As included in the product information for paracetamol in the EU, a large amount of data from pregnant women who used paracetamol during pregnancy indicates no risk of malformations in the developing foetus or in newborns.

In 2019, EMA reviewed available studies that investigated the neurodevelopment of children exposed to paracetamol in utero and found that the results were inconclusive and that no link with neurodevelopmental disorders could be established.[1][2]

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.

Pregnant women should speak to their healthcare professional if they have questions about any medication during pregnancy.

As for all medicines, EMA and the national competent authorities in the EU will continue to monitor the safety of medicines containing paracetamol and promptly evaluate any new data as they emerge….