This Practice Advisory was developed by the American College of Obstetricians and Gynecologists in collaboration with Nathaniel DeNicola, MD, MSHP, FACOG.
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
Related ACOG Resources
Other Resources
Please contact [email protected] with any questions.
References
- Headaches in pregnancy and postpartum. Clinical Practice Guideline No. 3. American College of Obstetricians and Gynecologists. Obstet Gynecol 2022;139:944–72. Available at: https://doi.org/10.1097/AOG.0000000000004766. Retrieved September 23, 2025.
Article Locations:
- American College of Obstetricians and Gynecologists. COVID-19 vaccination considerations for obstetric–gynecologic care. Practice Advisory. ACOG; 2020. Available at: https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2020/12/covid-19-vaccination-considerations-for-obstetric-gynecologic-care. Retrieved September 23, 2025.
Article Locations:
- U.S. Food and Drug Administration. FDA responds to evidence of possible association between autism and acetaminophen use during pregnancy. FDA; 2025. Available at: https://www.fda.gov/news-events/press-announcements/fda-responds-evidence-possible-association-between-autism-and-acetaminophen-use-during-pregnancy. Retrieved September 23, 2025.
Article Locations:
- U.S. Food and Drug Administration. FDA Drug Safety Communication: FDA has reviewed possible risks of pain medicine use during pregnancy. FDA; 2016. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-has-reviewed-possible-risks-pain-medicine-use-during-pregnancy. Retrieved September 23, 2025.
Article Locations:
- Brandlistuen RE, Ystrom E, Nulman I, Koren G, Nordeng H. Prenatal paracetamol exposure and child neurodevelopment: a sibling-controlled cohort study. Int J Epidemiol 2013;42:1702–13. Available at: https://doi.org/10.1093/ije/dyt183. Retrieved September 23, 2025.
Article Locations:
- Liew Z, Ritz B, Rebordosa C, Lee P, Olsen J. Acetaminophen use during pregnancy, behavioral problems, and hyperkinetic disorders. JAMA Pediatr 2014;168:313–20. Available at: https://doi.org/10.1001/jamapediatrics.2013.4914. Retrieved September 23, 2025.
Article Locations:
- Thompson JM, Waldie KE, Wall CR, Murphy R, Mitchell EA. Associations between acetaminophen use during pregnancy and ADHD symptoms measured at ages 7 and 11 years. ABC study group. PLoS One 2014;9:e108210. Available at: https://doi.org/10.1371/journal.pone.0108210. Retrieved September 23, 2025.
Article Locations:
- Stergiakouli E, Thapar A, Davey Smith G. Association of acetaminophen use during pregnancy with behavioral problems in childhood: evidence against confounding. JAMA Pediatr 2016;170:964–70. Available at: https://doi.org/10.1001/jamapediatrics.2016.1775. Retrieved September 23, 2025.
Article Locations:
- Liew Z, Ritz B, Virk J, Olsen J. Maternal use of acetaminophen during pregnancy and risk of autism spectrum disorders in childhood: a Danish national birth cohort study. Autism Res 2016;9:951–8. Available at: https://doi.org/10.1002/aur.1591. Retrieved September 23, 2025.
Article Locations:
- Prenatal acetaminophen use and outcomes in children. Society for Maternal-Fetal Medicine (SMFM) Publications Committee. Am J Obstet Gynecol 2017;216:B14–5. Available at: https://doi.org/10.1016/j.ajog.2017.01.021. Retrieved September 23, 2025.
Article Locations:
- Bauer AZ, Swan SH, Kriebel D, Liew Z, Taylor HS, Bornehag C, et al. Paracetamol use during pregnancy – a call for precautionary action. Nat Rev Endocrinol 2021;17:757–66. Available at: https://doi.org/10.1038/s41574-021-00553-7. Retrieved September 23, 2025.
Article Locations:
- Prada D, Ritz B, Bauer AZ, Baccarelli AA. Evaluation of the evidence on acetaminophen use and neurodevelopmental disorders using the Navigation Guide methodology. Environ Health 2025;24:56. Available at: https://doi.org/10.1186/s12940-025-01208-0. Retrieved September 23, 2025.
