Methandienone
Small controlled trials found faster weight gain, larger muscle measurements, and, in one study, greater training-performance improvement with methandienone. Strength results were inconsistent, fluid contributed to the weight change, and the studies also recorded higher blood pressure, hormone suppression, and treatment-limiting side effects.
Anabolic-androgenic steroid
- Dianabol / methandrostenolone
- Small controlled human studies
What is Dianabol?
Dianabol is methandienone, also called methandrostenolone. It is an oral anabolic-androgenic steroid, not a peptide.
Its 17-alpha methyl modification allows oral activity and places it among the anabolic steroids associated with serious cholestatic liver injury. It is a free steroid rather than a long-acting injection ester.
LiverTox · liver injury
Clinical reference
NIDDK / NLM, LiverTox.
17-alpha-alkylated androgens can cause severe cholestatic injury, peliosis and liver tumors. Jaundice and itching may be marked despite modest enzyme elevations; recovery can be prolonged after withdrawal.
A clinical synthesis across androgenic steroids, not a trial estimating the risk of a particular regimen.
Read the original sourceFDA · Par withdrawal
Regulatory decision
Federal Register, October 21, 1985, pp. 42599–42600.
FDA withdrew ANDAs 87-945 and 87-951 effective November 20, 1985 for lack of substantial evidence of effectiveness for their labeled uses.
Read the original sourceDoes methandienone build muscle and strength?
Small controlled studies found greater weight and muscle-size changes, and one found greater training-performance improvement. Strength gains in another did not exceed placebo, and some of the weight gain could be water.
| Study | Finding | Limit |
|---|---|---|
| 13 men enrolled | Greater performance improvement on drug; weight and blood pressure increased | Three withdrew for side effects; water retention complicated weight changes |
| 11 men | Mean weight gain 3.3 kg; muscle size increased | Strength improvement did not exceed placebo; intracellular fluid remained an explanation |
Weightlifters · controlled crossover trial
Randomized crossover trial
British medical journal. PMID 125133.
Thirteen experienced male weightlifters entered a double-blind crossover study. Performance improved more on methandienone, weight and systolic blood pressure rose, and three men withdrew because of side effects.
- Treatment
- Oral 10 or 25 mg/day with weight training and a high-protein diet.
The 13 enrolled men are not 13 complete paired observations. Water retention complicated the interpretation of weight gain.
Read the original sourceWeight training · body composition and strength
Double-blind crossover trial
Lancet (London, England). PMID 61389.
Eleven athletic men received methandienone or placebo in a six-week crossover experiment. Mean weight gain was 3.3 kg during drug treatment, with increased muscle size and potassium retention. Strength gains did not differ significantly from placebo.
- Treatment
- 100 mg/day in the experiment, not a treatment recommendation.
The investigators could not rule out intracellular fluid as a major contributor to the lean-compartment change.
Read the original sourceDoes 3.3 kg mean 3.3 kg of new muscle?
A lean-compartment measurement includes water. In the 11-man study, potassium retention and other measurements left uncertainty about how much of the change was new tissue.
Weight training · body composition and strength
Double-blind crossover trial
Lancet (London, England). PMID 61389.
Eleven athletic men received methandienone or placebo in a six-week crossover experiment. Mean weight gain was 3.3 kg during drug treatment, with increased muscle size and potassium retention. Strength gains did not differ significantly from placebo.
- Treatment
- 100 mg/day in the experiment, not a treatment recommendation.
The investigators could not rule out intracellular fluid as a major contributor to the lean-compartment change.
Read the original sourceWhat side effects matter most?
Measured concerns include liver injury, blood-pressure and cholesterol changes, impaired glucose tolerance, and hormone and sperm suppression. The old weightlifter trial recorded enough side effects for three men to withdraw.
That trial found a significant systolic blood-pressure rise. Its small size and short follow-up cannot estimate the frequency of heart attacks, strokes or serious liver injury in current users.
Weightlifters · controlled crossover trial
Randomized crossover trial
British medical journal. PMID 125133.
Thirteen experienced male weightlifters entered a double-blind crossover study. Performance improved more on methandienone, weight and systolic blood pressure rose, and three men withdrew because of side effects.
- Treatment
- Oral 10 or 25 mg/day with weight training and a high-protein diet.
