Aims: The aim of this study was to describe prescription use of acetaminophen, a widely used analgesic and antipyretic generally considered safe during pregnancy, among pregnant women from 2000 to 2023 in Denmark with special attention towards variations following the change in over-the-counter (OTC) availability in 2013.
Methods: In this population-based drug utilization study, individually linked data from nationwide health registries on pregnant women in Denmark between 2000 and 2023 were used to evaluate time trends on prescription use of acetaminophen and describe distributions of maternal characteristics among prescription-based drug users and non-users.
Results: Among 1 446 841 eligible pregnancies included, 27 per 1000 pregnant women redeemed at least one prescription for acetaminophen during pregnancy, and among these, 18% redeemed more than one. In 2023, 74 per 1000 pregnancies were exposed to prescription use of acetaminophen. Relative to non-users, prescription-based drug users were generally older and had a higher body mass index. They more frequently presented with pain-related, chronic or psychiatric conditions and used other prescription medications throughout the study period. However, these differences were less pronounced in the cohort restricted to pregnancies ending in 2015-2023 compared to 2000-2012.
Conclusions: Prescription use of acetaminophen in the pregnant population in Denmark has increased since 2000, with a notable sharp increase from 2013 onwards, coinciding with the regulatory restriction that reduced over-the-counter pack sizes, alongside a concurrent rise in general-population prescription use. Prescription-based drug users were more likely to have comorbidities and multiple medication use than non-users, although these differences have become less pronounced in recent years.
Keywords: acetaminophen; drug utilization; health registries; paracetamol; pregnancy.
© 2025 The Author(s). British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.