Description
Store at controlled room temperature of 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)
Frequency of most adverse events (except prostate cancer high grade) tends to decrease with continued use (>6 months). Frequency not always defined.
1% to 10%:
Endocrine & metabolic: Decreased libido (≤3%; incidence highest during first 6 months of therapy), gynecomastia (including breast tenderness, breast enlargement; ≤1%), increased luteinizing hormone, increased testosterone level, increased thyroid stimulating hormone level
Genitourinary: Impotence (≤5%; incidence highest during first 6 months of therapy), ejaculatory disorder (≤2%)
Hematologic & oncologic: Prostate cancer high grade (≤1%)
<1%, postmarketing, and/or case reports: Angioedema, cardiac failure, depressed mood, dermatological reaction (serious), dizziness, hypersensitivity, localized edema, malignant neoplasm of breast (males), pruritus, skin rash, testicular pain, testicular swelling, urticaria
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