Striant Side Effects

Generic Name: testosterone,testosterone cypionate

Please note - some side effects for Striant 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 Striant - for the Consumer

Striant

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 Striant:

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.

Striant Side Effects - for the Professional

Striant

In all clinical studies combined, a total of 308 patients were treated with Striant® for up to 12 months.

Twelve Week Trials

In the pivotal, Phase 3, open-label controlled study (Study 1), 98 patients received Striant® for up to 12 weeks. Adverse events judged possibly, probably, or definitely related to the use of Striant® and reported by >/= 1% of patients in Study 1 are listed in Table 2.

Please see "Gum-related adverse events and gum examinations" subsection for further information. The majority of gum-related adverse events were transient. Gum irritation generally resolved in 1 to 8 days. Gum tenderness resolved in 1 to 14 days.

The following adverse events judged possibly, probably or definitely related to the use of Striant® occurred in 1 patient each in Study 1: abdominal cramp, acne, anxiety, asthma (acute), breast enlargement, breast pain, buccal mucosal roughening, difficulty in micturition, fatigue, gingivitis, gum blister, gustatory sense diminished, hematocrit increased, lipids serum increased, liver function tests abnormal, nose edema, stinging of lips, and toothache.

There was one additional 12-week study in 12 patients. In this study, additional adverse events judged at least possibly related to Striant® and reported by 1 patient each included emotional lability and hypertension.

In two long-term extension trials, a total of 117 and 51 patients received Striant® for at least 6 months and 1 year, respectively.

Of 117 patients treated for at least 6 months, adverse events judged possibly, probably, or definitely related to treatment and reported by 1 patient each included: anxiety, buccal inflammation, depression, dry mouth, gastrointestinal disorder, gum redness, hypertension, infection, medication error, nausea, pruritis, renal function abnormal, stomatitis, taste bitter, taste perversion, and toothache. Polycythemia and increased serum prostate specific antigen (PSA) were reported in three and two patients, respectively.

Adverse events reported in the 51 patients treated for at least one year were similar to those reported after 6 months of treatment and lower in incidence.

In the pivotal controlled study (Study 1), all reported gum-related adverse events were collected and gum examinations were conducted at Baseline and every month thereafter.

In Study 1, a total of 16 patients reported 19 gum-related adverse events. Of these, ten patients (10.2%) reported 12 events of mild intensity, four patients (4.1%) reported 5 events of moderate intensity, and two patients (2.0%) reported 2 events of severe intensity. Most of these events were judged probably or definitely related to treatment with Striant®. Four patients (4.1%) discontinued treatment with Striant® due to gum or mouth-related adverse events including two with severe gum irritation, one with mouth irritation, and one with "bad taste in mouth". The majority of gum-related adverse events were transient. Gum irritation generally resolved in 1 to 8 days. Gum tenderness resolved in 1 to 14 days.

In Study 1, monthly gum examinations were conducted to assess for gingivitis, gum edema, oral lesions, ulcerations or leukoplakia. No cases of ulceration or leukoplakia were observed. No new oral lesions were observed. Gingivitis was common at Baseline (32.6%), and was reduced at Week 4 (10.2%), Week 8 (10.2%) and Week 12 (11.2%). Similar findings were seen for gum edema.

In the two long-term extension trials, gum examinations were conducted every 3 months while on treatment. In one of these trials, no patient had a gum abnormality, and in the other trial, moderate gingivitis and mild gum edema were reported by 1 patient each.

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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