AndroGel contains testosterone, a naturally occurring male hormone necessary for many processes in the body. It works by replacing or supplementing the testosterone that is naturally made in the body.

AndroGel is used to treat conditions in men that result from a lack of natural testosterone.

AndroGel will not enhance athletic performance and should not be used for this purpose.

You should not use AndroGel if you have prostate cancer, male breast cancer, are pregnant, or are breastfeeding.

Testosterone can cause birth defects in an unborn baby. A pregnant woman should avoid coming into contact with this medicine, or with a man's skin where the medicine has been applied.

Topical testosterone is absorbed through the skin and can cause side effects or symptoms of male features in a child or woman who comes into contact with this medicine. Call your doctor if a person who has close contact with you develops enlarged genitals, premature pubic hair, increased libido, aggressive behavior, male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any signs of male characteristics.

Misuse of AndroGel can cause dangerous or irreversible effects. Never use more than your prescribed dose. Do not share this medicine with another person.

Before taking this medicine

You should not use AndroGel if you are allergic to testosterone patches or gels, or if you have;

• prostate cancer; or

• male breast cancer.

To make sure AndroGel is safe for you, tell your doctor if you have ever had:

• cancer;

• enlarged prostate, urination problems;

• sleep apnea (breathing stops during sleep);

• high blood pressure, heart disease, heart attack, or stroke;

• a blood clot;

• diabetes; or

• liver disease or kidney disease.

Older men who use AndroGel may have an increased risk of prostate enlargement or cancer. If you are over 65, talk with your doctor about your specific risk.

AndroGel should not be used by a woman. Testosterone can cause birth defects in an unborn baby. A pregnant woman should avoid coming into contact with testosterone gel, or with a man's skin areas where the gel has been applied. If contact does occur, wash with soap and water right away.

Do not use AndroGel on anyone younger than 18 years old.

Use AndroGel exactly as it was prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than prescribed.

Misuse of AndroGel can cause dangerous or irreversible effects, such as enlarged breasts, small testicles, infertility, high blood pressure, heart attack, stroke, liver disease, bone growth problems, addiction, and mental effects such as aggression and violence.

Do not share this medicine with another person.

This medicine comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Apply AndroGel only to your shoulders, upper arms, and/or abdomen that will be covered by a short sleeve t-shirt. Wash your hands with soap and water before and after applying the gel. 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.

Do not apply AndroGel to your penis or scrotum.

Apply AndroGel to dry skin after showering or bathing. Allow the medicine to dry for at least 5 minutes before you dress. Avoid showering, swimming or bathing for at least 2 hours after you application.

AndroGel may be flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.

Cover treated skin areas with clothing to keep from getting this medicine on other people. If someone else does come into contact with a treated skin area, they must wash the contact area right away with soap and water.

While using AndroGel, you may need frequent blood tests.

Use AndroGel regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat.

You should not use AndroGel if you are allergic to testosterone patches or gels, or if you have;

• prostate cancer; or

• male breast cancer.

To make sure AndroGel is safe for you, tell your doctor if you have ever had:

• cancer;

• enlarged prostate, urination problems;

• sleep apnea (breathing stops during sleep);

• high blood pressure, heart disease, heart attack, or stroke;

• a blood clot;

• diabetes; or

• liver disease or kidney disease.

Older men who use AndroGel may have an increased risk of prostate enlargement or cancer. If you are over 65, talk with your doctor about your specific risk.

AndroGel should not be used by a woman. Testosterone can cause birth defects in an unborn baby. A pregnant woman should avoid coming into contact with testosterone gel, or with a man's skin areas where the gel has been applied. If contact does occur, wash with soap and water right away.

Do not use AndroGel on anyone younger than 18 years old.

Apply the gel as soon as you remember. Skip the missed dose if it is almost time to apply your next dose. Do not use extra gel to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not apply this medicine to your penis or your scrotum.

Avoid swimming, bathing, or showering for at least 5 hours after applying AndroFel.

Get emergency medical help if you have any signs of an allergic reaction to AndroGel: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using AndroGel and call your doctor at once if you have:

• increased urination (many times per day), loss of bladder control;

• painful or difficult urination;

• breast pain or swelling;

• painful or bothersome erections;

• swelling, rapid weight gain, shortness of breath during sleep;

• chest pain or pressure, pain spreading to your jaw or shoulder;

• liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• signs of a blood clot in the lung - chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

• signs of a blood clot in your leg - pain, swelling, warmth, or redness in one or both legs.

Topical testosterone is absorbed through the skin and can cause symptoms of male features in a woman or child who comes into contact with the medication. Call your doctor if your female partner has male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any other signs of male characteristics.

Common AndroGel side effects may include:

• redness, itching, burning, hardened skin or other irritation where the medicine was applied or where the skin patch was worn;

• increased red blood cells (may cause dizziness, itching, redness in your face, or muscle pain);

• increased prostate-specific antigen;

• increased blood pressure;

• headache;

• mood changes, strange dreams;

• frequent or prolonged erections;

• nausea, vomiting; or

• swelling in your lower legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines and any you start or stop using during your treatment with AndroGel, especially:

• insulin;

• a blood thinner; (warfarin, Coumadin, Jantoven); or

• a steroid medicine; methylprednisolone (Medrol), prednisone (Sterapred), and others.

This list is not complete. Other drugs may interact with testosterone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.