Androstenedione tablets and capsules
What is androstenedione?
Androstenedione is classified and sold as a dietary supplement. That means you can buy androstenedione without a prescription or without seeing a doctor. You should know that androstenedione products are often marketed in combination with other ingredients.
What should my health care professional know before I take androstenedione?
Women and children should not take androstenedione. Men should not take androstenedione if you have any of these conditions:
prostate disease or prostate problems
an unusual or allergic reaction to androstenedione, hormones, other medicines, foods, dyes, or preservatives
How should I take this medicine?
Women and children should not take androstenedione. Since natural male hormones are at their peak in the morning, it might be worthwhile to take androstenedione supplements in the morning, however, there is no evidence that doing so makes it work better. Do not take more than the recommended dose on the label.
What if I miss a dose?
Nothing bad will happen if you miss one or even several doses.
What drug(s) may interact with androstenedione?
Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.
You should not take androstenedione if you are already taking:
medroxyprogesterone (Provera® and others)
drugs known as aromatase inhibitors (anastrozole, letrozole, vorozole)
What should I watch for while taking androstenedione?
Check with your health care professional if you notice any changes in your voice, increase in breast size, or difficulty or inability to urinate.
What side effects may I notice from taking androstenedione?
Side effects that you should report to your prescriber or health care professional as soon as possible:
inability to urinate, or, difficulty urinating
swelling of the breasts
Side effects that usually do not require medical attention (report to your health care professional if they continue or are bothersome):
acne or oily skin
Where can I keep my medicine?
Keep out of the reach of children in a container that small children cannot open.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused tablets or capsules after the expiration date.
GENERAL INFORMATION REGARDING DIETARY SUPPLEMENTS:
Dietary supplements include amino acids, vitamins, minerals, herbs, botanicals, and other plant-derived substances, and extracts of these substances. These products are easy to identify as they must state "Dietary Supplement" on the label. A "Supplement Facts" panel is provided on the label for most products. Supplements are not drugs and are not regulated like drugs. You should note that rigid quality control standards are not required for dietary supplements. Big differences in potency and purity of these products can occur. Scientific data to support the use of a dietary supplement for a certain disease or ailment may not be available. This product is not intended to diagnose, treat, cure or prevent any disease.
The Food and Drug Administration suggests the following to help consumers protect themselves:
Always read product labels and follow directions.
"Natural" doesn't mean a product is safe for humans to take.
Look for products containing ingredients with the "USP" notation. This indicates the manufacturer followed the standards of the US Pharmacopoeia.
Supplements produced or distributed by a nationally known food or drug company are more likely to be made under tight controls as these companies have standards in place for their other products. You can write to the company for more information about how the product was made.
March 21, 2017
U.S. FDA-approved Package Insert