How to search the Interactive Adverse Drug Reaction overviews

The interactive ADR overviews are listed in alphabetical order according to the name of the active substance of the medicine or vaccine. Consequently, you can only search for an active substance and not the brand name of the medicine. You can find the name of the medicine’s active substance on the package or in the package leaflet. If the brand name of the medicine is mentioned in the report, it will appear from a summary at the beginning of the ADR overview.

When you search for a particular active substance, you will see a brief summary of your search.

The summary provides information on:

• The total number of ADR reports and the total number of adverse reactions for the medicine/active substance you have searched for
• The number of serious ADR reports and the number of fatal ADR reports

A report may include a description of several different symptoms or suspected adverse reactions. Consequently, the number of adverse reactions may be higher than the number of reports.

The ADR overview appears below the summary in graphs and tables according to the selected filter options.

You can search for different data in the reports, e.g.:

• How many reports concern men/women - Gender
• How many reports concern children/adults - Age group (ten-year bands)
• When was the report submitted to the Danish Medicines Agency - Year received
• Who reported the adverse reaction - Type of reporter (patient/relative and/or healthcare professional)
• How was the medicine taken - Route of administration (e.g. oral use)
• How serious is the reported adverse reaction - Seriousness and fatal outcome (see the seriousness criteria below)
• Where in the body did the symptoms/adverse reaction occur – Organ class (e.g. cardiac disorders, gastrointestinal disorders etc.)

In accordance with international criteria, the Danish Medicines Agency defines an adverse reaction report as serious if the condition requires hospitalisation or prolongation of hospitalisation, results in persistent or significant disability or incapacity, birth defects, congenital anomaly, or is life-threatening or results in death.

The ADR overview displays a table of all the reported adverse reactions by system organ class.

The system organ classes are based on the MedDRA system (Medical Dictionary for Regulatory Activities). MedDRA is a standardised international medical terminology designed to support detailed and uniform descriptions of medical information.

MedDRA is used for the coding of suspected adverse reactions, indications and the like in connection with the reporting of adverse reactions to the authorities. MedDRA is not available in Danish so most of the terminology in the overview is in English.

All the data in the ADR overviews come from the Danish Medicines Agency’s pharmacovigilance database. The cases have been sent to all relevant pharmaceutical companies and to the EudraVigilance database under the European Medicines Agency (EMA).

Consequently, the pharmaceutical companies should not report these cases of suspected adverse reactions to the Danish Medicines Agency.

The Danish Medicines Agency does not disclose the identification numbers of the adverse reaction reports that form the basis of the information in the ADR overviews.