Medication Guide

Medication Guide

Important facts from the AndroGel 1.62% Medication Guide

To download the Medication Guide, you need the Adobe® Acrobat® Reader®. If you don't have the Adobe Acrobat Reader, you can download it for free.

Click to download the full AndroGel 1.62% Medication Guide (PDF)

1. What is the most important information I should know about AndroGel 1.62%?

1. Early signs and symptoms of puberty have happened in young children who were accidentally exposed to testosterone through contact with men using AndroGel 1.62%.

Signs and symptoms of early puberty in a child may include:

  • enlarged penis or clitoris
  • early development of pubic hair
  • increased erections or sex drive
  • aggressive behavior

AndroGel 1.62% can transfer from your body to others.

2. Women and children should avoid contact with the unwashed or unclothed area where AndroGel 1.62% has been applied to your skin.

Stop using AndroGel 1.62% and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have occurred through accidental exposure to AndroGel 1.62%.

Signs and symptoms of exposure to AndroGel 1.62% in children may include:

  • enlarged penis or clitoris
  • early development of pubic hair
  • increased erections or sex drive
  • aggressive behavior

Signs and symptoms of exposure to AndroGel 1.62% in women may include:

  • changes in body hair
  • a large increase in acne

To lower the risk of transfer of AndroGel 1.62% from your body to others, you should follow these important instructions:

  • Apply AndroGel 1.62% only to your shoulders and upper arms that will be covered by a short-sleeve t-shirt.
  • 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. Keep the area covered until you have washed the application area well or have showered.
  • If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water.
  • If a woman or child makes contact with the AndroGel 1.62% application area, that area on the woman or child should be washed well with soap and water right away.

2. What is AndroGel 1.62%?

AndroGel 1.62% is a prescription medicine that contains testosterone. AndroGel 1.62% is used to treat adult males who have low or no testosterone.

Your healthcare provider will test your blood before you start and while you are taking AndroGel 1.62%.

It is not known if AndroGel 1.62% is safe or effective in children younger than 18 years old. Improper use of AndroGel 1.62% may affect bone growth in children.

AndroGel 1.62% is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your AndroGel 1.62% in a safe place to protect it. Never give your AndroGel 1.62% to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and is against the law.

AndroGel 1.62% is not meant for use in women.

3. Who should not use AndroGel 1.62%?

Do not use AndroGel 1.62% if you:

  • have breast cancer
  • have or might have prostate cancer
  • are pregnant or may become pregnant or are breast-feeding. AndroGel 1.62% may harm your 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.

Talk to your healthcare provider before taking this medicine if you have any of the above conditions.

4. What should I tell my healthcare provider before using AndroGel 1.62%?

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, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Using AndroGel 1.62% with certain other medicines can affect each other.

Especially, tell your healthcare provider if you take:

  • insulin
  • medicines that decrease blood clotting
  • corticosteroids

Know the medicines you take. Ask your healthcare provider or pharmacist for a list of all of your medicines, if you are not sure. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

5. How should I use AndroGel 1.62%?

  • It is important that you apply AndroGel 1.62% exactly as your healthcare provider tells you to.
  • 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 your 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%.
  • 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.
  • Let the application site dry completely before putting on a t-shirt.

Applying AndroGel 1.62%:

AndroGel 1.62% comes in a pump or in packets.

  • Before applying AndroGel 1.62% make sure that your shoulders and upper arms are clean, dry, and that there is no broken skin.
  • The application sites for AndroGel 1.62% are the upper arms and shoulders that will be covered by a short-sleeve t-shirt (see Figure A).

If you are using the AndroGel 1.62% pump:

  • Before using a new bottle of AndroGel 1.62% for the first time, you will need to prime the pump. To prime the AndroGel 1.62% pump, slowly push the pump all the way down 3 times. Do not use any AndroGel 1.62% that came out while priming. Wash it down the sink to avoid accidental exposure to others. Your AndroGel 1.62% pump is now ready to use.
  • Remove the cap from the pump. Then, position the nozzle over the palm of your hand and slowly push the pump all the way down. Apply AndroGel 1.62% to the application site. You may also apply AndroGel 1.62% directly to the application site.
  • Wash your hands with soap and water right away.

Dosing information for AndroGel 1.62% pump

Find your dose as prescribed by your physician

Daily dose of testosterone

Number of pump presses

Application method
(using the palm of the hand)

20.25 mg 1 Pump Press Apply 1 pump press to 1 upper arm and shoulder.
40.5 mg 2 Pump Presses Apply 1 pump press to 1 upper arm and shoulder and then apply 1 pump press to the opposite upper arm and shoulder.
60.75 mg 3 Pump Presses Apply 2 pump presses to 1 upper arm and shoulder and then apply 1 pump press to the opposite upper arm and shoulder.
81 mg 4 Pump Presses Apply 2 pump presses to 1 upper arm and shoulder and then apply 2 pump presses to the opposite upper arm and shoulder.

