A MAJOR evidence review published in medical journal The BMJ has found no clear link between paracetamol (acetaminophen) use during pregnancy and autism or ADHD in children, despite earlier studies suggesting a possible association.
Researchers say confidence in previous findings is “low to critically low” and that many apparent effects may instead be explained by shared genetic and environmental factors within families.
The review, conducted in direct response to recent public concern about the safety of paracetamol in pregnancy, examined nine systematic reviews encompassing 40 observational studies.
While most reviews reported a potential link between maternal paracetamol use and neurodevelopmental conditions such as autism or ADHD, seven of the nine warned their findings should be treated with caution due to study bias and unmeasured confounding factors.
After assessing the quality and overlap of these studies using established evidence tools, the researchers concluded that overall confidence in the existing evidence ranged from low to critically low.
Only one review included studies that properly adjusted for genetic and environmental influences shared by siblings. In those adjusted studies, the previously observed associations either disappeared or were significantly reduced, suggesting that these familial factors, rather than paracetamol itself, may account for much of the perceived risk.
Co-author Professor Helena Teede, Director of the Monash Centre for Health Research and Implementation, said the findings underline the importance of relying on high-quality, collective evidence when assessing risks and benefits.
“Science and vaccines have transformed public health and human survival, and while they have limited recognised side effects, the benefits clearly outweigh the risks of the diseases they prevent,” Prof Teede said.
“It is vital to continue research and to unlock committed but unspent funds from the Medical Research Future Fund to further improve health outcomes for our community.”
Regulatory agencies worldwide continue to recommend paracetamol as the safest option for treating pain and fever during pregnancy when used as directed. The researchers urge clinicians, regulatory bodies and pregnant women to be informed about the poor quality of earlier reviews and to base decisions on current, robust evidence.
Their conclusion is clear: the current evidence base is insufficient to definitively link paracetamol use in pregnancy with autism or ADHD, and higher-quality studies are needed to explore timing, dosage, and broader neurodevelopmental outcomes.
