Testosterone (AndroGel) Risks, Warnings, and Complications

PROSTATE PROBLEMS: Patients treated with androgens can develop worsening benign prostatic hyperplasia (BPH) and an increased risk of prostate cancer. If you have an enlarged prostate gland, your healthcare provider will monitor you for worsening signs and symptoms during topical testosterone therapy. They will also evaluate you for prostate cancer prior to starting treatment, likely with serum PSA values. This medication is not prescribed to prostate cancer patients.

SECONDARY EXPOSURE TO TESTOSTERONE: Secondary exposure to testosterone occurs primarily through skin-to-skin contact. It can result in virilization in women and children. Signs and symptoms in children may include enlargement of the genitalia, development of pubic hair, increased libido and erections, and aggression. It can also affect bone growth and cause a child to stop growing sooner than normal, with a resultant shorter adult height. Signs and symptoms of virilization in women may include changes in body hair distribution and increased acne. 

These symptoms of virilization usually go away once exposure to topical testosterone is stopped. However, in children, enlarged genitalia may not return to an age-appropriate size, and the bone age may remain ahead of chronological age. 

Take proper precautions while using a topical testosterone product. Women and children should avoid contact with uncovered or unwashed application sites where AndroGel 1% or AndroGel 1.62% have been used. Stop using topical testosterone and call your doctor without delay if women or children in your household show signs of virilization.

POLYCYTHEMIA: Treatment with topical testosterone can lead to polycythemia (an increase in hematocrit, which is a measure of red blood cell mass). This is associated with an increased risk of thromboembolic events (blood clots). If you develop elevated hematocrit, your healthcare provider may recommend lowering the dose of testosterone or discontinuing it until hematocrit comes back into normal range. Your provider will check your hematocrit before starting testosterone, again after 3-6 months, and then annually during treatment. 

VENOUS THROMBOEMBOLISM: Male subjects using topical testosterone can develop venous thromboembolic events, such as deep vein thrombosis (DVT) and pulmonary embolism (PE). Call your doctor immediately if you develop pain, swelling, redness, or warmth in a leg, shortness of breath, chest pain, or difficulty breathing. If your provider suspects a venous thromboembolic event, they will discontinue treatment with topical testosterone and order tests to identify the cause of your symptoms. 

CARDIOVASCULAR RISKS: It is unclear whether long-term use of topical testosterone products negatively impacts cardiovascular health in adult males. To date, epidemiologic studies and randomized controlled trials have been inconclusive in determining the risk of non-fatal heart attacks, strokes, and cardiovascular death in male subjects with elevated testosterone due to the use of these products compared to men who are not using these products. Your doctor will discuss this risk with you before starting testosterone replacement therapy.

ABUSE: Some people abuse prescription medicines such as testosterone by using them at higher doses, for reasons other than prescribed, or in combination with other anabolic androgenic steroids. Abuse of anabolic steroids carries a risk of serious cardiovascular and psychiatric complications, including heart attack, congestive heart failure, other heart problems, mini-strokes, stroke, liver disease, seizures, mania, depression, aggression, changes in behavior, delusions, and hallucinations. Using testosterone at higher doses than prescribed and then suddenly stopping it can cause withdrawal symptoms such as extreme fatigue, cravings, depression, restlessness, irritability, loss of appetite, sleep problems, and decreased libido. Always use topical testosterone at the same dose as prescribed by your doctor. This medication is a Schedule III controlled substance. If your healthcare provider suspects testosterone abuse, they may check serum testosterone concentrations to ensure they are within the therapeutic range. 

EFFECTS ON SPERM: Large doses of exogenous androgens, including testosterone gel, can suppress sperm formation and lower sperm count. Talk with your doctor about this risk if you plan to have children in the future.

ADVERSE EFFECTS ON THE LIVER: Prolonged use of high doses of androgens like methyltestosterone can cause serious hepatic adverse effects on the liver, including hepatitis (inflammation) and jaundice. Long-term treatment with intramuscular testosterone enanthate has produced multiple hepatic adenomas (tumors). Some of these complications can be life-threatening. However, topical testosterone is not known to cause these adverse reactions.

SWELLING: Androgens, including topical testosterone, can lead to increased sodium and fluid retention, causing edema (swelling). This can be a serious complication in people with congestive heart failure or other preexisting heart diseases, kidney disease, or liver disease. Before starting topical testosterone, give your doctor a complete medical history. 

SLEEP APNEA: Treatment of primary hypogonadism with testosterone can trigger sleep apnea, especially in men with other risk factors such as obesity or chronic lung diseases.

SERUM LIPID PROFILE: Testosterone can cause changes in the serum lipid profile (cholesterol levels), which may require dose adjustment or discontinuation of treatment.

HYPERCALCEMIA: Testosterone therapy should be used with caution in cancer patients who are at risk of hypercalcemia (increased serum calcium concentrations) and associated hypercalciuria (increased calcium in the urine). Your healthcare provider will order regular serum calcium concentrations to monitor you during testosterone treatment.