There is no new evidence that would require changes to the current long-standing recommendation, the Agency stressed. It cited a recent systematic review and meta-analysis published in The Lancet Obstetrics, Gynaecology & Women’s Health which found no evidence linking paracetamol to autism, ADHD or intellectual disability in children.

‘Paracetamol remains an important option to treat pain or fever in pregnant women,’ said EMA’s Chief Medical Officer, Steffen Thirstrup. ‘Our advice is based on rigorous assessment of the available scientific data and we have found no evidence that taking paracetamol during pregnancy causes autism in children.’

The unusual decision to issue a statement – which announces no change in advice and no new evidence to review – comes in response to misinformation which falsely linked the common pain reliever with developmental changes. This idea was repeated by senior politicians in the United States in recent months, sparking widespread concern worldwide.

Without naming those who have perpetuated the myth, the EU regulator pushed back against the baseless medical claim which has potential to cause distress and avoidable physical suffering for pregnant women with a fever.

The EMA said it has a large amount of data from pregnant women who used paracetamol during pregnancy, over a very long period of time, and has seen no evidence of any risk of malformations in the developing foetus or in newborns.

‘When needed, paracetamol can be used during pregnancy. As with any medicine for acute treatment, it should be used at the lowest effective dose, for the shortest possible time and as infrequently as possible,’ the EMA statement said. ‘Pregnant women should speak to their healthcare professional if they have questions about any medication during pregnancy.’

Previous research suggested a potential link between paracetamol use in the first year of life and later eczema, asthma and other diseases.

“Our study found that paracetamol and ibuprofen are incredibly safe to use in young children,” says lead researcher Professor Stuart Dalziel, Cure Kids Chair of Child Health Research at Waipapa Taumata Rau, University of Auckland, and Paediatrician at Starship Children’s Hospital.

Dalziel says paracetamol and ibuprofen are the most common medicines prescribed or bought over the counter for babies worldwide.

“These results give parents and health professionals high confidence to continue to use these important medications.”

Almost 4,000 babies across New Zealand participated from birth, with half randomised to ensure their parents provided paracetamol and half to ensure their parents  provided ibuprofen when the infants required medication for fever or pain relief in the first year of life.

The researchers asked parents at regular intervals whether their children had eczema or asthma symptoms, or bronchiolitis. They also checked prescribing and hospital records.

The results for the first year of data have now been analysed and published in the leading journal The Lancet Child & Adolescent Health.

Eczema affected about 16 percent of babies given paracetamol and 15 percent of those given ibuprofen. Bronchiolitis occurred in about five percent of babies in both groups. These differences were not significant. Serious side effects were rare, and none was caused by the medications.

The study found no association between either medication and eczema or bronchiolitis and confirmed that both drugs were safe to use.

It is the first randomised controlled trial – considered the gold standard for research – to address this question.

This paper is part of a longer project dubbed the ‘Paracetamol and Ibuprofen in the Primary Prevention of Asthma in Tamariki (PIPPA Tamariki) study’.

PIPPA Tamariki is the largest trial ever conducted in children in New Zealand, and participants are being followed from birth to age six.

The researchers will soon publish findings on the same children at age three, and later at age six.

The long-term objective of the study is to test whether there are any links between paracetamol and specific conditions that can only be accurately diagnosed once children reach school age.

“We know that two‑thirds of children who are wheezy at age three years don’t develop asthma by age six,” says Dalziel.

“Thus we need to wait until school age to ultimately test if paracetamol in the first year of life causes asthma.”

Similarly, developmental disorders such as autism and attention deficit hyperactivity disorder (ADHD) are more accurately diagnosed as children get older.

Lead author Dr Eunicia Tan, a senior lecturer at the University of Auckland and emergency physician at Middlemore Hospital, says, “Ultimately, the study will provide important evidence regarding the link between paracetamol use and asthma, eczema, hay fever, and developmental disorders, such as autism and ADHD.”

The study was funded by the Health Research Council of New Zealand and Cure Kids and run by the University of Auckland and the Medical Research Institute of New Zealand, Wellington.

The findings were published on January 16, 2026 in The Lancet Obstetrics, Gynaecology, & Women’s Health journal.

As background, the authors noted, “Concerns have emerged about the impact of paracetamol use in pregnancy on child neurodevelopment, particularly in relation to autism spectrum disorder. We aimed to synthesize available evidence to investigate associations between prenatal paracetamol exposure and autism spectrum disorder, attention-deficit hyperactivity disorder (ADHD), and intellectual disability.”

The authors concluded, “This systematic review and meta-analysis found no evidence that maternal paracetamol use during pregnancy increases the risk of autism spectrum disorder, ADHD, or intellectual disability among children. The null findings remained consistent when analyses were harmonized to studies with longer follow-up, those employing sibling comparisons, and those at low risk of bias.”

