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The side effects of bicalutamide, a nonsteroidal antiandrogen (NSAA), including its frequent and rare side effects, have been well-studied and characterized. The most common side effects of bicalutamide monotherapy in men include breast tenderness , breast growth , feminization , demasculinization , and hot flashes .
Bicalutamide, sold under the brand name Casodex among others, is an antiandrogen medication that is primarily used to treat prostate cancer. [10] It is typically used together with a gonadotropin-releasing hormone (GnRH) analogue or surgical removal of the testicles to treat metastatic prostate cancer (mPC).
Bicalutamide is used primarily in the treatment of early and advanced prostate cancer. [1] It is approved at a dosage of 50 mg/day as a combination therapy with a gonadotropin-releasing hormone analogue (GnRH analogue) or orchiectomy (that is, surgical or medical castration) in the treatment of stage D2 metastatic prostate cancer (mPC), [2] [3] and as a monotherapy at a dosage of 150 mg/day ...
Common (1–10%) General and psychiatric disorders • Asthenia • Decreased libido • Erectile dysfunction • Hot flashes: Skin and subcutaneous tissue disorders • Decreased body hair: Hepato-biliary disorders • Elevated liver enzymes [b] Uncommon (0.1–1%) Immune system disorders and hypersensitivity reactions • Angioedema • Hives
Footnotes: a = Phase III studies of combined androgen blockade (bicalutamide or flutamide + GnRH agonist) in men with advanced prostate cancer. b = Incidence >5% regardless of causality . c = 250 mg three times per day at 8-hour intervals.
The core side effects of NSAAs such as gynecomastia, sexual dysfunction, and hot flashes occur at similar rates with the different drugs. [48] [49] Conversely, bicalutamide is associated with a significantly lower rate of diarrhea compared to flutamide.
In any case, common side effects of antiandrogens in men include breast tenderness, breast enlargement, feminization, hot flashes, sexual dysfunction, infertility, and osteoporosis. In women, antiandrogens are much better tolerated , and antiandrogens that work only by directly blocking androgens are associated with minimal side effects.
[1] [2] However, the absolute bioavailability of bicalutamide has been found to be high in animals at low doses (109% in mice at 10 mg/kg; 72% in rats at 1 mg/kg; 100% in dogs at 0.1 mg/kg), but diminishes with increasing doses such that the bioavailability of bicalutamide is low at high doses (10% in rats at 250 mg/kg; 31% in dogs at 100 mg/kg).