Sources of medicine safety information

Medicines offer many health benefits, helping to treat or prevent illness and disease. However, it is important to be aware that using any medicine carries the risk of experiencing unwanted side effects.

Patients and healthcare professionals can find information about potential side effects from various sources, including product information, educational materials, and safety communications.

Product Information

Product information is available for every authorised medicine. It includes the Summary of Product Characteristics (SmPC), Package Leaflet (PL), and labelling.

This information describes when the medicine should be used, special warnings and precautions, and known side effects. When using a medicine, reviewing the product information, including any updates, is important.

Product information for all medicines authorised in Ireland by the HPRA is available on the HPRA website using the Find a Medicine search function. You can also find the product information for medicines authorised through the European Medicines Agency on the EMA website.

Educational Materials

Educational materials may be provided for certain medicines to help manage the risk of significant side effects. These resources highlight specific safety concerns and offer guidance on preventing and minimising risks. Educational materials can include guides, forms, or reminder cards for healthcare professionals, patients, or caregivers.

You can find products with educational materials using the Find a Medicine search function.

Safety Communications

Direct Healthcare Professional Communications (DHPC)

DHPCs are important tools for providing new information directly to healthcare professionals to ensure the safe and effective use of medicines. DHPCs update healthcare professionals on:

  • New major warnings or precautions
  • Important changes, such as restrictions of indication, new contraindications, or dosage changes
  • Suspension, withdrawal, or revocation of a medicine's licence for safety reasons
  • Quality problems with a medicine

DHPCs are disseminated by the pharmaceutical company responsible for the medicine at the request and approval of the HPRA.

DHPCs are also published under the 'Safety Notices' tab on the HPRA website.

For the latest safety information, you can search published DHPCs on the HPRA website or register to receive new DHPCs and other regulatory updates.

HPRA Drug Safety Newsletter

The HPRA produces regular Drug Safety Newsletters for HCPs. The newsletter provides clear, concise updates on the latest medicine safety information, directly supporting healthcare professionals in ensuring their safe and effective use. As a trusted and relevant resource, the newsletter addresses the needs of HCPs in today's increasingly complex information landscape.

The Drug Safety Newsletter can be downloaded from the publications section of our website.

Register to receive new Drug Safety Newsletters and other regulatory updates once published.

 Third-Party Publications

The HPRA also publish articles regularly in third-party publications, including MIMS Ireland and the Irish Medicines Formulary.