This sheet is about exposure to pseudoephedrine in pregnancy and while breastfeeding. This information is based on available published literature. It should not take the place of medical care and advice from your healthcare provider.

What is pseudoephedrine?

Pseudoephedrine is a decongestant that has been used to treat nasal congestion (“stuffy nose”) caused by colds or allergies. Pseudoephedrine can be combined with other ingredients to help treat symptoms that may come with having a cold or allergies. Pseudoephedrine has been sold under many different brand names. Some brand names are Biofed^®, Cenafed^®, Sudafed^®, Nexafed^®, and Zephrex^®.

Sometimes when people find out they are pregnant, they think about changing how they take their medication, or stopping their medication altogether. However, it is important to talk with your healthcare providers before making any changes to how you take this medication. Your healthcare providers can talk with you about the benefits of treating your condition and the risks of untreated illness during pregnancy.

The American College of Obstetricians and Gynecologists (ACOG) does not recommend the use of pseudoephedrine for the first 3 months of pregnancy. The drug label recommends that people who are pregnant or breastfeeding talk to their healthcare providers about this medication before taking it.

I take pseudoephedrine. Can it make it harder for me to get pregnant?

It is not known if pseudoephedrine could make it harder to get pregnant.

Does taking pseudoephedrine increase the chance of miscarriage?

Miscarriage is common and can occur in any pregnancy for many different reasons. Studies have not been done to see if pseudoephedrine increases the chance for miscarriage.

Does taking pseudoephedrine increase the chance of birth defects?

Every pregnancy starts out with a 3-5% chance of having a birth defect. This is called the background risk. Most studies looking at the use of pseudoephedrine in pregnancy have not found an increased chance for birth defects. However, some studies have found a small increased chance for specific birth defects, such as gastroschisis (an opening in the baby’s abdominal wall), small intestinal atresia (part of the small intestine is not fully developed) and hemifacial microsomia (part of the face is smaller than usual). The risk for these birth defects, if any, is considered to be small.

Does taking pseudoephedrine in pregnancy increase the chance of other pregnancy-related problems?

It is not known if pseudoephedrine can cause other pregnancy-related problems, such as preterm delivery (birth before week 37) or low birth weight (weighing less than 5 pounds, 8 ounces [2500 grams] at birth).

Does taking pseudoephedrine in pregnancy affect future behavior or learning for the child?

Studies have not been done to see if pseudoephedrine can cause behavior or learning issues for the child.

Breastfeeding while taking pseudoephedrine:

The drug label recommends that people who are breastfeeding talk to their healthcare providers about this medication before taking it. Your healthcare provider can talk with you about using pseudoephedrine and what treatment is best for you.

At recommended doses, only a small amount of pseudoephedrine gets into breast milk. In most cases, pseudoephedrine is not expected to cause side effects in the breastfed baby. A few cases of irritability have been reported. If you suspect the child has any symptoms (irritability, trouble with sleeping, tremors, trouble with feeding, or trouble with weight gain) contact the child’s healthcare provider.

Pseudoephedrine might lower the amount of milk that your body makes. If you notice a decrease in your milk supply, talk with your healthcare provider or a lactation specialist. Be sure to talk to your healthcare provider about all your breastfeeding questions.

If a male takes pseudoephedrine, could it affect fertility or increase the chance of birth defects?

Studies have not been done to see if pseudoephedrine could affect male fertility (ability to get partner pregnant) or increase the chance of birth defects above the background risk. In general, exposures that fathers or sperm donors have are unlikely to increase the risks to a pregnancy. For more information, please see the MotherToBaby fact sheet Paternal Exposures at https://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/.

