A NEW study from the Icahn School of Medicine at Mount Sinai adds to growing evidence that prenatal exposure to acetaminophen (paracetamol) may be linked to an increased risk of neurodevelopmental disorders, including autism spectrum disorder and attention-deficit/hyperactivity disorder (ADHD).
The research is the first to apply the rigorous Navigation Guide methodology to systematically evaluate the scientific literature on this topic. The team analyzed 46 studies involving more than 100,000 participants across multiple countries and found that higher-quality studies were more likely to report a connection between prenatal acetaminophen use and elevated risks of autism and ADHD.
“Given the widespread use of this medication, even a small increase in risk could have major public health implications,” said lead author Diddier Prada, MD, PhD, Assistant Professor of Population Health Science and Policy, Environmental Medicine, and Climate Science at Mount Sinai.
Acetaminophen is the most commonly used pain and fever reliever during pregnancy, with more than half of expectant mothers worldwide relying on it. While long considered the safest option, the Mount Sinai-led analysis highlights potential biological mechanisms behind the risk. These include the drug’s ability to cross the placental barrier, trigger oxidative stress, disrupt hormones, and cause epigenetic changes that may affect fetal brain development.
The researchers emphasized that their findings do not prove causation but strengthen the evidence for an association. They recommend cautious, time-limited use of acetaminophen during pregnancy under medical supervision, along with updated clinical guidelines and further research to confirm the risks and explore safer alternatives.
“Pregnant women should not stop taking medication without consulting their doctors,” Dr. Prada cautioned. “Our study underscores the importance of carefully weighing the benefits and risks with health care providers.”
The study, conducted in collaboration with UCLA, the University of Massachusetts Lowell, and the Harvard T.H. Chan School of Public Health, has broad implications for clinical practice and public health policy, as autism and ADHD diagnoses continue to rise globally.
Reference
Prada D et al. Evaluation of the evidence on acetaminophen use and neurodevelopmental disorders using the Navigation Guide methodology. Environ Health. 2025;DOI: 10.1186/s12940-025-01208-0.
