Major Study Finds No Link Between Acetaminophen Use in Pregnancy and Autism or ADHD
Largest Review to Date Addresses Long-Standing Safety Concerns
A major new study has found no evidence that taking acetaminophen during pregnancy increases the likelihood of autism, ADHD or intellectual disability in children. Published in The Lancet Obstetrics, Gynecology & Women's Health, the research was led by scientists from City St George's, University of London.
Why the Study Was Conducted
The researchers examined data from 43 earlier studies in a detailed systematic review and meta-analysis, aiming to settle long-running questions about the drug's safety during pregnancy. The review was prompted by public concern after claims made in September 2025 suggested acetaminophen could harm children's neurodevelopment.
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Earlier Claims and Scientific Concerns
While some earlier studies hinted at slight associations with autism, the new analysis found these claims were often based on flawed evidence. Many failed to control for bias, used incomplete data or overlooked sibling comparisons — an essential step in separating drug effects from family-related influences.
How the Research Was Conducted
Review of High-Quality Studies
The researchers examined 43 of the highest-quality studies, using the most robust research methods available, to compare pregnancies in which mothers took acetaminophen with those in which the drug was not used.
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Sibling-Comparison Analysis Explained
They combined findings from sibling-comparison studies, analyzing families where one child was exposed to acetaminophen in the womb and another was not. This powerful approach helps account for shared genetics, home environment and long-standing parental factors that standard observational studies often miss.
Large-Scale Data Strengthens Findings
In total, the sibling data covered:
- 262,852 children assessed for autism
- 335, 255 children assessed for ADHD
- 406, 681 children assessed for intellectual disability
The analysis confirmed that prenatal acetaminophen use was not associated with an increased risk of any of these conditions.
Expert Opinion: Acetaminophen Remains First-Line Treatment
Professor Asma Khalil, professor of obstetrics and maternal-fetal medicine at City St George's, University of London and the study's lead author, said the findings point away from acetaminophen as the cause of earlier reported risks. Instead, she explained, those links are more likely due to genetic predisposition or other maternal factors, such as fever or underlying pain.
"The message is clear," she said. "Acetaminophen remains a safe option in pregnancy when taken as recommended. It is the first-line treatment we advise for pregnant women experiencing pain or fever, and they should feel confident that they still have a safe way to manage their symptoms."
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Quality Assessment and Long-Term Consistency
All studies were assessed using the Quality in Prognosis Studies (QUIPS) tool, which evaluates multiple aspects of study design to determine the risk of bias. Crucially, the lack of any association between prenatal acetaminophen use and autism, ADHD or intellectual disability remained consistent in the highest-quality studies and in those with follow-up periods exceeding five years.
Study Limitations Acknowledged
Researchers noted that the study was limited by gaps in the available data, which made it impossible to analyze smaller subgroups in sibling-comparison research. Too few studies provided information on:
- Trimester-specific use
- Sex of the child
- Frequency of acetaminophen intake
Medical Guidance and Public Health Implications
Even so, the findings align closely with recommendations from major medical bodies worldwide. The team hopes the strength of this comprehensive review will dispel ongoing concerns, warning that avoiding acetaminophen for significant pain or fever can expose both pregnant women and their babies to known dangers, particularly untreated maternal fever.
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