Hydroxyzine Use During Breastfeeding for Urticaria
Hydroxyzine should not be given to breastfeeding mothers, as the FDA drug label explicitly states it should not be used during lactation due to unknown excretion into human milk. 1
Primary Recommendation
The FDA drug label for hydroxyzine clearly indicates that "since many drugs are excreted [in human milk], hydroxyzine should not be given to nursing mothers." 1 This is the definitive guidance that must be followed, as it represents the official regulatory position prioritizing infant safety when data are insufficient.
Alternative Treatment Approach
For a breastfeeding woman with new-onset urticaria, use second-generation non-sedating antihistamines as first-line therapy instead of hydroxyzine. 2
Recommended Antihistamines for Breastfeeding Women:
Cetirizine is the preferred choice, as it has been studied in breastfeeding with a relative infant dose of only 1.77% at 24 hours, well below the 10% safety threshold, with no reported adverse effects in infants 3
Loratadine is another safe option, as all antihistamines are considered safe during breastfeeding with minimal amounts excreted in breast milk 4
Other second-generation options include desloratadine, fexofenadine, and levocetirizine 2
Treatment Algorithm for Urticaria in Breastfeeding Women:
Start with cetirizine 10 mg daily as first-line therapy 2, 3
If inadequate response after 2-4 weeks, increase the dose up to 4 times the standard dose (cetirizine 40 mg daily) 2
Try at least two different non-sedating antihistamines before escalating therapy, as individual responses vary 2
Identify and avoid triggers including overheating, stress, alcohol, tight clothing, NSAIDs, and aspirin 2
Why Hydroxyzine Should Be Avoided:
Lack of safety data: The FDA explicitly states it is unknown whether hydroxyzine is excreted in human milk 1
Not first-line therapy: Guidelines recommend against hydroxyzine as first-line treatment due to sedating properties and contraindication in early pregnancy 5
No added benefit: Research shows that adding hydroxyzine at night to a non-sedating antihistamine increases daytime somnolence without improving treatment efficacy compared to higher-dose non-sedating antihistamines alone 6
Sedation risks: Hydroxyzine causes significant sedative effects that impair driving ability, work performance, and cognitive function, with drivers in fatal accidents being 1.5 times more likely to be taking first-generation antihistamines 7
Common Pitfall to Avoid:
Do not follow the outdated practice of combining a daytime non-sedating antihistamine with nighttime hydroxyzine in breastfeeding women. This approach is contraindicated by the FDA drug label 1, and research demonstrates it provides no therapeutic advantage while increasing daytime somnolence 6. Instead, escalate the dose of the non-sedating antihistamine up to 4-fold if needed 2.
Special Considerations:
Dose adjustment in renal impairment: Halve the cetirizine dose if moderate renal impairment is present 5
Short-course corticosteroids: Consider prednisolone for severe acute urticaria unresponsive to antihistamines, though this should be brief 5
Emergency management: Administer epinephrine 0.5 mL of 1:1000 intramuscularly if urticaria is accompanied by difficulty breathing, throat swelling, or anaphylaxis 5