Is cetirizine (antihistamine) safe to use during pregnancy?

Cetirizine Safety During Pregnancy

Cetirizine is considered safe during pregnancy, with sufficient human observational data demonstrating no increased risk of congenital malformations when used during the first trimester. 1, 2

Evidence for Cetirizine Safety

• Cetirizine is classified as an FDA Pregnancy Category B drug, indicating no evidence of harm to the fetus 3
• The American Academy of Allergy, Asthma, and Immunology recommends cetirizine as one of the preferred antihistamines during pregnancy due to its established safety profile 3
• Second-generation antihistamines, including cetirizine, have excellent safety records during pregnancy with no significant increase in congenital malformations when used during the first trimester 1, 4
• A prospective controlled study specifically examining cetirizine in pregnancy found no significant differences in pregnancy outcomes (including rates of major or minor anomalies) compared to control groups 5

Clinical Recommendations

• Cetirizine is considered a current second-generation antihistamine of choice for use during pregnancy 1
• When antihistamine treatment is necessary during pregnancy, cetirizine is among the preferred options due to its well-documented safety profile 3, 2
• In a UCB Pharma Patient Safety Database study of 228 pregnancies with maternal cetirizine exposure, the majority (83.7%) resulted in live births with only two congenital malformations reported, suggesting no association with adverse pregnancy outcomes above background rates 4

Important Considerations

• The first trimester is the most critical time for concern about potential congenital malformations due to medication exposure, as this is when organogenesis occurs 1, 3
• The FDA drug label for cetirizine recommends consulting a healthcare professional before use during pregnancy, highlighting the importance of medical supervision 6
• Benefit-risk assessment is crucial when treating pregnant women, weighing the potential benefit of symptom relief against potential risks to the fetus 3

Treatment Algorithm for Allergic Symptoms in Pregnancy

• First-line options:
  • Intranasal corticosteroids (e.g., budesonide) for nasal symptoms due to minimal systemic absorption 3, 7
  • Second-generation antihistamines: cetirizine or loratadine 1, 2
• Second-line options:
  • Sodium cromolyn nasal spray (safe but requires frequent dosing) 1, 3
  • Montelukast (Pregnancy Category B) 1

Medications to Avoid During Pregnancy

• Oral decongestants should be avoided during the first trimester due to conflicting reports of association with congenital malformations 1, 3
• Combining decongestants with acetaminophen or salicylates may increase risk of malformations 1
• Hydroxyzine should be used cautiously during the first trimester based on animal data 1, 8

Common Pitfalls

• Assuming all antihistamines have equivalent safety profiles during pregnancy 8
• Avoiding all medications during pregnancy despite evidence of safety, potentially leading to undertreated allergic symptoms that could negatively affect maternal and fetal outcomes 3, 7
• Using oral decongestants during the first trimester 1, 3