Is benzonate (cough suppressant) safe to use during breastfeeding?

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Benzonatate and Breastfeeding Safety

Benzonatate should be used with caution during breastfeeding as there is insufficient data on its excretion in human milk, and the FDA drug label specifically states "It is not known whether this drug is excreted in human milk." 1

Safety Assessment

Benzonatate is a non-narcotic antitussive medication that is chemically related to para-amino-benzoic acid class anesthetic agents. When evaluating its safety during breastfeeding, several factors must be considered:

  • The FDA drug label explicitly states that caution should be exercised when benzonatate is administered to nursing women due to lack of data on excretion in breast milk 1
  • Unlike many other medications commonly used during breastfeeding, benzonatate is not specifically listed as compatible with breastfeeding in current guidelines 2, 3
  • The chemical structure of benzonatate (related to local anesthetics) raises theoretical concerns about potential transfer to breast milk

Risk Mitigation Strategies

If benzonatate must be used during breastfeeding, consider these approaches to minimize infant exposure:

  • Take medication immediately after breastfeeding to maximize clearance time before the next feeding 4
  • Use the lowest effective dose (not exceeding 200mg per dose or 600mg daily as per FDA recommendations) 1
  • Limit duration of therapy to shortest period necessary 4
  • Monitor the infant for potential adverse effects, including:
    • Unusual drowsiness
    • Poor feeding
    • Changes in breathing pattern

Alternative Cough Suppressants

Consider safer alternatives with more established safety profiles during breastfeeding:

  • Codeine is considered compatible with breastfeeding by the American Academy of Pediatrics for short-term use as a cough suppressant 4
  • Non-pharmacological approaches should be first-line:
    • Adequate hydration
    • Honey (if infant is older than 12 months)
    • Humidification

Important Precautions

  • Benzonatate capsules must be swallowed whole - never broken, chewed, dissolved, cut or crushed 1
  • Keep medication out of reach of children, as accidental ingestion has resulted in death 1
  • Signs of toxicity can appear within 15-20 minutes of ingestion 1

Clinical Decision-Making

When deciding whether to use benzonatate during breastfeeding:

  1. Assess severity of cough and need for pharmacological intervention
  2. Consider safer alternatives first (codeine for short-term use)
  3. If benzonatate is deemed necessary, implement risk mitigation strategies
  4. Monitor infant closely for any adverse effects
  5. Discontinue if any concerning symptoms develop in the infant

While many medications are compatible with breastfeeding, the lack of specific data on benzonatate and the FDA's explicit caution statement warrant a conservative approach when considering its use in breastfeeding women.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Guideline

Breastfeeding and Medication Use

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Research

Use of cough and cold preparations during breastfeeding.

Journal of human lactation : official journal of International Lactation Consultant Association, 1999

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.

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