Tramadol

(Date of issue: January 2016. 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?

Tramadol is a medicine that is prescribed to treat moderate to severe pain. Tramadol affects the balance of certain ‘mood chemicals’ in the brain and is occasionally used as a recreational drug, often at doses higher than those used to treat pain.

Is it safe to take tramadol in pregnancy?

There is not yet enough information to assess whether or not tramadol is safe to use in pregnancy. Some studies have identified the possibility of effects on the fetus. Further studies are needed to work out whether these problems were caused by tramadol or by other factors. 

When deciding whether to use tramadol during pregnancy it is therefore best to weigh up how necessary tramadol is to your health against any possible risks to you or your baby (see below), some of which might depend on how many weeks pregnant you are.

It is important to appropriately treat pain in pregnancy. For some women with severe pain, treatment with tramadol in pregnancy might be considered the best option. Your doctor is the best person to help you decide what is right for you and your baby.

Recreational (social) use of tramadol in pregnancy is not advised. If you are pregnant and use tramadol recreationally you should speak to your doctor or midwife about this. If necessary, they will be able to get you help and support to safely stop using tramadol.

What if I have already taken tramadol during pregnancy?

If you have taken 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 to make sure that you are taking the lowest dose that works.

Can taking tramadol in 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.

Two studies have been carried out that, together, include around 1,900 babies born to women who used tramadol to treat pain in early pregnancy. The first small study provided no evidence that use of tramadol in pregnancy increases the risk of the baby having a birth defect. However, the second larger study suggested that babies born to women who used tramadol in early pregnancy were at increased risk of birth defects such as heart defects and talipes (club foot). Neither of these studies accounted for possible effects on the unborn babies of the mother’s underlying illnesses for which tramadol was being used. Further large studies are therefore required before we can say whether use of tramadol in early pregnancy increases the risk of birth defects in the baby.

Can taking tramadol in pregnancy cause miscarriage?

A single small study of around 150 women using tramadol to treat pain in early pregnancy showed that they were about four times more likely to have a miscarriage than pregnant women not using tramadol. This study did not account for possible effects on miscarriage rates of the women’s underlying illnesses. Further larger studies are therefore required to confirm this finding.

Can taking tramadol in pregnancy cause stillbirth?

No studies have investigated whether rates of stillbirth are increased in women who take tramadol in pregnancy.

Can taking tramadol in pregnancy cause preterm birth?

A single small study of around 150 women taking tramadol in the first trimester to treat pain provided no evidence that use increased the risk of preterm birth. Further large studies that include women taking tramadol at later stages of pregnancy are required before we can rule out that use of tramadol increases the risk of preterm birth.

Can taking tramadol in pregnancy cause my baby to be small at birth (low birth weight)?

No studies have investigated whether rates of low birth weight in the baby are increased following use of tramadol in pregnancy.

Can taking tramadol in pregnancy cause other health problems in the baby/child?

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

There are case reports in the scientific literature of withdrawal symptoms in newborn babies following exposure to tramadol in the womb. If you have taken tramadol regularly in the weeks before delivery your doctor or midwife might arrange for your baby to be born in a unit that can monitor and treat your baby for withdrawal symptoms if necessary.

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.

Because tramadol alters the levels of certain chemicals in the brain there are theoretical concerns that use in pregnancy may affect the baby’s brain development. However, there are currently no scientific studies that have examined learning and behaviour in children of women who took tramadol during pregnancy.

Will my baby need extra monitoring during pregnancy or after delivery?

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. Using tramadol in pregnancy is not expected to cause problems that would require extra monitoring of your baby during pregnancy. However, women with some of the underlying conditions that tramadol can be used to treat might be more closely monitored to ensure that their baby is growing and developing as expected. Extra monitoring of women who use tramadol recreationally may be suggested.

Babies born to women who have taken tramadol in late pregnancy might be closely monitored after birth to ensure that they are not experiencing withdrawal symptoms.

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

No studies have specifically investigated whether tramadol taken by the father can harm the baby through effects on the sperm, however most experts agree that this is very unlikely. More research on the effects of medicine use in men around the time of conception 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.  

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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