Androderm Side Effects

Generic Name: testosterone,testosterone cypionate

Please note - some side effects for Androderm may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Androderm - for the Consumer

Androderm Patch

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Androderm Patch:

Acne; bitter or strange taste in mouth; change in sex drive; fatigue; gum or mouth irritation; gum pain; gum tenderness or swelling; hair loss; headache.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast growth or pain; change in the size or shape of the testicles; dark urine or light-colored bowel movements; depression or mood changes; dizziness; gingivitis; interrupted breathing while sleeping; loss of appetite; nausea; painful or prolonged erection; stomach pain; swelling of the ankles or legs; urination problems; weight gain; yellowing of the skin or eyes.

Androderm Side Effects - for the Professional

Androderm

Adverse Events Associated with Androderm (testosterone transdermal system)

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.

Adverse Events Associated with Injection or Oral Treatments

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.

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.

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.

Side Effects by Body System

Cardiovascular

Cardiovascular side effects have included hypertension, and edema with and without congestive heart failure.

Endocrine

Endocrine side effects have included gynecomastia as a frequent and sometimes persistent side effect. Cautious use is recommended in patients with existing gynecomastia.

During exogenous administration of androgens, endogenous testosterone release is inhibited through feedback inhibition of pituitary luteinizing hormone (LH). Large doses of exogenous androgens may suppress spermatogenesis through inhibition of pituitary follicle stimulating hormone (FSH).

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 and there is no clinical evidence of thyroid dysfunction.

Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.

Virilization of children has been reported due to secondary exposure to testosterone. Signs and symptoms have included inappropriate enlargement of the penis or clitoris, premature development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases, these signs and symptoms regressed with removal of the exposure to testosterone. In a few cases, however, enlarged genitalia did not fully return to age-appropriate normal size and bone age remained modestly greater than chronological age.

Renal

Renal side effects have included retention of nitrogen, sodium, potassium, chloride, water and phosphorus, and decreased urinary excretion of calcium.

Hepatic

Hepatic side effects have included life-threatening peliosis hepatitis and hepatic abnormalities including hepatic neoplasms and hepatocellular carcinomas following prolonged therapy with high doses of androgen. Tumor regression did not occur in all cases following medication withdrawal.

Cholestatic hepatitis, jaundice, and abnormal liver function tests have occurred during androgen therapy. Drug-induced jaundice is usually reversible following drug discontinuation.

Genitourinary

Genitourinary side effects following chronic administration and/or large dosages of testosterone have included oligospermia and decreased ejaculatory volume. Elderly male patients have experienced prostatic enlargement resulting in urinary obstruction. Priapism and excessive stimulation has developed. Other urinary side effects have included nocturia, urinary hesitancy, urinary incontinence, urinary retention, urinary urgency, and weak urinary system.

In female patients the use of androgens has resulted in virilization including deepening voice, hirsutism, acne, clitomegaly (not reversible), and menstrual abnormalities. Discontinuation of testosterone at signs of mild virilization may prevent irreversible virilization.

Metabolic

Metabolic side effects have included osteolytic-induced hypercalcemia in immobilized patients or those with metastatic breast disease. Increased cholesterol levels and acute intermittent porphyria have been reported.

Other

Other side effects have included virilization in female patients. Virilization included deepening voice, hirsutism, acne, clitomegaly (not reversible), and menstrual abnormalities.

Female sexual partners of men using topical testosterone (residual on skin) have reported virilization.

Dermatologic

Dermatologic side effects have included hirsutism, acne, male-patterned baldness and seborrhea. Dermal reactions have been the most commonly reported side effects for transdermal testosterone and occur primarily at the site of application. Dermal effects have included 3 types: irritation including mild to moderate erythema (to 6%), induration (3%), itching (12%), and burning (3%); allergic contact dermatitis including pruritus (to 37%), vesicles (6%), and rash (2%); and burn-like blisters (12%).

Discontinuation rates for transdermal testosterone were as follows: due to chronic skin irritation (5%), allergic dermal reactions (4%), and burn-like, usually a single site (0%).

Triamcinolone 1% cream applied sparingly to skin under the reservoir reduced irritation and did not interfere with testosterone absorption. Ointment formulations reduce testosterone absorption.

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting.

Musculoskeletal

Testosterone is involved in termination of linear bone growth by closure of the epiphyseal growth centers. Appropriate monitoring of bone age is recommended during testosterone use in healthy males with delayed puberty.

Musculoskeletal side effects have included myalgia and pain.

Hematologic

Hematologic side effects have included alteration in clotting factors II, V, VII and X and polycythemia due to increased red cell production. Anemia has also been reported.

Hypersensitivity

Hypersensitivity side effects have included rash and anaphylactoid reactions.

Local

Local side effects have included inflammation and pain at injection or dermal application site.

Nervous system

Nervous system side effects have included altered libido (increased/decreased), headache (to 5%), anxiety, depression, generalized paresthesia, or sleep apnea syndrome.

Oncologic

Oncologic side effects have included carcinoma of the prostate, hepatic neoplasms, and hepatocellular carcinomas.

Respiratory

Respiratory side effects have included reports of potentiation of sleep apnea, particularly in obese patients or those with chronic lung disease. There have been rare postmarketing reports of transient reactions involving urge to cough, coughing fits, and respiratory distress immediately after the injection of testosterone enanthate, an oil-based depot preparation.

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