Pseudoephedrine (Sudafed) In Pregnancy: Is It Safe?

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Pseudoephedrine is an over-the-counter (OTC) medication used for symptomatic relief from sinus congestion and pressure and nasal congestion arising from upper airway allergies, hay fever, or the common cold sinus congestion. You should consult a doctor before taking pseudoephedrine in pregnancy. It is sold under the brand name Sudafed and is available in pharmacies without a prescription, and may also be included as one of the ingredients of OTC nasal decongestants. Read on as we tell you whether or not pseudoephedrine is safe during pregnancy, its possible risks, and side effects (1) (2).

In This Article

Is It Safe To Take Pseudoephedrine During Pregnancy?

Pseudoephedrine is classified as a pregnancy category B drug by the US Food and Drug Administration (USFDA). It means animal studies showed no risk to the fetus but there are no well-controlled studies on pregnant women.

  • A cover article titled “Over-the-Counter Medications in Pregnancy,” says that the use of pseudoephedrine during the first trimester may be associated with gastroschisis, a condition where elevated blood pressure causes vasoconstrictioniXNarrowing of blood vessels impacting the blood circulation. in the uterine arteries and affects the blood flow to the fetus. This theory is debatable as some evidence suggests that the effect is negligible at typical doses (3).
  • Studies using pharmaceutical data stated that the use of decongestant in the first trimester is associated with a small increase in the risk of defects such as gastroschisis, small intestinal atresiaiXA condition causing the partial or complete blockage of intestinal passages. , and hemifacial microsomiaiXA congenital condition where a part on one side of the face is underdeveloped. . However, these findings are inconsistent in magnitude, and the results could be influenced by the exposure to vasoconstrictive agents such as cigarette smoking (4).

Your doctor might prefer other safer prescription drug choices such as chlorpheniramine and tripelennamine (3). So, always consult your doctor before taking pseudoephedrine during pregnancy.

Gynecologist and laparoscopic surgeon Dr. Swati Chitnis says, “Levocetirizine and fexofenadine are alternatives to pseudoephedrine for pregnant women since they are not associated with increased risk of congenital abnormalities.”

Lag Liv, a mother of three, recalls how everyone advised her against taking any medications during pregnancy to alleviate her cold symptoms. Nonetheless, she followed medical guidance. She mentions, “I called my midwife this morning, and she approved Sudafed and Robitussin. I trust her and the practice and am elated to have some helpful drugs in my system (i).”

protip_icon Caution
Pseudoephedrine may not be suitable for women with hyperthyroidism, diabetes, liver problems, kidney problems, and heart diseases (12).

What Are The Possible Risks Of Taking Pseudoephedrine During Pregnancy?

Use of pseudoephedrine is also associated risks such as rise in blood pressure

Image: Shutterstock

In addition to the probable risk of gastroschisis (when used during the first trimester), the use of pseudoephedrine is associated with other perinatal health risks such as a raise in blood pressure due to its vasoconstricting property. Hence women with high blood pressure should take the medication only when prescribed by a doctor and not opt for self-medication (5).

Do not take pseudoephedrine within two weeks of taking monoamine oxidase inhibitor (MAO Inhibitor) antidepressants such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, etc., to avoid a possible drug interactions (6).

What Is The Recommended Dosage Of Pseudoephedrine During Pregnancy?

You should follow the dosage prescribed by your doctor.

Image: Shutterstock

The recommended doses of 30-60 mg of pseudoephedrine every 4-6 hours in the second and third trimesters could be used for pregnant women who do not have hypertension (7). However, your dosage might be different from the recommended dosage.Therefore, you should follow the dosage and the medication safety prescribed by your doctor.

What Are The Side Effects Of Pseudoephedrine During Pregnancy?

Decongestants might have the following side effects (8):

  • Drowsiness or sleepiness
  • Irritation in the lining of the nose
Side effects of oseudoephedrine in pregnancy

Image: Shutterstock

protip_icon Quick fact
Pseudoephedrine may also cause jitters and rapid heartbeats (5).