Article Locations:
- Ahlqvist VH, Sjöqvist H, Dalman C, Karlsson H, Stephansson O, Johansson S, et al. Acetaminophen use during pregnancy and children’s risk of autism, ADHD, and intellectual disability. JAMA 2024;331:1205–14. Available at: https://doi.org/10.1001/jama.2024.3172. Retrieved September 23, 2025.
Article Locations:
- Gustavson K, Ystrom E, Ask H, Ask Torvik F, Hornig M, Susser E, et al. Acetaminophen use during pregnancy and offspring attention deficit hyperactivity disorder – a longitudinal sibling control study. JCPP Adv 2021;1:e12020. Available at: https://doi.org/10.1002/jcv2.12020. Retrieved September 23, 2025.
Article Locations:
- Dreier JW, Andersen AN, Berg-Beckhoff G. Systematic review and meta-analyses: fever in pregnancy and health impacts in the offspring. Pediatrics 2014;133:e674–88. Available at: https://doi.org/10.1542/peds.2013-3205. Retrieved September 23, 2025.
Article Locations:
- Kerr SM, Parker SE, Mitchell AA, Tinker SC, Werler MM. Periconceptional maternal fever, folic acid intake, and the risk for neural tube defects. Ann Epidemiol 2017;27:777–82.e1. Available at: https://doi.org/10.1016/j.annepidem.2017.10.010. Retrieved September 23, 2025.
Article Locations:
- Tennant F. The physiologic effects of pain on the endocrine system. Pain Ther 2013;2:75–86. Available at: https://doi.org/10.1007/s40122-013-0015-x. Retrieved September 23, 2025.
Article Locations:
- Becker M, Weinberger T, Chandy A, Schmukler S. Depression during pregnancy and postpartum. Curr Psychiatry Rep 2016;18:32–7. Available at: https://doi.org/10.1007/s11920-016-0664-7. Retrieved September 23, 2025.
Article Locations:
Use of Language
The American College of Obstetricians and Gynecologists recognizes and supports the gender diversity of all patients who seek obstetric and gynecologic care. In original portions of this document, authors seek to use gender-inclusive language or gender-neutral language. When describing research findings, this document uses gender terminology reported by investigators. To review ACOG’s policy on inclusive language, see https://www.acog.org/clinical-information/policy-and-position-statements/statements-of-policy/2022/inclusive-language.
A Practice Advisory is a brief, focused statement issued to communicate guidance or information on an emergent clinical issue (eg, clinical study, scientific report, draft regulation). A Practice Advisory constitutes ACOG clinical guidance and is issued only online for Fellows but may also be used by patients and the media. Practice Advisories are reviewed periodically for reaffirmation, revision, withdrawal, or incorporation into other ACOG guidelines. This information is designed as an educational resource to aid clinicians in providing obstetric and gynecologic care, and use of this information is voluntary. This information should not be considered as inclusive of all proper treatments or methods of care or as a statement of the standard of care. It is not intended to substitute for the independent professional judgment of the treating clinician. Variations in practice may be warranted when, in the reasonable judgment of the treating clinician, such course of action is indicated by the condition of the patient, limitations of available resources, or advances in knowledge or technology. The American College of Obstetricians and Gynecologists reviews its publications regularly; however, its publications may not reflect the most recent evidence. Any updates to this document can be found on acog.org/clinical.
While ACOG makes every effort to present accurate and reliable information, this publication is provided “as is” without any warranty of accuracy, reliability, or otherwise, either express or implied. ACOG does not guarantee, warrant, or endorse the products or services of any firm, organization, or person. Neither ACOG nor its officers, directors, members, employees, or agents will be liable for any loss, damage, or claim with respect to any liabilities, including direct, special, indirect, or consequential damages, incurred in connection with this publication or reliance on the information presented.
Publications of the American College of Obstetricians and Gynecologists are protected by copyright and all rights are reserved. The College’s publications may not be reproduced in any form or by any means without written permission from the copyright owner.
The American College of Obstetricians and Gynecologists (ACOG) is the nation’s leading group of physicians providing evidence-based obstetric and gynecologic care. As a private, voluntary, nonprofit membership organization of more than 60,000 members, ACOG strongly advocates for equitable, exceptional, and respectful care for all women and people in need of obstetric and gynecologic care; maintains the highest standards of clinical practice and continuing education of its members; promotes patient education; and increases awareness among its members and the public of the changing issues facing patients and their families and communities. acog.org
