Side effects of medicines

Most people will need medicine at some point – either to prevent illness, relieve symptoms, or treat a condition. For some, medicine is essential for survival. Therefore, it is crucial that the medicines we use work as intended and cause as few side effects as possible.

The Danish Medicines Agency monitors the safety of all approved medicines on the Danish market. When evaluating medicines, their benefits are always weighed against the risk of side effects.

For medicines used to treat serious diseases, such as cancer, more severe side effects may be accepted if the treatment has a significant effect. Conversely, stricter requirements apply to side effects for medicines treating less serious conditions, where only mild side effects are typically acceptable.

Report side effects to medicines

Everyone can report side effects to the Danish Medicines Agency. Doctors, dentists, pharmacist prescribers, and midwives have a specific obligation to report. It is important to emphasise that a suspicion of an side effects is sufficient – certainty is not required.

When a new medicine is approved, it has been tested in a limited and carefully selected group of trial participants. This means we have knowledge about the medicine’s effects and the most common side effects, which are described in the package leaflet.

However, when the medicine is used by a large number of patients in everyday practice, other side effects may occur that have not been seen before. To ensure patient safety, it is important that the Danish Medicines Agency becomes aware of these. Reports of side effects therefore play a crucial role.

You can report a suspicion of an side effect here: Report side effects of medicines for human use (danish only)

The medicine’s package leaflet

All medicines come with a package leaflet, which is written for you as a user of the medicine. Here, you can read about the known side effects that may be associated with the treatment.

The package leaflet also explains how the medicine works and how to take it correctly.

You can also find the package leaflets of medicines on the Danish market at www.indlægsseddel.dk (click ‘English version’ at the top). The package leaflets are in Danish only.

The medicine’s summary of product characteristics (SPC)

The  summary of product characteristics (SPC) is written for healthcare professionals and provides a more detailed description of the medicine’s properties and the conditions associated with its use.

You can search for SPCs for medicines on the Danish market at www.produktresume.dk. The SPCs are in Danish only. 

Questions regardinq medicines

The Danish Medicines Agency answers general questions about medicines, including their effects and side effects. For example, the Danish Medicines Agency can inform you whether a symptom you have experienced is a known side effect of your medicine.

The Danish Medicines Agency does not provide clinical assessments of an individual person’s health or illness. If you are unsure whether you have experienced a side effect, or if you need treatment, you should contact your doctor.