May 30, 2017
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"The US Food and Drug Administration (FDA) has approved class-wide labeling changes for all prescription testosterone products, the agency announced today.

New safety information from published literature and case reports on the risks "...





There have been no reports of overdosage in the Aveed clinical trials. There is one report of acute overdosage with use of an approved injectable testosterone product: this subject had serum testosterone levels of up to 11,400 ng/dL with a cerebrovascular accident.

Treatment of overdosage would consist of discontinuation of Aveed together with appropriate symptomatic and supportive care.


Aveed should not be used in any of the following patients:

  • Men with carcinoma of the breast or known or suspected carcinoma of the prostate [see WARNINGS AND PRECAUTIONS].
  • Women who are or may become pregnant, or who are breastfeeding. Testosterone can cause fetal harm when administered to a pregnant woman. Aveed may cause serious adverse reactions in nursing infants. Exposure of a fetus or nursing infant to androgens may result in varying degrees of virilization [see Use In Specific Populations].
  • Men with known hypersensitivity to Aveed or any of its ingredients (testosterone undecanoate, refined castor oil, benzyl benzoate).
This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 11/7/2016


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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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