FDA Approves Fortesta

The U.S. Food and Drug Administration (FDA) has approved Fortesta Gel for the treatment of low testosterone, or 'Low T,' also known as hypogonadism. Symptoms associated with Low T include erectile dysfunction and decreased sexual desire, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics and osteoporosis.



Fortesta Medication Guide
Read this Medication Guide before you start using Fortesta and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

Important information about Fortesta

Fortesta can transfer from your body to others. This can happen if other people come into contact with the area where the Fortesta was applied.
Signs of puberty that are not expected (for example, pubic hair) have happened in young children who were accidentally exposed to testosterone through contact with men using topical testosterone products like Fortesta.

• Women and children should avoid contact with the unwashed or unclothed area where Fortesta has been applied. If a woman or child makes contact with the Fortesta application area, that area on the woman or child should be washed well with soap and water right away.
• To lower the risk of transfer of Fortesta from your body to others, you should follow these important instructions:
  • Apply Fortesta only to the front and inside area of your thighs that will be covered by clothing.
  • Wash your hands right away with soap and water after applying Fortesta.
  • After the Fortesta gel has dried, cover the application area with clothing. Keep the area covered until you have washed the application area well or have showered.
  • If you expect another person to have skin-to-skin contact with your thigh, first wash the application area well with soap and water.

Stop using Fortesta and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have occurred through accidental exposure to Fortesta:
Signs and symptoms in children may include:

• enlarged penis or clitoris
• early development of pubic hair
• increased erections or sex drive
• aggressive behavior

Signs and symptoms in women may include:

• changes in body hair
• a large increase in acne