Fexofenadine

(Date: November 2018. Version: 3)

This factsheet has been written for members of the public by the UK Teratology Information Service (UKTIS). UKTIS is a not-for-profit organisation funded by Public Health England on behalf of UK Health Departments. UKTIS has been providing scientific information to health care providers since 1983 on the effects that medicines, recreational drugs and chemicals may have on the developing baby during pregnancy.

What is it?

Fexofenadine (Telfast®) is a non-drowsy antihistamine which is used to treat hay fever, skin allergies and other allergic symptoms.

Is it safe to take fexofenadine in pregnancy?

When deciding whether to use fexofenadine during pregnancy it is important to weigh up the potential benefits to your health and wellbeing against any possible risks to you or your baby, some of which may depend on how many weeks pregnant you are. Your doctor or specialist will be able to help you make decisions about your treatment.

What if I have already taken fexofenadine during pregnancy?

If are taking any medicines while pregnant, you can discuss this with your doctor. You can then decide together whether ongoing treatment is appropriate, and if so, your doctor will ensure that you are taking the most effective dose.

Can taking fexofenadine in pregnancy cause birth defects in the baby?

A baby’s body and most internal organs are formed during the first 12 weeks of pregnancy. It is mainly during this time that some medicines are known to cause birth defects.

There is currently no concern that exposure to fexofenadine in early pregnancy is linked to birth defects in the baby. However, relatively small numbers of women taking fexofenadine have been studied and ongoing research is required to confirm this.

Can taking fexofenadine in pregnancy cause miscarriage or stillbirth?

The likelihood of miscarriage has been studied in very few women taking fexofenadine during early pregnancy, and while there is currently no concern of problems, more research into this subject is required.

No studies have assessed the likelihood of stillbirth in women taking fexofenadine. One study investigated pregnant women taking the highly related antihistamine terfenadine and did not find a link with stillbirth. Further research into women specifically taking fexofenadine is ideally required.

Can taking fexofenadine in pregnancy cause preterm birth, or my baby to be small at birth (low birth weight)?

No studies have investigated whether preterm birth (before 37 weeks of pregnancy) or having a low birth weight baby (<2,500 g) is more common in women who took fexofenadine during pregnancy.

One study of pregnant women taking the highly related antihistamine terfenadine did not find any links with preterm birth or low birth weight in the baby. While this is reassuring, information ideally needs to be collected from women taking fexofenadine in pregnancy.

Can taking fexofenadine in pregnancy cause learning and behavioural problems in the child?

A baby’s brain develops throughout pregnancy. It is therefore possible that taking certain medicines at any stage of pregnancy could have a lasting effect on a child’s learning or behaviour.

No studies have assessed the learning and behaviour of children exposed in the womb to fexofenadine. One study assessed one-year-old children who had been exposed in the womb to the highly related antihistamine terfenadine and found no effects on their development. Ongoing studies of children exposed to fexofenadine are ideally required.

Will my baby need extra monitoring?

Most women will be offered a scan at around 20 weeks of pregnancy to look for birth defects as part of their routine antenatal care. Taking fexofenadine in pregnancy would not normally require extra monitoring of your baby.

Are there any risks to my baby if the father has taken fexofenadine?

We would not expect any increased risk to your baby if the father took fexofenadine before or around the time you became pregnant.

Who can I talk to if I have questions?

If you have any questions regarding the information in this leaflet please discuss them with your health care provider. They can access more detailed medical and scientific information from www.uktis.org

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General information 

Up to 1 out of every 5 pregnancies ends in a miscarriage, and 1 in 40 babies are born with a birth defect. These are referred to as the background population risks.  They describe the chance of these events happening for any pregnancy before taking factors such as the mother’s health during pregnancy, her lifestyle, medicines she takes and the genetic make up of her and the baby’s father into account.

Medicines use in pregnancy

Most medicines used by the mother will cross the placenta and reach the baby. Sometimes this may have beneficial effects for the baby.  There are, however, some medicines that can harm a baby’s normal development.  How a medicine affects a baby may depend on the stage of pregnancy when the medicine is taken. If you are on regular medication you should discuss these effects with your doctor/health care team before becoming pregnant.

If a new medicine is suggested for you during pregnancy, please ensure the doctor or health care professional treating you is aware of your pregnancy.

When deciding whether or not to use a medicine in pregnancy you need to weigh up how the medicine might improve your and/or your unborn baby’s health against any possible problems that the drug may cause. Our bumps leaflets are written to provide you with a summary of what is known about use of a specific medicine in pregnancy so that you can decide together with your health care provider what is best for you and your baby.   

Every pregnancy is unique. The decision to start, stop, continue or change a prescribed medicine before or during pregnancy should be made in consultation with your health care provider. It is very helpful if you can record all your medication taken in pregnancy in your hand held maternity records.

   

www.medicinesinpregnancy.org

Disclaimer: This information is not intended to replace the individual care and advice of your health care provider. New information is continually becoming available. Whilst every effort will be made to ensure that this information is accurate and up to date at the time of publication, we cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes following decisions made on the basis of this information. We strongly advise that printouts should NOT be kept for any length of time, or for “future reference” as they can rapidly become out of date.

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