Written by Alissa Akselrod PharmD Candidate 2025 and Regina Ginzburg Pharm.D., CDCES, BC-ADM

In September 2025, the Food and Drug Administration (FDA) issued a warning about the potential link between the use of acetaminophen during pregnancy and the development of autism.¹ However, the American College of Obstetricians & Gynecologists (ACOG) and the American Academy of Pediatrics (AAP) do not agree with this statement and continue to recommend acetaminophen as a safe pain and fever reliever in pregnancy.^2,3 Some studies have suggested its use during pregnancy can increase neurodevelopmental disorders in children, including autism,^4,5 but clear evidence linking the two has not been found.

The concern for this correlation stemmed from one small, single-center study at the Boston Birth Center. The investigators used biomarkers of in-utero acetaminophen exposure to assess an association with Attention Deficit Hyperactivity Disorder (ADHD), autism spectrum disorder (ASD), and other neurodevelopmental disabilities.⁴ By using in-utero acetaminophen biomarkers, the study sought to eliminate bias from self-reporting acetaminophen use; however, cord plasma only measures maternal use of acetaminophen during the peripartum period, not fetal uptake. While the study found a link between acetaminophen and increased risk of ADHD and ASD in children, there were several important limitations to note. First, they did not measure genetic confounding factors, nor have a sibling control. When these factors were accounted for in other large population-based studies, these associations disappeared.⁵ Secondly, while there were levels of acetaminophen, one cannot exclude that the underlying medical reason (i.e., fever during pregnancy) could have contributed to the risk of autism. Furthermore, it is essential to note that this was a small cohort from a single area in the US, which limits the generalizability of the findings. Lastly, this is an observational study, and therefore, causality cannot be established.

Recent studies have not established any link between autism and acetaminophen use during pregnancy.^5,6 An umbrella review of systematic reviews evaluating nine systematic reviews that included 40 primary studies found that the overall confidence in most of these reviews were low to critically low and included potential risk of bias and numerous confounders.⁶ They noted only one review included two studies that accounted for familial factors, which did not show an increased risk of autism when adjusted for confounders (absolute risk 0.98, confidence interval 0.93 to 1.04). Another systematic review that examined the health effects of fever during pregnancy did not find an association with acetaminophen and ASD after adjusting for confounders, and there was also some evidence of that antipyretic use may have a protective effect against adverse outcomes.⁷

ACOG and AAP continue to recommend the use of acetaminophen as a pain and fever reliever during pregnancy.^2,3 While some investigators observed prenatal exposure had higher odds for ASD,⁴ it is important to note that important confounding variables, such as genetics, were not accounted for. Pain and fever should be treated during pregnancy, since they pose risks of neural tube defects, congenital heart defects, and oral clefts when severe and left untreated.^2,7 Acetaminophen is the best choice for pain and fever management during pregnancy due to its well-established safety profile.