Is cetirizine (antihistamine) safe to use during pregnancy?

Cetirizine Safety During Pregnancy

Cetirizine is safe to use during pregnancy and is recommended as a first-line antihistamine option, with extensive human data showing no increased risk of congenital malformations or adverse pregnancy outcomes. 1

Recommendation for Clinical Practice

Use cetirizine as a preferred second-generation antihistamine during pregnancy, including the first trimester, based on its FDA Pregnancy Category B classification and robust safety data. 1, 2

Evidence Supporting Safety

• Large-scale human data confirm safety: Multiple prospective studies and registry data demonstrate that cetirizine exposure during pregnancy, particularly in the first trimester when organogenesis occurs, shows no increased risk of major birth defects compared to unexposed pregnancies 3, 4, 5

• Specific outcome data are reassuring:

  • Major birth defects occurred in 4.0% of cetirizine-exposed pregnancies versus 3.8% in matched controls (OR 1.06; 95% CI 0.81-1.37), which is not statistically significant 6
  • Spontaneous abortion rates are comparable to background rates (8.4% vs 9.0% in controls) 6
  • No increased risk of preterm birth, small for gestational age, or stillbirth 6
  • In a cohort of 196 first-trimester exposures, no increase in major malformations was observed 5

• Professional society endorsement: The American Academy of Allergy, Asthma, and Immunology specifically recommends cetirizine as a preferred antiallergic medication during pregnancy due to its established safety profile 1

Clinical Algorithm for Use

First trimester (most critical period for organogenesis): 7

• Cetirizine is safe to initiate or continue 1, 8
• Prioritize cetirizine over first-generation antihistamines to avoid sedation and performance impairment 7

Second and third trimesters:

• Continue cetirizine as needed for symptom control 1
• No dose adjustments required based on pregnancy trimester 4

Important Clinical Considerations

Advantages over alternatives: 7, 1

• Superior to first-generation antihistamines (e.g., diphenhydramine) which have sedative effects and possible association with cleft palate 7
• More human pregnancy data than newer agents like desloratadine, levocetirizine, or fexofenadine, which have limited epidemiologic studies 7
• Avoid hydroxyzine in first trimester due to animal data concerns 7

Common pitfall to avoid: 9

• The FDA drug label states "ask a health professional before use" if pregnant, which may cause unnecessary concern—this is standard labeling language and does not reflect the extensive reassuring human data available 1, 4, 5

Combination therapy considerations: 1

• Cetirizine can be safely combined with intranasal corticosteroids (budesonide preferred) for more severe allergic rhinitis 1
• Avoid oral decongestants (pseudoephedrine, phenylephrine) during first trimester due to conflicting reports of gastroschisis and intestinal atresia 7, 1

Risk-Benefit Context

Untreated allergic symptoms pose their own risks: 1

• Severe untreated allergic rhinitis can negatively affect maternal and fetal outcomes 1
• The benefit-risk assessment strongly favors treatment with cetirizine when symptoms require management 1

Database and prospective study concordance: 4, 5

• UCB Pharma safety database analysis of 228 pregnancies showed 83.7% resulted in live births with only 2 congenital malformations reported 4
• Berlin teratology center prospective data on 196 first-trimester exposures confirmed no increased malformation risk 5