(Date of issue: January 2014. Version: 2.1)
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?
Loperamide (Imodium®, Norimode®, Diah-limit®, Diocalm ultra®, Normaloe®, Diaquitte®, Diasorb®, Entrocalm loperamide®) is a medicine usually used to treat short episodes of diarrhoea. Loperamide may also be prescribed to treat long-term diarrhoea due, for example, to irritable bowel syndrome, or to help digestion in people who have had part of their intestine removed.
Is it safe to take loperamide in pregnancy?
There is no yes or no answer to this question. When deciding whether or not to take loperamide during pregnancy it is important to weigh up the benefits of its use against the known or possible risks, some of which will depend on how many weeks pregnant you are.
This leaflet summarises the scientific studies relating to the effects of loperamide on a baby in the womb. It is advisable to consider this information before taking loperamide if you are pregnant.
It is important that you do not become dehydrated or unhealthy as a result of diarrhoea during pregnancy, and so for some women treatment with loperamide during pregnancy may be advised.
Your doctor is the best person to help you decide what is right for you and your baby.
What if I have already taken loperamide 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 loperamide in pregnancy cause birth defects in my 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.
There is mixed scientific evidence about whether taking loperamide during the first trimester of pregnancy may increase the chance of having a baby with a birth defect.
Although one small study showed that women who took loperamide were no more likely to have a baby with a birth defect than women who didn’t, a second larger study found that birth defects were more common in babies of mothers who took loperamide in pregnancy. This study also found a possible link between loperamide use in early pregnancy and hypospadias (where the urethral opening is somewhere on the underside of the penis instead of at the tip).
Can taking loperamide in pregnancy cause miscarriage, preterm birth, or my baby to be small at birth (low birth weight)?
There is no scientific evidence that women who take loperamide during early pregnancy have a higher chance of having a miscarriage, a pre term birth (before 37 weeks of pregnancy), or a low birth weight baby (weighing less than 2500g at birth). However, because these pregnancy outcomes have been studied in only a small number of women, more information is required before firm conclusions can be drawn.
Can taking loperamide in pregnancy cause stillbirth?
No link between loperamide use in pregnancy and stillbirth is known about, however no scientific studies have been carried out that have specifically investigated this.
Can taking loperamide 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 loperamide in pregnancy and learning or behavioural problems (such as ADHD or autism spectrum disorder) in the child later on in life. There are, however, no scientific studies that have specifically investigated a link with these problems.
Will my baby need extra monitoring during pregnancy?
Taking loperamide during pregnancy is not expected to cause any problems that would require extra monitoring of your baby. If you have an underlying illness that causes severe long-term diarrhoea, your doctor may wish to monitor your baby’s growth in the womb more closely.
Are there any risks to my baby if the father has taken loperamide?
We would not expect any increased risk to your baby if its father took loperamide 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.
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.