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Background: Recent data suggest an increased risk of congenital anomalies with prenatal exposure to opioid analgesics. We sought to further quantify the risk of anomalies after opioid analgesic exposure during the first trimester in a population-based cohort study. Methods: Using administrative health data from Ontario, we followed 599 579 gestational parent–infant pairs from singleton pregnancies without opioid use disorder. We identified opioid analgesics dispensed in the first trimester and congenital anomalies diagnosed during the first year of life. We estimated propensity score–adjusted risk ratios (RRs) between first trimester exposure (any opioid analgesic and specific agents) and congenital anomalies (any anomaly, organ system anomalies, major or minor anomalies and specific anomalies). Results: The prevalence of congenital anomalies was 2.8% in exposed infants and 2.0% in unexposed infants. Relative to unexposed infants, we observed elevated risks among those who were e

United statesMartha werlerWenbin liAstrid guttmannAlexa bowieSusan broglyMaria velezQueen university health sciences research ethics boardHuman developmentInternational classification of diseasesService ontarioCanadian institute of health informationNational institutes of healthNational ambulatory care reporting system databaseUs centers for diseaseSolutions canada inc