The FDA is advising that healthcare professionals who prescribe testosterone replacement therapy follow these recommendations:

  • Before initiating testosterone replacement therapy, ensure that the diagnosis of hypogonadism has been confirmed with laboratory testing. Verify that serum testosterone concentrations have been measured on at least two separate mornings and are consistently below the normal range. Avoid measuring testosterone concentrations later in the day, when measurements can be low even in men who do not have hypogonadism.
  • For each patient, weigh the potential increased risk of major adverse cardiovascular outcomes and other risks of testosterone replacement therapy against the potential benefits of treating hypogonadism.
  • Inform patients of the potential increased cardiovascular risk associated with testosterone replacement therapy.
  • Encourage patients to read the patient Medication Guide or patient information leaflet they receive with their testosterone prescriptions.
  • Report adverse events involving testosterone treatment to the FDA MedWatch program.

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