Frequently Asked Questions

1. Does pseudoephedrine cross the placenta?

It is not well documented whether pseudoephedrine crosses the placenta, but one study reported an alteration in fetal heart rate after its maternal use in pregnancy (9).

2. What kind of cold medicine is safe during pregnancy?

Certain OTC decongestants, such as chlorpheniramine and diphenhydramine (Benadryl) are safe to take when pregnant. Nonetheless, these medications also have a few side effects. It is, therefore, advisable to consult a doctor before taking any cold medications during pregnancy (10).

3. Is pseudoephedrine a teratogen?

According to a study published in the American Journal of Obstetrics and Gynecology (AJOG), no teratogenic effectiXA property of a substance capable of causing fetal abnormalities during pregnancy. was reported due to the use of oral decongestants during pregnancy (11). However, more large group studies are required to confirm this theory.

The safety of pseudoephedrine in pregnancy for nasal congestion is debatable. Although animal studies classify it as a category B drug, other studies indicate certain side effects in humans. Given the drug does not require any prescription, you may be tempted to opt for it to find relief from nasal congestion during pregnancy. However, since there is a possibility of side effects such as increased blood pressure and even hampering fetal health, it is advisable to consult your Ob/GYN. Ensure not to exceed the recommended dosage and ask your doctor about any safer alternatives to ease your discomfort and manage the condition.

This post is for informational purposes only and is not a replacement for a doctor’s consultation. Do not use any medication without talking to your doctor.

Infographic: Side Effects Of Pseudoephedrine During Pregnancy

While pseudoephedrine is an effective OTC decongestant, you must take caution when taking this medication during pregnancy. Although the potential side effects of pseudoephedrine may not harm the baby, it can cause discomfort and put the pregnant woman at risk of injury. See the infographic below to learn more about the potential side effects of this drug.

possible side effects of taking pseudoephedrine when pregnant (infographic)

Illustration: Momjunction Design Team

Get high-quality PDF version by clicking below.

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Key Pointers

  • Pseudoephedrine is a pregnancy category B drug with limited research conducted on its effects on pregnant women.
  • Risks of using pseudoephedrine during pregnancy include high blood pressure and gastroschisis.
  • A doctor should be consulted for safe use during pregnancy and their prescribed dosages should be followed by the woman.
  • Possible side effects of pseudoephedrine during pregnancy include drowsiness, nose irritation, headache, dry mouth, and restlessness.

Personal Experience: Source


MomJunction's articles are written after analyzing the research works of expert authors and institutions. Our references consist of resources established by authorities in their respective fields. You can learn more about the authenticity of the information we present in our editorial policy.

1. Sudafed- pseudoephedrine hydrochloride tablet; dailymed
2. Legal Requirements for the Sale and Purchase of Drug Products Containing Pseudoephedrine, Ephedrine, and Phenylpropanolamine; FDA
3. Ronald A. Black, M.D, and D. Ashley Hill, M.D; Over-the-Counter Medications in Pregnancy; American Association of Family Physicians
4. Martha M. Werler; Teratogen update: Pseudoephedrine; Wiley online Library
5. Robyn Horsager-Boehere, M.D; Which over-the-counter cold medications are safe during pregnancy?; UT Southwestern Medical Center
6. Health Information- codeine, guaifenesin, and pseudoephedrine; School of Medicine and Public Health- University of Wisconsin- Madison
7. Safe Medications for Pregnancy and Lactation; Atlanta Gynecology and Obstetrics
8. Wai-Ping Yau et al., Use of Decongestants During Pregnancy and the Risk of Birth Defects; American Journal of Epidemiology.
9. Decongestant; National Health Services
10. Which over-the-counter cold medications are safe during pregnancy?; The University of Texas Southwestern Medical Center.
11. Bengt A.J. Kallen and Petra Otterblad Olausson;Use of oral decongestants during pregnancy and delivery outcome; American Journal of Obstetrics and Gynecology (AJOG).
12. Pseudoephedrine (including Sudafed); NHS

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