If you are using AndroGel 1.62% packets:

  • Tear open the packet completely at the dotted line. Squeeze from the bottom of the packet to the top.
  • Squeeze all of the AndroGel 1.62% out of the packet into the palm of your hand. Apply AndroGel 1.62% to the application site. You may also apply AndroGel 1.62% directly to the application site.
  • AndroGel 1.62% should be applied right away.
  • Wash your hands with soap and water right away.

Dosing information for AndroGel 1.62% packets

Find your dose as prescribed by your physician

Daily dose of testosterone

Number of
packets

Application method
(using the palm of the hand)

20.25 mg One 20.25 mg packet Apply one 20.25 mg packet to 1 upper arm and shoulder.
40.5 mg One 40.5 mg packet Apply half of one 40.5 mg packet to 1 upper arm and shoulder and then apply the remaining amount to the opposite upper arm and shoulder.
60.75 mg One 40.5 mg packet and one 20.25 mg packet Apply one 40.5 mg packet to 1 upper arm and shoulder and then apply one 20.25 mg packet to the opposite upper arm and shoulder.
81 mg Two 40.5 mg packets Apply one 40.5 mg packet to 1 upper arm and shoulder and then apply one 40.5 mg packet to the opposite upper arm and shoulder.

6. What are the possible side effects of AndroGel 1.62%?

See “What is the most important information I should know about AndroGel 1.62%?

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%. This can include:
    • increased urination at night
    • trouble starting your urine stream
    • having to pass urine many times during the day
    • having an urge that you have to go to the bathroom right away
    • having a urine accident
    • being unable to pass urine or weak urine flow
  • Possible increased risk of prostate cancer. Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you use AndroGel 1.62%.
  • In large doses AndroGel 1.62% may lower your sperm count.
  • Swelling of your ankles, feet, or body, with or without heart failure.
  • Enlarged or painful breasts.
  • Have problems breathing while you sleep (sleep apnea).
  • Blood clots in your legs or lungs. Signs and symptoms of a blood clot in your leg can include leg pain, swelling, or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effects of AndroGel 1.62% include:

  • increased prostate specific antigen (a test used to screen for prostate cancer)
  • mood swings
  • hypertension
  • increased red blood cell count
  • skin irritation where AndroGel 1.62% is applied

Other side effects include more erections than are normal for you or erections that last a long time.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of AndroGel 1.62%. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

7. How should I store AndroGel 1.62%?

  • Store AndroGel 1.62% at 59°F to 86°F (15°C to 30°C).
  • When it is time to throw away the pump or packets, safely throw away used AndroGel 1.62% in household trash. Be careful to prevent accidental exposure of children or pets.
  • Keep AndroGel 1.62% away from fire.

Keep AndroGel 1.62% and all medicines out of the reach of children.

General information about the safe and effective use of AndroGel 1.62%

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AndroGel 1.62% for a condition for which it was not prescribed. Do not give AndroGel 1.62% to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about AndroGel 1.62%. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about AndroGel 1.62% that is written for health professionals.

For more information, go to www.androgel.com or call 1-800-241-1643.

8. What are the ingredients in AndroGel 1.62%?

Active ingredient: testosterone

Inactive ingredients: carbopol 980, ethyl alcohol, isopropyl myristate, purified water and sodium hydroxide.

If you have any questions about this information, be sure to discuss them with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-10881-800-FDA-1088.

If you cannot afford your medication, contact www.pparx.org for assistance.

Important facts from the AndroGel 1% Medication Guide

To download the Medication Guide, you need the Adobe® Acrobat® Reader®. If you don't have the Adobe Acrobat Reader, you can download it for free.

Click to download the full AndroGel 1% Medication Guide (PDF)

1. What is the most important information I should know about AndroGel 1%?

1. Early signs and symptoms of puberty have happened in young children who were accidentally exposed to testosterone through contact with men using AndroGel 1%.

Signs and symptoms of early puberty in a child may include:

  • enlarged penis or clitoris
  • early development of pubic hair
  • increased erections or sex drive
  • aggressive behavior

AndroGel 1% can transfer from your body to others.

2. Women and children should avoid contact with the unwashed or unclothed area where AndroGel 1% has been applied to your skin.

Stop using AndroGel 1% and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have occurred through accidental exposure to AndroGel 1%.

