On September 22, 2025, the U.S. Food and Drug Administration (FDA) initiated a label change to suggest that acetaminophen use by pregnant women may be associated with an increased risk of neurological conditions such as autism and attention-deficit/hyperactivity disorder (ADHD) in children. The agency also issued a related letter alerting physicians nationwide
The question of acetaminophen safety during pregnancy has been studied for more than a decade. In 2015, the FDA reviewed the available literature and determined that the evidence was inconclusive regarding a causal relationship between prenatal acetaminophen and ADHD. 4 In 2017, the Society for Maternal-Fetal Medicine (SMFM) conducted an independent review of large cohort studies 56789 and reached the same conclusion: No clear causal relationship had been established.