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Testosterone indications and side effects

Indications and Usage for Testosterone Topical Solution

Testosterone topical solution is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.

  • Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (FSH, LH) above the normal range.
  • Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.

Limitations of use:

  • Safety and efficacy of testosterone topical solution in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
  • Safety and efficacy of testosterone topical solution in males <18 years old have not been established.

Precautions

  • It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
  • This medicine should not be used by women, especially those who are pregnant or might become pregnant. Testosterone may cause birth defects if a pregnant woman comes in contact with the medicine. Make sure your doctor knows if your sexual partner is pregnant. If a pregnancy occurs while you are using this medicine, tell your doctor right away.
  • Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.
  • This medicine may increase the risk of prostate cancer, especially in older men. Make sure your doctor knows if you have prostate cancer, or if anyone in your family has prostate cancer.
  • This medicine may cause blood clotting problems. Tell your doctor right away if you have pain, redness, or swelling in the arm or leg, sharp pains in the chest, or trouble breathing.
  • This medicine may increase your risk of having heart or blood vessel problems, including a heart attack or stroke. Tell your doctor right away if you have chest pain that may spread to your arms, jaw, back, or neck, faintness, headache, nausea, vomiting, trouble breathing, trouble seeing or speaking, or unusual sweating.
  • Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
  • This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.
  • This medicine may cause swelling of the breasts (gynecomastia) and breast pain in some patients. If you have questions about this, talk to your doctor.
  • Hypercalcemia (high calcium in the blood) may occur in patients taking this medicine. Check with your doctor right away if you have stomach pain, confusion, constipation, depression, dry mouth, increased urination, loss of appetite, metallic taste, or muscle weakness.
  • This medicine may cause changes in the level of cholesterol and fats in your blood. If this condition occurs, your doctor may give you a medicine to adjust the cholesterol and fats. Talk to your doctor if you have concerns.
  • This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
  • In some cases, this medicine may decrease the amount of sperm men make and affect their ability to have children. Talk with your doctor before you use this medicine if you plan to have children.
  • Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common:

  • Bleeding from the gums or nose
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • bone or muscle pain
  • discouragement
  • dizziness
  • enlarged prostate
  • eye pain
  • feeling sad or empty
  • headache
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • nervousness
  • painful or difficult urination
  • pounding in the ears
  • ringing in the ears
  • slow or fast heartbeat
  • stomach pain
  • tingling of the hands or feet
  • trouble concentrating
  • trouble sleeping
  • unusual tiredness or weakness
  • unusual weight gain or loss

Rare:

  • Changes in behavior
  • thoughts of killing oneself
  • Incidence not known
  • Chest pain or discomfort
  • confusion
  • difficulty breathing
  • difficulty in speaking
  • double vision
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • nausea
  • pain in the chest, groin, or legs, especially the calves
  • pain or discomfort in the arms, jaw, back, or neck
  • severe, sudden headache
  • slow or slurred speech
  • sudden loss of coordination
  • sudden, severe weakness or numbness in the arm or leg
  • sweating
  • vision changes
  • vomiting

Get emergency help immediately if any of the following symptoms of overdose occur:

  • Symptoms of overdose
  • Blurred vision
  • inability to speak
  • seizures
  • severe or sudden headache
  • slurred speech
  • temporary blindness
  • weakness in the arm or leg on one side of the body, sudden and severe

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common:

  • Belching
  • bloated, full feeling
  • diarrhea
  • excess air or gas in the stomach
  • heartburn
  • indigestion
  • runny or stuffy nose
  • sore throat
  • stomach discomfort or upset

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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