EMA confirms the safety of paracetamol during pregnancy following a new study

A major review in The Lancet finds no link to autism or ADHD, supporting current EU guidelines that the medication remains safe when used correctly.

Amsterdam, January 23, 2026 – The European Medicines Agency (EMA) has reaffirmed that paracetamol is safe for use during pregnancy, following the publication of a new comprehensive study. The agency stated that there is no new evidence requiring changes to current EU recommendations, providing reassurance to millions of expectant mothers.

In brief

A new systematic review confirms that paracetamol does not increase the risk of neurodevelopmental disorders, such as autism or ADHD.

EMA maintains the recommendation that the medication is safe to use at the lowest effective dose, for the shortest time possible.

Extensive data continue to show no risk of malformations in fetuses or newborns exposed to the medication.

The update follows a recent systematic review and meta-analysis published in The Lancet Obstetrics, Gynaecology, & Women’s Health. This major scientific publication found no evidence that the use of paracetamol at recommended doses during pregnancy increases the risk of autism spectrum disorders, ADHD, or intellectual disability in children.

"Paracetamol remains an important option for treating pain or fever in pregnant women," said Steffen Thirstrup, the chief physician of EMA. "Our advice is based on a rigorous assessment of the available scientific data, and we found no evidence that taking paracetamol during pregnancy causes autism in children."

The EMA's position remains consistent with its 2019 review, which also found inconclusive results regarding neurodevelopmental risks. Furthermore, a large volume of data indicates no risk of physical malformations in the developing fetus. However, the agency continues to recommend caution: paracetamol should only be used if clinically necessary, at the lowest effective dose, and for the shortest duration possible. Pregnant women are encouraged to consult healthcare professionals if they have concerns.

https://2eu.brussels/ro/stiri/ema-confirma-siguranta-paracetamolului-in-sarcina-in-urma-unui-nou-studiu