Cetirizine Hydrochloride Safety in Pregnancy
Cetirizine is safe to use during pregnancy and is recommended as a preferred second-generation antihistamine based on extensive safety data from large registries and cohort studies showing no increased risk of congenital malformations. 1
Primary Recommendation
The American College of Obstetricians and Gynecologists recommends cetirizine as a preferred second-generation antihistamine for use during pregnancy, with benefits of symptom control outweighing theoretical risks, particularly for moderate to severe allergic rhinitis. 1
- Cetirizine is classified as FDA Pregnancy Category B, meaning no evidence of harm to the fetus exists, though well-controlled human studies are not available to exclude all harmful effects. 1
- Large birth registries, case-control studies, and cohort studies confirm the safety of cetirizine during the first trimester. 1
- The first trimester is the most critical period for medication-related congenital malformations, yet cetirizine has demonstrated safety even during organogenesis. 1
Supporting Safety Evidence
Multiple prospective studies demonstrate cetirizine's safety profile:
- A prospective controlled study of 39 women exposed to cetirizine during organogenesis 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. 2
- A Berlin teratology center cohort study of 196 first-trimester cetirizine exposures showed 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). 3
- UCB Pharma's safety database analysis of 228 pregnancies with cetirizine exposure reported 83.7% live births with only 2 congenital malformations among 41 live births, consistent with background rates. 4
- A meta-analysis confirmed cetirizine is not associated with increased teratogenic risk. 5
Clinical Algorithm for Use
When managing allergic symptoms in pregnancy, follow this approach:
Start with non-pharmacologic measures first: Use saline nasal rinses before adding cetirizine, as these have no fetal risk. 1
Add cetirizine when symptoms persist: Use standard dosing when benefits of symptom control outweigh theoretical risks. 1
For severe symptoms: Combine cetirizine with intranasal corticosteroids, particularly budesonide, which has strong safety data. 1
Timing considerations: Cetirizine can be used throughout pregnancy, including the first trimester when organogenesis occurs. 1, 2, 3
Comparison to Alternative Antihistamines
Cetirizine and loratadine are the most well-studied second-generation antihistamines in pregnancy, making them preferable to newer agents with limited pregnancy data. 1
- Avoid first-generation antihistamines like diphenhydramine due to lingering concerns about cleft palate association, plus sedative and anticholinergic properties. 1
- Avoid levocetirizine as a first choice due to limited pregnancy data, despite being cetirizine's active enantiomer. 1
- Second-generation antihistamines in general do not show significant increases in congenital malformations when used during the first trimester. 1
Important Caveats
The FDA drug label states to "ask a health professional before use" if pregnant, which reflects regulatory caution rather than evidence of harm. 6
- This conservative labeling does not reflect the extensive post-marketing safety data demonstrating cetirizine's safety profile. 2, 4, 3, 5
- No antihistamine has been categorized as definitively "safe" during pregnancy by regulatory standards, but cetirizine has the most robust safety evidence among second-generation agents. 7
- Every medication carries theoretical teratogenic risk, but cetirizine's risk/benefit profile strongly favors use when clinically indicated. 7
What to Avoid
Do not use oral decongestants during the first trimester due to conflicting reports of associations with gastroschisis and small intestinal atresia. 1