(Date of issue: December 2013. Version: 1.1a)
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?
Ibuprofen (Nurofen®, Arthrofen®, Ebufac®, Rimafen®, Brufen®, Fenbid®) is a ‘non-steroidal anti-inflammatory drug’ (NSAID) that is used to treat pain and fever and is available without a prescription.
Is it safe to take ibuprofen in pregnancy?
Use of ibuprofen during pregnancy is not advised unless prescribed by your doctor, especially if you are 30 or more weeks pregnant. For some women with certain illnesses, ibuprofen may be prescribed before 30 weeks of pregnancy. For most women, paracetamol is usually recommended to control pain or fever during pregnancy. If paracetamol does not control your pain it is important that you ask your doctor for advice before taking ibuprofen or any other NSAID. Your doctor is the best person to help you decide what is right for you and your baby.
This leaflet summarises the scientific studies relating to the effects of ibuprofen on a baby in the womb. It is advisable to consider this information before taking ibuprofen if you are pregnant.
What if I have already taken ibuprofen during pregnancy?
There is no strong scientific proof that taking ibuprofen before week 30 of pregnancy will harm a baby in the womb. However, 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 to make sure that you are taking the lowest dose that works.
If you have taken ibuprofen after week 30 of pregnancy it is important that you let your doctor or midwife know straight away as your baby’s wellbeing in the womb will need to be assessed.
Can taking ibuprofen in pregnancy cause miscarriage?
It is unclear whether taking ibuprofen in early pregnancy increases the chance of having a miscarriage. Some studies have shown that women who take NSAIDs during pregnancy are more likely to have a miscarriage than women who have not. The only study that has examined ibuprofen separately from other NSAIDs also showed a potential link.
However, women with certain illnesses such as lupus or rheumatoid arthritis are more likely to need to take ibuprofen and other NSAIDs in pregnancy. These illnesses are themselves thought to increase a woman’s chance of having a miscarriage. More research is needed to understand whether the increased risk of miscarriage reported in the above studies is due to the NSAIDs, the illnesses that women may need to take NSAIDs for in pregnancy, or a combination of both factors.
Can taking ibuprofen 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.
There is no convincing scientific evidence that taking ibuprofen during early pregnancy causes birth defects.
Most studies show that women who took ibuprofen during the first three months of pregnancy are no more likely to have a baby with a birth defect than women who didn’t. A small number of studies have suggested possible links between taking ibuprofen in early pregnancy and various specific birth defects. In some cases, other studies of the same birth defect have shown no link. In summary, these studies (detailed below) do not provide enough evidence to prove that ibuprofen causes any type of birth defects:
• One study suggested that ibuprofen use in pregnancy may increase the likelihood of having a baby with gastroschisis (where part of the baby’s bowel protrudes outside of the baby’s body through a hole next to the tummy button), but other studies have not shown this.
• One study indicated that boys born to women who took ibuprofen in pregnancy were more likely to have undescended testicles at birth (where the testes have not come down into the sac), but this was not found in another study.
• One study suggested that babies whose mothers had taken ibuprofen during early pregnancy were more likely to have spina bifida (a defect of the spine), cleft lip and/or cleft palate (a split of the lip and/or the roof of the mouth), or amniotic band syndrome (defects that occur because abnormal bands of membrane that have formed in the pregnancy sac get wrapped around the baby). However, no other studies have investigated any possible link between ibuprofen use in pregnancy and these birth defects and it is therefore not possible to say that there is a link based on only one study.
• Some studies (including one that looked specifically at ibuprofen) have suggested that women who take NSAIDs during early pregnancy may be more likely to have a baby with a heart defect, although other studies have not linked NSAID use in early pregnancy with heart defects.
Taken together, the results of these studies do not provide firm evidence to link taking ibuprofen during early pregnancy with any of the defects listed above.
What problems can taking ibuprofen after 30 weeks of pregnancy cause in my baby?
Premature closure of the ductus arteriosus
Before birth, a blood vessel in the baby called the ductus arteriosus needs to stay open to supply the baby in the womb with nutrients and oxygen from the mother. The ductus arteriosus closes just after birth to allow the baby’s blood to flow through its lungs once it starts breathing. “Premature closure of the ductus arteriosus” is the medical term used to describe this blood vessel closing before it is supposed to.
