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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 .
8.1 Vomiting: 4.0: 6.9 Rhinitis: 3.7: 5.4 Urinary incontinence: 3.7: 7.9 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.
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).
A dosage of bicalutamide of 2 mg/kg (or about 40 to 60 mg in boys that are 20 to 30 kg or 45 to 65 lbs) once daily is recommended for use in male peripheral precocious puberty. [149] Bicalutamide is used to block the actions of androgens in the condition, while the aromatase inhibitor is used to decrease levels of estrogens. [148]
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
Notes: Additional cases of bicalutamide-associated adverse liver changes have been reported. These include 11 cases in a 2006 Spanish pharmacovigilance system report (including 1 case of hepatitis , 2 cases of cholestatic hepatitis , 1 case of jaundice , 4 cases of elevated liver enzymes , and 1 case of elevated bilirubin ; no deaths) [ 18 ...
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Moreover, whereas flutamide at this dosage has been found to produce a 75% reduction in prostate-specific antigen levels in men with prostate cancer, a fall of 90% has been demonstrated with this dosage of bicalutamide. [112] In accordance, 50 mg/day bicalutamide has been found to possess equivalent or superior effectiveness to 750 mg/day ...
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