Hydroxyzine While Breastfeeding
Hydroxyzine should not be given to nursing mothers according to the FDA drug label, as it is unknown whether the drug is excreted in human milk 1. This represents the most authoritative guidance available and should be followed in clinical practice.
FDA Labeling Guidance
The FDA explicitly states that hydroxyzine should not be given to nursing mothers because excretion into human milk is unknown 1. When data on milk excretion are lacking for a medication, the standard of care is to avoid use during lactation unless the benefits clearly outweigh unknown risks to the infant.
Clinical Reasoning
The lack of data on hydroxyzine excretion into breast milk is a critical gap. While general pharmacokinetic principles suggest that:
- Hydroxyzine is lipophilic and could potentially transfer into breast milk
- First-generation antihistamines like hydroxyzine have sedating properties that could affect infants
- The drug has antimuscarinic effects, though recent evidence suggests these are less pronounced than with diphenhydramine 2
Without specific data on milk concentrations or infant exposure, the risk-benefit calculation cannot be made with confidence.
Alternative Approaches
If antihistamine therapy is needed in a breastfeeding mother:
- Consider non-sedating second-generation antihistamines with better-established safety profiles during lactation
- For sedation/anxiety: Shorter-acting benzodiazepines like midazolam have documented low transfer to breast milk and can be used with appropriate monitoring 3, 4
- For pruritus: Topical therapies should be maximized first
If Hydroxyzine Use Is Unavoidable
Should clinical circumstances absolutely require hydroxyzine use despite FDA guidance:
- Use the lowest effective dose for the shortest duration possible
- Monitor the infant closely for:
- Excessive drowsiness or sedation
- Poor feeding
- Respiratory depression
- Irritability or paradoxical excitation
- Consider timing doses immediately after breastfeeding to minimize infant exposure at peak milk concentrations
- Have the mother observe for any behavioral changes in the infant and report immediately
Critical Caveats
- The FDA contraindication is based on lack of data, not proven harm, but this uncertainty itself warrants caution
- Neonates and young infants (especially <6 weeks corrected age) have immature drug clearance mechanisms and are at highest risk for adverse effects from any medication exposure 3
- A single case report exists of neonatal withdrawal syndrome with high-dose maternal hydroxyzine use during pregnancy (600 mg daily), suggesting potential for infant effects 5
The safest recommendation is to avoid hydroxyzine during breastfeeding and select alternative agents with established safety data 1.