Side Effect (Adverse Drug Reaction) & Quality Defect Reporting

Report a suspected side effect

The Health Products Regulatory Authority (HPRA) monitors the safety and quality of all authorised medicines on the Irish market and part of this activity is carried out through the review and evaluation of suspected side effects (adverse drug reactions) and quality defects.

You can report a suspected side effect in a number of ways:

  • To your doctor, pharmacist or nurse who can then notify the HPRA.
  • By using the HPRA’s online form .
  • By downloading a copy of the HPRA adverse reaction (side effect) report form ( Word version ) and e-mailing the completed form to
  • By printing the HPRA’s adverse reaction (side effect) report form ( Word version ) and posting a completed copy to the HPRA by freepost.
  • By calling the HPRA on (01) 676 4971.

To report a suspected quality defect, you can:

  • Use the HPRA’s online reporting system
  • Email:
  • Post:
    Compliance Department – Quality DefectsHealth Products Regulatory AuthorityKevin O'Malley House, Earlsfort CentreEarlsfort Terrace, Dublin 2
  • Pharmacists may use the HPRA postage-paid 'green card' to report suspected quality defects, which is available upon request from the Market Compliance Section.
  • Fax: +353-1-6764061 (Note: Fax machine is manned during office hours only)
  • Telephone: (01) 6764971

Leaflets for people with sight challenges (XPIL)

Some pharmaceutical companies have chosen to display their Patient Information Leaflets (PIL) in PDF format and also as a text only version, called an XPIL. The XPIL is designed for people with sight challenges and can be read by screen readers, or printed in large print.