Adverse Drug Reaction Reports in the First Half of 2026

The number of reports of suspected adverse drug reactions received during the first half of 2026 was slightly lower than during the preceding six-month period. A total of 166 reports were received, compared with 172 reports submitted between July and December 2025.

New Database

In December 2025, a new database for receiving and processing adverse reaction reports was implemented. The new system enables reports to be classified and analysed in greater detail than the previous database, which may be relevant when comparing current figures with historical data.

Number of Reports in the First Half of 2026

Of the 166 reports received by the Icelandic Medicines Agency between January and June 2026, 32 were classified as serious and 134 as non-serious. The number of reports received in February deviates somewhat from the pattern observed in other months, particularly with regard to non-serious reports. This is explained by the fact that the Poison Information Centre at Landspítali submitted, in a single batch, reports of incidents that had occurred and been recorded by the Centre over a period of time.

It should be noted that reports of serious adverse drug reactions are of particular importance, although all adverse reaction reports contribute valuable information. Such reports may provide evidence that leads to the reassessment of a medicine's safety profile and effectiveness.

Sources of Reports

Pharmacists submitted the highest number of reports during the six-month period, accounting for 109 reports. Patients submitted 32 reports, physicians submitted 15 reports, and healthcare professionals, other than physicians or pharmacists submitted 9 reports.

Healthcare professionals are reminded that they are legally required to report suspected serious, new, or unexpected adverse reactions experienced by their patients. This obligation is laid down in Article 63 of the Medicines Act, which entered into force at the beginning of 2021.

Reports by Reporter Category

It should be emphasized that these reports concern suspected adverse drug reactions. This means that the reported events occurred following the use of a medicine, but it does not necessarily imply that there is a causal relationship between the medicine and the event.

The number of adverse reaction reports should always be interpreted in the context of the extent of use of the medicine or vaccine concerned.

The Importance of Reporting Adverse Drug Reactions

Adverse reaction reports play a vital role in pharmacovigilance by providing important information about the safety and effectiveness of medicines after they enter routine clinical use. For example, they may reveal adverse reactions that were not detected during clinical trials but become apparent when a medicine is used by larger and more diverse populations. Both members of the public and healthcare professionals are therefore encouraged to report suspected adverse drug reactions to the Icelandic Medicines Agency.

Anyone Can Report a Suspected Adverse Drug Reaction

Reports can be submitted electronically through the reporting portal on the Icelandic Medicines Agency's website. In addition, healthcare professionals may submit reports through the medical records system using the designated adverse reaction reporting form.