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The Debate on Acetaminophen Use in Pregnancy and Neurodevelopmental Disorders: Facts or Fiction?

Justine Pleau1, Lisiane F Leal2, Odile Sheehy1

  • 1Faculty of Pharmacy, University of Montreal, Montréal, QC; Unité de recherche sur les médicaments et la grossesse, Centre de recherche Azrieli, Centre Hospitalier Universitaire Sainte-Justine, Montréal, QC.

Journal of Obstetrics and Gynaecology Canada : JOGC = Journal D'Obstetrique Et Gynecologie Du Canada : JOGC
|November 14, 2025
PubMed

Insights

Acetaminophen use during pregnancy, especially in combination with other medications, may be linked to a higher risk of attention-deficit/hyperactivity disorder (ADHD) in children. However, potential misclassification in exposure and outcome data may influence these findings.

Area of Science:

  • Obstetrics and Gynecology
  • Pediatrics
  • Pharmacology

Background:

  • Maternal use of acetaminophen during pregnancy is common.
  • The association between prenatal acetaminophen exposure and attention-deficit/hyperactivity disorder (ADHD) risk in offspring requires further investigation.
  • Understanding potential biases in exposure and outcome assessment is crucial for accurate risk assessment.

Purpose of the Study:

  • To investigate the association between maternal acetaminophen use during the second and third trimesters and the risk of ADHD in children.
  • To evaluate the impact of potential exposure and outcome misclassification on the observed associations.

Main Methods:

  • A large cohort study of singleton live births in Quebec (1998-2013) was conducted.
  • Maternal acetaminophen use was identified via prescription data, categorizing exposure as unexposed, acetaminophen alone, or combination therapy.
  • Attention-deficit/hyperactivity disorder (ADHD) was diagnosed using a validated algorithm based on diagnostic codes and medication prescriptions.
  • Probabilistic bias analysis was employed to address potential misclassification errors.

Main Results:

  • Among 182,775 children, 1.0% were exposed to acetaminophen alone and 2.2% to combination therapy.
  • Acetaminophen combination therapy was associated with an increased ADHD risk (aHR 1.17; 95% CI 1.06-1.29).
  • Acetaminophen alone showed a weaker association (aHR 1.09; 95% CI 0.94-1.27).
  • Probabilistic bias analysis indicated potential overestimation of the risk (bias away from the null).

Conclusions:

  • The observed association between prenatal acetaminophen use and ADHD risk may be partly attributable to exposure and outcome misclassification.
  • Further research with robust methods is needed to confirm these findings and elucidate potential causal links.
Abstract

Keywords:
acetaminophenattention-deficit disorder with hyperactivitybiaspregnancy

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