(Date: September 2017. Version: 2)

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?

Buprenorphine is a strong opioid painkiller that is chemically similar to codeine and morphine. Buprenorphine is also used in ‘substitution therapy’ to wean people off recreational opioid drugs such as heroin.

Is it safe to use buprenorphine in pregnancy?

Although there is currently no suggestion that buprenorphine causes birth defects or other serious problems, not enough pregnancies have been studied to be able to say whether or not use in pregnancy is safe. All of the available studies on buprenorphine use in pregnancy relate to its use in substitution therapy and not as a painkiller.   

When making a decision about buprenorphine use in pregnancy it is therefore necessary for women and their doctors to weigh up the risks and benefits to both mother and baby of not taking a specific treatment against those of continuing the treatment. The outcome of this assessment will vary from person to person and will depend on the severity of the mother’s condition and the complications that could arise if her treatment is altered. In specific instances, medically supervised treatment with buprenorphine may be considered to pose a lower risk to a pregnant woman and her unborn baby than exposure to a recreational opioid drug such as heroin.

A summary of the studies providing information on the possible risks to a baby in the womb of buprenorphine exposure are summarised below. Some of these risks will depend on how many weeks pregnant you are.

What if I have already used buprenorphine during pregnancy?

If you 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, or whether you might need to switch to a different medicine.

Can using buprenorphine in early pregnancy cause my baby to be born with birth defects?

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.

Studies of over 600 women using buprenorphine in pregnancy do not suggest an increased chance of birth defects overall in their babies. Further research is required to confirm this finding. More detailed studies will be required if a link with a specific birth defect or group of defects needs to be investigated. 

Can using buprenorphine in pregnancy cause miscarriage?

No studies have addressed the chance of miscarriage in women taking buprenorphine in early pregnancy.

Can using buprenorphine in pregnancy cause stillbirth?

One small study found that women using buprenorphine in pregnancy did not have a higher chance of stillbirth compared to women not using buprenorphine. Although this offers some reassurance, large studies that are designed to assess the chance of stillbirth following buprenorphine exposure are required.

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

Two studies which together include a total of 343 babies exposed to buprenorphine in the womb both found that they were no more likely to have a low birth weight or be born preterm than babies not exposed to buprenorphine. Two smaller studies also found that babies exposed in the womb to buprenorphine did not have a higher chance of being born preterm, although one of these studies suggested a possible link with low birth weight. Overall, these results do not flag a reason for concern, however further well-designed studies based on many more women using buprenorphine in pregnancy are required to answer these questions.

Can using buprenorphine in pregnancy cause other problems in the baby/child?

Withdrawal symptoms at birth
Use of opioid drugs in pregnancy, especially for long periods and/or around the time of delivery, can result in the baby not breathing properly for a while after birth. The baby may also experience withdrawal symptoms including jitteriness, sleep problems, seizures, poor feeding, digestive problems and vomiting, which may lead to dehydration and reduced weight gain if not recognised and treated. Women using buprenorphine in pregnancy may therefore be advised to give birth in a unit with facilities to manage these problems in the baby should they occur.

Learning and behavioural problems in the child
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.

A single small study of 25 six-year-old children exposed in the womb to buprenorphine suggested a possible link with difficulties in certain aspects of learning and behaviour compared to children in the general population. However, small studies in younger children are not always reliable. Further well-designed larger studies of learning and behaviour in children exposed to buprenorphine in pregnancy are required to assess the accuracy of this finding.

Will I or my baby need extra monitoring during pregnancy?

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.

Women with conditions that cause severe pain or who use recreational opioids may be more closely monitored during pregnancy anyway. Depending on your individual circumstances your doctor may suggest extra monitoring of your baby or more frequent review of your baby’s growth in the womb.

Are there any risks to my baby if the father has used buprenorphine?

There are no scientific reports of babies born to men who used buprenorphine around the time of conception. Most experts agree that the majority of medicines used by the father are unlikely to harm the baby through effects on the sperm. However, more research on the effects of medicine use in men around the time of conception generally, and of buprenorphine specifically, is needed.

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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