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:
Suspected side effects reports should be as clear and accurate as possible, including:
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:
| Medicine | More information |
|---|---|
| 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 |
In December 2024, EMA's Emergency Task Force (ETF) stated that all monoclonal antibodies authorised to prevent and treat COVID-19 should be avoided.
The ETF explained that these antibodies are unlikely to provide any clinical benefit against the latest SARS-CoV-2 variants.
It stressed that vaccination remains the best option to prevent disease caused by these variants.
It also expected other authorised antiviral treatments to still be effective in case of infection.
In December 2022, the ETF first cautioned about the loss of activity of all approved monoclonal antibodies.
This is due to mutations of the spike protein on the surface of emerging COVID-19 strains that reduced the neutralising activity of these antibodies.
For more information, see:
In July 2024, EMA's Emergency Task Force (ETF) confirmed its recommendation to update the antigenic composition of authorised COVID-19 vaccines in preparation for the 2024 / 2025 vaccination campaign.
In April 2024, ETF issued a recommendation to update COVID-19 vaccines to target a new SARS-CoV-2 variant known as JN.1.
In February 2024, ETF issued a statement on the use of recently updated COVID-19 vaccines.
EMA and the European Centre for Disease Prevention and Control (ECDC) provide advice on COVID-19 vaccination.
Select the expandable panel below to access a list of joint statements issued to date:
More information on COVID-19 medicines, including other related ETF statements and recommendations:
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:
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:
Chloroquine and hydroxychloroquine are authorised for the treatment of malaria and certain autoimmune diseases.
For more information, see:
