Report side effects in humans from medicines and vaccines

Updated 14 January 2016

For healthcare professionals

Report adverse drug reaction from human medicines – for healthcare professionals

Report adverse drug reaction from human vaccines – for healthcare professionals


For medicine users and relatives

  1. Ask your doctor or pharmacist for advice
  2. Report side effects: report a side effect from human medicines - for medicine users and relatives

You can report side effects from all types of medicines (incl. vaccines) and herbal medicines, etc.

It does not matter if you or your relative bought them over-the-counter or on prescription from a doctor.

Our e-forms do not work with Internet Explorer 6. Alternatively you can use Firefox.

If for some reason you cannot use our e-forms, please call us on +45 4488 9595 or send an email to adr@dkma.dk.

We are also happy to send you a copy of the form by email or ordinary post. If you wish, you can also send us the side effect report by ordinary post or fax.

Always contact your doctor if you have side effects

You should always tell your doctor or dentist if you have side effects. Your doctor or dentist can determine whether the side effect means that your treatment needs to be changed.

They can also provide information from your health record, which is helpful to evaluate your side effect.

What is a side effect?

A side effect is an unwanted effect of your medicine. It could be:

  • Headache
  • Stomach ache
  • Cramps
  • Effects on liver and kidneys.

The package leaflet supplied with your medicine informs you of already known side effects.

What happens to the side effects that are reported?

At the Danish Medicines Agency we evaluate the reports we receive.

Sometimes, the instructions on how to take your medicine may be changed as a result. We also pass on the information to pharmaceutical authorities in all countries of the EU. This way, as many people as possible benefit from the information.