Acetaminophen use during pregnancy causes autism in children
the verdict
REFUTED
the evidence says no
refutedsupported
the weight of evidence
6 sources for · 4 against
While some initial observational studies suggested a weak correlation between prenatal acetaminophen exposure and autism, more rigorous sibling-controlled studies and major public health organizations have found no causal relationship, demonstrating that the observed associations are likely due to familial confounding and indication bias.
<h4>Objective</h4>To assess the quality, biases, and validity of evidence on maternal paracetamol (acetaminophen) use during pregnancy and the risk of autism spectrum disorder (referred to as autism) and attention deficit/hyperactivity disorder (ADHD) in offspring.<h4>Design</h4>Umbrella review of systematic reviews.<h4>Data sources</h4>Medline, Embase, PsycINFO, and the Cochrane Database of Systematic Reviews, along with grey literature, Epistemonikos, and the reference lists of included studies (inception to 30 September 2025).<h4>Inclusion criteria</h4>Systematic reviews of randomised trials and cohort, case-control, or cross sectional studies that reported maternal paracetamol use during pregnancy and the diagnosis of autism or ADHD in offspring. Details of the primary studies included in the reviews are reported, including adjustments for key confounders (maternal characteristics, indication for paracetamol use, and familial factors) and unmeasured confounders and ascertainment of outcomes.<h4>Results</h4>Nine reviews (40 studies) reporting on autism (six studies) and ADHD (17 studies) in offspring were included. Four reviews undertook meta-analysis. The overlap of primary studies included in the reviews was very high (corrected covered area 23%). The reviews reported a possible to strong association between maternal paracetamol intake and autism or ADHD or both in offspring. Seven of the nine reviews advised caution when interpreting the findings owing to the potential risk of bias and confounding in the included studies. Confidence in the findings of the reviews was low (two reviews) to critically low (seven reviews) based on the AMSTAR 2 (A MeaSurement Tool to Assess Systematic Reviews) criteria. Only one review included studies (n=2) reporting autism and ADHD in offspring that appropriately adjusted for familial factors and unmeasured confounding through sibling controlled analyses. In both studies, the increased risk of autism in offspring (one study, hazard ratio 1.05, 95% confidence interval 1.02 to 1.08) and ADHD (two studies, 1.07, 1.05 to 1.10 and 2.02, 1.17 to 3.25 ) observed in the whole cohort analyses did not persist in sibling controlled analyses for autism (0.98, 0.93 to 1.04) and ADHD (0.98, 0.94 to 1.02 and 1.06, 0.51 to 2.05).<h4>Conclusion</h4>Existing evidence does not clearly link maternal paracetamol use during pregnancy with autism or ADHD in offspring.<h4>Systematic review registration</h4>PROSPERO CRD420251154052.
ning
Acetaminophen use during pregnancy was not associated with children’s risk of autism, ADHD, or intellectual disability in sibling control analyses. This suggests that associations observed in other models may have been attributable to confounding. Abstract
Importance
Several studies suggest that acetaminophen (paracetamol) use during pregnancy may increase risk of neurodevelopmental disorders in children. If true, this would have substantial implications for management of pain and fever during pregnancy. Objective
To examine the associations of acetaminophen use during pregnancy with children’s risk of autism, attention-deficit/hyperactivity disorder (ADHD), and intellectual disability. Design, Setting, and Participants
This nationwide cohort study with sibling control analysis included a population-based sample of 2 480 797 children born in 1995 to 2019 in Sweden, with follow-up through December 31, 2021. Exposure
Use of acetaminophen during pregnancy prospectively recorded from antenatal and prescription records. Main Outcomes and Measures
Autism, ADHD, and intellectual disability based on International Classification of Diseases, Ninth Revision and International Classification of Diseases, Tenth Revision codes in health registers. Results
In total, 185 909 children (7.49%) were exposed to acetaminophen during pregnancy. Crude absolute risks at 10 years of age for those not exposed vs those exposed to acetaminophen were 1.33% vs 1.53% for autism, 2.46% vs 2.87% for ADHD, and 0.70% vs 0.82% for intellectual disability. In models without sibling control, ever-use vs no use of acetaminophen during pregnancy was associated with marginally increased risk of autism (hazard ratio [HR], 1.05 [95% CI, 1.02-1.08]; risk difference [RD] at 10 years of age, 0.09% [95% CI, −0.01% to 0.20%]), ADHD (HR, 1.07 [95% CI, 1.05-1.10]; RD, 0.21% [95% CI, 0.08%-0.34%]), and intellectual disability (HR, 1.05 [95% CI, 1.00-1.10]; RD, 0.04% [95% CI, −0.04% to 0.12%]). To address unobse
Importance
Whether maternal use of acetaminophen during pregnancy is associated with offspring's neurodevelopment remains debated.
