Notes: Additional cases of bicalutamide-associated adverse liver changes have been reported. These include 11 cases in a 2006 Spanishpharmacovigilance 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]
^Ikemoto I, Kiyota H, Abe K, Hasegawa T, Ohishi Y, Aizawa Y (20 May 2000). "ビカルタミドにより惹起された重症肝障害" [Bicalutamide-induced Liver Toxicity in a Patient with Prostate Cancer]. 臨床泌尿器科 [Rinsho Hinyokika (Clinical Urology)]. 54: 489–491. doi:10.11477/mf.1413902997.
^ abGretarsdottir, Helga M.; Bjornsdottir, Elin; Bjornsson, Einar S. (2018). "Bicalutamide-Associated Acute Liver Injury and Migratory Arthralgia: A Rare but Clinically Important Adverse Effect". Case Reports in Gastroenterology. 12 (2): 266–270. doi:10.1159/000485175. ISSN1662-0631. S2CID81661015.
^Wilde B, Diamond JB, Laborda TJ, Frank L, O'Gorman MA, Kocolas I. "Bicalutamide-Induced Hepatotoxicity in a Transgender Male-to-Female Adolescent". J Adolesc Health. doi:10.1016/j.jadohealth.2023.08.024. PMID37791922.
^Manso G, Thole Z, Salgueiro E, Revuelta P, Hidalgo A (April 2006). "Spontaneous reporting of hepatotoxicity associated with antiandrogens: data from the Spanish pharmacovigilance system". Pharmacoepidemiol Drug Saf. 15 (4): 253–9. doi:10.1002/pds.1168. PMID16294367. S2CID24515447.
^Kolvenbag GJ, Blackledge GR (January 1996). "Worldwide activity and safety of bicalutamide: a summary review". Urology. 47 (1A Suppl): 70–9, discussion 80–4. doi:10.1016/s0090-4295(96)80012-4. PMID8560681. The population exposed to bicalutamide consisted predominantly of patients with advanced prostate cancer, but also included patients with BPH and healthy male volunteers. A total of 3717 men in the clinical trial program had received bicalutamide as monotherapy in daily doses ranging from 10 to 450 mg or as a combination therapy in a daily dose of 50 mg (Table III). The majority of patients have received either 50 or 150 mg daily of bicalutamide. The total exposure to bicalutamide exceeds 2800 patient-years. [...] In the clinical trial program, no bicalutamide-treated patient died because of a hepatic adverse event during therapy. No cases of hepatic failure were attributed to bicalutamide monotherapy or combination therapy. In controlled studies, jaundice was reported with a similar incidence for bicalutamide and for the comparator therapies. There were 5 patients with jaundice in which bicalutamide-induced hepatotoxicity could not be excluded. One patient treated with 150 mg bicalutamide died of prostate cancer, chronic renal failure, and jaundice. The investigator considered chronic renal failure and jaundice (of unknown etiology) to be contributing factors to the patient's death.
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