(Date: September 2020. 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 the UK Health Security Agency (UKHSA) 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?

Pizotifen is a sedating (drowsy) antihistamine prescribed to prevent specific types of severe recurrent headache (vascular headaches, migraines and cluster headaches).

What are the benefits of taking pizotifen in pregnancy?

Pizotifen can prevent severe headaches. Treatment with pizotifen in pregnancy might be considered necessary for women who experience recurrent headaches that impact significantly on their quality of life or ability to carry out daily activities.

Are there any risks of taking pizotifen during pregnancy?

There are no studies of pregnant women specifically taking pizotifen and so the effects are largely unknown. It is not commonly used in pregnancy and would generally not be recommended unless there was no other option to prevent headaches that would seriously affect quality of life.

Are there any alternatives to taking pizotifen?

Possibly. Other medicines can be used to prevent or treat severe headaches. However, in rare cases, pizotifen may be the only medicine that works well, or a woman and her doctor may decide it is best to stay on it rather than try something new and risk a relapse.

Ideally, women planning a pregnancy should speak to their GP or specialist to determine whether pizotifen is still the best option for them. Similarly, women who have an unplanned pregnancy while taking pizotifen should be reviewed at the earliest opportunity by their GP or specialist.

What if I don't want to take medicines to prevent or treat severe headaches?

Severe headaches can potentially be improved by use of medicines that can be safely used in pregnancy. If untreated, they generally do not pose a direct health risk to the mother or baby, but can greatly affect quality of life and the ability to carry out activities of daily living.

Your doctor will be happy to talk to you about any concerns that you might have when considering use of a medicine in pregnancy.

Will my baby need extra monitoring?

All pregnant women in the UK should be offered a very detailed anomaly scan at around 20 weeks of pregnancy as part of their routine antenatal care. No extra monitoring for major birth defects is required following pizotifen use in pregnancy.

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

We would not expect any increased risk to your baby if the father takes pizotifen.

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.



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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