Hepatotoxicity with low and ultralow dose flutamide A surveillance study on 203 hyperandrogenic young females

Hepatotoxicity is a rare but possible event when using low- and ultralow-dose regimens of flutamide for hyperandrogenic treatment. We need larger studies in order to identify risk patterns for hepatotoxicity development.

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Vincenzina Bruni, M.D., Elena Peruzzi, M.D., Metella Dei, M.D., Sara Nannini, M.D., Viola Seravalli, M.D., Giovanni Sisti, M.D., Massimiliano Fambrini, M.D.

Vol 98, Issue 4, Pages 1047-1052



To investigate the impact of low- and ultralow-dose regimens of flutamide on liver function of young hyperandrogenic females.


A 10-year surveillance study.


University teaching hospital.


Two hundred and three hyperandrogenic young females (mean age: 20.9±4.9 years)


Inclusion criterion was receiving low- or ultralow- dose of Flutamide as antiandrogenic treatment. Patients were categorized into Groups A and B, according to the administered dose (Group A = 62.5 mg/daily, Group B = 125 mg/daily). The two groups were further subdivided into subgroups (A1, A2, B1, B2) depending on the co-administration of estroprogestagen oral contraceptives (OC) (A2, B2).

Main outcome measure(s):

Serum levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were periodically evaluated and used as markers of hepatotoxicity.


Mild-to-severe increase of circulating AST/ALT was detected in 19 (9.4%; 95% CI = 5.9%–14.4%) patients during the first year of treatment (mild = 16 [7.9%, 95% CI = 4.7%–12.7%], moderate = 2 [0.9%, 95% CI = 0.1%–3.9%], severe = 1 [0.5%, 95% CI = 0.0%–3.1%]). No statistical differences were observed in relation to flutamide dose regimens and coadministration of OC. The median time to hypertransaminasemia was 12 weeks (range: 2–48) with no difference between Group A and Group B. A significant correlation was observed between hepatotoxicity and pretreatment BMI, ALT basal level, and AST basal level.


Hepatotoxicity is a rare but possible event using low- and ultralow-dose regimens of flutamide. We need larger study populations in order to identify risk patterns for hepatotoxicity development.

Read the full text at: http://www.fertstert.org/article/S0015-0282(12)00653-X/fulltext

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