Science to Practice
Latest highlights on drug safety and efficacy

29.10.2025

There is an ongoing public and global debate about possible adverse developmental long-term effects of maternal use of paracetamol during pregnancy. During the last years, research has been focusing on allergic and neurodevelopmental outcomes in the infants exposed to paracetamol via maternal use, and these themes are obviously reflected in the mainstream media and discussions in social media, as well as among professionals.

Our medical team at Medbase has been following the accumulation of novel studies and clinical evidence of safety of medications, including paracetamol, for 18 years now. Up to date, we have included over 60 relevant references for original research on paracetamol use during pregnancy, and based on these data, given a clinically useful interpretation based only on rigorous scientific work.

Based on this very solid evidence, our Gravbase recommendation – part of Medbase’s clinical decision support on drug safety in pregnancy – confirms that paracetamol remains the preferred option for pain management during pregnancy, given that indication is clear, the need for long-term use is thoroughly assessed, and recommended daily doses are followed.

Eighteen years of clinical evidence still point to one conclusion: paracetamol remains the most reliable option when used as recommended.

In a recent article in the British Medical Journal, Dr Jeffrey K Aronson from the Centre for Evidence Based Medicine, Oxford, UK, discusses elegantly the importance of random discoveries in drug development and confounding factors in epidemiological studies on paracetamol, in which relatively vague associations with e.g. asthmatic outcomes and adverse neurodevelopmental outcomes, including ADHD and autism, have been suggested already since 2013. He especially acknowledges confounding by indication and other biases, like the use of antibiotics as well as viral infections in childhood and recall bias in questionnaire studies (1).

Confounders like household factors and environment can be partially overcome with sibling control analysis that was deployed also in a nationwide Swedish study with over 185 000 pregnancy exposures to paracetamol. The clinically likely unmeaningfully small 5% increase, leading to 0.09% difference in risk for autism at 10 years of age disappeared completely in the matched sibling-controlled analyses, highlighting the impact of shared genetic background and childhood environment on neurodevelopment (2).

For more comprehensive information, explore Gravbase and Lactbase, our specialised databases providing detailed insights on drug safety and efficacy during pregnancy and lactation.

News produced by Medbase Medical Team

References

1. Aronson JK. When I use a word . . . Paracetamol/acetaminophen-autism and asthma. BMJ. 2025 Sep 26;390:r2032. https://pubmed.ncbi.nlm.nih.gov/41005970/
2. Ahlqvist VH, Sjöqvist H, Dalman C, Karlsson H, Stephansson O, Johansson S, Magnusson C, Gardner RM, Lee BK. Acetaminophen Use During Pregnancy and Children’s Risk of Autism, ADHD, and Intellectual Disability. JAMA. 2024 Apr 9;331(14):1205-1214. https://pubmed.ncbi.nlm.nih.gov/38592388/