Is hydroxyzine safe for breastfeeding mothers?

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Last updated: August 13, 2025View editorial policy

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Hydroxyzine Safety During Breastfeeding

Hydroxyzine should not be given to breastfeeding mothers as stated in the FDA drug label. 1

Evidence Assessment

The FDA drug label explicitly states that hydroxyzine should not be given to nursing mothers because it is unknown whether the drug is excreted in human milk, and since many drugs are excreted this way, caution dictates avoiding its use during breastfeeding 1. This represents the strongest and most direct guidance available on this specific medication.

Clinical Considerations

Pharmacokinetic Concerns

  • Hydroxyzine is an antihistamine with sedative properties
  • The medication likely passes into breast milk due to its properties, though specific studies on hydroxyzine levels in breast milk are limited
  • Sedating antihistamines generally pose concerns for breastfed infants, particularly:
    • Risk of sedation in the infant
    • Potential for decreased milk production
    • Risk of central nervous system effects

Risk Factors to Consider

  • Infant age: Infants less than 6 weeks of age require extra caution with medications 2
  • Premature or compromised infants may be at higher risk for adverse effects
  • Frequency of breastfeeding and volume of milk consumed

Alternative Options

If antihistamine therapy is needed for a breastfeeding mother, consider:

  1. Non-sedating antihistamines which have better safety profiles during breastfeeding
  2. Topical treatments when possible to minimize systemic exposure 3
  3. Non-pharmacological approaches for anxiety or allergic symptoms

Monitoring Recommendations

If hydroxyzine must be used despite recommendations against it (in exceptional circumstances):

  • Use the lowest effective dose
  • Time administration to minimize infant exposure (immediately after breastfeeding)
  • Monitor the infant for:
    • Excessive sedation
    • Poor feeding
    • Decreased alertness
    • Changes in sleep patterns

Importance of Breastfeeding Considerations

While medication safety is paramount, it's important to note that the benefits of breastfeeding are substantial 4. However, in this specific case, the FDA guidance against hydroxyzine use during breastfeeding is clear 1. The risk assessment should consider both the potential risks of the medication to the infant and the benefits of continued breastfeeding 5.

Key Takeaway

Based on the FDA drug label, hydroxyzine should be avoided during breastfeeding. Alternative medications with established safety profiles in lactation should be selected when treatment is necessary for the mother.

References

Guideline

Breastfeeding and Medication Use

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Research

Medications in the breast-feeding mother.

American family physician, 2001

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

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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