Reporting suspected side effects of medicines in patients with COVID-19

24 April 2020

EMA and the national competent authorities are reminding patients with confirmed or suspected coronavirus disease (COVID-19) to report suspected side effects that they experience 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 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.

Patient reporting complements the information received from healthcare professionals who have continued to report suspected patient side effects with medicines taken during the pandemic.

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.

Patients and healthcare professionals should report suspected side effects directly to their national authority via the contact details available here or 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 regulators.

When reporting side effects at least the following information should be provided:

• information on the person who has experienced the side effect, including age and sex;
• whether the infection is confirmed through testing or is based on clinical symptoms;
• a description of the side effects;
• the name of the medicine (brand name as well as active substance) suspected to have caused the side effects;
• dose and duration of treatment with the medicine;
• the batch number of the medicine (found on the packaging);
• any other medicines being taken around the same time (including non-prescription medicines, herbal remedies or contraceptives);
• any other health condition that the person who experienced the side effect may have.

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

Patients should speak to their doctor, nurse or pharmacist if they are worried about any suspected side effect.