Is Cetirizine Safe for Pregnant Women?
Yes, cetirizine is considered safe during pregnancy and is one of the preferred antihistamine choices, particularly when antihistamine therapy is necessary for allergic conditions. 1, 2
Guideline Recommendations
Cetirizine is specifically recommended as a preferred second-generation antihistamine for pregnancy based on extensive safety data from large birth registries, case-control studies, and cohort studies that confirm no significant increase in congenital malformations when used during the first trimester. 2
Key Safety Evidence
Cetirizine and loratadine are classified as FDA Pregnancy Category B drugs, meaning there is no evidence of harm to the fetus during pregnancy, though well-controlled studies in humans are not available to exclude all harmful effects. 1
Multiple guidelines from major respiratory and allergy societies recommend cetirizine or loratadine as preferred options when antihistamine therapy is needed during pregnancy, as they have been most extensively used and studied. 1
The American College of Obstetricians and Gynecologists recommends cetirizine as a preferred second-generation antihistamine with benefits of symptom control outweighing theoretical risks, particularly for moderate to severe allergic rhinitis. 2
Clinical Research Supporting Safety
The largest prospective observational cohort study (n=196 first-trimester exposures) found no increased risk of major birth defects (OR 1.07; CI 0.21-3.59), spontaneous abortions (OR 0.97; CI 0.54-1.65), or preterm deliveries (OR 0.76; CI 0.35-1.5) compared to controls. 3
An earlier prospective controlled study of 120 women exposed to cetirizine during pregnancy found no significant differences in rates of live births, spontaneous or therapeutic abortion, stillbirth, major or minor anomalies, birth weight, or neonatal distress compared to controls. 4
Analysis of the UCB Pharma Patient Safety Database (228 pregnancies with outcomes) showed 83.7% resulted in live births with only 2 congenital malformations reported among 41 live births, consistent with background rates. 5
Practical Clinical Approach
When antihistamine therapy is necessary during pregnancy, cetirizine should be chosen over first-generation antihistamines due to its superior safety profile and lack of sedative and anticholinergic properties that characterize older agents. 6, 7
Treatment Algorithm
Start with non-pharmacologic measures first (saline nasal rinses) before adding cetirizine if symptoms are mild. 2
For moderate to severe allergic symptoms, cetirizine can be initiated at standard doses without waiting for non-pharmacologic measures to fail. 2
For more severe symptoms, combine cetirizine with intranasal corticosteroids (particularly budesonide), as both have strong safety data in pregnancy. 2
Important Caveats
While the FDA drug label states to "ask a health professional before use" during pregnancy, this conservative labeling does not reflect the substantial body of evidence supporting cetirizine's safety. 8
Avoid first-generation antihistamines like diphenhydramine due to lingering concerns about cleft palate association, despite chlorphenamine being historically chosen in the UK for its long safety record. 1, 2
The first trimester is the most critical period for medication-related concerns, but cetirizine's safety data specifically includes extensive first-trimester exposure without increased malformation risk. 2, 3