FORTESTA- testosterone gel, metered
Endo Pharmaceuticals Inc.
FORTESTA® (FOR-tes-ta) CIII
Gel for topical use
What is the most important information I should know about FORTESTA?
1. FORTESTA can transfer from your body to others including, children and women. Children and women should avoid contact with the unwashed or not covered (unclothed) areas where FORTESTA has been applied to your skin. Early signs and symptoms of puberty have occurred in young children who have come in direct contact with testosterone by touching areas where men have used FORTESTA.
Signs and symptoms of early puberty in a child when they come in direct contact with FORTESTA may include:
Abnormal sexual changes:
Signs and symptoms in women when they come in direct contact with FORTESTA may include:
Stop using FORTESTA and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have happened through accidental touching of the area where you have applied FORTESTA.
2. To lower the risk of transfer of FORTESTA from your body to others, follow these important instructions:
What is FORTESTA?
FORTESTA is a prescription medicine that contains testosterone. FORTESTA is used to treat adult males who have low or no testosterone due to certain medical conditions.
FORTESTA is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your FORTESTA in a safe place to protect it. Never give FORTESTA to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and is against the law.
FORTESTA is not meant for use in women.
Do not use FORTESTA if you:
Before using FORTESTA, tell your healthcare provider about all of your medical conditions including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Using FORTESTA with certain other medicines can affect each other. Especially, tell your healthcare provider if you take:
How should I use FORTESTA?
What are the possible side effects of FORTESTA?
FORTESTA can cause serious side effects including:
See “What is the most important information I should know about FORTESTA?”
Call your healthcare provider right away if you have any of the serious side effects listed above.
The most common side effects of FORTESTA include:
Other side effects include more erections than are normal for you or erections that last a long time.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of FORTESTA. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store FORTESTA?
Keep FORTESTA and all medicines out of the reach of children.
General information about FORTESTA
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FORTESTA for a condition for which it was not prescribed. Do not give FORTESTA to other people, even if they have the same symptoms you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about FORTESTA that is written for health professionals.
What are the ingredients in FORTESTA?
Active ingredients: testosterone
Inactive ingredients: propylene glycol, purified water, ethanol, 2-propanol, oleic acid, carbomer 1382, triethanolamine, and butylated hydroxytoluene.
Pharbil Waltrop GmbH
Im Wirrigen 25, 45731
Endo Pharmaceuticals Inc.
Malvern, PA 19355
© 2020 Endo Pharmaceuticals Inc. All rights reserved.
For more information about FORTESTA, go to www.fortestagel.com or call 1-800-462-3636.
This Medication Guide has been approved by the U.S. Food and Drug Administration.