Loratadine Safety in Pregnancy
Loratadine is safe to use during pregnancy and is one of the preferred second-generation antihistamines for pregnant women requiring allergy treatment.
Recommended Antihistamine Choice
Loratadine and cetirizine are the preferred second-generation antihistamines during pregnancy because they have been most extensively studied and have well-established safety profiles 1, 2. Among the available options, loratadine has particularly robust safety data with over 2,000 first-trimester exposures documented 3.
Safety Evidence
The safety profile of loratadine in pregnancy is reassuring across multiple studies:
No increased risk of major congenital malformations: Large prospective studies involving 2,147 women exposed to loratadine showed no increase in major birth defects compared to unexposed controls 3. Specific controlled studies found malformation rates of 2.3% in loratadine-exposed pregnancies versus 3.0% in controls, which was not statistically different 4.
First trimester exposure is safe: Among women exposed specifically during the first trimester (the critical period for organogenesis), the malformation rate was only 0.8% compared to 3.0% in controls 4. A multicenter study of 161 first-trimester exposures confirmed no increased risk 5.
No adverse pregnancy outcomes: Loratadine use is not associated with increased rates of spontaneous abortion, preterm birth, small-for-gestational-age infants, or stillbirth 6, 4, 5.
Clinical Algorithm for Antihistamine Selection in Pregnancy
When antihistamine therapy is necessary during pregnancy, follow this approach:
First-line options: Choose loratadine or cetirizine as they have the most extensive safety data 1, 2, 7
Alternative if loratadine/cetirizine unavailable: First-generation antihistamines like chlorphenamine have a long safety record with 200,000 first-trimester exposures showing no teratogenic risk, though they cause more sedation 8, 3
Avoid: Hydroxyzine should be specifically avoided in early pregnancy due to animal data showing potential risks 8
Important Caveats
Avoid oral decongestants during the first trimester, as they have conflicting reports of association with congenital malformations 8, 2. Combining decongestants with other medications may further increase malformation risk 8.
Consider non-pharmacological approaches first: Saline nasal lavage and allergen avoidance should be attempted before medication when feasible 2. Intranasal corticosteroids are also considered safe and effective first-line treatments 2, 3.
FDA Labeling
The FDA label for loratadine states: "If pregnant or breast-feeding, ask a health professional before use" 9. However, this conservative labeling does not reflect the substantial body of evidence supporting its safety.
Breastfeeding Considerations
Loratadine is compatible with breastfeeding, though antihistamines may theoretically reduce milk production in some women 1.