Safety information for Testim
It is important to read the Medication Guide that comes with Testim before you start using it, and each time you refill your prescription.
The most common side effects of Testim include: skin irritation where Testim is applied; increased red blood cell count; headache; increased blood pressure. 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 Testim. For more information, ask your doctor or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. If you have additional questions about side effects with Testim, please contact the Auxilium Drug Information Call Center at 1-877-663-0412 from 9 AM to 7 PM ET Monday through Friday.
What is Testim (testosterone gel) and testosterone gel?
Testim and testosterone gel are prescription medicines that contain testosterone. Testim and testosterone gel are used to treat adult males who have low or no testosterone. Your healthcare provider will test your blood before you start and while you use Testim and testosterone gel. It is not known if Testim and testosterone gel are safe or effective in children younger than 18 years old. Improper use of testosterone in children may affect bone growth.
Testosterone products that are applied to the skin may have different doses, strengths, or application instructions that may lead to different levels of testosterone in your body.
Testim and testosterone gel are controlled substances (CIII) because they contain testosterone that can be a target for people who abuse prescription medicines. Keep your Testim and testosterone gel in a safe place to protect it. Testim and testosterone gel are not meant for use in women.
IMPORTANT SAFETY INFORMATION
- Early signs of puberty have happened in young children who were accidentally exposed to testosterone through contact with men using Testim and testosterone gel
- Testim and testosterone gel can transfer from your body to others
- Women and children should avoid contact with the unwashed or unclothed area where Testim or testosterone gel has been applied. If a woman or child makes contact with the Testim or testosterone gel application area, that area on the woman or child should be washed well with soap and water right away
- To lower the risk of transfer of Testim or testosterone gel from your body to others, you should: Apply Testim or testosterone gel only to the areas of your shoulders and upper arms that will be covered by a short sleeve T-shirt and wash your hands right away with soap and water after applying Testim or testosterone gel. After the gel has dried, cover the application area with clothing and keep the area covered until you have washed the application area well or have showered. If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water
- Stop using Testim or testosterone gel and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have occurred through accidental exposure to Testim and testosterone gel
- Do NOT apply Testim or testosterone gel to the genitals or abdomen
- Do not use Testim or testosterone gel if you: have breast cancer; have or might have prostate cancer; are pregnant or may become pregnant or are breastfeeding. Testim and testosterone gel may harm your unborn or breastfeeding baby. Women who are pregnant or who may become pregnant should avoid contact with the area of skin where Testim or testosterone gel has been applied
- Tell your healthcare provider about all the medicines you take. Especially, tell your healthcare provider if you take: insulin, medicines that decrease blood clotting, corticosteroids
- Testim and testosterone gel can cause serious side effects including:
- If you already have enlargement of your prostate gland your signs and symptoms can get worse while using Testim or testosterone gel. These can include changes in urination
- Possible increased risk of prostate cancer. Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you use Testim or testosterone gel
- Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include leg pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
- In large doses, Testim and testosterone gel may lower your sperm count
- Swelling of your ankles, feet, or body, with or without heart failure. This may cause serious problems for people who have heart, kidney or liver disease
- Enlarged or painful breasts
- Having problems breathing while you sleep (sleep apnea)
- Testim and testosterone gel are flammable until dry. Let the Testim or testosterone gel dry before smoking or going near an open flame
- The most common side effects of Testim and testosterone gel include: skin irritation where Testim or testosterone gel is applied; increased red blood cell count; headache; increased blood pressure. Other side effects include more erections than are normal for you or erections that last a long time
The information on this Web site should not take the place of talking with your doctor or healthcare professional. If you have any questions, talk to your doctor or pharmacist.
You are encouraged to report negative side effects of prescription drugs. Contact Auxilium Pharmaceuticals, Inc. at 1-877-663-0412 or FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch.
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