Prenatal Acetaminophen (Paracetamol) Use and the Risk of Autism and/or Attention-Deficit/Hyperactivity Disorder Among Sibling-Matched Cohorts
Abstract
Importance: Paracetamol (acetaminophen) is the first-line analgesic and antipyretic recommended globally during pregnancy. Observational studies have reported associations with increased risks of autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD) in offspring, raising public and clinical concern; however, these findings may be substantially confounded by unmeasured familial factors.
Objectives: To assess the association between prenatal paracetamol exposure and risk of ASD and ADHD in offspring using a sibling-matched study design to control for familial confounding.
Design, setting, and participants: This population-based cohort study, conducted from January 1, 2001, to December 31, 2023, in Hong Kong, used deidentified electronic health records within a triangulation framework. From an initial cohort of 708 020 mother-child pairs (approximately 43.3% with prenatally paracetamol exposure), sibling-matched cohorts were constructed of children from families with discordant prenatal paracetamol exposure and sufficient follow-up (≥2 years for ASD and ≥5 years for ADHD). Data analysis was conducted from October 2, 2025, to March 24, 2026.
Exposure: Prenatal paracetamol exposure, identified from electronic dispensing records (British National Formulary [BNF], section 4.7.1) with data on drug name, strength, dosage, and prescription dates.
Main outcomes and measures: Incident diagnoses per the International Classification of Diseases, Ninth…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 124 participants or records.
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