Reporting a suspected side effect as a patient or carer

Anyone can report a suspected side effect directly to the HPRA.

If you are concerned that you or someone you care for has experienced a suspected side effect of a medicine, you may need to contact your healthcare professional, who can advise on any treatment that may be required. They can also report the suspected side effect to the HPRA on your behalf.

Reports of suspected side effects are carefully reviewed and help us continuously watch over the safety of medicines available in Ireland.

Did you know

  • You can report the suspected side effect if you experienced it yourself, or you can report it on behalf of someone else, such as a friend, relative, or person you care for.
  • You can make a report even if you suspect the medicine may have caused the side effect but are unsure.

If you are in doubt about reporting a side effect, please report every report counts.

Important: If you have concerns about your health, please consult your doctor, pharmacist, or nurse for advice. The HPRA cannot provide clinical advice.

How can I make a report?

You can use the online form to report a suspected side effect.

Alternatively, download and complete the side effect from medicine for human use form or the side effect for COVID-19 vaccines form as appropriate and email it to medsafety@hpra.ie or send it by Freepost to:

Pharmacovigilance Section,

HPRA,

Kevin O'Malley House

Earlsfort Centre

Earlsfort Terrace

Dublin 2, D02 XP77, Ireland

You can contact the HPRA's pharmacovigilance section by phone at +353-1-6764971

What information is needed to make a report?

When making a report, we ask that you provide as much detail as possible. However, you can still report even if some information is missing or unknown.

At a minimum, please include

  • Your name and contact information,
  • If you are reporting on behalf of someone else, you will need to provide a patient identifier, such as their age or gender,
  • Details of the medicine taken which you suspect caused the side effect,
  • A description of the suspected side effect(s), including the symptoms and, if available, any diagnoses.

You will also be asked to provide additional information, if available, such as any other medicines you may be taking, any background medical conditions. If you wish to, you can provide the contact details for your healthcare professionals and permission for us to contact them directly to gather more information.

Other helpful information to include in your report is the suspect medicine's brand, dose, and batch number. Including the batch number in vaccine reports is particularly important if known.

What happens after I make a report?

  • Our pharmacovigilance team carefully review all reports received.
  • After you submit a report, it will be assigned a unique number, which will be provided for your reference.
  • Our pharmacovigilance team may contact you for more information about your experience. The initial information is often sufficient, so we will only contact you if necessary.
  • To enable further evaluation, your report is recorded and stored in the HPRA's national adverse reactions database, along with other suspected side effect reports we have received. See below for further details on what information may be shared with other parties.

How is the information reported, processed, and shared?

Under our legal obligations, the HPRA may share a copy of your report with other organisations involved in the safety monitoring of medicines. However, your personal identifiers and contact details are removed before reports are shared. Please see the HPRAs privacy notice for full details of how your information is processed in line with GDPR.

Reports of suspected side effects are submitted to the EudraVigilance database, operated and managed by the European Medicines Agency (EMA). The EudraVigilance database is regularly analysed to detect any possible safety signals related to medicines.

Reports are also shared with other organisations involved in the safety monitoring of medicines. These organisations include the World Health Organisation and, where appropriate, the companies holding the medicines' licences (i.e., marketing authorisation holders or MAHs). Sharing this information ensures that all parties responsible for the ongoing safety monitoring of medicines have access to it.