Prenatal pregabalin exposure compared with no exposure showed a 1.1-fold association (95% CI 0.98–1.32) with the prevalence of any major congenital malformation among live and stillborn offspring, and a 1.7-fold association (95% CI 1.02–2.91) with stillbirth; the association was attenuated in Mantel–Haenszel meta-analysis for the latter outcome. We found no association between prenatal pregabalin exposure and risks of birth outcomes other than major congenital malformations or stillbirth. Prenatal exposure to pregabalin compared with no exposure to pregabalin and active comparators showed a 1.3-fold association (95% CI 1.03–1.63) with attention deficit/hyperactivity disorder; the association was attenuated in the analyses using active comparators and Mantel–Haenszel meta-analysis. There was no evidence of an association with other examined neurodevelopmental postnatal outcomes.