AndroGel® (Testosterone Gel) 1.62%

IMPORTANT SAFETY FACTS AndroGel 1% can transfer from your body to others. This can happen if other people come into contact with the area where the AndroGel 1% was applied. Signs of puberty that are not expected have happened in young children who were accidentally exposed to testosterone through skin-to-skin contact with men using topical testosterone products like AndroGel 1%. Women and children should avoid contact with the unwashed or unclothed area where AndroGel 1% has been applied. If a woman or child makes contact with the AndroGel 1% application area, the contact area on the woman or child should be washed well with soap and water right away. To lower the risk of transfer of AndroGel 1%, you should apply it only to your shoulders, upper arms, and/or stomach (abdomen), areas that will be covered by a short-sleeve T-shirt. Wash your hands right away with soap and water after applying. After the gel has dried, cover the application area with clothing until you have washed the application area well or have showered. If you expect another person to have skin-to-skin contact with your shoulders, upper arms, or stomach, first wash the application area well with soap and water. Do not apply AndroGel 1% to any other parts of your body, such as your penis, scrotum, chest, or back. Stop using AndroGel 1% and call your healthcare provider right away if you see any signs or symptoms of puberty in a child, or changes in body hair or increased acne in a woman, that may have occurred through accidental exposure to AndroGel 1%. Do not use AndroGel 1% if you have breast cancer or have or might have prostate cancer. AndroGel 1% is not meant for use in women and must not be used in women who are pregnant, may become pregnant, or are breastfeeding. AndroGel 1% may harm the unborn or breastfeeding baby. Women who are pregnant or who may become pregnant should avoid contact with the area of skin where AndroGel 1% has been applied. AndroGel 1% can cause serious side effects, including: If you already have enlargement of your prostate gland, your signs and symptoms can get worse while using AndroGel 1% (including changes in urination) Possible increased risk of prostate cancer In large doses, AndroGel 1% may lower your sperm count Swelling of your ankles, feet, or body, with or without heart failure. This may cause serious problems for people who have heart, kidney, or liver disease Enlarged or painful breasts Having problems breathing while you sleep (sleep apnea) Blood clots in the legs; this can include pain, swelling, or redness in your legs Tell your healthcare provider about all the medicines you take, especially if you take insulin, medicines that decrease blood clotting, or corticosteroids. AndroGel 1% is flammable until dry. Let AndroGel 1% dry before smoking or going near an open flame. The most common side effects of AndroGel 1% are acne, skin irritation where the gel is applied, increased cholesterol levels, increased prostate specific antigen (a test used to screen for prostate cancer), increased red blood cell count, and increased liver function tests. This is the most important information to know about AndroGel 1%. For further information, talk with your healthcare provider.

Reference: AndroGel 1% [package insert].

Click to view full Prescribing Information, including the Medication Guide, for AndroGel 1%.

Do not use AndroGel 1% if you have breast cancer, or if you have or might have prostate cancer.

Do not use AndroGel 1% in women who are pregnant, who may become pregnant, or are breast-feeding as AndroGel 1% may harm the unborn or breast-feeding baby.

Women who are pregnant or who may become pregnant should avoid contact with the area of skin where AndroGel 1% has been applied.

Reference: AndroGel 1% [package insert].

Click to view full Prescribing Information, including the Medication Guide, for AndroGel 1%.

Before you use AndroGel 1%, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, especially if you take insulin, corticosteroids, or medicines that decrease blood clotting.

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AndroGel® (Testosterone Gel) 1.62%

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