Testim® Safety Information

It is important to read the Medication Guide that comes with Testim before you start using Testim, and each time you refill your prescription.

Auxilium Pharmaceuticals Drug Information Center

If you have other questions about the safety and efficacy of Testim, or if you want to report an adverse event, please contact the Auxilium Pharmaceuticals Drug Information Center at 1-877-663-0412.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.

Indication
Testim 1% (testosterone gel) is a prescription medicine that contains testosterone. Testim is used to treat adult males who have low or no testosterone.
Important Safety Information

What is the most important information I should know about Testim?

Early signs and symptoms of puberty have happened in young children who were accidentally exposed to testosterone through contact with men using Testim.

Signs and symptoms of early puberty in a child may include:

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

Testim can transfer from your body to others. Women and children should avoid contact with the unwashed or unclothed area where Testim has been applied to your skin.

Stop using Testim and call your doctor right away if you see any signs and symptoms in a child or a woman that may have occurred through accidental exposure to Testim.

  • Signs and symptoms of exposure to Testim in a child may include: enlarged penis or clitoris, early development of pubic hair, increased erections or sex drive, aggressive behavior.

  • Signs and symptoms of exposure to Testim in women may include: changes in body hair; a large increase in acne.

To lower the risk of transfer of Testim from your body to others, you should: Apply Testim only to the areas of your shoulders and upper arms that a short sleeve T-shirt would cover. Wash your hands right away with soap and water after applying Testim and cover the application area with clothing after the gel has dried. If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water. If a woman or child comes in contact with the Testim application area, the contact area on the woman or child should be washed well with soap and water right away.

Do not use Testim if you: have breast cancer; have or might have prostate cancer; are allergic to testosterone or any of the ingredients in Testim, including soy.

Testim is not meant for use in women. If you are pregnant, may become pregnant, or are breast-feeding, Testim may harm your unborn or breast-feeding baby. Women who are pregnant or who may become pregnant should avoid contact with the area where Testim has been applied.

Other serious side effects include the following:
  • If you already have enlargement of your prostate gland, your signs and symptoms can get worse while using Testim
  • Possible increased risk of prostate cancer
  • In large doses, Testim may lower your sperm count
  • Swelling of your ankles, feet, or body, with or without heart failure. This may cause serious problems for people who have heart, kidney, or liver disease
  • Enlarged or painful breasts
  • Having problems breathing while you sleep (sleep apnea)
  • Blood clots in the legs. This can include pain, swelling, or redness of your legs

The most common side effects of Testim include: skin irritation where Testim is applied, increased red blood cell count, headache, and increased blood pressure.

Please see Full Prescribing Information and Medication Guide

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