Paracetamol in Pregnancy and Autism: Understanding the Evidence
Recent statements from US President Donald Trump linking paracetamol (acetaminophen) use during pregnancy to autism have caused understandable concern amongst expectant mothers worldwide. On 22 September 2025, President Trump repeatedly advised pregnant women to "fight like hell not to take" Tylenol (the US brand name for paracetamol), claiming it significantly increases autism risk. As a consultant obstetrician practising in the UK, I want to provide you with clear, evidence-based guidance on this important topic.
What Was Announced?
In a White House press conference, President Trump announced that the FDA would be updating drug labelling for paracetamol to reflect a "possible association" with autism and ADHD. He was considerably less nuanced than the FDA itself, stating: "Don't take Tylenol. Don't take it. Fight like hell not to take it."
The announcement came alongside other autism-related claims, including suggestions about childhood vaccines (which have been thoroughly debunked by decades of research) and promotion of a drug called leucovorin as an autism treatment. Health and Human Services Secretary Robert F. Kennedy Jr., a well-known vaccine critic, flanked the President during the announcement.
Important: The FDA's actual statement was far more measured than President Trump's remarks. Whilst initiating a label change process, the FDA explicitly noted that "a causal relationship has not been established and there are contrary studies in the scientific literature."
The International Medical Community's Response
The response from medical authorities worldwide was swift and unequivocal. Leading health organisations rejected President Trump's claims and reaffirmed that paracetamol remains safe during pregnancy when used appropriately.
UK Guidance
The UK Medicines and Healthcare products Regulatory Agency (MHRA) was clear and direct: "There is no evidence that taking paracetamol during pregnancy causes autism in children." Dr Alison Cave, the MHRA's Chief Safety Officer, emphasised that "paracetamol remains the recommended pain relief option for pregnant women when used as directed."
UK Health Secretary Wes Streeting stated in a television interview: "Don't pay any attention whatsoever to what Donald Trump says about medicine. I've just got to be really clear about this: there is no evidence to link the use of paracetamol by pregnant women to autism in their children. None."
The Royal College of Obstetricians and Gynaecologists (RCOG) maintains its guidance that paracetamol is the safest analgesic option during pregnancy.
European and Global Response
The European Medicines Agency (EMA) stated: "Available evidence has found no link between the use of paracetamol during pregnancy and autism."
The World Health Organization (WHO) emphasised: "There is currently no conclusive scientific evidence confirming a possible link between autism and use of acetaminophen during pregnancy. Extensive research has been undertaken over the past decade, including large-scale studies. At this time, no consistent association has been established."
Similar statements came from health authorities in Australia, Canada, and other countries, all reaffirming that current guidance remains unchanged.
Understanding the Scientific Evidence
To understand why medical authorities worldwide disagree with President Trump's characterisation, we need to examine the research carefully.
The Conflicting Studies
Some observational studies have suggested associations between paracetamol use during pregnancy and neurodevelopmental conditions. These include:
- Studies showing modest correlations in large populations
- A 2025 review by researchers from Harvard and Mount Sinai claiming "strong evidence of an association"
- Laboratory studies suggesting biological mechanisms
However, these studies have significant limitations that prevent us from concluding that paracetamol causes autism.
The Gold Standard Evidence
The most rigorous and methodologically sophisticated research tells a different story. In April 2024, a landmark Swedish study published in JAMA (one of the world's most prestigious medical journals) analysed 2.48 million children born between 1995 and 2019.
What made this study exceptional was its use of sibling control analysis. By comparing siblings within the same family - where one mother used paracetamol during pregnancy and another pregnancy she did not - the researchers could control for shared genetic and environmental factors. This is considered the gold standard methodology for addressing confounding in observational research.
The findings were clear: when properly controlling for familial factors, there was no evidence that paracetamol use during pregnancy increased the risk of:
- Autism spectrum disorder
- Attention-deficit/hyperactivity disorder (ADHD)
- Intellectual disability
The study found no dose-response relationship either. Whether women took low, medium, or high amounts of paracetamol, there was no increased risk when genetic and environmental factors were properly accounted for.
Why Some Studies Show Associations
So why do some studies suggest a link? The answer lies in something called confounding - factors that are associated with both paracetamol use and autism risk but are not caused by the paracetamol itself.
Consider these important points:
- Reason for use: Women take paracetamol because they have pain or fever. The underlying condition causing the fever or pain (such as infection) may itself affect fetal development.
- Genetic factors: Families may have genetic predispositions to both conditions requiring pain relief and neurodevelopmental differences.
