Report side effects of medicines for human use

Getting started

We use the reports of suspected side effects to monitor and assess if there are any signals of new or changed risks that need to be investigated further.  To help us, we encourage you to fill out as many fields as possible so that the information you report can be included in our surveillance activities.

What to include in the adverse reaction report

When you report a suspected adverse reaction to the Danish Medicines Agency, it is important that it includes details about the following:

• An identification of the suspected medicine or active substance, i.e. the name of the medicine (brand name) or the name of the medicine’s active substance(s).
• When a report from a doctor, dentist, prescribing pharmacist or midwife concerns a biological medicine on the list of selected biological medicines published on the website of the Danish Medicines Agency, it should to the extent possible include information about the medicine's name (i.e. the brand name) and batch number.
• A description of the suspected adverse reaction.
• One or more details about the affected patient: date of birth, CPR number (civil registration number), gender, age or initials. A report from a doctor, dentist, prescribing pharmacist or midwife should to the extent possible contain the patient’s CPR number. In other words, doctors, dentists, prescribing pharmacists or midwives who have information about the patient’s CPR number are obliged to disclose the CPR number in the report to the Danish Medicines Agency.
• Identification of the reporter.

In some cases, we may need to obtain additional information for us to be able to assess the report. If so, we will contact you to obtain the necessary information. 

If any significant new information becomes available in relation to suspected side effect previously reported, it is relevant to send the updated information to the Danish Medicines Agency. For instance, this could be results from examinations or new symptoms or changes to the already reported symptoms.

Getting started

We use the reports of suspected side effects to monitor and assess if there are any signals of new or changed risks that need to be investigated further. To help us, we encourage you to fill out as many fields as possible so that the information you report can be included in our surveillance activities.

You can report any suspected side effect of any type of medicine (also vaccines). It doesn’t matter if you obtained it on prescription or bought it over the counter. It is important that you describe the suspected side effect(s) you had in as much detail as possible.

You’ll find it useful to keep to hand the medicine pack or the information about the vaccine you had as you will need it to enter details about the medicine and the company manufacturing it. It is important that you include the medicine’s name (brand name) or the medicine’s active substance in case you don’t know the brand name in the report you send to the Danish Medicines Agency. Details about the vaccine you had can be found in your health record (under Vaccination) at the Danish e-Health Portal sundhed.dk. When you make a report about a vaccine, we’d also like to receive the vaccine batch number. The batch number is registered in your health record under Vaccination at sundhed.dk.

In some cases, we may need to obtain additional information for us to be able to assess the report. If so, we will contact you to obtain the necessary information.

It is also important to report if any significant new information becomes available in relation to suspected side effect previously reported. For instance, this could be results from examinations or new symptoms or changes to the already reported symptoms.

Always contact your doctor if you have side effects

Please note that the Danish Medicines Agency cannot make medical assessments or advise members of the public on personal health and disease matters, nor can we give advice to members of the public about treatment or vaccination.

This means the Danish Medicines Agency cannot advise you on whether to accept a treatment or vaccine offered to you, nor can we tell you if any precautions need to be taken in your case. The Danish Medicines Agency cannot advise members of the public about diagnostic examination, treatment or vaccination. The reason is that it requires a medical assessment.

If you have questions requiring medical assessment, we urge you to contact your GP or attending doctor. Always tell your doctor if you have side effects. Your doctor can tell you if your symptoms are likely to be caused by the medicine you are taking or if they can be explained by other factors. Your doctor can also assess if the side effect means your treatment should be changed. We also urge you to tell your doctor if you get serious symptoms after you commenced treatment with a medicine or had a vaccination.

If you have general questions about the Danish vaccination programme and vaccine strategy, we refer you to the Danish Health Authority and their information at the Danish Health Authority website.

What is a side effect?

A side effect, also called an adverse reaction, is an unwanted reaction of a medicine.

In the package leaflet supplied with the medicine, you can read about the known side effects and how often they occur (known frequencies of side effects).

