AndroGel: Testosterone Gel

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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AndroGel 1.62%
Safety FactsAndroGel 1%
Safety Facts
Print Safety Facts

  • IMPORTANT SAFETY FACTS

    AndroGel 1.62% can transfer from your body to others. This can happen if other people come into contact with the area where the AndroGel 1.62% 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 1.62%.

    Women and children should avoid contact with the unwashed or unclothed area where AndroGel 1.62% has been applied. If a woman or child makes contact with the AndroGel 1.62% 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 1.62%:

    • Apply AndroGel 1.62% only to shoulders and upper arms, areas that will be covered by a short-sleeve T-shirt.
    • Do not apply AndroGel 1.62% to any other parts of your body, such as your stomach area (abdomen), penis, or scrotum.
    • Wash your hands right away with soap and water after applying AndroGel 1.62%.
    • 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 or upper arms, first wash the application area well with soap and water.

    Stop using AndroGel 1.62% and call your healthcare provider right away if you see any signs and 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 1.62%.

    Reference: AndroGel® 1.62% [package insert]. North Chicago, IL: Abbott Laboratories.

    Click to view full Prescribing Information, including the Medication Guide, for AndroGel 1.62%.

  • DO NOT USE if

    Do not use AndroGel 1.62% if you have breast cancer or have or might have prostate cancer.

    Do not use AndroGel 1.62% in women who are pregnant, who may become pregnant, or are breast-feeding, as AndroGel 1.62% 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 1.62% has been applied.

    AndroGel 1.62% is not meant for use in women.

    Reference: AndroGel® 1.62% [package insert]. North Chicago, IL: Abbott Laboratories.

    Click to view full Prescribing Information, including the Medication Guide, for AndroGel 1.62%.

  • BEFORE USING AndroGel

    Before you use AndroGel 1.62%, tell your healthcare provider if you:

    • Have breast cancer
    • Have or might have prostate cancer
    • Have urinary problems due to an enlarged prostate
    • Have heart problems
    • Have kidney or liver problems
    • Have problems breathing while you sleep (sleep apnea)
    • Have any other medical conditions

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

    Reference: AndroGel® 1.62% [package insert]. North Chicago, IL: Abbott Laboratories.

    Click to view full Prescribing Information, including the Medication Guide, for AndroGel 1.62%.

  • SIDE EFFECTS

    AndroGel 1.62% 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 1.62% (including changes in urination)
    • Possible increased risk of prostate cancer
    • In large doses, AndroGel 1.62% 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
    • Problems breathing while you sleep (sleep apnea)
    • Blood clots in the legs; this can include pain, swelling, or redness of your legs

    The most common side effects of AndroGel 1.62% include increased prostate specific antigen (a test used to screen for prostate cancer), mood swings, high blood pressure, increased red blood cell count, and skin irritation where AndroGel 1.62% is applied.

    Reference: AndroGel® 1.62% [package insert]. North Chicago, IL: Abbott Laboratories.

    Click to view full Prescribing Information, including the Medication Guide, for AndroGel 1.62%.

  • USE

    AndroGel® (testosterone gel) 1.62% is a prescription medicine used to treat adult males who have low or no testosterone. It is not known if AndroGel 1.62% is safe or effective in children younger than 18 years old.

    Reference: AndroGel® 1.62% [package insert]. North Chicago, IL: Abbott Laboratories.

    Click to view full Prescribing Information, including the Medication Guide, for AndroGel 1.62%.

  • HOW TO USE AndroGel

    • It is important that you apply AndroGel 1.62% exactly as prescribed by your healthcare provider.
    • Your healthcare provider will tell you how much AndroGel 1.62% to apply and when to apply it.
    • Your healthcare provider may change your AndroGel 1.62% dose. Do not change your AndroGel 1.62% dose without talking to your healthcare provider.
    • AndroGel 1.62% is to be applied to the area of the shoulders and upper arms that will be covered by a short-sleeve T-shirt. Do not apply AndroGel 1.62% to any other parts of your body, such as your stomach area (abdomen), penis, or scrotum.
    • Apply AndroGel 1.62% at the same time each morning. AndroGel 1.62% should be applied after showering or bathing.
    • Wash your hands right away with soap and water after applying AndroGel 1.62%.
    • Let the application areas dry for a few minutes before putting on a shirt.
    • Avoid showering, swimming, or bathing for at least 2 hours after you apply AndroGel 1.62%.
    • AndroGel 1.62% is flammable until dry. Let AndroGel 1.62% dry before smoking or going near an open flame.

    Reference: AndroGel® 1.62% [package insert]. North Chicago, IL: Abbott Laboratories.

    Click to view full Prescribing Information, including the Medication Guide, for AndroGel 1.62%.

  • HELPFUL RESOURCES

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).

    If you cannot afford your medication, contact www.pparx.org or call the toll free number (1-888-4PPA-NOW) (1-888-477-2669) for assistance.

    Reference: AndroGel® 1.62% [package insert]. North Chicago, IL: Abbott Laboratories.

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