Isotretinoin skin gel

Date: May 2018, Version 3

What is it?

Isotretinoin skin gel (Isotrex®, Isotrexin®) contains a form of Vitamin A and is used to treat acne.

Can I use isotretinoin skin gel in pregnancy?

In most situations the use of isotretinoin skin gel during pregnancy is unlikely to cause harm to an unborn baby. Whereas Isotretinoin taken in tablet form during pregnancy can cause severe birth defects and learning difficulties in the baby, only a very small amount of isotretinoin from gel applied to the skin is likely to reach a baby in the womb. 

If, however, you have used very large amounts of gel for a long period of time or you have a skin condition that results in isotretinoin being more easily absorbed, potentially harmful levels of isotretinoin may accumulate in your bloodstream.

For this reason, and because there is not yet enough evidence to confirm that isotretinoin gel is completely safe, its use cannot be recommended during pregnancy. If you are using isotretinoin gel it is advisable to use a reliable form of contraception and to speak to your doctor before planning a pregnancy.

What if I have already used isotretinoin skin gel during pregnancy?

The available scientific evidence does not suggest that using isotretinoin skin gel during pregnancy is harmful to an unborn baby. However, if you have used isotretinoin skin gel whilst pregnant, you should speak to your doctor.

Can using isotretinoin gel in pregnancy cause my baby to be born with birth defects?

A single study showed that mothers who applied isotretinoin and related skin treatments to their skin during early pregnancy were no more likely to have a baby with a birth defect than mothers who did not use isotretinoin. Although there are some reports of babies with birth defects being born to women who applied isotretinoin gel during pregnancy, it is unlikely that the abnormalities in many of these babies were caused by the gel. In general, isotretinoin applied to skin is not well absorbed into the bloodstream and very little is expected to reach the baby in the womb.

Can using isotretinoin gel in pregnancy cause miscarriages?

One study has shown that women who use isotretinoin gel or similar types of skin creams during early pregnancy do not have a higher chance of having a miscarriage. Very little isotretinoin is absorbed from the gel, therefore we would not expect that normal use of isotretinoin gel during pregnancy would increase a woman’s chance of having a miscarriage.

Can using isotretinoin gel in pregnancy cause other problems for my baby?

No increased chance of giving birth prematurely (before 37 weeks of pregnancy), of having a baby weighing less than 2500g at birth, or of stillbirth, was shown in one study of women who used isotretinoin gel and related skin treatments during early pregnancy. 

Can using isotretinoin gel in pregnancy cause learning and behavioural problems in the child?

No studies have been carried out to examine whether there is an increased risk of behavioural and learning problems in children whose mothers used isotretinoin gel while they were pregnant. However, very little isotretinoin is absorbed from the gel form, therefore no effect on the baby’s brain development in the womb would be expected.

Will my baby need extra monitoring during pregnancy?

Use of isotretinoin gel during pregnancy is not expected to cause any problems that would require extra monitoring of your baby before or after birth.

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

We would not expect any increased risk to your baby if the father used isotretinoin gel 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  

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.