(50 y) in the US as a surrogate. The gender/menopause categories were then associated with clinical characteristics, causal drugs, histologic features and injury category (HC, CS/MIX). Results: Men, women of < 50 y, and women of ≥ 50 y comprised 42%, 26%, and 32% of the population, with mean ages of 50, 36, and 62 y respectively. The distribution of injury type was different among the gender/menopause categories (p=0.01); more men (54%) and women of ≥ 50 y (57%) showed CS/MIX injury while women of < 50 y predominantly showed HC injury (70%). After adjusting for injury types, biopsies from women, regardless of age group, were associated with more noticeable plasma cell infiltration, less cholestasis, more apoptosis, more hepatocyte rosettes, and more lobular disarray, compared to those of men (p<0.05). On the other hand, compared to those of men and women ≥ 50 y, more severe interface hepatitis (p=0.0092 and p=0.028, respectively) and fewer iron-stained hepatocytes (p<0.0001 and p=0.0593, respectively) were noted in biopsies of women < 50 y. The findings were consistent even after excluding 6 cases ascribed to anabolic steroids and nitrofurantoin, both of which showed gender-specific distributions in causal drug categories. Conclusions: Gender and age cut-off (average age at menopause) were significantly associated with injury types, specific histologic features and severity of DILI features. Further analyses on gender and/or reproductive state related differences in clinical manifestations and histologic features may shed light on better understanding of heterogeneity of DILI manifestations. Study supported by NIDDK, NIH. See website https://dilin.dcri.duke.edu/publications-1 for a complete listing of DILIN funding sources, DILIN sites, investigators, co-investigators, coordinators, and staff.