They included 43 studies in this systematic review, and 17 studies in the meta-analysis.

The largest and most rigorous studies, specifically those with sibling comparisons, provided strong evidence that paracetamol-use during pregnancy is not a cause of autism, ADHD or intellectual disabilities.

Sibling comparison studies are designed to compare outcomes between siblings with different exposures (one sibling exposed to a drug, the other not) to control for shared genetic and environmental factors, and helping to isolate an accurate effect of exposure.

They reported that, when considering sibling comparison studies, paracetamol exposure during pregnancy was not associated with the risk of autism spectrum disorder (p=0·45), ADHD (p=0·31), or intellectual disability (p=0·63).

They also reported finding no association between paracetamol use during pregnancy and autism spectrum disorder (p=0·78), ADHD (p=0·49), or intellectual disability (p=0·28) when considering only studies at low risk of bias.

Low-risk-of-bias studies have strong designs, methods, and reporting, meaning their results are considered valid and reliable.

“This absence of association persisted when considering all studies with adjusted estimates and those with more than 5 years of follow-up,” they noted.

In an COMMENT appearing with the study, the authors said, “For now, this study reinforces that the strongest epidemiological evidence does not support a link between paracetamol use during pregnancy and neurodevelopmental harm, confirming that, when clinically-indicated, paracetamol remains an important and evidence-supported option for the management of fever and pain during pregnancy, particularly in settings where untreated maternal infection and fever pose well-established risks to fetal survival and neurodevelopment.

The work which was led by Anick Bérard, a Canadian researcher, points to methodological inadequacies in previous reviews and studies. It offers reassurance for pregnant women, public health agencies, and healthcare providers in alignment with recommendations from the Centers for Disease Control and Prevention (CDC), American College of Obstetricians and Gynecologists (ACOG), and The Society of Obstetricians and Gynecologists of Canada (SOGC).

Paracetamol/acetaminophen is the most commonly used over-the-counter pain reliever during pregnancy, taken in an estimated 70% of all pregnancies. In 2021, a commentary about a possible increased risk of NDDs in children exposed to acetaminophen in utero was published, leading to substantial concerns in the general population and among prescribers. However, this publication—as well as a subsequent narrative review by the same group of researchers—was met with criticism of its methodology, choice and quality of studies considered, and lack of mechanistic data.

Acetaminophen exposure during pregnancy is difficult to assess in epidemiological studies because it is available over the counter without a prescription and is used as needed. Hence, there is inconsistency between studies regarding the risk of NDDs associated with its use in pregnancy.

‘Given the significant methodological challenges in this area, additional individual studies will inevitably suffer the same limitations as are already present in published studies,’ explains Dr Bérard of the University of Montreal and CHU Sainte-Justine, Montréal, Quebec, Canada. ‘An integrative approach, summarising the present state of knowledge and quantifying specific methodological areas of biases, as our study does, is needed in order to have a significant impact in future studies performed as well as on the causal effect of acetaminophen use during pregnancy on the risk of specific NDDs.’

Dr Bérard and an international group of experts in the field conducted a comprehensive search of major bibliographic databases and grey literature to identify human studies evaluating the association between prenatal acetaminophen exposure and the risk of NDDs in offspring. Sixteen studies retrieved met eligibility criteria.

The authors conclude that the observed increase in risk is likely not causal and can be explained by inherent biases and underlying genetic factors. They recommend further studies to examine this association more robustly.

Commenting on the study, noted expert in the field Dr David Coghill, University of Melbourne, said it was a landmark piece of work that highlights the importance of good science and strong methods. ‘The findings of no association between acetaminophen [paracetamol] use during pregnancy and the risk of autism and ADHD in the child are not unexpected. These new findings support the position of professional organisations and regulatory bodies around the world that women should continue to use acetaminophen during pregnancy and do so without fear. The fact that they contradict the recent announcements by the US government must be acknowledged and acted on.’

The researchers say confidence in the findings of existing evidence reviews and studies on this topic is low to critically low, and suggest that any apparent effect seen in previous studies may be driven by shared genetic and environmental factors within families.

Regulatory bodies, clinicians, pregnant women, parents, and those affected by autism and ADHD should be informed about the poor quality of the existing reviews and women should be advised to take paracetamol when needed to treat pain and fever in pregnancy, they add.

Paracetamol (acetaminophen) is the recommended treatment for pain and fever in pregnancy and is considered safe by regulatory agencies worldwide.

Existing systematic reviews on this topic vary in quality, and studies that do not adjust for important factors shared by families or parents’ health and lifestyle cannot accurately estimate the effects of exposure to paracetamol before birth on neurodevelopment in babies.

To address this uncertainty, researchers carried out an umbrella review (a high-level evidence summary) of systematic reviews to assess the overall quality and validity of existing evidence and the strength of association between paracetamol use during pregnancy and the risks of autism or ADHD in offspring.

