Public-health advice during COVID-19 pandemic
The European Medicines Agency (EMA) is providing impartial advice to patients and healthcare professionals on the safe use of medicines during the COVID-19 pandemic, in particular in patients with or at risk of COVID-19 infection.
Patients should report any suspected side effects that they experiencing with their medicines.
This includes treatments and vaccines for COVID-19 itself. However, it is also important to report suspected side effects to other medicines, especially in patients who have COVID-19.
Healthcare professionals should also report the suspected side effects that their patients experience.
Side effect reports help regulators understand more about how medicines work. This complements the knowledge generated in clinical trials and other studies.
Patients and healthcare professionals can report suspected side effects to:
- their national competent authority;
- the manufacturer of the medicine using the instructions in the package leaflet;
- their doctor, nurse or pharmacist (if reported by the patient).
Suspected side effects reports should be as clear and accurate as possible, including:
- 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;
- 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.
Patients and vaccine recipients should speak to their doctor, nurse or pharmacist if they are worried about any side effect.
Suspected side effect reports of medicines authorised in the EU are publicly accessible via the www.adrreports.eu website.
EMA is urging patients to beware of potential falsified medicines sold by unregistered websites and vendors.
These vendors may be exploiting fears during the COVID-19 pandemic and claiming that their products can prevent or cure COVID-19. They may also appear to provide easy access to medicines that are otherwise not readily available.
EU citizens should be particularly vigilant if they come across vendors claiming to sell COVID-19 vaccines and treatments. These types of medicines are not usually available for sale online.
EMA advises citizens to follow official vaccination programmes instead of seeking out alternative sources of vaccines.
Patients can stay safe when buying medicines online by following EU advice. For more information, see Buying medicines online
EMA is continuously reviewing the available clinical evidence on the safe use of medicines during the COVID-19 pandemic and providing reliable advice where necessary.
This includes medicines that are not intended to treat COVID-19 itself.
Advice is available on the following medicines:
|Ibuprofen and ketoprofen||EMA gives advice on the use of non-steroidal anti-inflammatories for COVID-19|
|Angiotensin-converting-enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs)||Latest data support continued use of ACE inhibitors and ARB medicines during COVID-19 pandemic|
EMA advises against the use of ivermectin for the prevention or treatment of COVID-19 outside randomised clinical trials.
In March 2021, EMA found that the published data from laboratory and observational studies, clinical trials and meta-analyses, do not support its use for COVID-19. It therefore concluded that using ivermectin to prevent or treat COVID-19 cannot be recommended outside controlled clinical trials.
Ivermectin is authorised for the treatment of some parasitic worm infestations and certain skin conditions, as well as for veterinary use.
For more information, see:
Some doctors have used chloroquine or hydroxychloroquine to treat patients with COVID-19.
These medicines have not shown any beneficial effects in treating COVID-19 in large randomised clinical trials. These include:
Chloroquine and hydroxychloroquine may cause certain side effects, including heart rhythm problems. The risk of these side effects could be greater in patients receiving them:
- in higher doses than recommended for the medicines’ authorised indications;
- in combination with other medicines that have similar effects on the heart, such as the antibiotic azithromycin.
Chloroquine and hydroxychloroquine are authorised for the treatment of malaria and certain autoimmune diseases.
For more information, see:
- PRAC Highlights: Update to information on psychiatric disorders for chloroquine and hydroxychloroquine (27/11/2020)
- COVID-19: reminder of the risks of chloroquine and hydroxychloroquine (29/05/2020)
- COVID-19: reminder of risk of serious side effects with chloroquine and hydroxychloroquine (23/04/2020)
- COVID-19: chloroquine and hydroxychloroquine only to be used in clinical trials or emergency use programmes (01/04/2020)