The 13 enrolled men are not 13 complete paired observations. Water retention complicated the interpretation of weight gain.
Read the original sourceFDA · steroid-product risks
Regulatory safety review
US FDA, 2017.
FDA describes liver injury, adverse lipids, androgenic effects, mood changes and reproductive suppression associated with anabolic-steroid products.
Class-level harms are not a compound-specific incidence estimate.
Read the original sourceCan liver damage occur without a huge ALT increase?
Yes. Steroid-associated cholestasis can cause severe itching, dark urine and yellow skin or eyes while enzyme elevations remain modest. These symptoms need prompt medical assessment. Simply changing the dose or formulation is not a treatment for suspected liver injury.
LiverTox · liver injury
Clinical reference
NIDDK / NLM, LiverTox.
17-alpha-alkylated androgens can cause severe cholestatic injury, peliosis and liver tumors. Jaundice and itching may be marked despite modest enzyme elevations; recovery can be prolonged after withdrawal.
A clinical synthesis across androgenic steroids, not a trial estimating the risk of a particular regimen.
Read the original sourceWhat did the human glucose study find?
In nine patients tested off and on methandienone, glucose-tolerance tests showed a larger insulin response and worse glucose tolerance during treatment. Model-estimated insulin sensitivity fell by a factor of four. The study was a small within-person comparison, not a randomized diabetes-outcomes trial.
Human study · glucose and insulin
Within-person human intervention
Clinical science. PMID 3539458.
Nine patients underwent oral and intravenous glucose-tolerance testing off and on methandienone. During treatment, glucose tolerance worsened, insulin responses increased and model-estimated insulin sensitivity fell by a factor of four.
This was a nine-person off-treatment versus on-treatment comparison, not a randomized controlled trial and not a clinical diabetes-endpoint study.
Read the original sourceDoes it suppress testosterone, and do effects reverse after stopping?
Yes. A 15-athlete study found large declines in sperm density, motility and normal morphology during two months of methandienone use. A separate controlled training study measured lower circulating testosterone.
Sperm density fell 46% after one month and 73% after two months in the uncontrolled athlete study. The report also described very low or absent sperm counts in several participants. It had no untreated comparison group, so it documents changes during exposure without supplying a comparative risk rate.
Athletes · sperm suppression
Uncontrolled human intervention
Contraception. PMID 837689.
Fifteen male athletes received oral methandienone for two months. Mean sperm density fell 46% after one month and 73% after two months, with reduced motility and normal morphology; the report described severe suppression in several participants.
- Treatment
- Oral methandienone 15 mg/day for two months in the study.
There was no untreated comparator. The abstract reports reversal after discontinuation but does not define the follow-up schedule or establish recovery after longer exposure.
Read the original sourceThe 1975 report said its observed side effects disappeared after stopping. That short study did not establish a universal fertility-recovery time, exclude persistent harm or show how much weight would remain.
Weight training · body composition and strength
Double-blind crossover trial
Lancet (London, England). PMID 61389.
Eleven athletic men received methandienone or placebo in a six-week crossover experiment. Mean weight gain was 3.3 kg during drug treatment, with increased muscle size and potassium retention. Strength gains did not differ significantly from placebo.
- Treatment
- 100 mg/day in the experiment, not a treatment recommendation.
The investigators could not rule out intracellular fluid as a major contributor to the lean-compartment change.
Read the original sourceWeightlifters · controlled crossover trial
Randomized crossover trial
British medical journal. PMID 125133.
Thirteen experienced male weightlifters entered a double-blind crossover study. Performance improved more on methandienone, weight and systolic blood pressure rose, and three men withdrew because of side effects.
- Treatment
- Oral 10 or 25 mg/day with weight training and a high-protein diet.
The 13 enrolled men are not 13 complete paired observations. Water retention complicated the interpretation of weight gain.
Read the original sourceFDA · steroid-product risks
Regulatory safety review
US FDA, 2017.
FDA describes liver injury, adverse lipids, androgenic effects, mood changes and reproductive suppression associated with anabolic-steroid products.
Class-level harms are not a compound-specific incidence estimate.
Read the original sourceWhat about acne, hair loss, mood and effects in women?
