There is a single report of acute overdosage after parenteral administration of an approved testosterone product in the literature. This subject had serum testosterone concentrations of up to 11,400 ng/dL, which were implicated in a cerebrovascular accident. There were no reports of overdose in the FORTESTA clinical trial.
Treatment of overdosage would consist of discontinuation of FORTESTA, washing the application site with soap and water, and appropriate symptomatic and supportive care.
- FORTESTA is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS].
- FORTESTA is contraindicated in women who are or may become pregnant, or who are breastfeeding. FORTESTA may cause fetal harm when administered to a pregnant woman. FORTESTA may cause serious adverse reactions in nursing infants. Exposure of a female fetus or nursing infant to androgens may result in varying degrees of virilization. Pregnant women or those who may become pregnant need to be aware of the potential for transfer of testosterone from men treated with FORTESTA. If a pregnant woman is exposed to FORTESTA, she should be apprised of the potential hazard to the fetus [see Use in Specific Populations].
Last reviewed on RxList: 8/16/2012
This monograph has been modified to include the generic and brand name in many instances.
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