Signs and symptoms of exposure to AndroGel 1% in children may include:

  • enlarged penis or clitoris
  • early development of pubic hair
  • increased erections or sex drive
  • aggressive behavior

Signs and symptoms of exposure to AndroGel 1% in women may include:

  • changes in body hair
  • a large increase in acne

To lower the risk of transfer of AndroGel 1% from your body to others, you should follow these important instructions:

  • Apply AndroGel 1% only to areas that will be covered by a short-sleeve t-shirt. These areas are your shoulders and upper arms, or stomach area (abdomen), or shoulders, upper arms and stomach area.
  • Wash your hands right away with soap and water after applying AndroGel 1%.
  • After the gel has dried, cover the application area with clothing. Keep the area covered until you have washed the application area well or have showered.
  • If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water.
  • If a woman or child makes contact with the AndroGel 1% application area, that area on the woman or child should be washed well with soap and water right away.

2. What is AndroGel 1%?

AndroGel 1% is a prescription medicine that contains testosterone. AndroGel 1% is used to treat adult males who have low or no testosterone.

Your healthcare provider will test your blood before you start and while you are taking AndroGel 1%.

It is not known if AndroGel 1% is safe or effective in children younger than 18 years old. Improper use of AndroGel 1% may affect bone growth in children.

AndroGel 1% is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your AndroGel 1% in a safe place to protect it. Never give your AndroGel 1% to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and is against the law.

AndroGel 1% is not meant for use in women.

3. Who should not use AndroGel 1%?

Do not use AndroGel 1% if you:

  • have breast cancer
  • have or might have prostate cancer
  • are pregnant or may become pregnant or are breast-feeding. AndroGel 1% may harm your 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.

Talk to your healthcare provider before taking this medicine if you have any of the above conditions.

4. What should I tell my healthcare provider before using AndroGel 1%?

Before you use AndroGel 1%, 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, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Using AndroGel 1% with certain other medicines can affect each other.

Especially, tell your healthcare provider if you take:

  • insulin
  • corticosteroids
  • medicines that decrease blood clotting

Know the medicines you take. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

5. How should I use AndroGel 1%?

  • It is important that you apply AndroGel 1% exactly as your healthcare provider tells you to.
  • Your healthcare provider will tell you how much AndroGel 1% to apply and when to apply it.
  • Your healthcare provider may change your AndroGel 1% dose. Do not change your AndroGel 1% dose without talking to your healthcare provider.
  • AndroGel 1% is to be applied to the area of your shoulders, upper arms, or abdomen that will be covered by a short-sleeve t-shirt. Do not apply AndroGel 1% to any other parts of your body such as your penis, scrotum, chest, or back.
  • Apply AndroGel 1% at the same time each morning. AndroGel 1% should be applied after showering or bathing.
  • Wash your hands right away with soap and water after applying AndroGel 1%.
  • Avoid showering, swimming, or bathing for at least 5 hours after you apply AndroGel 1%.
  • AndroGel 1% is flammable until dry. Let AndroGel 1% dry before smoking or going near an open flame.
  • Let the application areas dry completely before putting on a short-sleeve t-shirt.

Applying AndroGel 1%:

AndroGel 1% comes in a pump or in packets.

  • Before applying AndroGel 1%, make sure that your shoulders, upper arms, and abdomen are clean, dry, and that there is no broken skin.
  • The application sites for AndroGel 1% are the shoulders, upper arms, or abdomen that will be covered by a short-sleeve t-shirt (See Figure A).

If you are using the AndroGel 1% pump:

  • Before using a new bottle of AndroGel 1% for the first time, you will need to prime the pump. To prime the AndroGel 1% pump, slowly push the pump all the way down 3 times. Do not use any AndroGel 1% that came out while priming. Wash it down the sink to avoid accidental exposure to others. Your AndroGel 1% pump is now ready to use.
  • Remove the cap from the pump. Then, position the nozzle over the palm of your hand and slowly push the pump all the way down. Apply AndroGel 1% to the application site. You may also apply AndroGel 1% directly to the application site.
  • Wash your hands with soap and water right away.
  • Your healthcare provider will tell you the number of times to press the pump for each dose.

If you are using AndroGel 1% packets:

  • Tear open the packet completely at the dotted line. Squeeze from the bottom of the packet to the top.
  • Squeeze all of the AndroGel 1% out of the packet into the palm of your hand. Apply AndroGel 1% to the application site. You may also apply AndroGel 1% from the packet directly to the application site.
  • AndroGel 1% should be applied right away.
  • Wash your hands with soap and water right away.

6. What are the possible side effects of AndroGel 1%?

See “What is the most important information I should know about AndroGel 1%?