They identified nine systematic reviews that included a total of 40 observational studies reporting on paracetamol use during pregnancy and the risk of autism, ADHD, or other neurodevelopmental outcomes in exposed babies.

Four reviews included meta-analysis (a statistical method that combines data from several studies to give a single, more precise estimate of an effect).

The researchers used recognised tools to carefully assess each review for bias and rated their overall confidence in the findings as high, moderate, low, or critically low. They also recorded the degree of study overlap across reviews as very high.

All reviews reported a possible to strong association between a mother’s paracetamol intake and autism or ADHD, or both in offspring. However, seven of the nine reviews advised caution when interpreting the findings owing to the potential risk of bias and impact of unmeasured (confounding) factors in the included studies.

Overall confidence in the findings of the reviews was low (two reviews) to critically low (seven reviews).

Only one review included two studies that appropriately adjusted for possible effects of genetic and environmental factors shared by siblings, and accounted for other important factors such as parents’ mental health, background, and lifestyle.

In both these studies, the observed association between exposure to paracetamol and risk of autism and ADHD in childhood disappeared or reduced after adjustment, suggesting that these factors explain much of the observed risk, say the researchers.

They acknowledge some limitations. For example, the included reviews differed in scope and methods, they were unable to explore the effects of timing and dose, and their analyses were limited to autism and ADHD outcomes only.

However, they say this overview brings together all relevant evidence and applies established methods to assess quality, and shows “the lack of robust evidence linking paracetamol use in pregnancy and autism and ADHD in offspring.”

They conclude: “The current evidence base is insufficient to definitively link in utero exposure to paracetamol with autism and ADHD in childhood. 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.”

In the first study of its kind, researchers found that ibuprofen and paracetamol are not only driving antibiotic resistance when used individually but amplifying it when used together.

Assessing the interaction of non-antibiotic medications, the broad-spectrum antibiotic ciprofloxacin, and Escherichia coli (E. coli) – a common bacteria that causes gut and urinary tract infections ­­– researchers found that ibuprofen and paracetamol significantly increased bacterial mutations, making E. coli highly resistant to the antibiotic.

It’s an important finding that has serious health implications, particularly for people in aged care homes, where multiple medications are regularly administered.

The World Health Organization reports that antimicrobial resistance is a global threat to public health, and that bacterial resistance was directly responsible for 1.27 million global deaths in 2019.

Lead researcher UniSA’s Associate Professor Rietie Venter says the findings raise important questions about the risks of polypharmacy in aged care.

“Antibiotics have long been vital in treating infectious diseases, but their widespread overuse and misuse have driven a global rise in antibiotic-resistant bacteria,” Assoc Prof Venter says.

“This is especially prevalent in residential aged care facilities, where older people are more likely to be prescribed multiple medications – not just antibiotics, but also drugs for pain, sleep, or blood pressure – making it an ideal breeding ground for gut bacteria to become resistant to antibiotics.

“In this study we looked at the effect of non-antibiotic medicines and ciprofloxacin, an antibiotic which is used to treat common skin, gut or urinary tract infections.

“When bacteria were exposed to ciprofloxacin alongside ibuprofen and paracetamol, they developed more genetic mutations than with the antibiotic alone, helping them grow faster and become highly resistant. Worryingly, the bacteria were not only resistant to the antibiotic ciprofloxacin, but increased resistance was also observed to multiple other antibiotics from different classes.

“We also uncovered the genetic mechanisms behind this resistance, with ibuprofen and paracetamol both activating the bacteria’s defences to expel antibiotics and render them less effective.”

The study assessed nine medications* commonly used in residential aged care: ibuprofen (an anti-inflammatory pain relief), diclofenac (an anti-inflammatory to treat arthritis), acetaminophen (paracetamol for pain and fever), furosemide (for high blood pressure), metformin (for high sugar levels linked to Diabetes), atorvastatin (to help lower cholesterol and fats in the blood), tramadol (a stronger pain medication post-surgery) , temazepam (used to treat sleeping problems), and pseudoephedrine (a decongestant).

Assoc Prof Venter says the study shows how antibiotic resistance is a more complex challenge than previously understood, with common non-antibiotic medications also playing a role.

“Antibiotic resistance isn’t just about antibiotics anymore,” Assoc Prof Venter says.

“This study is a clear reminder that we need to carefully consider the risks of using multiple medications – particularly in aged care where residents are often prescribed a mix of long-term treatments.

“This doesn’t mean we should stop using these medications, but we do need to be more mindful about how they interact with antibiotics – and that includes looking beyond just two-drug combinations.”

The researchers are calling for further studies into drug interactions among anyone on long-term medication treatment regimes so we can gain a greater awareness of how common medications may impact antibiotic effectiveness.

