Infarmed reports 12,349 suspected adverse drug reactions in 2025

The National Pharmacovigilance System (SNF) recorded 12,349 notifications of suspected adverse drug reactions in 2025, representing a 9.2% increase compared to 2024. Infarmed attributes this rise to increased engagement from both healthcare professionals and citizens following awareness efforts.

According to the 2025 SNF Activity Report, 59.1% of cases were classified as serious. Márcia Silva, Director of Pharmacovigilance at Infarmed, noted that this figure is lower than the European average of 75% reported by EudraVigilance. Silva explained that the classification of serious cases often reflects the impact on the user's life and that Infarmed maintains the classification provided by the notifier even if there is disagreement. While some cases involve death, the system notes that a death does not automatically imply causality between the medication and the outcome; such relationships are subject to further evaluation and integration into European-level data.