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Testoderm

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Testoderm

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Testoderm Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Testoderm (testosterone transdermal) is a form of testosterone (a male hormone) used to treat conditions in men that result from a lack of natural testosterone. The brand name of this medication is discontinued, but generic versions may be available. Common side effects 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.

One system is applied at about the same time each day. The adhesive side of the Testoderm TTS system should be placed on a clean, dry area of skin on the arm, back, or upper buttocks immediately upon removal from the protective pouch. Testoderm may interact with insulin, blood thinners, or steroids. Tell your doctor all medications and supplements you use. Testoderm should not be used by women and therefore is unlikely to be used while pregnant or breastfeeding. Testosterone can cause birth defects. 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.

Our Testoderm (testosterone transdermal) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Testoderm in Detail - Patient Information: Side Effects

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 entire detailed patient monograph for Testoderm (Testosterone (transdermal)) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Testoderm FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Adverse events are reported in this section by product. Adverse events reported during use of a given product may occur in patients who are treated with any TESTODERM (testosterone (transdermal)) product.

Adverse Events with TESTODERM (testosterone (transdermal)) Ò TTS
In clinical studies of 457 participants (116 hypogonadal males and 341 healthy adult males) treated for up to 6 weeks with TESTODERM (testosterone (transdermal)) TTS, the most commonly reported adverse events were application site reactions of transient itching (12%) and moderate or severe erythema (3%).

Adverse events reported by less than 1% of TESTODERM (testosterone (transdermal)) TTS users in clinical trials that were of probable or unknown relationship to drug were:

Body as a Whole: abdominal pain, back pain, infection;
Cardiovascular System: congestive heart failure, hypertension, tachycardia;
Digestive System: diarrhea, nausea;
Metabolic and Nutritional System: hyperglycemia, hyperlipemia, hyponatremia;
Musculoskeletal System: arthralgia;
Nervous System: nervousness, depression, dizziness, dry mouth, insomnia, decreased libido, personality disorder, CNS stimulation;
Respiratory System: bronchitis;
Skin System: application site reactions--papules/pustules, edema, vesicles, pain, other--, acne, alopecia, hirsutism;
Urogenital System: abnormal ejaculation, breast pain, dysuria, urinary tract infection, and impaired urination.

Topical Reactions
Of 457 study participants, 3 men (1%) discontinued prematurely because of application site reactions.

There were no clinically significant differences in skin tolerability in younger (<65 years old) and older (³ 65 years old) subjects.

A contact sensitization rate of 0.5% for TESTODERM (testosterone (transdermal)) TTS was observed in a 6-week study of 233 normal male volunteers.

In one study with 14 days of daily use, 42% of patients reported 3 or more detachments of their TESTODERM (testosterone (transdermal)) TTS; of these detachments, 33% occurred during exercise.

Adverse Events with TESTODERM (testosterone (transdermal))
In clinical studies of 104 patients treated with TESTODERM (testosterone (transdermal)) , the most common adverse effects reported were local effects. In US clinical trials, most of the 72 patients filling out a daily questionnaire reported scrotal itching, discomfort, or irritation at some time during therapy. Of all the daily questionnaire responses, 7% reported itching, 4% discomfort, and 2% irritation. All topical reactions decreased with duration of use.

The following adverse effects (greater than 1%) were reported in association with TESTODERM (testosterone (transdermal)) therapy in 104 patients using the product for up to three years. These effects are listed in decreasing frequency of occurrence with the percentages of patients reporting the effect in parentheses: Gynecomastia (5%), acne (4%), prostatitis/urinary tract infection (4%), breast tenderness (3%), stroke (2%). For this same patient population, the following adverse effects were reported by 1% of users: memory loss, pupillary dilation, abnormal liver enzymes, scrotal cellulitis, deep vein phlebitis, benign prostatic hyperplasia, rectal mucosal lesion over prostate, hematuria/bladder cancer, papilloma on scrotum, and congestive heart failure.

See CLINICAL PHARMACOLOGY, Clinical Studies, regarding effects on serum lipids.

Adverse Events with TESTODERM (testosterone (transdermal)) WITH ADHESIVE
In a pharmacokinetic study in 50 normal men, skin assessment scores following a single 24-hour application of TESTODERM (testosterone (transdermal)) WITH ADHESIVE to scrotal skin were similar to those for TESTODERM (testosterone (transdermal)) . Other adverse events reported during the study were headache (6%), dizziness (6%), back pain, pain, nausea, and pustular rash (1% each).

General Adverse Events with Androgen Replacement Therapy
Skin and Appendages:
Hirsutism, male pattern baldness, seborrhea, and acne.
Endocrine and Urogenital: Gynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high doses (see CLINICAL PHARMACOLOGY).
Fluid and Electrolyte Disturbances: Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates.
Gastrointestinal: Nausea, cholestatic jaundice, alterations in liver function tests. Rare instances of hepatocellular neoplasms and peliosis hepatis have occurred (see WARNINGS).
Hematologic: Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia.
Nervous System: Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.
Metabolic: Increased serum cholesterol.
Miscellaneous: Rarely, anaphylactoid reactions.

DRUG ABUSE AND DEPENDENCE

The TESTODERM (testosterone (transdermal)) products contain a Schedule III controlled substance as defined by the Anabolic Steroids Control Act.

TESTODERM (testosterone (transdermal)) TTS is designed for application to arm, back or upper buttocks skin.

TESTODERM (testosterone (transdermal)) and TESTODERM (testosterone (transdermal)) WITH ADHESIVE are designed for application to scrotal skin only. Because scrotal skin is at least five times more permeable to testosterone than other skin sites, TESTODERM (testosterone (transdermal)) or TESTODERM (testosterone (transdermal)) WITH ADHESIVE will not produce adequate serum testosterone concentrations if applied to non-scrotal skin.

Ingestion of testosterone, or the contents of any of the TESTODERM (testosterone (transdermal)) products will not result in clinically significant serum testosterone concentrations due to extensive first-pass metabolism. In addition, an intramuscular injection of testosterone from any of the TESTODERM (testosterone (transdermal)) products will not produce adequate serum testosterone levels due to its short half-life (about 10 minutes).

Read the entire FDA prescribing information for Testoderm (Testosterone (transdermal)) »

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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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