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/.
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OTIS/MotherToBaby encourages inclusive and person-centered language. While our name still contains a reference to mothers, we are updating our resources with more inclusive terms. Use of the term mother or maternal refers to a person who is pregnant. Use of the term father or paternal refers to a person who contributes sperm.
