Updated 16 November 2016
- Reports of suspected adverse reactions only
When doctors, patients and relatives report an adverse drug reaction to the Danish Medicines Agency, they only need to have a suspicion that the medicine may have caused the symptoms experienced. Consequently, a report of a suspected adverse reaction does not necessarily mean that the medicine caused the reaction.
- Assessment of relationship with medicines is based on many aspects
Many aspects need to be considered when assessing whether a particular medicine has caused an adverse reaction. When the Danish Medicines Agency monitors the safety of medicines, we analyse all aspects thoroughly.
- Information about known adverse reactions is available in the product information
The ADR overviews do not present a complete summary of the risks associated with the use of medicines. Conclusions on the safety and risks of medicines cannot be made on the basis of the information in the interactive ADR overviews alone. You can read more about known adverse reactions for a particular medicine in the package leaflet or the summary of product characteristics.
- The overviews do not reflect the risk of adverse reactions
The ADR overviews cannot be used to assess how great the risk is of having an adverse drug reaction from a particular type of medicine. The reasons are that there is limited information about how many people have taken a particular type of medicine without experiencing an adverse reaction and that not all suspected adverse reactions are reported to the Danish Medicines Agency.
- The figures in the various ADR overviews cannot be used to compare risks
The safety of various medicines cannot be compared by comparing the figures presented in the interactive ADR overviews. The number of suspected adverse reactions reported for individual medicines vary greatly. A report may also concern several medicinal products and will appear from several ADR overviews
- If you have any questions as to the medicine you are taking, please contact your doctor
Are you concerned about the medicine you are taking, please contact the doctor who prescribed the medicine or the pharmacy. You should not stop taking any prescribed medicine without talking to your doctor.