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%. This can include:
    • increased urination at night
    • trouble starting your urine stream
    • having to pass urine many times during the day
    • having an urge that you have to go to the bathroom right away
    • having a urine accident
    • being unable to pass urine or weak urine flow
  • Possible increased risk of prostate cancer. Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you use AndroGel 1%.
  • In large doses AndroGel 1% may lower your sperm count.
  • Swelling of your ankles, feet, or body, with or without heart failure.
  • Enlarged or painful breasts.
  • Have problems breathing while you sleep (sleep apnea).
  • Blood clots in your legs or lungs. Signs and symptoms of a blood clot in your leg can include leg pain, swelling, or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effects of AndroGel 1% include:

  • acne
  • skin irritation where AndroGel 1% is applied
  • lab test changes
  • increased prostate specific antigen (a test used to screen for prostate cancer)

Other side effects include more erections than are normal for you or erections that last a long time.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of AndroGel 1%. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

7. How should I store AndroGel 1%?

  • Store AndroGel 1% at 59°F to 86°F (15°C to 30°C).
  • Safely throw away used AndroGel 1% in household trash. Be careful to prevent accidental exposure of children or pets.
  • Keep AndroGel 1% away from fire.

Keep AndroGel 1% and all medicines out of the reach of children.

General information about the safe and effective use of AndroGel 1%

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AndroGel 1% for a condition for which it was not prescribed. Do not give AndroGel 1% to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about AndroGel 1%. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about AndroGel 1% that is written for health professionals.

For more information, go to www.androgel.com or call 1-800-241-1643.

8. What are the ingredients in AndroGel 1%?

Active ingredient: testosterone

Inactive ingredients: carbomer 980, ethyl alcohol 67.0%, isopropyl myristate, purified water and sodium hydroxide.

If you have any questions about this information, be sure to discuss them with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-10881-800-FDA-1088.

If you cannot afford your medication, contact www.pparx.org for assistance.

Have questions? We have answers. Call our hotline at 1-855-AGEL-1621-855-AGEL-162.

USE: AndroGel® (testosterone gel) 1% and 1.62%

AndroGel® (testosterone gel) 1% and 1.62% are controlled substances, available by prescription, used to treat adult males who have low or no testosterone. It is not known if AndroGel is safe or effective in children younger than 18 years old. Testosterone products that are applied to the skin may have different doses, strengths, or application instructions that may lead to different levels of testosterone in your body.

Important Safety Information

  • AndroGel can transfer from your body to others. This can happen if other people come into contact with the area where AndroGel 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.
  • Women and children should avoid contact with the unwashed or unclothed area where AndroGel has been applied. If a woman or child makes contact with the AndroGel 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%, you should apply it only to your 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. 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.
  • To lower the risk of transfer of AndroGel 1%, you should apply it only to areas that will be covered by a short-sleeve T-shirt. These areas include shoulders, upper arms, and stomach area. Do not apply AndroGel to your penis or scrotum. Wash your hands right away with soap and water after applying AndroGel. After the gel has dried, cover the application area with clothing. If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water.
  • Stop using AndroGel 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.
  • Do not use AndroGel if you have breast cancer or have or might have prostate cancer.
  • AndroGel is not meant for use in women and must not be used in women who are or may become pregnant or are breastfeeding. AndroGel 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 has been applied.
  • Before you use AndroGel, tell your healthcare provider if you have breast cancer; prostate cancer; urinary problems due to enlarged prostate; heart, kidney, or liver problems; problems breathing while you sleep (sleep apnea); and/or have any other medical conditions.
  • AndroGel 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 (including changes in urination)
    • Possible increased risk of prostate cancer
    • In large doses, AndroGel 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 your legs or lungs. Signs and symptoms of a blood clot in your leg can include leg pain, swelling, or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
  • Tell your healthcare provider about all the medicines you take, especially if you take insulin, medicines that decrease blood clotting, or corticosteroids.
  • AndroGel is flammable until dry. Let AndroGel dry before smoking or going near an open flame.
  • The most common side effects of AndroGel 1.62% are 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 the gel is applied. The most common side effects of AndroGel 1% are acne, skin irritation where the gel is applied, increased cholesterol levels, increased prostate specific antigen, increased red blood cell count, and increased liver function tests.
  • AndroGel 1% and 1.62% application sites and dosages are not interchangeable with each other, or with other topical testosterone products.
  • This is the most important information to know about AndroGel. For further information, talk with your healthcare provider.

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.or call 1-800-FDA-1088

If you cannot afford your medication, contact www.pparx.org for assistance.

References: 1. AndroGel 1.62% [package insert]. North Chicago, IL: AbbVie Inc. 2. AndroGel 1% [package insert]. North Chicago, IL: AbbVie Inc.