Use of paracetamol during pregnancy remains unchanged in the EU New
In the EU, the active substance paracetamol (also known as acetaminophen, particularly in the Anglo-American region) can continue to be used for pain relief and fever reduction during pregnancy if this is considered clinically necessary. Contrary to recent and scientifically unconfirmed reports, there are currently no new findings in the EU that would justify a change to the existing EU recommendations for use. "Paracetamol remains an important option for the treatment of pain and fever in pregnant women," confirms Steffen Thirstrup, Chief Medical Officer at the European Medicines Agency (EMA). "Our positive recommendation is based on a careful evaluation of all available scientific data. We have found no robust evidence that the use of paracetamol during pregnancy causes autism in children."
As also stated in the product information (SmPC) for paracetamol in the EU, extensive data from pregnant women who have taken paracetamol during their pregnancy do not indicate that there is a risk of such events in the unborn child or the newborn. As early as 2019, the EMA comprehensively reviewed all available studies with regard to the neurological development of children who came into contact with paracetamol in the womb. The data were inconclusive and, as a result, no association with neurodevelopmental disorders could be identified or proven.
Paracetamol can therefore continue to be used during pregnancy if necessary. However, as with any medication for acute treatment, it should always be taken in the lowest effective dose, for the shortest period of time necessary and generally as infrequently as possible. Pregnant women should always consult their doctor if they have any questions about taking any medication during pregnancy. As with all medicines, the EMA and EU national medicines authorities continue to monitor the safety of medicines containing paracetamol and will promptly assess any new data. If necessary, regulatory action will be taken immediately to protect public health.
Original notification from the European Medicines Agency on the use of paracetamol in the EU.
Background: On 22 September 2025, the US Food and Drug Administration (FDA) published a scientifically controversial press release in which it announced that the US product information for acetaminophen would refer to a possible link between the use of acetaminophen during pregnancy and the later diagnosis of autism or attention deficit/hyperactivity disorder (ADHD) in the offspring. However, the FDA communication also states that no causal relationship has been established.
