Can a woman at 28 weeks gestation safely use pseudoephedrine (Sudafed) or other nasal decongestants?

Pseudoephedrine (Sudafed) and Nasal Decongestants at 28 Weeks Gestation

At 28 weeks gestation, oral pseudoephedrine (Sudafed) and other nasal decongestants should be avoided, and intranasal corticosteroids (such as budesonide, fluticasone, or mometasone) should be used instead as they are safe, effective, and do not carry the fetal cardiovascular risks associated with decongestants. 1

Why Decongestants Should Be Avoided Throughout Pregnancy

The primary concern extends beyond the first trimester. While guidelines emphasize avoiding oral decongestants during the first trimester due to associations with gastroschisis and small intestinal atresia 2, the American College of Allergy, Asthma, and Immunology recommends caution with decongestants throughout pregnancy due to documented fetal heart rate changes, particularly in pregnant women at 25 weeks gestation 1. This is directly relevant to your 28-week patient.

Specific Risks at 28 Weeks:

• Fetal heart rate changes have been documented with topical decongestant use during pregnancy, highlighting cardiovascular effects on the fetus 1
• Both oral and topical decongestants carry fetal risks through the same mechanism—the critical distinction in safety is between drug classes (corticosteroids versus decongestants), not routes of administration 1
• The safety of intranasal decongestants during pregnancy has not been adequately studied in controlled trials 1

Recommended Treatment Algorithm

First-Line Therapy:

• Saline nasal rinses are the safest first-line treatment with no fetal risk 1
• Should be used before considering any pharmacologic intervention 1

Second-Line Therapy (If Saline Inadequate):

• Intranasal corticosteroids should be added, with the following options 1:
  • Budesonide (Pregnancy Category B with extensive human safety data) 2
  • Fluticasone 1
  • Mometasone 1
• A meta-analysis confirmed these do not increase risk of major malformations, preterm delivery, low birth weight, or pregnancy-induced hypertension 1
• These provide superior long-term efficacy compared to decongestants 1

Third-Line Options:

• Sodium cromolyn nasal spray (Pregnancy Category B) is safe but requires frequent 4-times-daily dosing, limiting patient acceptance 2
• Montelukast (Pregnancy Category B) may be considered if there was a uniquely favorable prepregnancy response 2

Critical Pitfalls to Avoid

Do not assume topical decongestants are safer than oral forms—both carry fetal cardiovascular risks 1. The maternal benefit of temporary nasal decongestion does not justify potential fetal risks when safer, equally effective alternatives exist 1.

Avoid combining decongestants with other medications—the risk of malformations increases when decongestants are combined with acetaminophen or salicylates 2.

Do not use oxymetazoline or other topical decongestants for more than 3 days—this leads to rebound congestion and rhinitis medicamentosa 1.

Evidence Quality Considerations

While one older study from 1990 showed no significant alterations in uterine or fetal blood flow after a single 60-mg dose of pseudoephedrine in third-trimester patients 3, this conflicts with more recent guideline recommendations from the American College of Allergy, Asthma, and Immunology documenting fetal heart rate changes 1. The guideline evidence should take precedence, especially given that single-dose studies may not capture cumulative effects or individual patient variability.

The accumulating evidence from case-control studies supports associations between first-trimester decongestant use and specific birth defects 4, 5, and the vasoconstrictive mechanism of action raises concerns throughout pregnancy, not just during organogenesis 4.