Objective
To evaluate the associations of maternal prenatal prescriptions of acetaminophen with attention-deficit/hyperactivity disorder (ADHD) and autism spectrum disorders (ASDs) among offspring.
Design, Setting, Participants
This cohort study analyzed 2 092 926 singleton births between 2004 and 2015 in Taiwan, with 1 231 819 having at least 1 sibling. Estimated hazard ratios (HRs) and 95% CIs were examined for offspring ADHD or ASDs according to prenatal acetaminophen prescriptions, adjusting for confounding factors.
Exposure
Prescriptions of acetaminophen were extracted from the National Health Insurance Research Database (NHIRD). Acetaminophen use was defined as having at least 2 dispense records during pregnancy, and the total number of prescriptions and the estimated mean daily dispensed dose were examined.
Main Outcomes and Measures
The primary outcome was ascertaining diagnoses of ADHD and ASDs from the NHIRD.
Results
Of the 2 092 926 singleton births between 2004 and 2015, 48.3% (n = 1 012 159) were born to mothers with at least 2 acetaminophen prescriptions during pregnancy. In the full cohort ASD dataset (N = 2 092 926), 23 557 children (0.01%) had ASD, and in the full ADHD dataset (N = 2 079 935), 116 387 children (0.06%) had ADHD. In the full cohort, offspring ADHD and ASDs were associated with prenatal prescriptions to acetaminophen, with associations noted for higher frequencies of acetaminophen use or higher mean daily dispensed doses of acetaminophen. In sibling-matched analyses, the associations between prenatal exposures to acetaminophen and ADHD and ASDs among offspring were null. However, a positive association was observed when only the older sibling was exposed (HR, 1.33 [95% CI, 1.17-1.52] for ADHD; HR, 1.75 [95% CI, 1.29-2.36] for ASDs), and a negative association was observed when only the younger sibling was exposed (HR, 0.75 [95% CI, 0.67-0.84] for ADHD; HR, 0.74 [95% CI, 0.57-0.96] for ASDs). The divergence of associations persisted in the bidirectional analyses of higher frequencies of acetaminophen use or higher mean daily doses of acetaminophen.
Conclusions and Relevance
The findings of this cohort study in Taiwan suggest that positive associations were observed between maternal prenatal acetaminophen prescriptions and offspring's ADHD or ASDs in the full cohort but not in the sibling-matched analyses. A substantial divergence in associations in the sibling bidirectional analyses indicates unaddressed sources of bias and prevents firm conclusions from being drawn using the sibling design.
Paracetamol (acetaminophen) is frequently used during pregnancy to treat pain and fever. Recently, public concern increased after claims by the US president that prenatal exposure to acetaminophen may increase the risk of autism in children. While regulatory agencies and professional organizations have reaffirmed the safety of paracetamol use during pregnancy, systematic reviews of observational studies on this topic vary in their methods, control for confounding, and findings. As a result, the strength and validity of the evidence remain uncertain. This study aims to evaluate the quality of existing evidence and the reported associations between prenatal paracetamol exposure and risks of autism and ADHD in children. This umbrella review conducted searches of Medline, Embase, PsycINFO, the Cochrane Database of Systematic Reviews, Epistemonikos, and gray literature through September 2025 to identify systematic reviews and meta-analyses evaluating maternal paracetamol use during pregnancy and risks of autism spectrum disorder or attention deficit/hyperactivity disorder in offspring. Independent reviewers screened studies and assessed full texts for eligibility. Systematic reviews were included if they evaluated randomized trials or observational studies examining prenatal paracetamol exposure and neurodevelopmental outcomes in children. The AMSTAR 2 tool was used to assess the methodological quality of each review. Data on study characteristics, exposure definitions, outcomes, confounder adjustment, and effect estimates were extracted by 2 independent reviewers. Findings were summarized narratively, and the degree of overlap of primary studies across reviews was accounted for to avoid over-weighting. Among 663 articles identified, 9 systematic reviews met the inclusion criteria. Forty primary studies were represented, most of which were prospective cohort studies. Overall methodological quality was low, with some of the common limitations including a lack of protocol registration, incomplete search strategies, and inadequate assessment of bias in primary studies. There was a considerable overlap of primary studies between reviews. All reviews reported a positive association between prenatal acetaminophen use and adverse neurodevelopmental outcomes, though they recognized a lack of causal association due to residual confounding and other