October 4, 2015



AndroGel Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, headache, dizziness, hair loss, trouble sleeping, change in sexual desire, redness/swelling of the skin, change in skin color, and acne may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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 right away if you have any serious side effects, including: breast pain/enlargement, swelling of the feet/ankles (edema), weight gain, very slow/shallow/difficult breathing (possibly while sleeping), weakness, trouble urinating, mental/mood changes (such as 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, fast/irregular heartbeat.

Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, unusual sweating, trouble breathing, weakness on one side of the body, slurred speech, confusion, sudden vision changes, pain/swelling/warmth in the groin/calf.

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. Your doctor may need to adjust your diabetes medications.

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

This medication can decrease sperm production, an effect that may lower male fertility. Consult your doctor for more details.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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.

Read the AndroGel (testosterone gel for topical use) Side Effects Center for a complete guide to possible side effects

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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breast cancer (males), prostate problems (such as cancer, enlarged prostate or BPH), liver problems, heart problems (such as heart failure, heart attack), stroke, kidney problems, diabetes, high cholesterol level, lung disease, obesity, difficulty breathing during sleep (apnea), high blood pressure, bone cancer, blood clots (such as in the leg, lungs).

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. Get medical help right away 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.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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 by women. Women accidentally exposed to this medication may have side effects due to testosterone gel. If you notice symptoms in a woman such as changes in body hair or a large increase in acne, talk to her doctor and your doctor right away. Women who are pregnant or breast-feeding must avoid contact with this medication. This medication may harm an unborn or breast-feeding baby. Consult your doctor for more details.

AndroGel - User Reviews

AndroGel User Reviews

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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