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
Long track record means that new, unexpected side effects are unlikely. Testosterone (the active ingredient in Androderm) was first approved by FDA in 1953 - but the patch form Androderm was approved by FDA in 1995 based on studies where about 100 people took approved doses of the drug for at least 1 month. Since the drug has now been used by large numbers of people over a longer time, the emergence of rare but serious side effects is less likely than with new drugs.
FDA is requiring that the manufacturers of all testosterone products including ANDRODERM 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 Androderm - 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 Androderm 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 Androderm harms baby and potential benefits do not outweigh potential harms (FDA Category X)
Do not breastfeed - Androderm gets into breast milk and can harm baby