sourceHow does it affect muscle and red cells?
Oxymetholone has androgenic and anabolic effects and can stimulate red-cell production. Those effects cannot be cleanly separated from endocrine and other adverse effects.
A higher red-cell count is useful only in the right medical context. It is not evidence that the drug safely improves endurance in a person without anemia.
Anadrol label · anemia and safety
Historical FDA label
FDA, NDA 016848, 2004.
The label describes treatment of anemias caused by deficient red-cell production. Warnings include serious liver injury, adverse lipids, fluid retention, androgenic effects and fertility impairment.
This is a historical label for a product currently listed as discontinued.
Read the original sourceWhat about fertility, swelling or virilization?
Reported risks include reduced testicular function and sperm production, menstrual changes, virilization and fluid retention.
The historical label contraindicates pregnancy and severe liver dysfunction, among other conditions. Anticoagulant and glucose-lowering treatment can require closer monitoring. Breast enlargement does not establish a specific estrogen-receptor mechanism.
Anadrol label · anemia and safety
Historical FDA label
FDA, NDA 016848, 2004.
The label describes treatment of anemias caused by deficient red-cell production. Warnings include serious liver injury, adverse lipids, fluid retention, androgenic effects and fertility impairment.
This is a historical label for a product currently listed as discontinued.
Read the original sourceDoes the cited study establish a human half-life?
The human abstract reports the time and concentration of the peak, not a terminal half-life. Those are different measurements.
The 5.56-hour value comes from rat toxicokinetics and should not be used to predict human clearance or set an interval.
Human PK study · peak, not half-life
Human analytical pharmacokinetic study
Journal of chromatography. B, Analytical technologies in the biomedical and life sciences. PMID 12101054.
After a 50 mg oral dose, the report gives a mean peak concentration of 18.8 ng/mL at 210 minutes. Its abstract does not report a terminal elimination half-life.
Peak timing cannot be relabeled as half-life. The abstract does not report participant count or a full concentration-time analysis.
Read the original sourceNTP study · chronic animal toxicity
Government animal toxicology study
National Toxicology Program technical report series. PMID 12571678.
NTP found clear evidence of carcinogenic activity in female rats, including liver tumors, and equivocal evidence in males after two years of exposure.
This is animal hazard evidence, not a numerical estimate of human cancer risk.
Read the original sourceIs Anadrol-50 currently marketed in the US?
Drugs@FDA lists the Anadrol-50 oral product as Discontinued. Its application and historical label remain in Drugs@FDA.
Those historical documents do not verify an online product’s contents or current approval status.
FDA listing · discontinued product
Regulatory product record
US FDA, NDA 016848.
Drugs@FDA lists the 50 mg oral Anadrol-50 product under NDA 016848 with a marketing status of Discontinued.
An application history or archived label is not evidence of active availability.
Read the original sourceStudies and sources
Anadrol label · anemia and safety
Historical FDA label
FDA, NDA 016848, 2004.
The label describes treatment of anemias caused by deficient red-cell production. Warnings include serious liver injury, adverse lipids, fluid retention, androgenic effects and fertility impairment.
This is a historical label for a product currently listed as discontinued.
Read the original sourceFDA listing · discontinued product
Regulatory product record
US FDA, NDA 016848.
Drugs@FDA lists the 50 mg oral Anadrol-50 product under NDA 016848 with a marketing status of Discontinued.
An application history or archived label is not evidence of active availability.
Read the original sourceOlder-men trial · lean mass and cholesterol
Randomized trial
American journal of physiology. Endocrinology and metabolism. PMID 12388137.
In 31 men aged 65 to 80, 12-week lean-mass changes were 0.0 kg with placebo, 3.3 kg with 50 mg daily and 4.2 kg with 100 mg daily. Strength improved, HDL fell in both active groups and ALT rose substantially in the higher-dose group.
The study measured lean mass, not exclusively new muscle protein, and did not assess long-term safety.
Read the original sourceHIV-wasting trial · liver toxicity
Randomized placebo-controlled trial
HIV clinical trials. PMID 12815555.
In 89 participants, weight increased by 3.5 kg with twice-daily treatment, 3.0 kg with three-times-daily treatment and 1.0 kg with placebo. Liver enzymes exceeded five times baseline in 25%, 43% and 8%, respectively.
- Participants / model
- Men and women with HIV-associated wasting and normal gonadal status.
- Treatment
- 50 mg per administration for 16 weeks.
The higher exposure did not produce a greater weight gain but had more liver toxicity. These are study regimens, not treatment advice.
Read the original sourceHuman PK study · peak, not half-life
Human analytical pharmacokinetic study
Journal of chromatography. B, Analytical technologies in the biomedical and life sciences. PMID 12101054.
After a 50 mg oral dose, the report gives a mean peak concentration of 18.8 ng/mL at 210 minutes. Its abstract does not report a terminal elimination half-life.
Peak timing cannot be relabeled as half-life. The abstract does not report participant count or a full concentration-time analysis.
Read the original sourceNTP study · chronic animal toxicity
Government animal toxicology study
National Toxicology Program technical report series. PMID 12571678.
NTP found clear evidence of carcinogenic activity in female rats, including liver tumors, and equivocal evidence in males after two years of exposure.
This is animal hazard evidence, not a numerical estimate of human cancer risk.
Read the original sourceWhy is Oxymetholone in S tier?
S reflects controlled human outcome data that measured both anabolic effects and important harms. Anadrol-50 is listed as discontinued in the US.