Fexofenadine is a non-sedating antihistamine used for the symptomatic relief of allergic disorders. Although there are very limited data on the use of fexofenadine in pregnancy, this drug is the active metabolite of terfenadine, which was previously considered the non-sedating antihistamine of choice in pregnancy prior to its withdrawal in the UK in the late 1990s (due to non-pregnancy-related adverse effects).
There are insufficient data to determine the risks of adverse pregnancy outcome following use of fexofenadine or terfenadine in pregnancy. The limited published data that are available do not suggest an increased risk of spontaneous abortion, intrauterine death or preterm delivery after maternal exposure. Neither has an increased risk of having an infant with a congenital malformation, low birth weight, neonatal problems or neurodevelopment delay up to one year of age been found following in utero exposure to either fexofenadine and/or terfenadine in pregnancy. The available evidence is, however, very limited.
Due to the limited data, use of fexofenadine should be reserved for cases where no other suitable treatment is available and both prescriber and patient should take into account the relative lack of experience of use in pregnancy.
Exposure to fexofenadine at any stage in pregnancy would not usually be regarded as medical grounds for 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.