Your safety is our first priority. Learn more about key medication details, possible side effects, warnings, and other important information about testosterone replacement therapy below.
Prescribing Information
Testosterone replacement therapy, commonly called TRT, may be prescribed when clinically appropriate for men with clinically evaluated testosterone deficiency based on symptoms, medical history, and laboratory testing. Safety information may vary depending on the testosterone formulation prescribed, including injection, gel, cream, or another dosage form.
Black Box Warning
Certain testosterone products may include boxed warnings. Testosterone injection products may carry warnings related to abuse and misuse, which can lead to serious cardiovascular and psychiatric adverse reactions. Certain topical testosterone products may also include warnings about accidental secondary exposure to testosterone, especially in children.
Common Side Effects
Common side effects may include:
Acne
Oily skin
Fluid retention
Mood changes
Increased red blood cell count
Changes in libido
Breast tenderness or enlargement
Injection-site reaction, if injectable
Skin irritation, if topical
Worsening of sleep apnea in susceptible patients
Important Safety Information
Do not use testosterone if you have known or suspected prostate cancer, male breast cancer, serious uncontrolled heart, liver, or kidney disease, or a known allergy to testosterone or any ingredient in the medication.
Tell your provider if you have heart disease, high blood pressure, sleep apnea, enlarged prostate or urinary symptoms, liver disease, kidney disease, a history of blood clots, fertility concerns, mood disorders, prostate cancer risk, or are trying to conceive.
Testosterone may increase red blood cell count, worsen sleep apnea, affect fertility and sperm production, contribute to fluid retention, affect prostate monitoring, and may increase cardiovascular or blood clot risk in certain patients.
TRT generally requires ongoing lab monitoring, which may include testosterone levels, blood count, PSA, liver markers, estradiol, and other labs determined by your provider.
If using topical testosterone, avoid skin-to-skin transfer to children, pregnant women, partners, or others. Wash hands after use and cover application sites as instructed by your provider and dispensing pharmacy.
Seek urgent medical help if you experience chest pain, shortness of breath, one-sided weakness, severe leg swelling, severe mood changes, signs of an allergic reaction, or symptoms of a blood clot.
To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