- Lifestyle and environmental factors: Factors such as stress, diet, socioeconomic status, and access to healthcare may be associated with both medication use and autism diagnosis rates.
- Diagnostic patterns: Families who seek medical care for pain or fever during pregnancy may be more likely to seek evaluations for their children, leading to higher diagnosis rates.
Key Point: Association does not equal causation. When studies properly account for confounding factors using sibling comparisons, the apparent association disappears. This strongly suggests that the associations seen in some studies are due to confounding rather than a direct effect of paracetamol.
Criticisms of the Research Trump Referenced
The 2025 review that President Trump's administration cited has been heavily criticised by independent autism researchers. Critics note that the review:
- Was not rigorously conducted
- Cherry-picked studies supporting a predetermined conclusion
- Failed to adequately weight the highest-quality evidence
- Did not properly address the crucial Swedish sibling study
- Ignored studies showing no association
Even the authors of that review were careful to note that their findings showed only an association, not causation, and recommended "judicious acetaminophen use" rather than avoidance.
The Real Risks of Untreated Fever and Pain
What President Trump's announcement failed to adequately address are the well-documented risks of not treating fever and pain during pregnancy.
Risks of Untreated Fever
High fever during pregnancy, particularly in the first trimester, poses proven risks:
- Miscarriage: Elevated maternal temperature increases miscarriage risk
- Neural tube defects: First-trimester fever is associated with spina bifida and anencephaly
- Congenital heart defects: Maternal fever increases cardiac malformation risk
- Other birth defects: Including oral clefts and other structural abnormalities
- Preterm birth: Infections causing fever can trigger early labour
Research has shown that maternal fever during pregnancy is itself associated with autism risk - meaning that treating fever may actually reduce autism risk, not increase it.
Risks of Untreated Pain
Severe, untreated pain during pregnancy can lead to:
- Increased stress hormones affecting fetal development
- Sleep deprivation and its associated complications
- Reduced mobility and physical activity
- Depression and anxiety
- Reduced quality of life
Why Paracetamol Is the Only Safe OTC Option
Other common pain relievers during pregnancy:
- Ibuprofen and other NSAIDs: Avoided during pregnancy, can cause kidney problems in the fetus, reduce amniotic fluid, and may cause premature closure of a vital fetal blood vessel
- Aspirin: Not used for pain relief or fever in pregnancy, usually prescribed to reduce risk of pre-eclampsia and help with fetal growth development
- Codeine and other opioids: Can be prescribed for pain relief if necessary by your obstetrician
Paracetamol, by contrast, has been used safely throughout pregnancy for decades with an excellent safety record.
Understanding Autism Spectrum Disorder
Autism is a complex neurodevelopmental condition affecting approximately 1 in 100 people globally (WHO estimates 1 in 127). It is characterised by differences in social communication and interaction, alongside restricted and repetitive patterns of behaviour, interests, or activities.
What Causes Autism?
The causes of autism are not fully understood, but research indicates:
- Strong genetic component: Autism runs in families, with numerous genes involved
- Multiple factors: No single cause, but rather interactions between genetic susceptibility and environmental influences
- Early brain development: Differences begin during fetal brain development
- Not caused by vaccines: This has been conclusively disproven by decades of rigorous research
Why Diagnoses Have Increased
President Trump referenced increasing autism rates as evidence of an epidemic. However, experts attribute rising diagnosis rates to:
- Improved awareness and recognition of autism
- Broadened diagnostic criteria
- Better access to diagnostic services
- Reduced stigma leading more families to seek evaluation
- Earlier diagnosis
These factors account for much of the increase in diagnosis rates without requiring an actual increase in the underlying prevalence of autism.
Current Evidence-Based Guidance
Despite President Trump's statements, guidance from UK and international medical authorities remains unchanged.
When to Use Paracetamol in Pregnancy
Paracetamol should be used during pregnancy when:
- You have a fever (temperature above 38°C)
- You are experiencing pain that affects your daily activities or wellbeing
- Your healthcare provider recommends it
How to Use Paracetamol Safely
Follow these guidelines for safe use:
- Use the lowest effective dose: Start with the minimum dose (500mg) that relieves symptoms
- Take for the shortest necessary duration: Use only as long as needed
- Follow dosing instructions: Do not exceed 4 grams (eight 500mg tablets) in 24 hours
- Space doses appropriately: Wait at least 4-6 hours between doses
- Avoid long-term regular use: Unless specifically advised by your healthcare provider
- Check other medications: Many cold and flu remedies contain paracetamol - avoid taking multiple products containing the same active ingredient
When to Seek Medical Advice
Contact your healthcare provider if:
- You have a persistent fever lasting more than 24-48 hours
- Your pain is severe or not adequately controlled
- You have a persistent or new type of headache
- You need paracetamol regularly for more than a few days
- You have any concerns about medication safety
- You are unsure whether to take paracetamol
Non-Medication Approaches
For minor discomforts, consider these complementary approaches:
- For headaches: Rest in a quiet, dark room; cold compress on forehead; staying hydrated; gentle head and neck massage
- For pelvic or back pain: Pregnancy support belt; gentle stretching; warm (not hot) bath; pregnancy yoga
- For fever: Light clothing; tepid sponging; staying hydrated; rest
However, these approaches should complement, not replace, appropriate medication when needed. Suffering unnecessarily is not good for you or your baby.
