In clinical studies of 122 patients treated with Androderm, the most common adverse events reported were skin reactions at the site of system application. Transient mild to moderate erythema was observed at the site of application in the majority of patients at some time during treatment.

The adverse reactions reported by more than 1% of patients are listed below shown in order of decreasing frequency.

The following reactions occurred in less than 1% of patients: fatigue; body pain; pelvic pain; hypertension; peripheral vascular disease; increased appetite; accelerated growth; anxiety; confusion; decreased libido; paresthesia; thinking abnormalities; vertigo; acne; bullae at application site; mechanical irritation at application site; rash at application site; contamination of application site; prostate carcinoma; dysuria; hematuria; impotence; urinary incontinence; urinary tract infection; testicular abnormalities.

Three types of application site reactions occurred: irritation which included mild to moderate erythema, induration or burning; allergic contact dermatitis; and burn-like blister reactions.

Chronic skin irritation caused 5% of patients to discontinue treatment. Mild skin irritation may be ameliorated by treatment of affected skin with over-the-counter topical hydrocortisone cream applied after system removal.

Applying a small amount of 0.1% triamcinolone acetonide cream (Rx) to the skin under the central drug reservoir of the Androderm system has been shown to reduce the incidence and severity of skin irritation. The administration of 0.1% triamcinolone acetonide cream (Rx) does not significantly alter transdermal absorption of testosterone from the system. Ointment formulations should not be used for pretreatment as they may significantly reduce testosterone absorption.

Five patients (4%) developed allergic contact dermatitis after 3 to 8 weeks treatment that required discontinuation. These reactions were characterized by pruritus, erythema, induration and in some instances vesicles or bullae, which recurred with each system application. Rechallenge with components of the system showed ethanol sensitization in 4 patients. One patient's reaction was attributed to testosterone. None of these patients had adverse sequelae related to oral alcohol ingestion or to injectable testosterone use. Older patients may be more prone to develop allergic contact dermatitis.

Fourteen patients (12%) had burn-like blister reactions that involved bullae, epidermal necrosis or the development of ulcerated lesions. These reactions typically occurred once, at a single application site; 5 patients experienced a single recurrence. None withdrew from the clinical trials. These reactions occurred at a rate of approximately 1 in 6,500 system applications (1 in 3,250 treatment days). The majority of these lesions were associated with system application over bony prominences or on parts of the body that may have. been subject to prolonged pressure during sleep or sitting (e.g., over the deltoid region of the upper arm, the greater trochanter of the femur, or the ischial tuberosity). The more severe lesions healed over several weeks with scarring in some cases. Such lesions should be treated as burns.

Skin and Appendages: Hirsutism, male pattern of baldness, seborrhea, and acne.

Endocrine and Urogenital: Gynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages (see CLINCAL 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.

Androderm (testosterone transdermal system) is a Schedule III controlled substance under the Anabolic Steroids Control Act.

Oral consumption of the Androderm system or the gel contents of the system will not result in clinically significant serum testosterone concentrations in the target organs due to extensive first-pass metabolism.

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 anticoagulants require close monitoring especially when androgens are stared 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.

Androgens may decrease levels of thyroxine-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.

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