If a medicine is to be approved, it is decisive that its possible side effects are no worse than the symptoms or the disease that it is intended to treat or prevent. The known side effects and side effect frequencies are also described in the medicine’s authorised summary of product characteristics. The summary of product characteristics is published either on the website of the Danish Medicines Agency (produktresume.dk) or on the website of the European Medicines Agency (www.ema.europa.eu).

Reporting of suspected side effects

When healthcare professionals, members of the public, carers and relatives report side effects to the Danish Medicines Agency, they only need to suspect that the experienced symptoms are side effects caused by a medicine. In other words, a reported suspected side effect does not necessarily mean that there is in fact an established connection between the medicine and the experienced symptoms. The experienced symptoms could, for example, be symptoms of disease with no relation to the medicine, occurring in coincidental temporal association with the medicine. The experienced symptoms could, for example, also be caused by other treatment.

Doctors, dentists, midwives and prescribing pharmacists have a statutory obligation to report suspected side effects to the Danish Medicines Agency, which is laid down in section 4 of the Executive Order on the Reporting of Adverse Drug Reactions of Medicinal Products.  Stricter reporting requirements apply to new, authorised medicines in the first two years of actual placing of the medicine on the market. The stricter reporting requirements mean that doctors, dentists, midwives or prescribing pharmacists have an obligation to report to the Danish Medicines Agency all suspected side effects (except those caused by medication errors) experienced by the patients they are or have been treating. After this period, the reporting obligation applies to all suspected serious or unexpected side effects. However, the Danish Medicines Agency may in special circumstances decide that a medicine should be subject to stricter reporting requirements for a longer period. This is done to gather more knowledge about the side effects of the medicine and to intensify surveillance activities. In the case of generic products, the reporting obligation applies to serious or unexpected suspected serious side effects in patients that the doctor, dentist, midwife or prescribing pharmacist is or has been treating from the date of actual placing of the medicine on the market. Likewise, the Danish Medicines Agency may for a generic medicine, in special circumstances, decide that it should be subject to stricter reporting requirements.

The Danish Medicines Agency keeps an updated list of authorised medicines subject to stricter reporting requirements. The list is published on the website of the Danish Medicines Agency.

All serious adverse reactions must be reported no later than 15 days after the doctor became aware of an occurrence. A serious adverse reaction means a reaction which results in death or is life-threatening, which requires hospitalisation or prolongation of hospitalisation, which results in persistent or significant disability or incapacity, or which is a congenital anomaly or birth defect. An unexpected adverse reaction means an adverse reaction the nature, severity or outcome of which is not mentioned in the medicine’s summary of product characteristics.

Other healthcare professionals can report all suspected adverse reactions to the Danish Medicines Agency, cf. section 6 of the Executive on Reporting of Adverse Reactions.

You or your carer or relative can also report all suspected side effects to the Danish Medicines Agency using the e-form on our website (in Danish only). You can also report a side effect using an adverse reaction report form that you can order by contacting the Danish Medicines Agency and sending it by letter or email. For letters, please send to the address: Danish Medicines Agency, Pharmacovigilance, Axel Heides Gade 1, 2300 Copenhagen S, Denmark; for emails, please submit it to: Send an email.
If you send personal data (about health matters), we recommend you to use secure email if you are using the form (and intend to send it by email). You can find information about secure emails on this page. 

What happens when you report a side effect?

The Danish Medicines Agency monitors and assesses on an ongoing basis if any of the received reports of suspected side effects point to safety signals of new or changed risks that require further investigations.

In some cases, reports may lead to changes in how the side effects are described in the product information or changes in the way you should use the medicine. 

The Danish Medicines Agency collaborates with the European Medicines Agency (EMA) and the drug regulatory authorities in other EU/EEA countries on the safety monitoring of medicines.

The drug regulatory authorities and the medicine manufacturers report suspected side effects of authorised medicines to the EMA’s common European database of side effects. This database provides access to reports of suspected side effects in the entire EU/EEA and reports of suspected side effects from third countries.