Side Effects of Testosterone
Common Side Effects
Irritation at the application or injection site, hair loss, acne, headaches, confusion, mood changes, male breast enlargement and decreased libido
Potential Serious Side Effects
Enlarged prostate, hypertension, elevated prostate-specific antigen (PSA) levels and liver damage
Boxed Warning
Different versions of testosterone therapy drugs may contain boxed warnings for increased blood pressure or virilization of children through secondary exposure.

Latest Testosterone Side Effect Information

As of March 31, 2024, the U.S. Food and Drug Administration has received over 36,000 reports testosterone side effects.

FDA Adverse Event Reports for Testosterone Side Effects
Total cases reported36,238
Serious cases (including deaths)17,392
Deaths1,180
Source: FAERS Database

Disclaimer: Reports sent to the FDA don’t necessarily mean the drug caused an adverse event. Consult a health care professional before stopping or changing medication.

The most frequently reported side effects of testosterone treatments are myocardial infarction (heart attack), decreased blood testosterone, deep vein thrombosis (a type of blood clot), cerebrovascular accident (stroke) and pulmonary embolism (blood clot in the lungs). These serious testosterone side effects account for 36.12% of all adverse events reported to the FDA.

Most Reported Testosterone Side Effects
  • Heart attack: 9.82%
  • Decreased Blood Testosterone: 7.69%
  • Deep Vein Thrombosis: 6.39%
  • Stroke: 6.29%
  • Pulmonary Embolism: 5.93%
  • All Other Side Effects: 63.88%

Testosterone therapy may also affect male fertility, according to Dr. Scott Sills, Medical Director for the Center for Advanced Genetics.

“The role of testosterone supplements is a very interesting issue — the issue is that taking testosterone is antagonistic to sperm production,” Dr. Sills told Drugwatch. “So while its immediate effects may be highly desirable, the long-term dividend of [testosterone] supplements is really deleterious to the male factor component of fertility.”

Case Study: AndroGel and Cardiac Side Effects
Michael Gallagher, a 54-year-old man, began using AndroGel, a testosterone replacement therapy manufactured by AbbVie Inc. and Abbott Laboratories, to treat symptoms of low testosterone. Influenced by the companies’ aggressive marketing, he believed AndroGel to be a safe and effective solution, according to court documents.

Health Complications

After starting AndroGel, Gallagher experienced severe health issues, including a heart attack and congestive heart failure, according to court documents. He claimed these conditions significantly impacted his personal and professional life, forcing him to retire early.

Side Effects of AndroGel

According to Gallager’s testosterone lawsuit complaint, AndroGel has been linked to serious side effects, including life-threatening cardiac events, strokes and thrombolytic events. Despite these risks, the manufacturers heavily promoted the drug without adequately warning consumers about the potential dangers.

Conclusion

Michael Gallagher’s case highlights the rare but severe risks associated with testosterone therapy, emphasizing the importance of thorough medical evaluation and awareness of potential side effects. Before starting testosterone replacement therapy, patients should be cautious and consult healthcare professionals to fully understand the risks involved in such treatments.

Common Testosterone Side Effects

Common testosterone side effects are often hormonal or psychological. Acne, changes to sexual desire and breast tenderness commonly occur. Mood swings, depression and anxiety are also possible. If you choose to pursue testosterone replacement therapy, it’s important to understand the common side effects you may experience.

Common Side Effects of Testosterone Therapy
  • Acne
  • Anxiety
  • Breast enlargement or pain
  • Decreased libido
  • Depression
  • Fatigue
  • Hair loss
  • Headache
  • Hoarseness or deepening of the voice
  • Hot flashes
  • Increased aggression
  • Infertility due to low sperm count or suppressed ovulation
  • Insomnia
  • Mood swings
  • Muscle pain or weakness
  • Pain in the joints and/or back
  • Weight gain

Some people taking testosterone therapy experience irritation at the injection or application site. This can manifest as burn-like blisters, bleeding, redness, hardness, pain, itching or a burning sensation.

Patients experiencing any pain in the abdominal region after taking testosterone medication should report it to a health care provider immediately, as this may indicate liver damage.



Serious Side Effects of Testosterone

Serious side effects of testosterone may include blood clots and infertility. Though the evidence is conflicting, serious side effects may also include cardiac issues and increased risk of prostate cancer. While not life-threatening, some patients may view hair loss, breast size changes and an irreversibly deeper voice as severe negative side effects.

Various testosterone supplement manufacturers have faced significant lawsuits due to adverse side effects.

Heart Attack Risk

Research is conflicting on if testosterone replacement therapy leads to increased risks of cardiovascular events. In 2015, the FDA required testosterone product labels to include the potential increased risk of heart attack and stroke while on the medication. They advise anyone on testosterone replacement therapy who experienced chest pain, shortness of breath, slurred speech or weakness in one half of the body to immediately consult a physician. As of 2024, the FDA has not retracted this advice.

One patient, Bill Golding, started taking testosterone supplements when he was 58. He told Drugwatch that prior to that, he worked out regularly and got a clean bill of health from his doctors with each annual check-up. But shortly after starting testosterone, he suffered his first heart attack.

“I am short of breath now, and I can’t work out like I used to,” he told Drugwatch. “Now, I have a regimen of pills. My cardiologist said I will be on at least one of them for the rest of my life.”

Symptoms of Cardiac Issues
  • Difficulty urinating
  • Erections that last too long or are painful
  • Nausea or vomiting
  • Pain, swelling or warmth in the lower leg
  • Swelling of the hands, feet or ankles
  • Trouble breathing
  • Weakness or numbness in one arm or leg
  • Yellowing of the skin or eyes

However, more recent research appears to contradict heart risks. A 2017 study published in the Methodist DeBakey Cardiovascular Journal found a correlation between testosterone replacement therapy and improved cardiovascular conditions.

If you are concerned about your heart health, talk to your doctor before beginning any form of testosterone replacement therapy.

Prostate Cancer Risk

While an increased risk of prostate cancer steered some patients away from testosterone replacement therapy in the early 2000s, a 2022 study in the journal Uro found that the conclusions of prior studies may have overestimated these harmful effects. According to this newer research, testosterone replacement therapy may instead counteract several metabolic problems.

Another 2016 literature review in Urological Oncology also found no significant correlation between testosterone levels and the chance of developing prostate cancer.

However, warnings related to prostate cancer risk are still on many testosterone replacement therapy product labels. Researchers may need to perform further studies to determine the level of risk.

Medications That May Cause Low Testosterone

Several medications may lower testosterone, such as certain antidepressants like serotonin-uptake-inhibitors, opioids, certain blood pressure medications, cholesterol-lowering medication such as statins and some heartburn medications, such as proton pump inhibitors.

“A client I had… suffered a side effect from proton pump inhibitor or PPI, which was… low testosterone,” Rebecca Montrone, a Certified Holistic Health Practitioner and founder of Wondrous Roots, told Drugwatch.

Everything that you put in your stomach has to be metabolized through the liver. The process that metabolises proton pump inhibitors — such as Prevacid or Nexium — also metabolizes and clears testosterone, according to Montrone. If it clears too quickly, your body will quit making enough testosterone, leaving you with “Low-T.”

“I mean, I know a lot of guys who would be like, ‘I’ll take the heartburn,’” Montrone said.

It’s important to talk with your doctor or pharmacist about side effects from all the medications you take.

FDA Warnings Related to Testosterone Use

The FDA issued several warnings about the cardiovascular risks of testosterone use and the possibility of abuse.

Stroke, Heart Attack and Death

In 2014, the FDA issued a warning based on its investigation into stroke, heart attack and death in patients who were using FDA-approved testosterone products. Following this warning, the FDA has updated requirements for labeling testosterone products to ensure patients understand the increased risk of stroke and heart attack that is associated with testosterone use.

Abuse and Dependence

The FDA put out a warning in 2016 regarding the potential for abuse of and dependence on prescription testosterone products as well as other anabolic androgenic steroids. Usually, abuse of prescription testosterone products happens when patients take them in doses higher than what their doctor prescribes or in combination with various other anabolic androgenic steroids.

After this warning came out, the labeling requirement updates ensured that patients and prescribers are aware of the risks that come with abusing these substances.

Boxed Warnings for Testosterone

Topical testosterone products contain a warning about the possibility of secondary exposure causing virilization in children. An FDA boxed warning indicates a likelihood of a serious or life-threatening side effect developing.

According to the boxed warning, symptoms of virilization in children may manifest as “enlargement of the penis or clitoris, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age.”

Injectable testosterone medications such as Xyosted include a boxed warning for increased blood pressure.

Managing Side Effects of Testosterone

Minor side effects, such as rash and acne, may clear up on their own. They may also be treatable with over-the-counter solutions such as acne treatments or soothing lotions.

More severe symptoms like fever and vomiting may indicate something more serious, such as a cardiac condition. If you experience severe symptoms while on testosterone, talk to your prescribing health care provider to ensure they aren’t a sign of a serious health concern.

Alternatives to Testosterone

General life-style changes, such as getting adequate sleep, vitamin D, zinc and exercise, may help increase testosterone levels.

Additionally, there is some evidence that human chorionic gonadotropin (hCG) may stimulate the production of testosterone in the testes. While hCG is commonly used as a fertility aid in women, a study published in Cureus in 2022 showed subjective increases in libido and sexual function among men taking hCG.

If you respond poorly to testosterone replacement therapy and would like to explore other options, be sure to consult your doctor before beginning or ending any sort of hormone therapy treatment.

Editor Lindsay Donaldson contributed to this article.

Please seek the advice of a medical professional before making health care decisions.