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^â product.

Adverse Events with TESTODERM^Ò TTS
In clinical studies of 457 participants (116 hypogonadal males and 341 healthy adult males) treated for up to 6 weeks with TESTODERM^â 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^â TTS users in clinical trials that were of probable or unknown relationship to drug were:

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^â 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^â TTS; of these detachments, 33% occurred during exercise.

Adverse Events with TESTODERM^â
In clinical studies of 104 patients treated with TESTODERM^â , 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^â 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^â WITH ADHESIVE
In a pharmacokinetic study in 50 normal men, skin assessment scores following a single 24-hour application of TESTODERM^â WITH ADHESIVE to scrotal skin were similar to those for TESTODERM^â . 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^â products contain a Schedule III controlled substance as defined by the Anabolic Steroids Control Act.

TESTODERM^â TTS is designed for application to arm, back or upper buttocks skin.

TESTODERM^â and TESTODERM^â 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^â or TESTODERM^â 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^â 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^â products will not produce adequate serum testosterone levels due to its short half-life (about 10 minutes).

Drug Interactions
Anticoagulants: C-17 substituted derivatives of testosterone, such as methandrostenolone, have been reported to decrease the anticoagulant requirements of patients receiving oral anticoagulants. Patients receiving oral anticoagulant therapy require close monitoring, especially when androgens are started or stopped.

Oxyphenbutazone: Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone.

Insulin: In diabetic patients, the metabolic effects of androgens may decrease blood glucose and therefore, insulin requirements.

Propranolol: In a published pharmacokinetic study of an injectable testosterone product, administration of testosterone cypionate led to an increased clearance of propranolol in the majority of men tested.⁶

Corticosteroids: The concurrent administration of testosterone with ACTH or corticosteroids may enhance edema formation; thus these drugs should be administered cautiously, particularly in patients with cardiac or hepatic disease.⁷

Drug/Laboratory Test Interactions
Androgens may decrease levels of thyroxin-binding globulin, resulting in decreased total T₄ serum levels and increased resin uptake of T₃ and T₄. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

The TESTODERM^â products contain a Schedule III controlled substance as defined by the Anabolic Steroids Control Act.

TESTODERM^â TTS is designed for application to arm, back or upper buttocks skin.

TESTODERM^â and TESTODERM^â 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^â or TESTODERM^â 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^â 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^â products will not produce adequate serum testosterone levels due to its short half-life (about 10 minutes).

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