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Fundam Clin Pharmacol. 2018 Jun;32(3):330-336. doi: 10.1111/fcp.12343. Epub 2018 Jan 25.

Adverse drug reactions of analgesic medicines: analysis of the Romanian pharmacovigilance database.

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Faculty of Pharmacy, Department of Pharmacology, Physiology and Pathophysiology, University of Medicine and Pharmacy Iuliu Hatieganu, 400012, Cluj-Napoca, Romania.
Pharmacovigilance and Risk Management Service, National Agency for Medicines and Medical Devices, 011478, Bucharest, Romania.
Regional Pharmacovigilance Centre, CHU de Bordeaux, 33076, Bordeaux, France.
Inserm U657, 33076, Bordeaux, France.
University of Bordeaux, 33076, Bordeaux, France.
Faculty of Pharmacy, Department of Toxicology, University of Medicine and Pharmacy Iuliu Hatieganu, 400012, Cluj-Napoca, Romania.


The results of national safety studies are essential for decision-making at the regulatory level and have also educational implications for prescribing patterns. The aim of this study was to analyze the adverse drug reactions (ADRs) of analgesic medicines spontaneously reported to Pharmacovigilance and Risk Management Service of the Romanian National Agency for Medicines and Medical Devices between 2011 and 2015. For the 71 reports, patients had a mean age of 39.8 years; 60.6% of patients were female, and 38% male and 1.4% were unknown. Reporters were mainly physicians (74.7%), and 52.1% of ADR reports were transmitted through marketing authorization holders. Of the serious ADRs (32.4%), 34.7% led to hospitalization or prolonged hospitalization. The most frequent ADRs reported were skin and subcutaneous tissue disorders (25.8%) and general disorders and administration site conditions (19.2%). Metamizole, alone or in combination, was the main analgesic suspected in almost 15.5% of the cases and remains one of the most popular analgesics in Romania. Ten cases were assessed as preventable or potentially preventable (14%), of which two cases were serious. Even if the level of reporting is still low, this study conducted on ADRs of analgesics reported to the national pharmacovigilance center represents an essential step toward promoting the rational use of analgesics in Romania.


Romania; adverse drug reaction; analgesics; metamizole

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