After the Kefauver Harris Amendment was passed in 1962, the . FDA began the DESI review process to ensure the safety and efficacy of drugs approved under the more lenient pre-1962 standards, including Dianabol.  In 1965, the FDA pressured CIBA to further document its legitimate medical uses, and re-approved the drug for treating post-menopausal osteoporosis and pituitary-deficient dwarfism .  After CIBA's patent exclusivity period lapsed, other manufacturers began to market generic metandienone in the .
Dianabol is a 17 alpha alkylated (17aa) anabolic steroid which can raise liver enzymes and cause damage at high doses and prolonged usage. It easily converts into estrogen and therefore anti-estrogens arimidex , femara and nolvadex are effective to reduce the risk of gynecomastia (bitch tits) and bloating. Cystic acne can form on the face, neck and shoulder regions due to stimulation of the sebaceous gland along with a sudden loss in mass and when the body excretes water after the cycle. Headaches, stomach aches, high blood pressure, nausea, and vomiting side effects may also occur.