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Pseudoephedrine (e.g. Sudafed®)

Last Update: 20 Jun 2025

Welcome to our fact sheet on pseudoephedrine during pregnancy and breastfeeding or chestfeeding. This information is based on available published literature. It should not take the place of medical care and advice from your healthcare provider.

The HEALTHY PREGNANCY HUB team is collaborating with MotherToBaby to share information on this topic. The original version is available here (March 2024).

Serene, our chatbot, can also answer your questions about medications during pregnancy.

Please note that this fact sheet is based on United States information and has been adapted for Canada, with a review by our Canadian experts. Minor differences may exist between the two countries. Always consult your healthcare professional for information tailored to your situation.

1. 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®, Zephrex®, and many more. 

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/ chestfeeding talk to their healthcare providers about this medication before taking it. 

2. What does research say about the risks during pregnancy?

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 very 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 very 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. 

3. Breastfeeding​/ chestfeeding​ while taking pseudoephedrine

The drug label recommends that individuals who are breastfeeding or chestfeeding 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 human milk. In most cases, pseudoephedrine is not expected to cause side effects in the nursing 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 or chestfeeding questions. 

4. What about fathers and sperm donors?

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 a male’s fertility (ability to get a person 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 risks to a pregnancy. For more information, please see the MotherToBaby fact sheet Paternal Exposures here.

Key points

  • Pseudoephedrine is a decongestant used to relieve stuffy nose caused by colds or allergies. It is found in products like Sudafed®, Biofed®, Cenafed®, Nexafed®, and Zephrex®.
  • The American College of Obstetricians and Gynecologists (ACOG) does not recommend using pseudoephedrine in the first 3 months of pregnancy.
  • It is not known if pseudoephedrine affects fertility, miscarriage risk, or other pregnancy-related problems like preterm birth or low birth weight.
  • Most studies do not show a higher risk of birth defects, but a few studies have suggested a small increase in rare birth defects, like gastroschisis or small intestinal problems.
  • Pseudoephedrine can reduce milk supply, and small amounts pass into human milk. Most babies don’t have side effects, but a few have shown signs like irritability or trouble sleeping.
  • There are no studies about pseudoephedrine and male fertility or birth defect risks, but medications taken by the father or sperm donor are not likely to affect pregnancy.
  • Always talk to your healthcare provider before taking this medication during pregnancy or while breastfeeding or chestfeeding.

References

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Disclaimer

HEALTHY PREGNANCY HUB provides a source of information validated by health professionals; however, this information is provided for informational purposes only and should not replace professional advice. Medical standards and practices evolve as new data becomes available, so it is imperative to consult your doctor or a qualified health professional for any questions or concerns regarding your health without delay or omission. It is the responsibility of your treating physician or any other health professional, based on their independent experience and knowledge of the patient, to determine the best way to evaluate and treat you.

HEALTHY PREGNANCY HUB does not specifically recommend or endorse any test, practitioner, treatment, product, or opinion mentioned on our platform. HEALTHY PREGNANCY HUB also does not replace the individual patient assessment based on the examination by the healthcare provider of each patient and the consideration of laboratory data and other patient-specific factors.

The use of the information available on our site is at your own risk. No person involved in the creation, production, promotion, or marketing of HEALTHY PREGNANCY HUB guarantees or represents, expressly or implicitly, anything regarding the information available on the platform, which is provided “as it is”. All warranties are expressly excluded and disclaimed, including but not limited to implied warranties of merchantability or fitness for a particular purpose, as well as any warranties arising by law or otherwise in law or from trade or usage. Any statements or representations made by any other person or entity are void.

While consulting symptoms or other medical information on our platform may guide your discussions with your healthcare professional, this information should not be used to make a medical diagnosis or determine treatment. Before making changes to your supplement or medication regimen, please discuss with your medical team or contact 811 (Canada) to ensure the relevance of these changes to your individual situation.

Credits
MotherToBaby
Organization of Teratology Information Specialists (OTIS)
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Evelyne Rey
CHU Sainte-Justine
Brigitte Martin
Centre Hospitalier Universitaire Sainte-Justine
Sherif Eltonsy
University of Manitoba
Sacha Williams
McGill University
Modupe Tunde-Byass
University of Toronto
Émy Roberge
Centre hospitalier universitaire Sainte-Justine

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