AndroGel (testosterone gel) 1% is a clear, colorless hydroalcoholic gel containing 1% testosterone. Topical administration of AndroGel 5 g, 7.5 g, or 10 g contains 50 mg, 75 mg, or 100 mg of testosterone, respectively, is to be applied daily to the skin's surface. Approximately 10% of the applied testosterone dose is absorbed across skin of average permeability during a 24-hour period.

The active pharmacologic ingredient in AndroGel is testosterone. Testosterone USP is a white to practically white crystalline powder chemically described as 17-beta hydroxyandrost-4-en-3-one. The structural formula is:

Inactive ingredients in AndroGel are carbomer 980, ethanol 67.0%, isopropyl myristate, purified water, and sodium hydroxide. These ingredients are not pharmacologically active.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: breast pain/enlargement, swelling of the feet/ankles (edema), weight gain, very slow/shallow/difficult breathing (possibly while sleeping), weakness.

Tell your doctor immediately if any of these rare but very serious side effects occur: trouble urinating, mental/mood changes (e.g., depression, agitation, hostility), change in size/shape of the testicles, testicle pain/tenderness, stomach/abdominal pain, dark urine, yellowing of eyes/skin, change in the amount of urine, calf tenderness/swelling/pain.

In patients with diabetes, especially those taking insulin, testosterone may decrease your blood sugar. Be prepared to treat low blood sugar while you are using this medication. Symptoms of low blood sugar include shakiness, nervousness, rapid pulse, and sweating. If you are experiencing these symptoms, consult your doctor.

For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using testosterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as soy), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: breast cancer (males), prostate cancer.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, prostate problems (e.g., enlarged prostate or BPH), heart problems, kidney problems, diabetes, high cholesterol level, lung disease, obesity, difficulty breathing during sleep (apnea), high blood pressure, bone cancer.

Direct contact with the application site can expose others to this medication. Women and children should avoid contact with the unwashed or unclothed area where the medication has been applied. 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 application area, that area on the woman or child should be washed well with soap and water right away.

If this medication accidentally gets into your eyes, rinse the eyes immediately with clean, warm water. Seek medical attention if necessary.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Some men, particularly the elderly, are at a higher risk for developing enlarged prostates or prostate cancer while using this medication. Your risk of prostate problems should be checked by your doctor before you start testosterone.

Children may be more sensitive to the side effects of this drug. In children, it may affect bone growth. Monitor your child's height periodically.

This medication should not be used in women. Women accidentally exposed to this medication may have side effects due to testosterone gel. Tell both of your doctors immediately if you notice symptoms in a woman such as changes in body hair or a large increase in acne. Avoid contact with this medication if you are pregnant or breast-feeding. This medication may cause harm to an unborn or breast-feeding baby. Consult your doctor for more details.