Danish Medicines Agency publishes annual medical cannabis safety report – no new safety signals identified

STENOCARE A/S NASDAQ FIRST NORTH GROWTH MARKET, DENMARK TICKER:  STENO STENOCARE A/S (“STENOCARE”) today highlights the newly published annual report from the Danish Medicines Agency on suspected adverse reactions and the use of medical cannabis products in Denmark during 2025. The report for 2025 shows only three suspected adverse reaction cases, no identified signals of new or changed safety risks, and a significant increase in the use of medical cannabis, with 22,410 prescriptions dispensed to 2,465 patients.

The Danish Medicines Agency has published their annual report for all reported and suspected adverse reactions from medical cannabis products. According to the report, the Danish Medicines Agency received only three reports of suspected adverse reactions related to medical cannabis products during 2025. Following its assessment of the reported cases, the Agency concluded that no signals of new or changed safety risks were identified.

The report is published as part of the Danish Medicines Agency’s ongoing monitoring of the safety and use of medical cannabis in Denmark.

Three suspected adverse reaction reported during 2025

Two of the three reports concerned suspected serious adverse reactions, while one concerned suspected non-serious adverse reactions. The Danish Medicines Agency stated that all reported suspected adverse reactions were already known from approved medicines containing medical cannabis.

Furthermore, no suspected manufacturing quality-related adverse reactions were identified during the period, and the reports did not give rise to any additional risk mitigation measures.

The number of adverse reaction reports was unchanged from 2024, despite a significant increase in the use of medical cannabis during 2025.

Growing use provides perspective on the safety data

The annual report also provides updated information about the use of medical cannabis in Denmark and thereby puts the safety reporting into perspective.

During 2025, a total of 22.410 prescriptions for medical cannabis products were sold to 2.465 patients in Denmark. Compared with 2024, this represents an increase of 64% in the number of prescriptions and 54% in the number of patients. In 2024, 13.665 prescriptions were sold to 1.605 patients.

During 2025, Danish patients had access to 13 different medical cannabis products under the Danish Pilot Programme.

The combination of increasing use and continued safety monitoring provides important context for understanding the development of medical cannabis treatment in Denmark.

Permanent medical cannabis legalisation from 2026

The Danish medical cannabis pilot programme was introduced in 2018 and became a permanent medical cannabis legalisation on 1 January 2026.

The newly published report therefore provides the final full-year safety and usage data from the period immediately preceding the transition to the permanent framework.

Thomas Skovlund Schnegelsberg, CEO of STENOCARE, comments:

“The annual report from the Danish Medicines Agency provides important information about the safety of medical cannabis in Denmark. Despite a substantial increase in the number of patients and prescriptions during 2025, only three suspected adverse reaction cases were reported, and importantly, the Danish Medicines Agency identified no signals of new or changed safety risks.

The continued systematic monitoring by the Danish Medicines Agency is important for patients, physicians and the medical cannabis sector. In the annual report, the Agency also considers that adverse reactions might be underreported and will therefore maintain focus on reminding physicians of their reporting obligations. This is an important part of ensuring continued and robust safety monitoring.

The fact that the report documents increasing use gives valuable perspective on the extent of treatment in Denmark as the country has now transitioned from the pilot programme to permanent legalisation.”

About the reported cases

The three suspected adverse reaction reports received during 2025 related to treatment for neuropathic pain in two cases and appetite stimulation in one case. The patients were between 21 and 82 years old at the time the suspected adverse reactions occurred.

The full annual report from the Danish Medicines Agency is available in Danish: https://laegemiddelstyrelsen.dk/da/special/medicinsk-cannabis/ordningen-med-medicinsk-cannabis/cannabisprodukter-i-ordningen/bivirkninger-og-sikkerhed-ved-medicinsk-cannabis/~/media/77C8A32A60B9459984B4AF9AA35722D3.ashx