Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition.
Men (age 18 or older) with low testosterone (level less than 300ng/dL) from medical conditions such as undescended testes, pituitary tumors, damage to testes from trauma, chemotherapy or radiation
Medium track record for this form of the drug means that new, unexpected side effects are possible. Testosterone was first approved by FDA in 1953 but the gel form - Androgel 1.62% - was only approved in 2011 based on studies where about where about 200 people took approved doses of the drug for 6 months. Rare but serious side effects may emerge when a drug is given in a new form.
FDA is requiring that the manufacturers of all testosterone products including Androgel 1.62% conduct a randomized trial to see whether these drugs increase the chance of heart attack or stroke
Children should not use or have contact with Androgel 1.62% - it can cause premature puberty (enlarged penis or clitoris, early public hair, increased erections or sex drive, or aggressive behavior)
Women should not use or have contact with Androgel 1.62% - because it can cause masculine body changes (changes in hair distribution and increase in acne) and it can harm the baby if they are pregnant.
Do not take: Controlled human studies show Androgel 1.62% harms baby and potential benefits do not outweigh potential harms (FDA Category X)
Do not breastfeed - Androgel 1.62% gets into breast milk and can harm baby