AndroGel is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.

Androgens are contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate. AndroGel is not indicated for use in women.

Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hyperplasia and prostatic carcinoma.

The most frequent adverse events reported by ≥5% of patients associated with the consistent use of AndroGel included abnormal lab test, acne, prostate disorder, and application site reaction.