To estimate the prevalence of exposure to acamprosate in pregnancy in New South Wales (NSW), Australia, to compare the maternal health of women exposed to acamprosate during pregnancy with non-exposed women, and to compare neonatal outcomes in neonates exposed to acamprosate in utero with non-exposed neonates. A population-based retrospective cohort study, comparing maternal and neonatal health outcomes in women exposed to acamprosate during pregnancy with women with a recent history of problematic alcohol use (alcohol comparison group), and women from the general community (community comparison group) using state-wide linked health data. New South Wales, Australia. The study included women treated with acamprosate for more than 30 days during pregnancy between 2003 and 2012 (n = 54) and two matched comparison groups (1 : 3); an alcohol comparison group (n = 162) and a community comparison group (n = 162). The prevalence of acamprosate exposure was calculated per 100 000 pregnancies. Three primary measures of maternal and neonatal health were used: maternal hospital admissions, birth weight and fetal alcohol syndrome (FAS). Exposure to acamprosate occurred in 7.7 [95% confidence interval (CI) = 6.0-9.7] in every 100 000 pregnancies. Rates of hospital admissions during pregnancy and 42 days post-partum in acamprosate-treated women were not significantly different from women in the community comparison group [adjusted rate ratio (RR) = 0.85, 95% CI = 0.65-1.11], but were significantly lower compared with the alcohol comparison group (adjusted RR = 1.26, 95% CI = 1.00-1.60). Acamprosate-exposed neonates were not significantly different from the alcohol comparison group or the community comparison group in terms of birth weight or proportion of small-for-gestational-age neonates or incidence of congenital abnormalities (including FAS). The prevalence of acamprosate use in pregnancy in New South Wales, Australia is low. Acamprosate exposure in utero is not clearly associated with poor maternal or neonatal health outcomes.