"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 "...
Testim Patient Information Including Side Effects
Brand Names: Androderm, AndroGel 2.5 g/packet, AndroGel 5 g/packet, AndroGel Packets, AndroGel Pump 1.25 g/actuation, Axiron, FIRST-Testosterone, FIRST-Testosterone MC, Fortesta, Testim
Generic Name: testosterone topical (Pronunciation: tes TOS ter one TOP i kal)
- What is testosterone topical (Testim)?
- What are the possible side effects of testosterone topical?
- What is the most important information I should know about testosterone topical?
- What should I discuss with my healthcare provider before using testosterone topical?
- How should I use testosterone topical?
- What happens if I miss a dose?
- What happens if I overdose?
- What should I avoid while using testosterone topical?
- What other drugs will affect testosterone topical?
- Where can I get more information?
What is testosterone topical (Testim)?
Testosterone is a naturally occurring male hormone necessary for many processes in the body.
Testosterone topical (for the skin) is used to treat conditions in men that result from a lack of natural testosterone.
Testosterone topical may also be used for purposes not listed in this medication guide.
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 fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Topical testosterone is absorbed through the skin and can cause symptoms of male features in a woman or child who comes into contact with the medication. Call your doctor if your female partner has male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any other signs of male characteristics.
Less serious side effects may include:
- redness, itching, burning, or hardened skin where the skin patch is worn;
- breast swelling or tenderness;
- increased acne or hair growth;
- headache, depressed mood; or
- changes in your sex drive.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the Testim (testosterone gel) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about testosterone topical?
This medication should not be used by a woman. Testosterone can cause birth defects in an unborn baby. A pregnant woman should avoid coming into contact with testosterone topical gel, or with a man's skin areas where a testosterone topical patch has been worn or the gel has been applied. If contact does occur, wash with soap and water right away.
Topical testosterone is absorbed through the skin and can cause side effects or symptoms of male features in a child or woman who comes into contact with the medication. Call your doctor if a person who has close contact with you develops enlarged genitals, premature pubic hair, increased libido, aggressive behavior, male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any signs of male characteristics.
The testosterone transdermal patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.
Additional Testim 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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