SECONDARY EXPOSURE TO TESTOSTERONE
- Virilization has been reported in children who were secondarily exposed to testosterone gel [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].
- Children should avoid contact with unwashed or unclothed application sites in men using FORTESTA [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].
- Healthcare providers should advise patients to strictly adhere to recommended instructions for use [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS and PATIENT INFORMATION].
FORTESTA is a clear, colorless, odorless, gel containing testosterone. FORTESTA is available in a metered-dose pump. Each pump actuation provides 10 mg of testosterone and each container is capable of dispensing 120 pump actuations. One pump actuation dispenses 0.5 g of gel.
The active pharmacologic ingredient in FORTESTA is testosterone. Testosterone USP is a white to almost white powder described chemically as 17-beta hydroxyandrost-4-en-3-one.
C19H28O2 MW 288.42
Pharmacologically inactive ingredients in FORTESTA are: propylene glycol, purified water, ethanol, 2-propanol, oleic acid, carbomer 1382, triethanolamine and butylated hydroxytoluene.
What are the possible side effects of testosterone topical?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using testosterone topical and call your doctor at once if you have any of these serious side effects:
- burn-like blistering of the skin where the transdermal patch is worn;
- skin irritation with patch-wearing that does not get better with time;
- problems with urination;
- swelling of your ankles;
- frequent, prolonged, or bothersome erections; or
- nausea, stomach pain, low...
Last reviewed on RxList: 8/16/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Fortesta 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.
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