limitations. Meta-analyses reported pooled risk estimates for ADHD of ~1.2 to 1.4, with smaller positive associations for autism. Stronger associations were reported when exposure occurred with higher frequency, longer duration, or later in gestation. However, the few studies that accounted for familial influence using sibling-controlled analyses found attenuated associations, which suggests that unmeasured familial or environmental confounding could explain a significant portion of the observed relationship. The findings suggest that the previously reported association between prenatal paracetamol exposure and autism or ADHD is more likely explained by bias and confounding than a causal effect. Prior systematic reviews often reported small positive associations, but the primary studies included were heterogeneous and frequently lacked adequate control for confounding. In the few studies that accounted for shared familial factors using sibling comparisons, the associations were reduced, suggesting that genetic, environmental, or other family-level factors play a large role in the observed relationship. Strengths of this umbrella review include a comprehensive search strategy and a formal assessment of review quality and study overlap. Limitations include the heterogeneity and generally low methodological quality of the included reviews, as well as reliance on previously published data. (Summarized from 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: umbrel
<h4>Objective</h4>This meta-analysis aimed to assess the ASD risk in offspring exposed to prenatal acetaminophen compared to non-exposed offspring.<h4>Methods</h4>A systematic search was conducted across PubMed, Embase, and Cochrane Central Register of Controlled Trials databases up to October 2025. Studies were included if they involved pregnant women, compared exposed versus non-exposed groups, were RCTs or cohort studies, and reported ASD outcomes. Data was extracted independently by two authors, with discrepancies resolved by consensus. Statistical analyses used odds ratios (ORs) with 95% confidence intervals, Cochran Q, and I² statistics with a random-effects model. Study quality was appraised using the ROBINS-E tool.<h4>Results</h4>Eight studies, involving 2,560,208 patients, were included. Pooled results showed an 18% increased risk of ASD diagnosis (p <0.0001) and a non-significant 16% increase for ASD symptoms (p=0.1719). Dose-response relationships and gender-specific effects were reported by studies, while familial confounding and "some concerns" to "high" risk of bias were identified.<h4>Conclusion</h4>A consistent, albeit modest, association was found. These findings emphasize the necessity for careful benefit-risk assessments and informed dialogue with expectant mothers regarding pain and fever management during pregnancy.<b>PROSPERO</b>: CRD420251160888.
President Trump Makes an Announcement on Medical and Scientific Findings for America's Children ← President Trump Makes an Announcement on Medical and Scientific Findings for America's Children ( 2025 ) by Donald John Trump and Robert Francis Kennedy → A brief transcription of U.S. President Donald Trump delivering an announcement on medical and scientific findings on September 22, 2025. Questions from reporters and remarks from mothers are thus excluded, as they are not in the public domain, however, the words said by Donald Trump, Robert F. Kennedy Jr. , Jay Bhattacharya, Marty Makary, Mehmet Oz, and Dorothy Fink are in the public domain, as they were part of their official duties as federal government employees. 5101637 President Trump Makes an Announcement on Medical and Scientific Findings for America's Children 2025 Donald John Trump and Robert Francis Kennedy (1954- ) President Trump Makes an Announcement on Medical and Scientific Findings for America's Children ( 784.15 MB, 1:55:06, help , file info or download ) PRESIDENT TRUMP: Thank you very much. So I've been waiting for this meeting for 20 years actually, and it's not that everything's 100 percent understood or known, but I think we've made a lot of strides. I wish it was done a long time ago. Today we're delighted to be joined by America's top medical and public health professionals as we announce historic steps to confront the crisis of autism. Horrible, horrible crisis. I want to thank the man who brought this
