Testosterone Topical

Name: Testosterone Topical

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

Adverse Effects

>10%

Pruritus at application site (37%)

Skin reactions at application site (16.1%)

Blisters under skin (12%)

1-10%

Erythema at application site (7%)

Vesicles at application site (6%)

Allergic contact dermatitis (4%)

Burning at application site (3%)

Induration at application site (3%)

Frequency Not Defined

Abnormal dreams

Acne

Anaphylaxis

Bladder irritability

Breast soreness

Cholestatic jaundice

Deep vein thrombosis

Dry skin

Fatigue

Gynecomastia

Headache

Insomnia

Menstrual irregularities

Priapism

Suppression of factors II, V, VII

Virilization

Postmarketing Reports

Vascular Disorders: Venous thromboembolism

Cardiovascular disorders: Myocardial infarction, stroke

Patient Handout

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What is the most important information I should know about testosterone topical?

You should not use this medicine if you have prostate cancer or male breast cancer.

Testosterone can cause birth defects in an unborn baby. A pregnant woman should avoid coming into contact with this medicine, or with a man's skin where the medicine has been applied.

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 this medicine. 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.

Misuse of testosterone can cause dangerous or irreversible effects. Never use more than your prescribed dose. Do not share this medicine with another person.

What should I discuss with my healthcare provider before using testosterone topical?

You should not use this medicine if you are allergic to testosterone patches or gels, or if you have;

  • prostate cancer; or

  • male breast cancer.

To make sure testosterone is safe for you, tell your doctor if you have ever had:

  • cancer;

  • enlarged prostate, urination problems;

  • sleep apnea (breathing stops during sleep);

  • heart disease, heart attack, or stroke;

  • a blood clot;

  • diabetes; or

  • liver disease or kidney disease.

Older men who use testosterone topical may have an increased risk of prostate enlargement or cancer. If you are over 65, talk with your doctor about your specific risk.

This medicine 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 patches or gels, or with a man's skin areas where a patch has been worn or the gel has been applied. If contact does occur, wash with soap and water right away.

Do not use testosterone topical on anyone younger than 18 years old.

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.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Testosterone topical side effects

Get emergency medical help if you have 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:

  • increased urination (many times per day), loss of bladder control;

  • painful or difficult urination;

  • breast pain or swelling;

  • painful or bothersome erections;

  • swelling, rapid weight gain, shortness of breath during sleep;

  • chest pain or pressure, pain spreading to your jaw or shoulder;

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

  • signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

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.

Common side effects may include:

  • redness, itching, burning, hardened skin or other irritation where the medicine was applied or where the skin patch was worn;

  • headache, mood changes;

  • increased red blood cells (may cause dizziness, itching, redness in your face, or muscle pain);

  • vomiting, diarrhea;

  • strange dreams;

  • frequent or prolonged erections; or

  • high blood pressure--severe headache, blurred vision, pounding in your neck or ears.

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.

What other drugs will affect testosterone topical?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • insulin;

  • a blood thinner (warfarin, Coumadin, Jantoven); or

  • steroid medicine (methylprednisolone, prednisone, and others.)

This list is not complete. Other drugs may interact with testosterone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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