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The new study, which is published in Arthritis Care and Research, shows that care must be taken when repeated doses are required for chronic painful conditions such as osteoarthritis in older people.

The study was led by Professor Weiya Zhang, from the NIHR Biomedical Research Centre in the School of Medicine at the University of Nottingham.

Professor Zhang said: “Due to its perceived safety, paracetamol has long been recommended as the first line drug treatment for osteoarthritis by many treatment guidelines, especially in older people who are at higher risk of drug-related complications.”

The study analysed data from the Clinical Practice Research Datalink-Gold. Participants were aged 65 and over with an average age of 75,  and had been registered with a UK GP practice for at least a year between 1998 and 2018.

Researchers looked at the health records of 180,483 people who had been prescribed paracetamol repeatedly (≥2 prescriptions within six months) during the study. Their health outcomes were then compared to 402,478 people of the same age who had never been prescribed paracetamol repeatedly.

The findings showed that prolonged paracetamol use was associated with an increased risk of peptic ulcers, heart failure, hypertension and chronic kidney disease.

Professor Zhang adds: “Whilst further research is now needed to confirm our findings, given its minimal pain-relief effect, the use of paracetamol as a first line pain killer for long-term conditions such as osteoarthritis in older people needs to be carefully considered.”
The full study can be found here.

The analysis, which included all randomized controlled trials published to date (18 studies with 3,478 patients), showed that muscle relaxants and non-steroidal anti-inflammatory drugs (NSAIDs) could effectively and rapidly reduce symptoms.

The combination of NSAIDs and paracetamol (also known as acetaminophen) was associated with a greater improvement than NSAIDs alone.

“This is a first step towards the optimization of the management of acute low back pain. However, specific patient characteristics such as having allergies and comorbidities must always be taken into consideration,” said lead author Alice Baroncini, MD, PhD, of RWTH University Hospital in Germany. “Further research will need to focus on the identification of the type of drugs that not only offer the best and quickest pain relief, but also show the lowest rate of symptom recurrence.”

URL upon publication: https://onlinelibrary.wiley.com/doi/10.1002/jor.25508

Patients who have a long-term prescription for the painkiller, usually used for the treatment of chronic pain, should opt for the lowest effective dose for the shortest possible time, researchers say.

The University of Edinburgh study, published in the scientific journal Circulation, is the first large randomised clinical trial to address this question and complements earlier work in observational studies.

Paracetamol was often suggested as a safer alternative to another class of painkillers called non-steroidal anti-inflammatory drugs (NSAIDs), which are known to increase blood pressure and risk of heart disease.

In the latest study, 110 patients with a history of high blood pressure were prescribed one gram of paracetamol four times a day – a routinely prescribed dose in patients with chronic pain – or a matched placebo for two weeks. All patients received both treatments, with the order randomised and blinded.

Those prescribed paracetamol saw a significant increase in their blood pressure, compared with those taking the placebo.

This rise was similar to that seen with NSAIDs, and might be expected to increase the risk of heart disease or stroke by around 20 per cent, experts say.

The research team says the findings should lead to a review of long-term paracetamol prescriptions to patients – particularly those with high blood pressure, or those at particular risk of heart disease or stroke.

Lead Investigator Dr Iain MacIntyre, Consultant in Clinical Pharmacology and Nephrology at NHS Lothian, said: “This is not about short-term use of paracetamol for headaches or fever, which is, of course, fine – but it does indicate a newly discovered risk for people who take it regularly over the longer term, usually for chronic pain.”

Professor James Dear, Personal Chair of Clinical Pharmacology at the University of Edinburgh, said: “This study clearly shows that paracetamol – the world’s most used drug – increases blood pressure, one of the most important risk factors for heart attacks and strokes. Doctors and patients together should consider the risks versus the benefits of long-term paracetamol prescription, especially in patients at risk of cardiovascular disease.”

Principal Investigator Professor David Webb, Chair of Therapeutics and Clinical Pharmacology at the University of Edinburgh, also said: “We would recommend that clinicians start with a low dose of paracetamol, and increase the dose in stages, going no higher than needed to control pain. Given the substantial rises in blood pressure seen in some of our patients, there may be a benefit for clinicians to keep a closer eye on blood pressure in people with high blood pressure who newly start paracetamol for chronic pain.”

Professor Sir Nilesh Samani, Medical Director at the British Heart Foundation, who funded the study, said: “This research shows how quickly regular use of paracetamol can increase blood pressure in people with hypertension who are already at increased risk of heart attacks and strokes. It emphasises why doctors and patients should regularly review whether there is an ongoing need to take any medication, even something that may seem relatively harmless like paracetamol, and always weigh up the benefits and risks. However, if you take paracetamol occasionally to manage an isolated headache or very short bouts of pain, these research findings should not cause unnecessary concern.”