These are androgenic or class-level concerns. Voice deepening, excess hair growth and menstrual disruption are particularly relevant to women. The small athletic studies do not provide reliable methandienone-specific rates for these outcomes.
FDA · steroid-product risks
Regulatory safety review
US FDA, 2017.
FDA describes liver injury, adverse lipids, androgenic effects, mood changes and reproductive suppression associated with anabolic-steroid products.
Class-level harms are not a compound-specific incidence estimate.
Read the original sourceWas it studied for osteoporosis?
Yes. A historical trial measured preservation of total body calcium in postmenopausal women. It did not establish fewer fractures.
The 26-month trial enrolled 26 women, with 16 completing follow-up. FDA later withdrew specific generic approvals for lack of substantial evidence supporting their labeled uses. A positive small surrogate-endpoint study and a regulatory withdrawal can both be part of the record.
Osteoporosis · historical controlled study
Historical controlled clinical trial
Metabolism: clinical and experimental. PMID 319322.
Twenty-six postmenopausal women entered a 26-month double-blind study. Among 16 completers, total body calcium rose 2% with methandrostenolone and fell 3% with placebo.
Ten treated and six placebo participants completed follow-up. Total body calcium is not a fracture endpoint, and attrition limits certainty.
Read the original sourceFDA · Par withdrawal
Regulatory decision
Federal Register, October 21, 1985, pp. 42599–42600.
FDA withdrew ANDAs 87-945 and 87-951 effective November 20, 1985 for lack of substantial evidence of effectiveness for their labeled uses.
Read the original sourceFDA · Bolar withdrawal
Regulatory decision
Federal Register, December 13, 1985, pp. 50963–50964.
FDA withdrew ANDAs 87-465 and 87-466 effective January 13, 1986. The notice concerns inadequate evidence of effectiveness, not a modern safety trial.
Read the original sourceWhy can weight rise faster than lasting muscle tissue?
Androgen signaling can change protein metabolism, while fluid retention can change scale weight independently. The controlled studies could not cleanly separate these contributions.
A visible or rapid change therefore does not measure new contractile tissue. The same human experiments recorded endocrine or blood-pressure changes alongside the sought effects.
Weightlifters · controlled crossover trial
Randomized crossover trial
British medical journal. PMID 125133.
Thirteen experienced male weightlifters entered a double-blind crossover study. Performance improved more on methandienone, weight and systolic blood pressure rose, and three men withdrew because of side effects.
- Treatment
- Oral 10 or 25 mg/day with weight training and a high-protein diet.
The 13 enrolled men are not 13 complete paired observations. Water retention complicated the interpretation of weight gain.
Read the original sourceWeight training · body composition and strength
Double-blind crossover trial
Lancet (London, England). PMID 61389.
Eleven athletic men received methandienone or placebo in a six-week crossover experiment. Mean weight gain was 3.3 kg during drug treatment, with increased muscle size and potassium retention. Strength gains did not differ significantly from placebo.
- Treatment
- 100 mg/day in the experiment, not a treatment recommendation.
The investigators could not rule out intracellular fluid as a major contributor to the lean-compartment change.
Read the original sourceWhat does the evidence show about the quoted 3-6-hour half-life?
The cited sources do not establish a qualifying human plasma study that supports that range.
A urinary metabolite peak or detection window combines metabolism and excretion. It is not the time required for the blood concentration of the original drug to fall by half, and cannot define a safe dosing interval.
Human pharmacokinetics · terminal half-life unknown
PubMed and primary clinical records
PubMed and primary clinical records for oral methandienone pharmacokinetics.
The cited sources do not establish a terminal human plasma half-life for oral methandienone. Urinary metabolite timing cannot validate the commonly repeated 3–6-hour range.
Is the old US approval still valid?
The cited Par approvals were withdrawn in 1985 and the Bolar approvals in 1986. No current online product inherits those approvals.
The withdrawal notices specifically cite inadequate evidence of effectiveness. They should not be described as proof that modern performance use is either safe or ineffective.
FDA · Par withdrawal
Regulatory decision
Federal Register, October 21, 1985, pp. 42599–42600.
FDA withdrew ANDAs 87-945 and 87-951 effective November 20, 1985 for lack of substantial evidence of effectiveness for their labeled uses.
Read the original sourceFDA · Bolar withdrawal
Regulatory decision
Federal Register, December 13, 1985, pp. 50963–50964.