This narrative review critically examines the potential association between paracetamol (acetaminophen) use during pregnancy and autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD) in children. Paracetamol remains the most widely used analgesic-antipyretic agent during pregnancy, used by approximately 60% of pregnant women. It is considered the first-line therapeutic option because non-steroidal anti-inflammatory drugs, particularly when used after 20 weeks of gestation, have been associated with adverse neonatal outcomes, including fetal renal dysfunction, oligohydramnios, and, rarely, neonatal renal failure, while their third-trimester use has also been linked to premature closure of the ductus arteriosus. In this context, unsubstantiated risk claims surrounding paracetamol create an important dilemma for clinicians and patients in clinical decision-making.The review evaluated large birth cohorts, sibling-controlled analyses, and meta-analyses from the literature, with a predominant focus on large-scale studies from Scandinavian countries (Norway, Denmark, Sweden). While several studies have reported small-to-moderate increases in risk between prenatal paracetamol exposure and ASD and ADHD, these associations lose significance in some sibling-controlled analyses, which are methodologically more rigorous.Current evidence suffers from substantial methodological limitations, including unmeasured confounding factors (particularly genetic susceptibility, familial characteristics, and maternal illnesses), validation problems in outcome measures, the absence of a demonstrable dose-response relationship, and confounding by indication. Furthermore, no valid, reproducible animal model specific to ASD exists.In conclusion, the available data do not support a causal relationship between paracetamol use during pregnancy and ASD or ADHD in offspring, and the reported associations remain questionable. Exaggerating unproven risks regarding medication use in pregnancy may unnecessarily amplify public concerns, discourage pregnant patients from receiving necessary treatment, and disrupt the balance between benefits and risks. Therefore, risk assessments should be conducted using an objective, evidence-based, cautious, and balanced approach.
Magnusson C, Gardner RM, Lee BK (April 2024). "Acetaminophen Use During Pregnancy and Children's Risk of Autism, ADHD, and Intellectual Disability". JAMA.
The causes of autism are a subject of scientific research, but understanding of the etiology of autism is incomplete. It is influenced by a complex interplay of genetic, epigenetic, prenatal, perinatal, and environmental factors. Genetics play a major role, with heritability estimates ranging from 60–90%. De novo mutations—including copy number variations and gene-disrupting mutations—contribute t
At a White House press briefing on September 22, 2025, President Trump, joined by Kennedy and other senior officials, said the FDA would revise drug labels to discourage the use of acetaminophen (sold under the brand name Tylenol) during pregnancy, citing a possible link to autism. Medical and public health experts disputed the claim. Steven J. Fleischman, president of the American College of Obstetricians and Gynecologists, wrote, "It is highly unsettling that our federal health agencies are willing to make an announcement that will affect the health and well-being of millions of people without the backing of reliable data." A month later, on October 29, Kennedy retracted his statements from the press conference, stating that acetaminophen use in pregnancy is not linked to autism.
On November 10, 2025, in response to President Trump's false claim, a 2025 British Medical Journal umbrella review was fast-tracked and confirmed no convincing evidence that paracetamol (acetaminophen) use during pregnancy increases the risk of autism spectrum disorder (ASD) or attention deficit hyperactivity disorder (ADHD) in children. The review, led by researchers at the University of Liverpool, analysed nine systematic reviews covering 40 observational studies and concluded that any apparent associations were likely due to family genetics, maternal health, or other shared factors rather than the drug itself. The findings were published after President Trump and Kennedy both claimed that paracetamol use during pregnancy was contributing to rising autism rates, urging women to avoid the common painkiller. Health experts and the World Health Organization rejected those claims, emphasizing that paracetamol remains the safest recommended medication for fever and pain relief during pregnancy, as untreated fever can pose serious risks to fetal development.
Acetaminophen and paracetamol are the identical chemical drug compound. The name acetaminophen (brand name Tylenol) is commonly used in the United States while the name paracetamol (brand name Panadol) is commonly used in Europe and world wide.
pregnancy remains safe and there is no evidence it causes autism in children". GOV.UK. 23 September 2025. "Drug Safety Communication: Acetaminophen use
Paracetamol, or acetaminophen, is an analgesic and antipyretic agent used to treat fever and mild to moderate pain. It is a widely available over-the-counter drug sold generically or under various brand names, including Tylenol and Panadol.
Paracetamol relieves pain in acute mild migraine and episodic tension headaches. At a standard dose, paracetamol slightly reduces fever, though it is inferior
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