Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2010 Jan;115(1):109-115.
doi: 10.1097/AOG.0b013e3181c52616.

Acetaminophen use in pregnancy and risk of birth defects: findings from the National Birth Defects Prevention Study

Marcia L Feldkamp  1 , Robert E Meyer, Sergey Krikov, Lorenzo D Botto
Affiliations

Acetaminophen use in pregnancy and risk of birth defects: findings from the National Birth Defects Prevention Study

Marcia L Feldkamp et al. Obstet Gynecol. 2010 Jan.

Abstract

Objective: To investigate whether exposure during the first trimester of pregnancy to single-ingredient acetaminophen increases the risk of major birth defects.

Methods: Data from the National Birth Defects Prevention Study, a population-based, case-control study, were used. Women who delivered between January 1, 1997, and December 31, 2004, and participated in the telephone interview were included. Type and timing of acetaminophen use were assigned based on maternal report. Women reporting first-trimester acetaminophen use in a combination product were excluded, resulting in a total of 11,610 children in the case group and 4,500 children in the control group for analysis.

Results: The prevalence of first-trimester single-ingredient-acetaminophen use was common: 46.9% (n=5,440) among women in the case group and 45.8% (n=2,059) among women in the control group (P=.21). Overall, acetaminophen was not associated with an increased risk of any birth defect. Among women reporting a first-trimester infection and fever, use of acetaminophen was associated with a statistically significantly decreased odds ratio (OR) for anencephaly or craniorachischisis (adjusted OR 0.35, 95% confidence interval [CI] 0.08-0.80), encephalocele (adjusted OR 0.17, 95% CI 0.03-0.87), anotia or microtia (adjusted OR 0.25, 95% CI 0.07-0.86), cleft lip with or without cleft palate (adjusted OR 0.44, 95% CI 0.26-0.75), and gastroschisis (adjusted OR 0.41, 95% CI 0.18-0.94).

Conclusion: Single-ingredient-acetaminophen use during the first trimester does not appear to increase the risk of major birth defects. It may decrease the risk of selected malformations when used for a febrile illness.

Level of evidence: II.

PubMed Disclaimer

References

    1. Rayburn W, Shukla U, Stetson P, Piehl E. Acetaminophen pharmacokinetics: comparison between pregnant and nonpregnant women. Am J Obstet Gynecol 1986;155:1353–6.
    1. Nies AS, Spielberg SP. Principles of therapeutics. In: Hardman JG, Limbird LE, Molinoff PB, Ruddon RW, editors. Goodman & Gilman: the pharmacological basis of therapeutics. New York (NY): McGraw Hill; 1996. p. 43–62.
    1. Thulstrup AM, Sørensen HT, Nielsen GL, Andersen L, Barrett D, Vilstrup H, et al. Fetal growth and adverse birth outcomes in women receiving prescriptions for acetaminophen during pregnancy. EuroMap Study Group. Am J Perinatol 1999;16:321–6.
    1. Aselton P, Jick H, Milunsky A, Hunter JR, Stergachis A. First-trimester drug use and congenital disorders. Obstet Gynecol 1985;65:451–5.
    1. Werler MM, Mitchell AA, Hernandez-Diaz S, Honein MA. Use of over-the-counter medications during pregnancy. Am J Obstet Gynecol 2005;193:771–7.

Publication types

MeSH terms