Selected References:

• Aljazaf K, et al. 2003. Pseudoephedrine: effects on milk production in women and estimation of infant exposure via breastmilk. Br J Clin Pharmacol 56(1):18-24. [PMC free article: PMC1884328] [PubMed: 12848771]
• Anastasio GD, et al. 1992. Fetal tachycardia associated with maternal use of pseudoephedrine, an over-the-counter oral decongestant. J Am Board Fam Pract 5(5):527-8. [PubMed: 1414455]
• Eglash A. 2014. Treatment of maternal hypergalactia. Breastfeed Med. 9:423-5. [PMC free article: PMC4216483] [PubMed: 25361472]
• Findlay JW, et al. 1984. Pseudoephedrine and triprolidine in plasma and breast milk of nursing mothers. Br J Clin Pharmacol 18(6):901-906. [PMC free article: PMC1463694] [PubMed: 6529531]
• Głowacka K, et al. 2021. Pseudoephedrine-Benefits and Risks. Int J Mol Sci; 22(10):5146. PMID: 34067981 PMCID: PMC8152226 DOI: 10.3390/ijms22105146 [PMC free article: PMC8152226] [PubMed: 34067981] [CrossRef]
• Heinonen OP, et al. 1977. Birth Defects and Drugs in Pregnancy. Littleton, MA: John Wright-PSG. pp 345-56.
• Ito S, et al. 1993. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol 168(5):1393-1399. [PubMed: 8498418]
• Miller RK. 1992. From the pages of Teratology: vitamin A to pseudoephedrine issues in patient counseling. Teratology 45(4):341-343. [PubMed: 1585265]
• Pseudoephedrine Drug Label. https://dailymed​.nlm​.nih.gov/dailymed/drugInfo​.cfm?setid=1056d9da-8a3f-4b7a-878e-7f8d45d298cd&audience=consumer. [Accessed 2024].
• Rosa F. 1993. Personal communication. Cited in: Briggs GG, et al. 2005. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Seventh Edition. Baltimore, MD: Williams & Wilkins.
• Schatz M, et al. 1997. Asthma and allergy in pregnancy. Clin Perinatol 24(2):407-432. [PubMed: 9209810]
• Smith CV, et al. 1990. Effect of a single dose of oral pseudoephedrine on uterine and fetal Doppler blood flow. Obstet Gynecol; 76(5 Pt 1):803-806. [PubMed: 2216228]
• Smith J, et al. 1994. Drugs of choice for pregnant women. In: Koren G. Maternal-fetal Toxicology. A Clinician’s Guide. 1994. Second Edition. New York NY: Marcel Dekker Inc.
• Soussan C, et al. 2014. Drug-induced adverse reactions via breastfeeding: a descriptive study in the French Pharmacovigilance Database. Eur J Clin Pharmacol.70:1361-6. [PubMed: 25183382]
• The American College of Obstetricians and Gynecologists (ACOG). “Ask ACOG: What medicine can I take for allergies while I'm pregnant?” https://www​.acog.org​/womens-health/experts-and-stories​/ask-acog​/what-medicine-can-i-take-for-allergies-while-im-pregnant (Retrieved: March 13, 2024).
• The American College of Obstetricians and Gynecologists (ACOG) and The American College of Allergy, Asthma and Immunology (ACAAI). The use of newer asthma and allergy medications during pregnancy. Ann Allergy Asthma Immunol. 2000 May; 84(5):475-80. PMID: 10830999. [PubMed: 10830999]
• Torfs CP, et al. 1996. Maternal medications and environmental exposures as risk factors for gastroschisis. Teratology 54(2):84-92. [PubMed: 8948544]
• Yau W-P, et al. 2013. Use of decongestants during pregnancy and the risk of birth defects. Am J Epidemiol. 178(2):198-208. [PMC free article: PMC3816336] [PubMed: 23825167]
• Werler MM, et al. 2003. Association of vasoconstrictive exposures with risks of gastroschisis and small intestinal atresia. Epidemiology 14(3):349-54. [PubMed: 12859037]
• Werler MM, et al. 1992. First trimester maternal medication use in relation to gastroschisis. Teratology 45(4):361-367. [PubMed: 1533958]
• Werler MM, et al. 2002. Maternal medication use and risks of gastroschisis and small intestinal atresia. Am J Epidemiol 155(1):26-31. [PubMed: 11772781]
• Werler MM, et al. 2004. Vasoactive exposures, vascular events, and hemifacial microsomia. Birth Defects Res A Clin Mol Teratol 70(6):389-395. [PubMed: 15211707]