FDA withdrew ANDAs 87-465 and 87-466 effective January 13, 1986. The notice concerns inadequate evidence of effectiveness, not a modern safety trial.
Read the original sourceStudies and sources
Weightlifters · controlled crossover trial
Randomized crossover trial
British medical journal. PMID 125133.
Thirteen experienced male weightlifters entered a double-blind crossover study. Performance improved more on methandienone, weight and systolic blood pressure rose, and three men withdrew because of side effects.
- Treatment
- Oral 10 or 25 mg/day with weight training and a high-protein diet.
The 13 enrolled men are not 13 complete paired observations. Water retention complicated the interpretation of weight gain.
Read the original sourceWeight training · body composition and strength
Double-blind crossover trial
Lancet (London, England). PMID 61389.
Eleven athletic men received methandienone or placebo in a six-week crossover experiment. Mean weight gain was 3.3 kg during drug treatment, with increased muscle size and potassium retention. Strength gains did not differ significantly from placebo.
- Treatment
- 100 mg/day in the experiment, not a treatment recommendation.
The investigators could not rule out intracellular fluid as a major contributor to the lean-compartment change.
Read the original sourceOsteoporosis · historical controlled study
Historical controlled clinical trial
Metabolism: clinical and experimental. PMID 319322.
Twenty-six postmenopausal women entered a 26-month double-blind study. Among 16 completers, total body calcium rose 2% with methandrostenolone and fell 3% with placebo.
Ten treated and six placebo participants completed follow-up. Total body calcium is not a fracture endpoint, and attrition limits certainty.
Read the original sourceAthletes · sperm suppression
Uncontrolled human intervention
Contraception. PMID 837689.
Fifteen male athletes received oral methandienone for two months. Mean sperm density fell 46% after one month and 73% after two months, with reduced motility and normal morphology; the report described severe suppression in several participants.
- Treatment
- Oral methandienone 15 mg/day for two months in the study.
There was no untreated comparator. The abstract reports reversal after discontinuation but does not define the follow-up schedule or establish recovery after longer exposure.
Read the original sourceHuman study · glucose and insulin
Within-person human intervention
Clinical science. PMID 3539458.
Nine patients underwent oral and intravenous glucose-tolerance testing off and on methandienone. During treatment, glucose tolerance worsened, insulin responses increased and model-estimated insulin sensitivity fell by a factor of four.
This was a nine-person off-treatment versus on-treatment comparison, not a randomized controlled trial and not a clinical diabetes-endpoint study.
Read the original sourceFDA · Par withdrawal
Regulatory decision
Federal Register, October 21, 1985, pp. 42599–42600.
FDA withdrew ANDAs 87-945 and 87-951 effective November 20, 1985 for lack of substantial evidence of effectiveness for their labeled uses.
Read the original sourceFDA · Bolar withdrawal
Regulatory decision
Federal Register, December 13, 1985, pp. 50963–50964.
FDA withdrew ANDAs 87-465 and 87-466 effective January 13, 1986. The notice concerns inadequate evidence of effectiveness, not a modern safety trial.
Read the original sourceLiverTox · liver injury
Clinical reference
NIDDK / NLM, LiverTox.
17-alpha-alkylated androgens can cause severe cholestatic injury, peliosis and liver tumors. Jaundice and itching may be marked despite modest enzyme elevations; recovery can be prolonged after withdrawal.
A clinical synthesis across androgenic steroids, not a trial estimating the risk of a particular regimen.
Read the original sourceFDA · steroid-product risks
Regulatory safety review
US FDA, 2017.
FDA describes liver injury, adverse lipids, androgenic effects, mood changes and reproductive suppression associated with anabolic-steroid products.
Class-level harms are not a compound-specific incidence estimate.
Read the original sourceHuman pharmacokinetics · terminal half-life unknown
PubMed and primary clinical records
PubMed and primary clinical records for oral methandienone pharmacokinetics.
The cited sources do not establish a terminal human plasma half-life for oral methandienone. Urinary metabolite timing cannot validate the commonly repeated 3–6-hour range.
Why is Methandienone in B tier?
Methandienone remains B tier for direct human evidence, with substantial limits from small trials, mixed strength results and serious safety concerns.