Are oral decongestants, such as pseudoephedrine (PSE) and phenylephrine (PE), safe for use in pregnant women, particularly those in the first trimester?

Oral Decongestants in Pregnancy: Safety Recommendations

Oral decongestants, including pseudoephedrine and phenylephrine, should be avoided during pregnancy, particularly in the first trimester, due to associations with congenital malformations and lack of adequate safety data. 1, 2, 3

Evidence Against Oral Decongestant Use

First Trimester Risks

• Both pseudoephedrine and phenylephrine have conflicting reports of associations with congenital malformations, including gastroschisis and small intestinal atresia, when used in the first trimester. 4, 1, 2
• Animal studies of phenylephrine showed decreased fetal body weights at 0.4 times the human daily dose and increased incidence of agenesis of the intermediate lobe of the lung at doses as low as 0.08 times the human daily dose. 3
• Expert panels specifically recommend avoiding oral decongestants due to increased risk of fetal gastroschisis and contribution to maternal hypertension. 1, 5

Concerns Throughout Pregnancy

• The American College of Allergy, Asthma, and Immunology recommends caution with decongestants throughout all trimesters due to reported fetal heart rate changes with their administration. 1
• Oral decongestants can exacerbate maternal hypertension, adding additional risk to both mother and fetus. 1, 5

Safer Alternative Approaches

First-Line Treatment

• Saline nasal rinses are the safest first-line treatment for nasal congestion during pregnancy and should be used before considering any pharmacologic intervention. 1, 5
• Saline nasal irrigation has proven safety with no fetal risk and can be used at any gestational age. 1, 5

Second-Line Pharmacologic Treatment

• If saline rinses provide inadequate relief, intranasal corticosteroid sprays (budesonide, fluticasone, or mometasone) are safe and effective for maintenance therapy at recommended doses throughout pregnancy, including the first trimester. 4, 1, 5, 2
• Modern intranasal corticosteroids have negligible systemic absorption and extensive safety data showing no increased risk of major malformations, preterm delivery, low birth weight, or pregnancy-induced hypertension. 1, 5
• Budesonide remains the agent with the preponderance of safety data and is category B in pregnancy. 4

Clinical Decision Algorithm

1. Start with saline nasal rinses for all pregnant patients with nasal congestion, regardless of trimester. 1, 5

2. Add intranasal corticosteroid spray (budesonide, fluticasone, or mometasone at standard doses) if saline alone is inadequate. 1, 5, 2

3. Avoid all oral decongestants (pseudoephedrine and phenylephrine), especially in the first trimester, but preferably throughout pregnancy. 1, 5, 2

4. Consult with the patient's obstetrician if symptoms remain severe despite intranasal corticosteroids. 4

Important Caveats

Topical Decongestants Also Problematic

• While the question focuses on oral decongestants, topical nasal decongestants (like oxymetazoline) should also be avoided, particularly in the first trimester, due to concerns about fetal heart rate changes and systemic absorption. 1, 5
• Topical decongestants can be absorbed systemically, as evidenced by cerebrovascular adverse events and documented fetal heart rate changes. 5

Risk-Benefit Consideration

• The maternal benefit of temporary nasal decongestion does not justify the potential fetal risks when safer, equally effective alternatives exist. 1
• Intranasal corticosteroids provide superior long-term efficacy compared to decongestants and have extensive safety data. 1

Common Pitfall to Avoid

• Do not assume that "sparing use" or "short-term use" of oral decongestants makes them acceptable in pregnancy—the association with congenital malformations occurs with first trimester exposure, and safer alternatives should always be used first. 1, 2, 6