The brand name of the drug is AndroGel, and its active ingredient is testosterone in the form of a hydroalcoholic gel. Testosterone belongs to the drug class of androgens. The formulation is a 1% gel, administered topically. Key inactive ingredients include carbomer 980, ethyl alcohol, isopropyl myristate, purified water, and sodium hydroxide.

How should I use this medication?

This medication is for external use only. Do not take by mouth. Wash your hands before and after use. Do not get it in your eyes. If you do, rinse your eyes with plenty of cool tap water. Use it as directed on the prescription label at the same time every day. Do not use it more often than directed. Make sure that you are using your product correctly. Allow the skin to air-dry, then cover with clothing to prevent others from coming in contact with the medication on your skin. This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets. This medication can be abused. Keep your medication in a safe place to protect it from theft. Do not share this medication with anyone. Selling or giving away this medication is dangerous and against the law. Store at room temperature between 20 and 25 degrees C (68 to 77 degrees F). Keep closed until use. Protect from heat and light. This medication is flammable. Avoid exposure to heat, fire, flame, and smoking. Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain -Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded -Increase in blood pressure -Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing of the skin or eyes, unusual weakness or fatigue -Mood swings, irritability or hostility -Prolonged or painful erection -Sleep apnea—loud snoring, gasping during sleep, daytime sleepiness -Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision -Swelling of the ankles, hands, or feet -Thoughts of suicide or self-harm, worsening mood, feelings of depression Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome): -Acne -Change in sex drive or performance -Irritation at application site -Unexpected breast tissue growth

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Breast cancer -Diabetes -Heart disease -Heart failure -Kidney disease -Liver disease -Lung or breathing disease (asthma, COPD) -Polycythemia -Prostate cancer or disease -Sleep apnea -An unusual or allergic reaction to testosterone, other medications, foods, dyes, or preservatives -If you or your partner are pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

-Medications for diabetes -Medications that treat or prevent blood clots like warfarin -Steroid medications like prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. You may need blood work while you are taking this medication. Heart attacks and strokes have been reported with the use of this medication. Get emergency help if you develop signs or symptoms of a heart attack or stroke. Talk to your care team about the risks and benefits of this medication. This medication can transfer from your body to others. If a person or pet comes in contact with the medication, they may have a serious risk of side effects. If you cannot avoid skin-to-skin contact, cover the application site with clothing. If accidental contact happens, wash the skin of the person or pet right away with soap and water. A partner who is pregnant or trying to get pregnant should avoid contact with the medication and treated skin. Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy. This medication may affect blood sugar. Ask your care team if changes in diet or medications are needed if you have diabetes. This medication is banned from use in athletes by most athletic organizations.

What are the most serious risks of this medication?

The testosterone in these skin products can transfer to other people accidentally, and may cause problems in children, infants, and females. Follow all instructions for use carefully. In children, symptoms of exposure can include a change in pubic hair or the genitals, a change in sex drive, or aggressive behavior. In women, an increase in acne or facial hair may occur. If any of these symptoms are noted in another person, stop using the product and contact your health care provider.