Loratadine is a non-sedating antihistamine used for the symptomatic relief of allergic conditions including rhinitis (hay fever) and chronic idiopathic urticaria.
The available data do not provide evidence that loratadine use in pregnancy is associated with an increase in overall congenital malformation rate amongst exposed offspring. A single study has suggested an association between first trimester loratadine exposure and an increased risk of hypospadias in male infants, but more recent studies, which together describe the outcomes of a large number of exposed pregnancies, have failed to confirm this finding. A single study reported a possible association with transverse reduction limb defects but involved only a small number of loratadine-exposed infants, therefore this finding may reflect confounding as a result of the methodology employed. As such, the available data do not provide conclusive evidence that loratadine use in pregnancy is associated with an increased risk of any specific congenital malformation but are too limited to exclude an association.
Data regarding the risk of spontaneous abortion after exposure to loratadine are conflicting but currently do not provide strong evidence of an association. The limited published data do not suggest associations with intrauterine death, intrauterine growth restriction, preterm delivery or neonatal complications. There are no data regarding infant neurodevelopment after in utero exposure to loratadine.
Where use of a non-sedating antihistamine is required in pregnancy, and loratadine is being considered, patients should be made aware of the limitations in the available data relating to the fetal safety of gestational loratadine use. Exposure to loratadine at any stage of pregnancy would not usually be regarded as medical grounds for termination of pregnancy or any additional fetal monitoring. However, other risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.
This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to NHS health care professionals who are logged in.
If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.
If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.