Side effects of bicalutamide
Side effect Bicalutamide 150 mg/day + standard care ( n = 4022 ) (% ) Placebo + standard care ( n = 4031 ) (% )
Gynecomastia 66.2 7.7
With breast pain 53.1 ND
Without breast pain 13.1 ND
Breast pain 72.8 7.2
With gynecomastia 53.1 ND
Without gynecomastia 19.7 ND
Asthenia 10.2 7.2
Pharyngitis 10.0 10.5
Erectile dysfunction 9.0 6.1
Hot flashes 9.0 5.2
Back pain 8.7 10.4
Constipation 8.2 6.7
Arthralgia 7.3 8.9
Urinary tract infection 7.1 6.1
Flu-like symptoms 7.0 7.1
Abdominal pain 6.6 6.6
Diarrhea 6.3 6.4
Hypertension 6.2 6.5
Pelvic pain 6.2 6.2
Pain 6.1 6.7
Overview
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, gynecomastia, feminization, demasculinization, and hot flashes. Less common side effects of bicalutamide monotherapy in men include sexual dysfunction, depression, fatigue, weakness, and anemia. Bicalutamide is well-tolerated and has few side effects in women. General side effects of bicalutamide that may occur in either sex include diarrhea, constipation, abdominal pain, nausea, dry skin, itching, and rash. In men with prostate cancer, bicalutamide monotherapy has been associated with an increased risk of non-cancer death, in part due to an increased incidence of heart failure. This is thought to be a consequence of androgen deprivation. Bicalutamide monotherapy has been found to cause unfavorable liver changes in around 3% of men, with such changes necessitating discontinuation in about 0.3 to 1% of men. Very rarely, bicalutamide has been associated with liver damage, lung disease, and sensitivity to light. It has also uncommonly been associated with hypersensitivity reactions. Bicalutamide has a theoretical risk of birth defects in male fetuses.