"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 "...
Male adolescent patients receiving androgens for delayed puberty should have bone development checked every six months.
The physician should instruct patients to report any of the following side effects of androgens:
Adult or adolescent males – too frequent or persistent erections of the penis.
Women – hoarseness, acne, changes in menstrual periods, or more facial hair.
All patients – any nausea, vomiting, changes in skin color, or ankle swelling.
Clinical studies of DELATESTRYL did not include sufficient numbers of subjects, aged 65 and older, to determine whether they respond differently from younger subjects. Testosterone replacement is not indicated in geriatric patients who have age-related hypogonadism only (“andropause”), because there is insufficient safety and efficacy information to support such use. Current studies do not assess whether testosterone use increases risks of prostate cancer, prostate hyperplasia, and cardiovascular disease in the geriatric population.
When properly given, injections of DELATESTRYL are well tolerated. Care should be taken to slowly inject the preparation deeply into the gluteal muscle, being sure to follow the usual precautions for intramuscular administration, such as the avoidance of intravascular injection. There have been rare postmarketing reports of transient reactions involving urge to cough, coughing fits, and respiratory distress immediately after the injection of DELATESTRYL, an oil-based depot preparation (see DOSAGE AND ADMINISTRATION).
Last reviewed on RxList: 5/29/2015
This monograph has been modified to include the generic and brand name in many instances.
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