Tylenol Use in Pregnancy Not Linked to Autism, Study Finds

A nationwide Danish study published on Monday reported no association between using Tylenol (acetaminophen/paracetamol) during pregnancy and a later autism diagnosis in children. The research was published in JAMA Pediatrics and drew on population-level data covering births across Denmark.

The analysis included more than 1.5 million children born between 1997 and 2022 . Within that group, 31,098 children were identified as having been exposed to Tylenol in the womb, based on the study’s data sources.

Autism was diagnosed in 1.8% of children in the exposed group, compared with 3% among those classified as unexposed. Researchers reported that the overall finding of no association held after accounting for individual risk factors, including the medication’s dosage and the trimester in which it was used.

The Danish results are consistent with a 2024 Swedish study that also found no link between prenatal Tylenol use and autism. At the same time, the new findings differ from a 2025 review of 46 earlier studies that described a possible, though unproven, relationship between prenatal acetaminophen exposure and neurodevelopmental disorders.

In the United States, the Food and Drug Administration (FDA) previously began a process to change acetaminophen labeling to add a warning about a potential increased risk of autism and ADHD. That step has faced criticism from medical groups, according to the source material.

For global health systems and consumer markets, the study adds to a growing set of large-scale research examining widely used over-the-counter medicines during pregnancy. The findings may be closely watched by clinicians, regulators, and manufacturers because acetaminophen is sold internationally under multiple brand names and is commonly used for pain and fever management.

Even with the Danish study’s scale, uncertainty remains because the broader evidence base includes mixed conclusions across prior research, including the 2025 review that did not establish proof of harm. Further scrutiny is also likely to focus on how different studies define exposure, measure outcomes, and adjust for confounding factors, as reflected by the Danish study’s attention to dosage and timing by trimester.

Any future regulatory decisions, including whether to proceed with label changes, would carry implications for public guidance and for companies operating in the global non-prescription drug market. For now, the Danish study’s central conclusion is that it did not find an association between prenatal Tylenol exposure and autism diagnoses in children.