"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 "...
No cases of overdose with ANDRODERM have been reported in clinical trials. There is one report of acute overdosage by injection of testosterone enanthate: testosterone concentrations of up to 11,400 ng/dL were implicated in a cerebrovascular accident. Treatment of overdosage would consist of discontinuation of ANDRODERM together with appropriate symptomatic and supportive care.
- ANDRODERM is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see WARNINGS AND PRECAUTIONS].
- ANDRODERM is contraindicated in women who are, or who may become pregnant, or who are breastfeeding. ANDRODERM may cause fetal harm when administered to a pregnant woman. ANDRODERM may cause serious adverse reactions in nursing infants. If a pregnant woman is exposed to ANDRODERM, she should be apprised of the potential hazard to the fetus [see Use in Specific Populations].
Last reviewed on RxList: 11/7/2016
Additional Androderm Information
Report Problems to the Food and Drug Administration
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.
Find out what women really need.