Key takeaways:
- No clear causal link was found between prenatal paracetamol use and autism or ADHD, according to an umbrella review published in The BMJ.
- Most existing studies were rated low to critically low in quality, with significant methodological weaknesses and poorly controlled confounders.
- Positive associations reported in earlier research may stem from shared familial or environmental factors, rather than medication exposure itself.S
- ibling analyses showed no increased risk, suggesting genetic and household influences account for previous signals of harm.
- Researchers emphasize the need for high-quality studies that better evaluate timing, duration, and true risk factors behind neurodevelopmental outcomes.
Researchers from BMJ Group have found no clear link between paracetamol use during pregnancy with autism or attention-deficit/hyperactivity disorder (ADHD) in offspring, publishing their findings in The BMJ.1
According to the researchers, prior trials about this topic have low to critically low evidence, indicating shared genetic and environmental factors within families may be the source of any apparent association. Regulatory agencies worldwide recommend and consider paracetamol to be safe for managing pain and fever during pregnancy.
“Given the heterogeneous quality and reporting of studies, a robust overview of existing evidence is urgently needed to guide healthcare professionals, women, and families in interpreting the risks of paracetamol use during pregnancy,” wrote investigators.2
Deeper dive into neurodevelopment
The umbrella review was conducted to evaluate the quality and validity of current evidence evaluating the link between prenatal paracetamol exposure and offspring autism and ADHD risks. Articles published through September 30, 2025, were identified through searches of the Embase, Medline, Cochrane, and PsycINFO databases.
Titles and abstracts were screened by 2 independent reviewers, followed by full-text screening. A third reviewer was consulted to resolve disagreements.
Review characteristics, types of outcomes and their definition, cofounders, risk of bias, methods of synthesis, effect estimates, and findings were extracted for analysis. Additional input was provided by a carer of a child and grandchild with autism, alongside a woman with lived experience of ADHD.
Review weaknesses
There were 40 primary studies across 9 systematic reviews included in the final analysis, 37 of which were prospective cohorts, 2 case-control studies, and 1 an ecological study. Of the systematic reviews, 4 were meta-analyses. All reviews were published in the past 10 years, and autism was reported in 6 of the studies and ADHD in 17.
Significant weakness across multiple domains was noted in the reviews. This included:
- Lacking a previously registered protocol
- Not providing a comprehensive literature search strategy
- Not presenting a list of excluded studies with justifications
A positive association between prenatal paracetamol use and adverse impacts on offspring neurodevelopment was reported in all reviews. However, 7 of 9 reviews warned against concluding these factors are causally linked because of the lack of data, bias in primary studies, and inadequately controlled cofounders.
Influence of sibling analyses
In the meta-analyses, relative risks or odds ratios for ADHD development following prenatal paracetamol exposure ranged from 1.2 to 1.4. For autism, these estimates were smaller but positive.
Two studies adjusting for shared familial factors reported small, positive associations. However, sibling analyses indicated a null effect for these estimates. One of the studies reported a hazard ratio of 1.07 for ADHD following paracetamol exposure, reduced to 0.98 when including siblings.
The same effect was reported for autism, declining from 1.05 in the general cohort to 0.98 in the sibling analysis. Based on this data, investigators concluded that the current evidence is inadequate for linking maternal paracetamol use during pregnancy to offspring autism and ADHD.
“High-quality studies that control for familial and unmeasured confounders can help improve evidence on the timing and duration of paracetamol exposure, and for other child neurodevelopmental outcomes,” wrote investigators.
References
- Existing evidence does not clearly link paracetamol use during pregnancy with autism or ADHD in children. BMJ Group. November 9, 2025. Accessed November 18, 2025. https://www.eurekalert.org/news-releases/1105107.
- Sheikh J, Allotey J, Sobhy S, et al. Maternal paracetamol (acetaminophen) use during pregnancy and risk of autism spectrum disorder and attention deficit/hyperactivity disorder in offspring: umbrella review of systematic reviews. BMJ. 2025;391. doi:10.1136/bmj-2025-088141
