Adverse drug reactions of non-opioid and opioid analgesics reported to Croatian national authority from 2007 to 2014

Petra Sunara, Darko Krnic, Livia Puljak


Objective. Adverse drug reactions (ADRs) are commonly observed in the health services because of system weaknesses and individual errors. Analgesics are widely used and it can be expected that with the increased use one can expect increased number of ADRs of analgesics. The aim of this study was to analyze ADRs of non-opioid and opioid analgesics reported to the Croatian Agency for Medicinal Products and  Medical Devices (HALMED) from  2007  to 2014.  Methods. HALMED provided data on generic drug name, year of the ADR re- port, type of report, institution, reporting person, patient’s age, sex and ADR type. Results. In the analyzed period 796 ADRs of analgesics were reported, of which 367 (46%) were serious ADRs. Number of ADR reports was continuously increasing during the analyzed period. There were 20 analgesics that had ≥5 reports, making 597 (75%) of all ADR reports for analgesics. The most common adverse reaction re- ports of those 20 analgesics referred to individual drugs (n=16; 80%). Most of the ADR reports were filed by physicians (n=257; 43%), fol- lowed by pharmacists (n=252; 42%). Most side effects (n=572; 96%) were reported spontaneously through appropriate forms by patients or health professionals. ADRs were most commonly reported in wom- en (n=352; 59%) and most of them have occurred in adults (n=354; 59%). The most common ADRs of opioid and non-opioid analgesics have been reported on the skin and mucous membranes. Most serious ADRs were result of action of opioid analgesics. Conclusion. Num- ber of ADR reports in Croatia is continuously increasing and a consid- erable number of them refers to serious ADRs. To keep better track of medications and ADRs it is necessary to educate and encourage health professionals and patients in reporting side effects


Adverse drug reactions ; Opioids ; Non-opioids ; Analgesics ; Croatia



  • There are currently no refbacks.

2019 Department of Medical Sciences, Academy of Sciences and Arts of Bosnia and Herzegovina, Sarajevo, Bosnia and Herzegovina. All rights reserved.
The full text of articles published in this journal can be used free of charge for personal and educational purposes while respecting authors and publishers’ copyrights. For commercial purposes no part of this journal may be reproduced without the written permission of the publisher.