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Updated: Apr 15, 2026

Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale
Published on: August 25, 2014
Use of paracetamol during pregnancy and child neurological development
Laurence de Fays1, Karen Van Malderen1, Karen De Smet1
1Federal Agency for Medicines and Health Products (FAMHP), Brussels, Belgium.
Insights
Paracetamol is still considered safe for pain and fever during pregnancy. Current studies suggest a weak association with developmental issues, but more research is needed to confirm any causal link.
Area of Science:
- Obstetrics and Gynecology
- Developmental Pediatrics
- Pharmacology
Background:
- Paracetamol (acetaminophen) is the primary treatment for pain and fever in pregnant individuals.
- Recent studies suggest a potential link between prenatal paracetamol exposure and attention-deficit-hyperactivity disorder/hyperkinetic disorder (ADHD/HKD) or developmental concerns in children.
- Observed effects are generally weak to moderate, with study design limitations hindering causal inference.
Purpose of the Study:
- To evaluate the current evidence regarding the safety of paracetamol use during pregnancy.
- To assess the potential association between in utero paracetamol exposure and neurodevelopmental outcomes in children.
- To review findings from epidemiological and animal studies on paracetamol's effects on fetal development.
Main Methods:
- Review of recent epidemiological studies investigating prenatal paracetamol exposure and child neurodevelopment.
- Analysis of recent animal research examining the impact of therapeutic paracetamol doses on early development.
- Examination of potential biological mechanisms, including effects on neurotrophic factors and neurotransmitter systems.
Main Results:
- Epidemiological studies indicate a weak to moderate association between prenatal paracetamol use and ADHD/HKD or developmental issues.
- Animal studies suggest potential alterations in cognition and behavior following early developmental exposure to therapeutic paracetamol doses.
- Proposed mechanisms involve interference with brain-derived neurotrophic factor, neurotransmitter systems, and cyclooxygenase-2, but human relevance is uncertain.
Conclusions:
- Current evidence is insufficient to establish a causal link between prenatal paracetamol exposure and ADHD/HKD or adverse neurodevelopmental outcomes.
- Further well-designed cohort studies are required to confirm or refute the observed associations.
- Paracetamol remains the recommended first-line treatment for pain and fever in pregnancy based on existing knowledge.
Abstract:
Paracetamol (acetaminophen) remains the first line for the treatment of pain and fever in pregnancy. Recently published epidemiological studies suggested a possible association between paracetamol exposure in utero and attention-deficit-hyperactivity disorder/hyperkinetic disorder (ADHD/HKD) or adverse development issues in children. However, the effects observed are in the weak to moderate range, and limitations in the studies' design prevent inference on a causal association with ADHD/HKD or child neurological development. In parallel, recent animal data showed that cognition and behaviour may be altered following exposure to therapeutic doses of paracetamol during early development. These effects may be mediated by interference of paracetamol with brain-derived neurotrophic factor, neurotransmitter systems (including serotonergic, dopaminergic, adrenergic, as well as the endogenous endocannabinoid systems), or cyclooxygenase-2. However, no firm conclusion can be made on the relevance of these observations to humans. We conclude that additional well-designed cohort studies are necessary to confirm or disprove the association. In the context of current knowledge, paracetamol is still to be considered safe in pregnancy and should remain the first-line treatment for pain and fever.
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