Testosterone is used as hormone replacement therapy in adult men with certain medical conditions that cause low or no testosterone levels.

Testosterone will not enhance athletic performance and should not be used for that purpose.

Testosterone may also be used for purposes not listed in this medication guide.

You should not take testosterone if you are allergic to it, or if you have:

• low testosterone levels due to getting older;
• known or suspected prostate cancer; or
• male breast cancer.

Tell your doctor if you have ever had:

• heart problems;
• high blood pressure;
• diabetes;
• chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing disorder;
• urination problems due to an enlarged prostate;
• depression, anxiety, a mood disorder, suicidal thoughts or actions;
• cancer;
• high red blood cell count (hematocrit) or high hemoglobin levels on a blood test; or
• liver or kidney disease.

Testosterone is not approved for use in women.

It may be harder for you to get a woman pregnant while you are using this medicine.

Using testosterone may increase your risk of developing prostate cancer. Ask your doctor about your individual risk.

Use Testosterone Oral (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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

Testosterone can increase your blood pressure, which can increase your risk of heart attack, stroke, or death. You may need to stop using testosterone or start taking blood pressure medication.

Call your doctor at once if you have:

• pain or swelling in your breasts;
• sleep apnea (breathing stops during sleep);
• unusual changes in mood or behavior, new or worsening depression, suicidal thoughts or actions;
• heart problems--swelling, rapid weight gain, feeling short of breath;
• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• signs of a blood clot in the lung--chest pain, sudden cough or shortness of breath, wheezing, rapid breathing, coughing up blood;
• signs of a blood clot deep in the body--pain, swelling or warmth in your leg; or
• signs of an enlarged prostate--increased urination, a weak stream of urine, an urgent need to urinate, or loss of bladder control.

Common side effects may include:

• increased red blood cell counts;
• an enlarged prostate;
• erections that are more frequent or that last longer than usual;
• increased blood pressure;
• nausea, heartburn, burping;
• diarrhea;
• headache;
• swelling in your lower legs;
• joint, muscle or back pain;
• cold symptoms;
• breast swelling; or
• weight gain.

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.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.