Taking ibuprofen or another NSAID after 30 weeks of pregnancy can cause the ductus arteriosus to close while the baby is still in the womb, and the baby may then need to be delivered early. It is important to contact your doctor or midwife straight away if you have taken a NSAID after 30 weeks of pregnancy, especially if you have taken several doses or more than the recommended dose.
Persistent pulmonary hypertension of the newborn (PPHN)
PPHN or ‘persistent pulmonary hypertension of the newborn’ occurs when a newborn baby’s lungs do not adapt to breathing outside the womb. It is thought to be linked, in some cases, to early closure of the ductus arteriosus (see above). PPHN only affects around 1 or 2 out of every 1,000 newborn babies in the general population but is important as it can be serious.
Although one study has shown a link between PPHN and taking NSAIDs, including ibuprofen, during pregnancy, another study did not show a link. More studies are needed to investigate whether taking ibuprofen in the third trimester increases the risk of PPHN in the baby.
Oligohydramnios (reduced fluid around the baby)
Use of ibuprofen and other NSAIDs after 30 weeks of pregnancy may result in oligohydramnios (where there is too little amniotic fluid in the sac around the baby). Oligohydramnios can cause a number of complications, including:
• The baby’s lungs being under-developed (because inhaling amniotic fluid while in the womb helps to expand and develop the lungs).
• The baby’s bladder being under-developed (because urine expands and develops the bladder).
• The baby’s skull and leg bones being misshapen and the baby having ‘flattened’ facial features (because amniotic fluid ‘cushions’ the baby in the womb).
• Compression (squashing) of the umbilical cord, which may result in reduced blood flow from the mother to the baby in the womb.
If you have taken ibuprofen after 30 weeks of pregnancy, your doctor may wish to check your amniotic fluid levels by ultrasound scan.
Wherever possible, use of ibuprofen during the third trimester of pregnancy should be avoided. Please discuss any concerns that you may have with your doctor.
Can taking ibuprofen in pregnancy cause preterm birth?
A single study provided very weak evidence that women who had taken ibuprofen during the first trimester may be more likely to give birth early (before 37 weeks of pregnancy). Women who took ibuprofen during the second and third trimesters did not appear to be at increased risk of having a pre-term birth. Because this result is from just one study it does not confirm that taking ibuprofen in early pregnancy increases the chance of having a premature baby and more data needs to be collected on this subject.
Can taking ibuprofen in pregnancy cause my baby to be small at birth (low birth weight)?
One study suggested that women who take ibuprofen during the second trimester of pregnancy are at an increased risk of having a baby weighing less than 2500g at birth. However, more research is required to understand whether low birth weight is caused by ibuprofen, the illness for which the mother was taking ibuprofen, or a combination of both these factors.
Can taking ibuprofen in pregnancy cause learning or 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.
There is no known link between taking ibuprofen in pregnancy and learning or behavioural problems such as attention deficit hyperactivity disorder (ADHD) or autism spectrum disorder in the child. There are, however, no scientific studies that have specifically investigated a link with these problems.
One small study found that three year old children who had been exposed to ibuprofen while in the womb were more likely to start walking at a later age. More information is needed to know whether ibuprofen use in pregnancy affects a child’s development later on in life.
Can taking ibuprofen in pregnancy cause other health problems in the child?
One study has suggested that babies whose mothers took ibuprofen during the second and third trimesters of pregnancy had a higher chance of developing asthma by 18 months of age. However, it is possible that women who need to take ibuprofen are more likely to themselves have asthma. Asthma can run in families which may explain why this study has found a link. More research is needed to investigate whether ibuprofen use in pregnancy increases the chance of asthma in the child.
Will 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. Taking ibuprofen before 30 weeks of pregnancy would not normally require extra monitoring of your baby.
If you have taken ibuprofen after 30 weeks of pregnancy you may need extra scans or monitoring of your baby.
Are there any risks to my baby if the father has taken ibuprofen?
We would not expect any increased risk to your baby if the father took ibuprofen before or around the time your baby was conceived.
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.