Acetaminophen, also sold as paracetamol and commonly known by the brand name Tylenol, is widely recommended by clinicians as a first-line treatment for pain or fever during pregnancy when used at the lowest effective dose for the shortest necessary duration. Its safety profile has come under scrutiny in recent years after several observational reports produced conflicting findings, leaving some expectant parents uncertain about whether to use the medicine.
Contrasting Earlier Warnings
Public attention escalated in September 2025 when President Donald Trump stated that acetaminophen use during pregnancy was “associated with a very increased risk of autism,” advising pregnant individuals to avoid the product. The president reiterated the warning on social media and suggested the drug be withheld from young children as well. The claims were not accompanied by new scientific evidence.
Shortly afterward, the U.S. Food and Drug Administration circulated a communication to physicians noting that data on a causal relationship remain inconclusive. The agency emphasized that additional research was underway and acknowledged the lack of proof that acetaminophen causes autism.
The Department of Health and Human Services echoed those uncertainties at the time, saying numerous experts had voiced concerns about the medication’s use in pregnancy. Major medical organizations, including the American College of Obstetricians and Gynecologists (ACOG), cautioned that discouraging acetaminophen without scientific justification could deprive pregnant patients of an important therapy for pain and fever.
Key Findings of the New Analysis
The review team reported several core observations:
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- No elevated risk of autism spectrum disorder, ADHD or intellectual disability was detected among children whose mothers used acetaminophen according to labeling instructions.
- The sibling-comparison design effectively controlled for shared genetics and environment, strengthening confidence that results were not confounded by familial factors.
- Earlier observational studies may have mistaken the effects of underlying conditions—such as fever or infection—for effects of the drug. Because pregnant individuals typically take acetaminophen to relieve symptoms, the illness itself could influence fetal brain development, complicating interpretation of past research.
Although the authors regarded the evidence as reassuring, they acknowledged limitations. Only a subset of available studies used sibling designs, and the data could not fully account for every variable that influences medication use or neurodevelopment. The investigators advised following established clinical guidance: use acetaminophen only when necessary, adhere to recommended dosages and consult a healthcare professional if symptoms persist.
Industry and Government Reactions
Kenvue, the manufacturer of Tylenol, said it would review the findings but maintained its longstanding position that independent science supports the drug’s safety during pregnancy. An official within HHS, however, criticized the review’s methodology, arguing that it excluded a large portion of relevant evidence and relied on a study design that may understate potential risk.
Outside experts in maternal-fetal health highlighted the risks of leaving fever or severe pain untreated. Uncontrolled fevers have been linked to adverse pregnancy outcomes, and alternative analgesics such as non-steroidal anti-inflammatory drugs or opioids carry their own contraindications. For these reasons, ACOG continues to list acetaminophen as the preferred over-the-counter option for pregnant patients who need pharmacologic relief according to its current guidance.
Next Steps in Research
The review’s authors called for additional high-quality investigations to address remaining gaps, particularly studies that can incorporate medication dosage, timing of exposure and concurrent maternal illnesses. They noted that such data would allow clinicians to refine recommendations while balancing the benefits of symptom control against any potential risks.
Until further evidence emerges, mainstream obstetric guidance remains unchanged: pregnant individuals may take acetaminophen in accordance with product labeling and should seek medical advice for ongoing or severe symptoms. Health authorities continue to monitor emerging research to ensure recommendations reflect the most reliable evidence available.
Crédito da imagem: Ronaldo Schemidt/AFP via Getty Images
