Public-health advice during COVID-19 pandemic

Throughout the COVID-19 pandemic, the European Medicines Agency (EMA) has provided impartial advice to patients and healthcare professionals on the safe use of medicines, 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 urges patients to beware of potential falsified medicines sold by unregistered websites and vendors.

These vendors may exploit fears during the COVID-19 pandemic and claim 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 should only buy medicines from vendors registered with the national competent authorities in the EU Member States. This reduces the risk of buying sub-standard or falsified medicines.

Patients can stay safe when buying medicines online by following EU advice. For more information, see Buying medicines online

EMA has continuously reviewed the available clinical evidence on the safe use of medicines throughout the COVID-19 pandemic and has provided reliable advice where necessary.

This included medicines not intended to treat COVID-19 itself.

Advice is available on the following medicines:

In December 2022, EMA’s Emergency Task Force (ETF) cautioned that monoclonal antibodies authorised to treat COVID-19 were unlikely to be effective against emerging strains of the SARS-CoV-2 virus.

The Task Force stated that mutations of the spike protein on the surface of these emerging COVID-19 strains reduced the neutralising activity of these antibodies.

The ETF expected other authorised antiviral treatments to still be effective against emerging strains.

• ETF warns that monoclonal antibodies may not be effective against emerging strains of SARS-CoV-2  (09/12/2022)

For more information, see:

EMA and the European Centre for Disease Prevention and Control (ECDC) jointly provided advice on COVID-19 vaccination:

• EMA and ECDC statement on updating COVID-19 vaccines to target new SARS-CoV-2 virus variants(06/06/2023)
• ECDC and EMA issue advice on fourth doses of mRNA COVID-19 vaccines (06/04/2022)
• EMA and ECDC recommendations on heterologous vaccination courses against COVID-19: ‘mix-and-match’ approach can be used for both initial courses and boosters (07/12/2021)
• ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines (02/09/2021)
• ECDC and EMA update on COVID-19 (04/08/2021)
• EMA and ECDC update on COVID-19 (14/07/2021)

For more information on COVID-19 vaccines, see:

• COVID-19 vaccines: key facts

In December 2022, EMA's Emergency Task Force (ETF) issued a statement on COVID-19 vaccination:

• ETF concludes that bivalent original/Omicron BA.4-5 mRNA vaccines may be used for primary vaccination (06/12/2022) 

EMA advises healthcare professionals that there is not enough evidence that inhaled corticosteroids such as budesonide or ciclesonide are beneficial for people with COVID-19.

In May 2021, EMA found it could not exclude the possibility of harm in people with normal levels of oxygen inhaling corticosteroids to treat COVID-19.

Inhaled corticosteroids are generally used for treating inflammatory conditions in the lung, such as asthma.

For more information, see:

• Insufficient data on use of inhaled corticosteroids to treat COVID-19 (27/05/2021)

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:

• EMA advises against use of ivermectin for the prevention or treatment of COVID-19 outside randomised clinical trials (22/03/2021)

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:

• the Solidarity trial;
• the Recovery trial
• the Discovery trial.

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)