Study supports neurodevelopmental safety of maternal paracetamol use

A systematic review and meta-analysis support the safety of paracetamol on child neurodevelopment when used appropriately during pregnancy.

“[We] found no evidence that maternal paracetamol use during pregnancy increases the risk of autism spectrum disorder (ASD), attention-deficit/hyperactivity disorder (ADHD), or intellectual disability among children,” said the investigators.

The systematic review included 43 studies, and the meta-analysis included 17. In the sibling comparison studies, paracetamol exposure during pregnancy was not associated with the risk of ASD (odds ratio [OR], 0.98; p=0.45), ADHD (OR, 0.95; p=0.31), and intellectual disability (OR, 0.93; p=0.63). [Lancet Obstet Gynaecol Womens Health 2026;doi.org/10.1016/ S3050-5038(25)00211-0]

The lack of association was sustained when looking at all studies with adjusted estimates (OR, 1.08; p=0.30 for ASD, OR, 1.10; p=0.08 for ADHD, and OR, 1.04; p=0.14 for intellectual disability) and studies with low risk of bias according to QUIPS* (OR, 1.03; p=0.78, OR, 0.97; p=0.49, and OR, 1.11; p=0.28, respectively) and those with >5 years of follow-up (OR, 1.09; p=0.22, OR, 1.09; p=0.22, and OR, 1.11; p=0.10).

“[T]he null findings in sibling designs indicate that familial and genetic factors, including the well-established tendency for autistic traits to run in families, are more plausible explanations for previously observed associations than any direct effect of paracetamol,” they explained.

As such, the results cannot be taken as evidence of causality; instead, these underline the complexity of distinguishing medication effects from underlying maternal and familial factors, the researchers added.

A small causal effect may have major implications

Paracetamol remains one of the most frequently used medicines during pregnancy and is in the WHO List of Essential Medicines. [https://list.essentialmeds.org/medicines/15, accessed January 24, 2026]

However, in September 2025, the US government suggested that prenatal paracetamol exposure may contribute to autism, citing evidence linking maternal paracetamol use to neurodevelopmental harm. [https://www.bbc.co.uk/news/articles/cx20d4lr67lo, accessed January 24, 2026; Environ Health 2025;24:56]

Given the widespread use of paracetamol during pregnancy, a small causal effect on neurodevelopment may have major public health implications, the researchers pointed out.

Also, avoiding paracetamol based on unfounded evidence may expose mothers and foetuses to the risks tied to untreated pain and fever (eg, miscarriage, preterm birth, congenital defects). [Epidemiology 2005;16:216-219; Pediatrics 2014;133:e674-e688; Mol Autism 2021;12:60]

“Thus, the politicization of scientific uncertainty creates confusion among pregnant [women] and clinicians … [D]iscouraging the appropriate use of paracetamol has the potential to cause greater harm than the drug itself,” they said.

The current results reinforce the recommendations of professional associations, such as ACOG, RCOG, FIGO, and SMFM**, the researchers noted. “These organizations continue to recommend paracetamol as the first-line analgesic and antipyretic in pregnancy when used as directed. Regulatory agencies such as the EMA***, the UK MHRA^#, and Health Canada hold similar positions.”

Balanced, empathetic risk messaging is imperative

“[The results confirm that] paracetamol remains an important and evidence-supported option for the management of fever and pain during pregnancy, particularly in settings where untreated maternal infection and fever pose well-established risks to foetal survival and neurodevelopment,” said Dr Hannah Blencowe from the London School of Hygiene and Tropical Medicine, London, UK, and colleagues, in a commentary. [Lancet Obstet Gynaecol Womens Health 2026;doi.org/10.1016/PII]

Blencowe and colleagues also underlined the importance of balancing maternal and foetal needs when communicating the risk around medication use. “Pregnant women tend to overestimate the risk of medication-related harms and might be especially susceptible to misinformation. Limited understanding of the underlying causes of ADHD and ASD could leave affected mothers particularly susceptible to self-blame.”

Moreover, discouraging paracetamol use may cause unnecessary anxiety and subsequently lead to ineffective management of maternal pain or fever, or the use of alternative drugs that may be risky during pregnancy.

“The public health community has an ethical responsibility to avoid overstating weak observational signals that might drive harmful behavioural change. Balanced, empathetic risk messaging regarding potential exposures during pregnancy that presents existing empirical evidence while acknowledging uncertainties and countering misinformation is essential,” they said.