A Clinician's Perspective
As an obstetrician caring for pregnant women daily, I understand how frightening statements like President Trump's can be. My patients often come to appointments worried about every medication, every food, every decision they make during pregnancy.
Here's what I tell them: pregnancy is a time when evidence-based medicine matters more than ever. We have decades of safety data on paracetamol use during pregnancy. Tens of millions of women have used it safely. The highest-quality research, controlling for confounding factors, shows no causal link to autism.
What we do know with certainty is that untreated high fever and severe pain pose real, documented risks to pregnancy. When you're running a fever, taking paracetamol is not just safe - it may be protective.
The Harm of Misinformation
The Society for Maternal-Fetal Medicine warns that untreated fever can cause grave harms including miscarriage, birth defects, and premature birth. When political figures advise pregnant women to avoid the only safe over-the-counter pain and fever medication available to them, real harm can result.
Dr Veronica Gillispie-Bell from the American College of Obstetricians and Gynaecologists noted: "It puts us in a very difficult predicament. Our professional societies and the science tells us that Tylenol is safe, but when you have the FDA saying something different, it puts us in a very, very difficult position."
What If You're Still Concerned?
If you remain worried about paracetamol use, here are some steps you can take:
Discuss With Your Healthcare Provider
Your midwife, GP, or obstetrician can:
- Explain the evidence in detail
- Address your specific concerns
- Help you weigh risks and benefits for your individual situation
- Discuss alternative pain management strategies
- Provide reassurance based on current evidence
Focus on What We Know
When making decisions during pregnancy, focus on evidence, not headlines:
- Trust guidance from established medical authorities (RCOG, NHS, WHO, EMA)
- Recognise that the highest-quality research shows no causal link
- Understand that untreated fever and pain pose real risks
- Remember that paracetamol has an excellent decades-long safety record
Consider the Source
When evaluating medical claims, consider:
- Is this from a reputable medical authority or a political figure?
- What do the world's leading obstetric organisations say?
- Is the claim based on the highest-quality research?
- Do experts in this field agree with the claim?
Critical: Never stop taking medication prescribed by your healthcare provider based on news reports or political statements. Always discuss medication decisions with a qualified healthcare professional.
The Bigger Picture: Evidence-Based Medicine
This controversy highlights the importance of evidence-based medicine and why we must evaluate research quality carefully.
Hierarchy of Evidence
Not all studies are created equal. In medical research, we consider:
- Highest quality: Randomised controlled trials, systematic reviews with sibling controls
- Medium quality: Large cohort studies, case-control studies
- Lower quality: Small observational studies, case reports
- Weakest: Anecdotal reports, personal testimonies
The Swedish sibling study represents the highest quality evidence available on this question. It trumps (no pun intended) smaller, less rigorously controlled studies.
Why Medical Consensus Matters
When every major medical authority worldwide - RCOG, NHS, WHO, EMA, and obstetric colleges across multiple countries - agrees on guidance, that consensus represents the careful evaluation of all available evidence by experts in the field.
This consensus should carry more weight than selective citation of particular studies or political statements, however well-intentioned.
Frequently Asked Questions
On 22 September 2025, President Trump announced that the FDA would be updating labels for paracetamol (called Tylenol in the US) to reflect a "possible association" with autism. He repeatedly told pregnant women "Don't take Tylenol" and to "fight like hell not to take it," claiming it significantly increases autism risk. His statements were considerably stronger than the FDA's actual, more measured position.
No. The highest-quality research - a Swedish study of 2.48 million children using sibling control analysis - found no evidence that paracetamol use during pregnancy causes autism, ADHD, or intellectual disability. When genetic and environmental factors are properly controlled for, there is no increased risk. Every major medical authority worldwide (WHO, NHS, RCOG, EMA) maintains that paracetamol is safe during pregnancy.
