ACOG Recommendation

ACOG reaffirms that acetaminophen remains the analgesic and antipyretic of choice during pregnancy. Judicious use at the lowest effective dose for the shortest necessary duration, in consultation with an obstetrician–gynecologist or other obstetric care professional, remains consistent with best practice.

The current weight of evidence does not support a causal link between prenatal acetaminophen use and neurodevelopmental disorders. At this time, no change in clinical practice is warranted based on new publications and ACOG’s recommendations for the use of acetaminophen for specific indications 12 remain current.

Background

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. 3 The agency also issued a related letter alerting physicians nationwide. 3

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. 10

These reviews identified recurring methodological limitations in the studies linking acetaminophen use in pregnancy to neurodevelopmental outcomes:

• Reliance on maternal self-report with its potential for recall bias;
• Lack of detailed data on dosage, duration, and timing of exposure;
• Heterogeneous outcome assessments of child neurodevelopment, often relying on parental or teacher surveys;
• Failure to control for genetic and familial confounders; and
• Neglect of postnatal acetaminophen exposure, which is common and biologically relevant.

In 2021, concern over acetaminophen safety was renewed, with a consensus statement that argued for precautionary restrictions on prenatal use. 11 This statement was widely criticized for overstating the strength of the evidence and for failing to account for critical clinical context. ACOG subsequently issued a statement and confirmed that the standard of care for acetaminophen use in pregnancy remained unchanged.

An August 2025 study assessed whether prenatal acetaminophen exposure increases the risk of neurodevelopmental disorders, including ADHD, autism spectrum disorder, or intellectual disability. 12 This review included 10 new studies published since 2021. However, analysis shows that most of these new studies continue to share the same flaws as previous studies. Notably, only two studies—Ahlqvist 2024 13 (Swedish nationwide cohort, sibling-controlled) and Gustavson 2021 14 (Norwegian Mother, Father, and Child Cohort, sibling-controlled)—adequately addressed genetic confounding and familial factors. Both found no significant association between prenatal acetaminophen and neurodevelopmental outcomes once these confounders were considered.

Implementation Considerations

Clinical Context and Risk–Benefit Balance

Untreated maternal conditions for which acetaminophen is indicated—such as fever, migraines and other headaches, and pain—can lead to significant maternal and fetal morbidity and mortality. Fever during pregnancy, for example, has been associated with increased risk of neural tube defects and other birth defects such as oral clefts and cardiac defects. 1516 Inadequate treatment of pain can destabilize maternal physiology, with potential downstream effects on fetal well-being. 1718

All medication use follows a risk–benefit calculation, which should consider both the pregnant individual and fetus during pregnancy. Overstating theoretical drug risks can lead to undertreatment, which is not without its own health risks. It is therefore essential that physicians continue to reassure patients about the safety of acetaminophen when clinically appropriate.

Patient Counseling

Patients are increasingly exposed to media reports and online content that amplify concern about prenatal acetaminophen. Clinicians should be prepared to:

• Counsel patients on risk–benefit calculation and appropriate acetaminophen dosing, including maximum daily limits. 1
• Acknowledge the ongoing research and limitations of existing studies, emphasizing that the strongest and most methodologically rigorous studies1314 show no evidence of causal association.
• Reassure patients that appropriate acetaminophen use remains the standard of care.

Coverage and Access

Acetaminophen is available over the counter, inexpensive, and widely used. If public fear leads to decreased availability or increased regulatory restriction, patients may be left with fewer safe options for analgesia and fever control in pregnancy. It is important for women’s health professionals to continue to advocate for access to acetaminophen as an essential medication in prenatal care.

Conclusion

ACOG reaffirms that acetaminophen remains the safest first-line analgesic and antipyretic in pregnancy. Clinicians should continue to recommend its judicious use, provide evidence-based counseling, and reassure patients that current data do not support a causal link to neurodevelopmental disorders.

Resources

These materials are for information purposes only and are not meant to be comprehensive. Referral to these resources does not imply ACOG’s endorsement of the organization, the organization’s website, or the content of the resource. The resources may change without notice.

Related ACOG Guidance

• Clinical Practice Guideline No. 3: Headaches in Pregnancy and Postpartum
• Practice Advisory: COVID-19 Vaccination Considerations for Obstetric–Gynecologic Care
• Clinical Consensus No. 1: Pharmacologic Stepwise Multimodal Approach for Postpartum Pain Management
• Committee Statement No. 819: Informed Consent and Shared Decision Making in Obstetrics and Gynecology