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Testosterone Replacement Therapy Side Effects: Men Face Unique Challenges As They Age

Terri Ackerman

Last updated: October 20, 2016 7:19 pm

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As men grow older, they may face unique challenges during a process some call “andropause.” Unlike women, who may undergo changes rapidly in a relatively shorter period of time, men generally experience physical changes gradually as they age. 1

Although men may remain fertile during the course of their lifetime, their testosterone level and sperm count may begin to decrease over time. In addition, along with changes in their testicular tissue, men may experience erectile dysfunction. 2

Testosterone Replacement Therapy and Aging

Some men may experience a condition called hypogonadism, responsible for lower levels of testosterone. This condition should not be confused with the aging process, in which men may experience a normal, but gradual decline in their levels of testosterone. 3

Symptoms of lower testosterone in men may include:

  • Decreased sex drive
  • Fewer and weaker erections
  • Reduced energy level
  • Mood changes, such as depression or irritability
  • Decreased muscle mass and strength
  • Increase in body fat
  • Anemia
  • Calcium loss from bone 4

Medical Groups Concerned with Testosterone Replacement Therapy Side Effects

The American Urological Association is concerned about the dangers associated with testosterone replacement therapy, and cautions that men should not take testosterone for nonmedical reasons, such as body-building, preventing changes related to aging or “performance enhancement.” 5

In addition, testosterone replacement therapy risks include blood clots. If a blood clot develops in a deep vein, known as a deep vein thrombosis or DVT, it could become detached, move through the bloodstream, and become stuck in the lungs, known as a pulmonary embolism or PE. Blocked blood flow could lead to life-threatening complications. 6

Testosterone replacement therapy side effects may include:

  • Acne
  • Breast soreness or enlargement
  • Possibly increased risk of prostate cancer
  • Possibly increased risk of heart attack or stroke
  • High red blood cell count
  • Swelling of the feet or ankles or other parts of the body
  • Worsening of sleep apnea 7

More information about testosterone replacement therapy side effects and risks is available.

FDA Investigating Testosterone Replacement Therapy Risks

The U.S. Food and Drug Administration (FDA) has approved testosterone replacement therapy for men diagnosed with hypogonadism. Testosterone for the treatment of men with confirmed hypogonadism comes in a variety of forms, including gels, patches, injections and adhesive applied to the gums. 8

In January 2014 the FDA announced that it was “investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.” 9

In June 2014 the FDA announced it was requiring testosterone manufacturers to “include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins…also known as venous thromboembolism (VTE)…” 10

In March 2015 the FDA issued an updated Safety Communication cautioning that “prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions” and that the “benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.” 11

In addition to requiring manufacturers to “change their labeling to clarify the approved uses of these medications” the FDA “concluded that there is a possible increased cardiovascular risk associated with testosterone use.” Because of this, the FDA decided to require “labeling changes for all prescription testosterone products to reflect the possible increased risk of heart attacks and strokes associated with testosterone use.” 12

Life-Threatening Testosterone Replacement Therapy Risks

The FDA has advised patients taking testosterone to seek immediate medical attention if they experience any of the following symptoms. They may be signs of a heart attack or stroke. 13

  • Chest pain
  • Shortness of breath or trouble breathing
  • Weakness in one part or one side of the body
  • Slurred speech
  1. https://www.nlm.nih.gov/medlineplus/ency/article/004017.htm  

  2. https://www.nlm.nih.gov/medlineplus/ency/article/004017.htm  

  3. http://www.urologyhealth.org/Documents/Media%20Center/Update-for-Men-on-Testosterone-Replacement-Therapy-TRT.pdf
    http://www.medpagetoday.com/resource-center/hypogonadism/testosterone-decline-with-aging/a/35000 

  4. http://www.urologyhealth.org/Documents/Media%20Center/Update-for-Men-on-Testosterone-Replacement-Therapy-TRT.pdf 

  5. http://www.urologyhealth.org/Documents/Media%20Center/Update-for-Men-on-Testosterone-Replacement-Therapy-TRT.pdf  

  6. http://www.mayoclinic.org/healthy-lifestyle/sexual-health/in-depth/testosterone-therapy/art-20045728?pg=2 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm402054.htm 

  7. http://www.mayoclinic.org/healthy-lifestyle/sexual-health/in-depth/testosterone-therapy/art-20045728?pg=2 http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021015s040lbl.pdf 

  8. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm161874.htm 

  9. http://www.fda.gov/Drugs/DrugSafety/ucm383904.htm 

  10. http://www.fda.gov/Drugs/DrugSafety/ucm401746.htm 

  11. http://www.fda.gov/Drugs/DrugSafety/ucm436259.htm 

  12. http://www.fda.gov/Drugs/DrugSafety/ucm436259.htm 

  13. http://www.fda.gov/Drugs/DrugSafety/ucm436259.htm