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Testosterone Side Effects: How Scary Are They?

Despite new data about testosterone treatment for men with "low T" the FDA remains adamant that this is a no-no! It warns about testosterone side effects.

Treatment with the male hormone testosterone has been highly controversial for years. The FDA makes it clear that testosterone side effects are worrisome and physicians should NOT prescribe the hormone the way this doctor did.

Q. At my recent physical, my doctor gave me the results of my blood work. My testosterone was low and he recommended T shots.

I had been experiencing some ED and lethargy but attributed that to my age. The shots have helped me but I wonder about adverse effects. Are there any?

A. Testosterone, either as an injection or topical gel, is contentious. The FDA cautions doctors not to prescribe this male hormone to healthy men with “low T” linked to aging. The agency states that testosterone is only for men with hypogonadism and warns about an increased risk of heart attacks and strokes.

The FDA Warns of Testosterone Side Effects:

Here, in its own words, is the latest FDA Safety Announcement (March 3, 2015):

“The U.S. Food and Drug Administration (FDA) cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. 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. We are requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. We are also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests…

  • “Patients using testosterone should seek medical attention immediately if symptoms of a heart attack or stroke are present, such as:
  • Chest pain
  • Shortness of breath or trouble breathing
  • Weakness in one part or one side of the body
  • Slurred speech”

What Does the Science Say About Testosterone Side Effects?

A study in the New England Journal of Medicine (Feb. 18, 2016) contradicts the FDA’s stance.  It demonstrated that men with low testosterone experienced improved sexual function and mood after using a testosterone gel with no increased risk of cardiovascular complications. Another analysis of available data also found no link to heart attacks and strokes (Expert Opinion on Drug Safety, Oct. 2014).

The FDA moves slowly. It can take the agency decades to discover serious side effects from prescription or over-the-counter medications. Equally, it can take the FDA many years to reverse direction on a warning like the one about testosterone side effects re: heart attacks and strokes.

That is not to say that testosterone side effects are imaginary. Here is what clinical trials revealed with one testosterone topical gel (AndroGel):

Testosterone Side Effects:

  • Increased PSA readings
  • Mood swings, anxiety, irritability, impatience, anger, aggression, insomnia
  • Increased blood pressure
  • Sinusitis
  • Increased hemoglobin
  • Skin irritation in the area of the gel
  • Acne
  • Urinary difficulties, hesitancy, nighttime bathroom runs

The Bottom Line on Testosterone:

There is still tremendous confusion about testosterone treatment. We did a deep dive on the pros and cons of testosterone therapy at this link.

You can also learn more about the controversy regarding testosterone and prostate cancer here.

Should you wish to learn how to avoid pricey T shots or gels that violate FDA’s recommendations, you may wish to listen to our one-hour radio interview with John La Puma, MD on how to boost testosterone naturally.

Share your own story about low T and testosterone in the comment section below.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.”.
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