Reporting side effects

What is a side effect?

A side effect is any unwanted medical occurrence in a patient who has been given a pharmaceutical product that may or may not have been caused by treatment with the product. A side effect can therefore be any unfavorable and unintended sign, symptom, or disease associated with the use of the product.

Why report side effects?

By reporting side effects you help us to ensure the safety of our products and our patients. Your information will also enable us to fulfill our reporting responsibilities to health authorities, which requires that we provide information on side effects with our products – even in cases where a relationship between the product and the effect is not established.

If you or the person you are reporting on behalf of are currently suffering from severe side effects you should contact your local doctor or other medical health professional before reporting the side effect.

How to report side effects?
The reporting of side effects is normally carried out by healthcare professionals, and you are therefore recommended to speak with a healthcare professional, such as your doctor or pharmacist. Increasingly, patients are able to report suspected side effects directly through various methods such as online patient reporting forms hosted by national medicines regulatory authorities or by telephone.

If you are experiencing a side effect or think you may be experiencing one, you should seek advice from a healthcare professional. The European Medicines Agency cannot accept side-effect reports directly from patients or consumers. The Agency is also not in a position to provide individual medical advice or to confirm whether your symptoms are being caused by your medicine.