Date: October 2019, Version 3

What is it?

Risperidone (Risperdal®) belongs to a group of medicines called atypical antipsychotics and is used to treat schizophrenia, mania, and aggression.

Is it safe to take risperidone in pregnancy?

When deciding whether or not to take risperidone during pregnancy it is important to weigh up how necessary risperidone is to your health against the possible risks to you or your baby, some of which will depend on how many weeks pregnant you are. Psychiatric illness can sometimes occur for the first time, or may get worse during pregnancy. For some women, treatment with an antipsychotic such as risperidone may be offered by a specialist so that they have the best chance of remaining well.

What if I have already taken risperidone during pregnancy?

If you have taken or are taking any medicines it is always a good idea to let your doctor know that you are pregnant so that you can decide together whether you still need the medicines that you are on and, if so, to make sure that you are taking the lowest dose that works and only for as long as you need to.

It is very important that you do not suddenly stop taking risperidone as this could be dangerous. Do not make any changes to your medication without first talking to your doctor.

Can taking risperidone 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.

A total of around 2,000 pregnant women taking risperidone have been studied. In the background population, around three in every 100 babies is born with a birth defect. One large study of pregnant women taking risperidone found that around four in every 100 of their babies had a birth defect, suggesting a slight increase. However, a further study did not find any link between risperidone use in pregnancy and birth defects in the baby.

One large study found that babies born to women taking risperidone were no more likely to have a heart defect than babies born to women not taking risperidone.

Studies of over 10,000 women who used any type of antipsychotic during pregnancy do not collectively raise alarm of a link with birth defects. While this is reassuring, further studies of women specifically taking risperidone are ideally required.

Can taking risperidone in pregnancy cause miscarriage?

One small study of 116 women who took risperidone in pregnancy found that they had a higher chance of miscarriage compared to women not taking risperidone. However, this was considered to be most likely due to lifestyle factors that are more common in women taking antipsychotics (including smoking) rather than a direct effect of the drug itself.

Studies of around 3,000 women who used any type of antipsychotic during pregnancy do not raise concern of a direct link with miscarriage. While this is reassuring, further studies of women specifically taking risperidone are required.

Can taking risperidone in pregnancy cause stillbirth?

No studies have specifically investigated whether women who take risperidone during early pregnancy have a higher chance of stillbirth.

Studies of stillbirth in pregnant women taking any antipsychotic have produced mixed findings, with three studies finding no link but one large study finding a possible link. Studies of women specifically taking risperidone are required before definite conclusions can be drawn.

Can taking risperidone in pregnancy cause preterm birth?

No studies have specifically investigated whether women who take risperidone during early pregnancy have a higher chance of preterm birth.

Some (but not all) studies of pregnant women taking any antipsychotic have shown a possible link with preterm delivery, but it is thought likely that lifestyle factors in pregnant women taking antipsychotics are likely to have contributed to this finding. Because only small numbers of women specifically taking risperidone have been studied, more information on this subject is needed.

Can taking risperidone in pregnancy affect a baby’s growth in the womb and his/her birth weight?

Low birth weight
No studies have investigated whether risperidone use in pregnancy might affect a baby’s birth weight. Studies of pregnant women taking any antipsychotic do not overall raise alarm that their use slows the baby’s growth in the womb. Information about women specifically taking risperidone ideally needs to be collected.

Increased birth weight
Weight gain, high blood sugar and diabetes are common side effects of antipsychotic use in non-pregnant individuals. If these problems occur in pregnancy they can in turn cause increased growth of a baby in the womb. Some studies, but not others, have found a possible link between antipsychotic use in pregnancy and having a large baby. However, no studies have yet investigated whether babies born to women specifically taking risperidone are more prone to having a high birth weight.

Can taking risperidone in pregnancy cause other health problems in the child?

Withdrawal symptoms at birth (neonatal withdrawal)
Withdrawal symptoms are thought to occur as the newborn baby’s body has to adapt to suddenly no longer getting certain types of medicines through the placenta.

Taking risperidone and other antipsychotics during pregnancy can lead to neonatal withdrawal. Close monitoring of your baby for a few days after birth may therefore be advised if you have taken risperidone regularly in the weeks before delivery. Your doctor may therefore advise that your baby is delivered at a hospital with facilities to deliver this care.

Learning and behavioural problems
A baby’s brain continues to develop right up until the end of 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 investigated learning and behaviour in children exposed in the womb to risperidone.

Will I or my baby need extra monitoring?

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

Weight gain and increased blood sugar (hyperglycaemia) can be side-effects of risperidone. If you are taking risperidone during pregnancy and are gaining more weight than expected, or have higher than expected levels of sugar in your urine, your doctor may offer you a glucose tolerance test to measure how your body responds to sugar.

If you have taken risperidone around the time of delivery your baby may require extra monitoring after birth because of the possible risk of neonatal withdrawal.

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

We would not expect any increased risk to your baby if the father took risperidone 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.

How can I help to improve drug safety information for pregnant women in the future?

Our online reporting system (MyBump Portal) allows women who are currently pregnant to create a secure record of their pregnancy, collected through a series of questionnaires. You will be asked to enter information about your health, whether or not you take any medicines, your pregnancy outcome and your child's development. You can update your details at any time during pregnancy or afterwards. This information will help us better understand how medicines affect the health of pregnant women and their babies. Please visit the MyBump Portal to register.

General information
Sadly, miscarriage and birth defects can occur in any pregnancy.

Miscarriage occurs in about 1 in every 5 pregnancies, and 1 in every 40 babies are born with a birth defect. This is called the ‘background risk’ and happens whether medication is taken or not.

Most medicines cross the placenta and reach the baby. For many medications this is not a problem. However, some medicines can affect a baby’s growth and development.

If you take regular medication and are planning to conceive, you should discuss whether your medicine is safe to continue with your doctor/health care team before becoming pregnant. If you have an unplanned pregnancy while taking a medicine, you should tell your doctor as soon as possible.

If a new medicine is suggested for you during pregnancy, please make sure that the person prescribing it knows that you are pregnant. If you have any concerns about a medicine, you can check with your doctor, midwife or pharmacist.

Our Bumps information leaflets provide information about the effects of medicines in pregnancy so that you can decide, together with your healthcare provider, what is best for you and your baby.