What FDA-evaluated cough medications are safe for pregnant women?

Medical Advisory BoardAll articles are reviewed for accuracy by our Medical Advisory Board
Educational purpose only • Exercise caution as content is pending human review
Article Review Status
Submitted
Under Review
Approved

Last updated: February 8, 2025View editorial policy

Personalize

Help us tailor your experience

Which best describes you? Your choice helps us use language that's most understandable for you.

From the Guidelines

Pregnant women can safely use FDA-evaluated cough medications such as salbutamol, terbutaline, and theophylline, which are classified as category A or B.

FDA- Evaluated Cough Medications

  • Salbutamol is a short-acting β2-agonist (SABA) that is considered compatible during pregnancy, with no evidence of teratogenic effects 1.
  • Terbutaline is also a SABA that is considered probably safe during pregnancy, although it may cause maternal and fetal tachycardia, maternal hyperglycemia, and neonatal hypoglycemia 1.
  • Theophylline is a methylxanthine that is considered compatible during pregnancy, with no evidence of teratogenic effects, but blood levels should be monitored 1.

Considerations for Use

When using these medications during pregnancy, it is essential to weigh the benefits and risks, considering the potential for maternal and fetal adverse effects.

  • Intranasal corticosteroids, such as budesonide, may also be used during pregnancy due to their safety and efficacy profile, although most are given an FDA Pregnancy Category C rating 1.
  • Montelukast is a Pregnancy Category B drug that may be considered if there has been a favorable pre-pregnancy response, although animal reproductive studies and unpublished human safety data are reassuring 1. It is crucial to use these medications at the lowest effective dose and to monitor for potential adverse effects. Additionally, breastfeeding women should be cautious when using these medications, as some may pass into breast milk.

From the Research

FDA-Evaluated Cough Medications for Pregnant Women

There are several FDA-evaluated cough medications that are considered safe for pregnant women, including:

  • Acetaminophen, which has a good safety record 2
  • Chlorpheniramine, an antihistamine that is commonly used to relieve cough and cold symptoms 2
  • Dextromethorphan, a cough suppressant that is often used in combination with other medications 3
  • Guaifenesin, an expectorant that helps to thin and loosen mucus, making it easier to cough up 3

Safety Categories for Medications

The FDA has assigned a risk category to each medication, including:

  • Category A: Controlled studies show no risk or controlled studies suggest no increased risk of congenital anomalies or other adverse pregnancy outcomes
  • Category B: The use of the drug in pregnant women is not suspected to cause significant harm, but there are no controlled data in human pregnancy 4
  • Category C: Risk cannot be ruled out, but there are no controlled data in human pregnancy 4

Precautions and Considerations

Pregnant women should always consult with their healthcare provider before taking any medication, including over-the-counter cough medications, to discuss the potential risks and benefits 5, 3, 2, 4. Additionally, women should be aware of the potential risks associated with certain medications, such as birth defects or other adverse pregnancy outcomes 3, 2.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

An overview of over the counter drugs in pregnancy and lactation.

Kathmandu University medical journal (KUMJ), 2006

Research

Safety of Over-the-Counter Medications in Pregnancy.

MCN. The American journal of maternal child nursing, 2019

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

Have a follow-up question?

Our Medical A.I. is used by practicing medical doctors at top research institutions around the world. Ask any follow up question and get world-class guideline-backed answers instantly.