Testosterone Side Effects

Some side effects of testosterone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to testosterone: transdermal cream, transdermal film extended release, transdermal gel, transdermal ointment, transdermal solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking testosterone: 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 of testosterone 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.

For Healthcare Professionals

Applies to testosterone: buccal film extended release, compounding powder, intramuscular solution, subcutaneous implant, transdermal cream, transdermal film extended release, transdermal gel, transdermal ointment, transdermal solution

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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