Statement on paracetamol use in pregnancy

ANZCA and FPM are aware of recent claims from the US questioning the safety of paracetamol use in pregnancy.
These claims are not based on new evidence. Over the past 15 years, numerous studies have examined this question, producing conflicting results.
Recent biomarker studies (2019–2021) have suggested a possible association between late pregnancy paracetamol exposure and neurodevelopmental outcomes, but these studies remain observational and cannot prove causation.
Large cohort studies, including recent Swedish data, have found no such association.
Both the Therapeutic Goods Administration (Australia) and Medsafe (New Zealand) classify paracetamol as a Pregnancy Category A medicine: it has been taken by a large number of pregnant women without proven increase in malformations or other harmful effects.
Their advice is that paracetamol can be used in pregnancy when clinically necessary, but always at the lowest effective dose for the shortest possible duration.
It is also important to note that untreated fever or significant pain in pregnancy can themselves be harmful to both mother and baby. Women should therefore seek medical advice if they are concerned.
Paracetamol’s safety profile is superior to non-steroidal anti-inflammatory agents such as ibuprofen or diclofenac and the latter agents should not be used in pregnancy without specific medical advice.
At present, paracetamol remains the recommended first-line option for pain relief in pregnancy when required.
Medicines regulators continue to monitor emerging evidence and will update advice if new high-quality data emerges.