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) explicitly states: "There is no evidence that taking paracetamol during pregnancy causes autism in children." The RCOG maintains that paracetamol is the safest analgesic option during pregnancy. UK Health Secretary Wes Streeting said: "Don't pay any attention whatsoever to what Donald Trump says about medicine... there is no evidence to link the use of paracetamol by pregnant women to autism in their children. None."
Some observational studies show associations, but association does not equal causation. These apparent links are likely due to confounding factors - such as the reason for taking paracetamol (fever or infection), genetic factors, and environmental influences. When studies properly control for these factors using sibling comparisons, the association disappears. This strongly suggests the apparent link is not causal.
Untreated fever during pregnancy poses proven risks including miscarriage, neural tube defects (such as spina bifida), congenital heart defects, other birth defects, and preterm birth. Research shows that maternal fever during pregnancy is associated with autism risk - meaning treating fever may actually reduce autism risk. Paracetamol is the only safe over-the-counter option for treating fever during pregnancy.
No. Ibuprofen and other NSAIDs have well-documented risks during pregnancy, including kidney problems in the fetus, reduced amniotic fluid, and premature closure of a vital fetal blood vessel. Paracetamol is the only safe over-the-counter pain and fever medication during pregnancy.
Use the lowest effective dose for the shortest necessary duration. Take only when needed for pain or fever. Do not exceed 4 grams (eight 500mg tablets) in 24 hours. Space doses at least 4-6 hours apart. Check that other medications don't contain paracetamol. Avoid long-term regular use unless advised by your healthcare provider. If you need it regularly or have concerns, speak with your midwife or doctor.
Confounding refers to factors associated with both the exposure (paracetamol use) and the outcome (autism) that can create an apparent association when none exists. For example, women take paracetamol because they have fever or pain. The underlying condition causing the fever (like infection) might itself affect fetal development. Sibling studies control for confounding by comparing children from the same family, eliminating shared genetic and environmental factors.
No. Whilst medication should only be used when necessary, some conditions require treatment to protect both mother and baby. Untreated fever, severe pain, infections, high blood pressure, diabetes, and other conditions pose greater risks than appropriate medications. Always discuss medication decisions with your healthcare provider rather than avoiding all treatment out of fear.
No, you should not worry. The highest-quality evidence shows no causal link between paracetamol use during pregnancy and autism. Tens of millions of women have used paracetamol safely during pregnancy. If you took it for fever or pain, you made the right decision based on decades of safety data and current medical guidance. Untreated fever poses proven risks, whilst the purported autism link is not supported by rigorous research.
The FDA initiated a label change to reflect "possible association" based on some observational studies, but importantly noted that "a causal relationship has not been established and there are contrary studies in the scientific literature." The FDA's position is more nuanced than President Trump's statements. The agency acknowledged that paracetamol "is the only over-the-counter drug approved for use to treat fevers during pregnancy" and that "high fevers in pregnant women can pose a risk to their children."
Autism has a strong genetic component and runs in families. Multiple genes are involved, and the causes involve complex interactions between genetic susceptibility and various environmental influences during early brain development. There is no single cause. Importantly, autism is not caused by vaccines (this has been conclusively disproven) or by paracetamol. Rising diagnosis rates reflect improved awareness, broadened diagnostic criteria, and better access to services rather than an actual epidemic.
The most reliable sources are: NHS website (nhs.uk), UK Teratology Information Service (UKTIS), Royal College of Obstetricians and Gynaecologists (RCOG), your midwife or GP, and hospital maternity departments. Always consult healthcare professionals rather than relying on news reports or social media. If you're uncertain about any medication during pregnancy, speak with your midwife or doctor before making changes.
Final Thoughts
The recent statements linking paracetamol to autism have understandably caused concern, but the evidence simply does not support this claim. The highest-quality research, employing the most rigorous methodologies, finds no causal link. Every major medical authority worldwide continues to recommend paracetamol as the safest option for pain and fever during pregnancy.
What we do know with certainty is that untreated fever and severe pain pose real, documented risks to pregnancy. When you need pain relief or fever reduction during pregnancy, paracetamol remains your safest choice, used appropriately at the lowest effective dose for the shortest necessary time.
As healthcare providers, we have a responsibility to base our guidance on the highest-quality evidence, evaluated by experts in the field, and endorsed by international medical authorities. That evidence overwhelmingly supports the continued safe use of paracetamol during pregnancy.
If you have concerns about any medication during pregnancy, please don't hesitate to reach out to discuss your individual situation. Your health and your baby's health are too important to be guided by political statements rather than medical evidence.
