Topiramate (Topamax▼) pregnancy prevention programme and restrictions on use

Medicines containing topiramate, marketed under the brand name Topamax▼, are approved in Ireland to treat different types of epilepsy, either alone or with other medicines. Topiramate is also used in adults to prevent migraines after other possible treatment options have been considered.

Topiramate can harm an unborn child when taken during pregnancy. Children exposed during pregnancy have a higher risk for birth defects and may be smaller and weigh less than expected. They may also have a higher risk for autism spectrum disorders, intellectual disability, and attention deficit hyperactivity disorder.

Important contraindications, warnings, and risk minimisation measures are in place to prevent topiramate exposure during pregnancy.

Important information

If you are a patient treated with topiramate and have questions, speak with your doctor. Your doctor will explain what this means for you and any steps you may need to follow.

If you are taking topiramate for epilepsy, you should not stop taking it unless you have discussed it with your doctor first. This is because your epilepsy may become worse, which may also put you and your unborn child at risk.

Pregnancy prevention programme

In 2023, the EMAs safety committee (PRAC) recommended new measures to avoid topiramate exposure during pregnancy, including a pregnancy prevention programme.

The recommendations have been implemented in Ireland, and new materials to support the pregnancy prevention programme are available. These materials aim to support the safe prescribing and dispensing of topiramate and help ensure patients are fully informed of the risks of use during pregnancy and can discuss options with their doctors.


These materials should be used together with the approved product information for topiramate, which is accessible here.

Product information

The approved product information* contains the Summary of Product Characteristics (SmPC) and the Package Leaflet (PL), providing detailed warnings and recommendations for healthcare professionals and patients about topiramate. Copies of the current versions of the product information are available from the HPRA website by searching for 'topiramate' or 'Topamax' in the 'Find a Medicine' search box.

* What is contained in the product information?

The product information is comprised of the Summary of Product Characteristics (SmPC) and Package Leaflet (PL). These documents are issued when a medicine is first licensed for use and are reviewed and updated as necessary throughout the lifetime of a medicine. The SmPC is mainly intended for use by healthcare professionals and includes detailed information on the use, dosing recommendations, precautions for use and the known side effects of the medicine concerned. SmPCs for products authorised in Ireland are accessible from the HPRA's webpage using the 'Find a Medicine' function. The PL reflects the more comprehensive information described in the SmPC but must be presented in an abbreviated and easy-to-read format for patients. The PL should be included in the medicine box received from your pharmacist.

Reporting suspected side effects (adverse reactions)

Topiramate–containing medicines are subject to additional monitoring requirements, and healthcare professionals and patients are requested to report any suspected adverse reactions associated with their use via the HPRA reporting forms.

Any medicine subject to additional monitoring in the EU is identifiable by an inverted black triangle after the medicine's name ▼ and the following explanatory statement in the product information.

▼ This medicinal product is subject to additional monitoring.

HPRA-approved communications for healthcare professionals

The HPRA communications, listed below, include Direct Healthcare Professional Communications (DHPCs) and articles in the HPRA Drug Safety Newsletter. In addition, the HPRA provided articles which were published in MIMS (Ireland) and the Irish Medicines Formulary (IMF). All communications are published on the HPRA website and are linked below.

Further information on the EU-wide review of topiramate is also available here.