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Adverse Event Reporting

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 adverse drug reactions (ADRs) and quality defects.

Healthcare professionals

All healthcare professionals are encouraged to use the national reporting system to report suspected adverse effect in one of the following ways:

By using the HPRA’s online form .
By downloading a copy of the HPRA adverse reaction report form ( Word version ) and e-mailing the completed form to medsafety@hpra.ie
By printing the HPRA’s adverse reaction 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: qualitydefects@hpra.ie
Post:
Compliance Department – Quality Defects
Health Products Regulatory Authority
Kevin O'Malley House, Earlsfort Centre
Earlsfort 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

Members of the public

If you are concerned that you have had a side effect to a medicine, contact your doctor, nurse or pharmacist who can advise on next steps. They may also report the suspected side effect to the HPRA. Should you wish, you may also report the suspected side effects directly to the HPRA (as outlined above).

Experiencing a side effect while taking a medicine does not necessarily mean that it is has been caused by that medicine. However, the HPRA encourages people to report all suspected side effects so that if there is an issue it can be addressed.