Hydroxyzine Use During Breastfeeding
Hydroxyzine should not be given to breastfeeding mothers according to the FDA drug label, which explicitly states that "hydroxyzine should not be given to nursing mothers" due to unknown excretion into human milk 1.
FDA Guidance Takes Priority
The FDA drug label 1 provides the clearest directive: since it is not known whether hydroxyzine is excreted in human milk, and because many drugs are excreted in breast milk, the official recommendation is to avoid hydroxyzine during breastfeeding. This represents the most authoritative guidance available and should guide clinical decision-making.
Supporting Safety Concerns from Research
The FDA's cautious stance is supported by emerging safety data:
French pharmacovigilance data identified hydroxyzine as implicated in adverse drug reactions transmitted through breast milk, with the study specifically noting that hydroxyzine "may be implicated in adverse effects" despite being thought to be relatively benign 2.
Neonatal withdrawal syndrome has been documented in at least one case where maternal hydroxyzine use (150 mg/day) resulted in neonatal seizures, with hydroxyzine plasma concentrations confirmed in both mother and infant 3. This demonstrates that hydroxyzine does cross into breast milk in clinically significant amounts.
Long-term neurodevelopmental concerns have been raised in pediatric populations, with one study showing associations between hydroxyzine exposure and increased rates of tics, anxiety, and conduct disturbances 4, though this was in directly exposed children rather than breastfed infants.
Contradictory Evidence
One older review article 5 from 2010 states that "all antihistamines are considered safe to use during breastfeeding, as minimal amounts are excreted in the breast milk." However, this general statement lacks specific data on hydroxyzine and predates the more recent safety concerns documented in the French pharmacovigilance database 2 and the neonatal withdrawal case 3.
Clinical Recommendation
Given the FDA contraindication, documented adverse events, and lack of safety data, hydroxyzine should be avoided in breastfeeding mothers. Alternative antihistamines with better-established safety profiles during lactation should be considered instead. If antihistamine therapy is essential, consult specialized lactation pharmacology resources (LactMed) for safer alternatives with documented compatibility with breastfeeding.
Key Pitfalls to Avoid
- Do not assume hydroxyzine is safe simply because other antihistamines may be compatible with breastfeeding
- Do not rely on older general statements about antihistamine safety that lack drug-specific data
- Be aware that even if small amounts transfer to milk, neonatal withdrawal syndromes can occur with chronic maternal use