Template:Published case reports of bicalutamide-associated liver injury

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Published case reports of bicalutamide-associated liver injury
# Age Sex Dosage Use Onset Outcome Source + Refs
1 60 years Male 50 mg/day Prostate cancer 2 days Survived Dawson et al. (1997) [1][2][3]
2 79 years Male 80 mg/day Prostate cancer 1.5 months Survived Ikemoto et al. (2000) [4]
3 59 years Male 50 mg/day Prostate cancer 4 days Death O'Bryant et al. (2008) [5][6]
4 61 years Male 50 mg/day Prostate cancer 3.5 months Death Castro Beza et al. (2008) [7]
5 81 years Male 150 mg/day Prostate cancer 3 weeks Survived Hussain et al. (2014) [8][9]
6 62 years Male 100 mg/day Prostate cancer 4.5 months Survived Yun et al. (2016) [6][10]
7 67 years Male 150 mg/day Prostate cancer 3 weeks Survived Gretarsdottir et al. (2018) [11]
8 79 years Male Unknown Prostate cancer 15 days Survived Saito (2020) [12]
9 17 years Trans female Unknown Gender-affirming hormone therapy 1 year Survived Reed (2023) [13][14][15][16]
10 17 years Trans female 50 mg/day Gender-affirming hormone therapy 3 months Survived Wilde et al. (2023) [17]
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] and a number of cases in the FDA Adverse Event Reporting System (FAERS).[19] Also 5 cases of jaundice were reported out of ~3,700 men in clinical trials but no cases of liver failure or of liver-toxicity-related death clearly attributable to bicalutamide were observed.[20] Sources: Main: [11][21]