How to report side effects of medicines in patients with COVID-19

Reporting side effects during the COVID-19 response

In light of the ongoing temporary closure of the HPRA offices due to the COVID-19 public health measures, we ask that reports of side effects for medicines are submitted through our online reporting system. Alternatively, please e-mail Post and fax should be avoided during this time.

The HPRA, together with other national competent authorities and the European Medicines Agency, is reminding patients, and healthcare professionals caring for patients, with confirmed or suspected coronavirus disease (COVID-19) to report suspected side effects experienced with any of the medicines they are taking. This includes medicines to treat COVID-19, as well as medicines taken by patients to manage long-term, pre-existing conditions. It also includes medicines that patients might be using off-label to treat COVID-19.

Patients and healthcare professionals are reminded that there are currently no medicines authorised to treat COVID-19. However, in the context of the pandemic, several treatments authorised for other diseases are being used in patients with COVID-19.

Why is it important to report suspected side effects?

The HPRA greatly appreciates, and depends upon, the contribution of patients and busy healthcare professionals in continuing to report suspected adverse reactions (including those not related to COVID-19 infection), particularly at this time. The collection and evaluation of comprehensive reports are essential to ensure that appropriately detailed case information is available for the continuous surveillance of the safety of medicines.

Understanding of the new virus is still incomplete, including possible interactions with medicines patients might be taking. By reporting suspected side effects of medicines used in the context of COVID-19, patients and healthcare professionals can help gather valuable evidence to inform decisions on the safe and effective use of medicines as the pandemic evolves.

Information provided by patients and healthcare professionals through their reports will add to the knowledge currently being generated through clinical trials and other studies.

How to report suspected side effects

Patients and healthcare professionals can report suspected side effects in the following ways:

  • to the manufacturer of the medicines using the instructions in the patient leaflet

  • patients can also report side effects to their doctor, nurse or pharmacist who will then pass on the information to the HPRA.

Information to include when reporting suspected side effects

When reporting side effects/suspected adverse reactions, as much as possible of the following information should be provided (however, please note that non-availability of all this information should not discourage report submission):

  • Information on the patient who has experienced the side effect, including age (or age group) and sex, and any additional available information such as weight/BMI, pregnancy status, other medical conditions/co-morbidities etc.

  • A description of the side effect/suspected adverse reaction experienced, including clinical course, and outcome where known;

  • The name of the medicine (brand name as well as active substance) suspected to have caused the side effect/adverse reaction;

  • Dose and duration of treatment with the medicine;

  • The batch number of the medicine administered (essential for reports involving biological medicines) – this can be found on the outer packaging of the medicine

  • Any medicines taken around the same time (concomitant medications) (this includes other prescription medicines, non-prescription medicines, herbal remedies or contraceptives etc.);

  • For reports involving coronavirus infection, details on whether infection has been confirmed through testing or is based on clinical symptoms;

  • Reporter (healthcare professional or patient) details.

When reporting suspected side effects, patients and healthcare professionals are encouraged to provide as accurate and complete information as possible.

Please note the HPRA cannot provide medical advice to individual patients and patients should speak to their doctor, nurse or pharmacist if they are worried about any suspected side effect.

Further information

View our helpful infographics below for guidance on how to report side effects to the HPRA:

We have also published a consumer information leaflet providing more information about side effects for patients and why it is important that they are reported to the HPRA. Download it using the link below.