The darolutamide product information has recently been updated to include information about hepatotoxicity.

Darolutamide is a non-steroidal androgen receptor antagonist used in the treatment of prostate cancer. In the ARAMIS trial involving 1508 men with nonmetastatic, castration-resistant prostate cancer, darolutamide was associated with some changes in liver enzymes. Elevated serum aspartate aminotransferase (AST) occurred more commonly in the darolutamide group compared to placebo (23% versus 14%); serum bilirubin was also more frequently raised in the darolutamide group (16% versus 7%). However, elevations in AST and bilirubin were typically mild to moderate. Increases in alanine aminotransferase (ALT) levels were uncommon.

Cases of idiosyncratic drug-induced liver injury (DILI) with increases in ALT or AST of ≥ grade 3, including cases accompanied with bilirubin two or more times the upper limit of normal, have been reported during therapy with darolutamide. The onset ranged from around one month up to a year after starting darolutamide and were reversible following discontinuation. The manufacturer recommends permanent discontinuation of darolutamide if liver function test results suggestive of idiosyncratic DILI occur.


  1. Fizazi K, Shore N, Tammela TL, Ulys A, Vjaters E, Polyakov S, et al. Darolutamide in nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2019; 380: 1235-46.
  2. Nubeqa® (Darolutamide) Australian approved product information. Pymble: Bayer Australia. Approved August 2023.
  3. Therapeutic Goods Administration. Australian Public Assessment Report for Darolutamide. Woden: TGA; 2020.

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