{"id":7482,"date":"2022-12-14T16:34:21","date_gmt":"2022-12-14T16:34:21","guid":{"rendered":"https:\/\/cinmed.me\/farmakovigilanca\/lista-ozbiljnih-nezeljenih-dejstava\/"},"modified":"2026-03-24T09:14:21","modified_gmt":"2026-03-24T08:14:21","slug":"list-of-serious-adverse-reactions","status":"publish","type":"page","link":"https:\/\/cinmed.me\/en\/pharmacovigilance\/list-of-serious-adverse-reactions\/","title":{"rendered":"List of serious adverse reactions"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7482\" class=\"elementor elementor-7482 elementor-3425\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-b1cc3b4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b1cc3b4\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-wider\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-b11a068\" data-id=\"b11a068\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-24bc737 elementor-widget elementor-widget-image\" data-id=\"24bc737\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"522\" src=\"https:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/6.-lista-ozbiljnih-nezeljenih-dejstava-finalna-slika-1024x522.png\" class=\"attachment-large size-large wp-image-8809\" alt=\"lista ozbiljnih nezeljenih dejstava\" srcset=\"https:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/6.-lista-ozbiljnih-nezeljenih-dejstava-finalna-slika-1024x522.png 1024w, https:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/6.-lista-ozbiljnih-nezeljenih-dejstava-finalna-slika-300x153.png 300w, https:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/6.-lista-ozbiljnih-nezeljenih-dejstava-finalna-slika-768x391.png 768w, https:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/6.-lista-ozbiljnih-nezeljenih-dejstava-finalna-slika.png 1201w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cb5dca3 elementor-widget elementor-widget-text-editor\" data-id=\"cb5dca3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>According to the <a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2026\/02\/Law-on-medicinal-products_-eng.pdf\" target=\"_blank\" rel=\"noopener\">Law on Medicinal Products<\/a>, <strong>serious adverse reaction<\/strong> to a medicine is any adverse reaction that can cause death, is life-threatening, hospitalization or prolongation of hospitalization if for that there was no need before the usage of medicine, permanent or significant impairment or disability, congenital anomalies or distortions during nursing and other medically significant condition.<\/p><p><strong>Important Medical Event Terms-IME List<\/strong>, created on the initiative of EudraVigilance Expert Working Group, EV-EWG, is a guideline aimed at facilitating classification, analysis and assessment of collected data on adverse reactions. Important medical events from this list are marked by CS (Core Serious) and are considered adverse serious reactions even when they are not precisely defined by basic seriousness criteria.\u00a0\u00a0<\/p><p>IME list is based on coding of adverse reactions by using <strong>Medical\u00a0 Dictionary for Regulatory Activities (MedDRA)<\/strong>.<\/p><p>Coding by using MedDRA is a result of the need for terminology standardisation in communication between regulatory authorities and pharmaceutical companies. Important medical events are given in the IME list according to the PT (Preferred Terms) coding level by using MedDRA. This coding level is commonly used to search database, as well as for data analysis. Seriousness of adverse reaction coded at LLT (Lowest Level Terms) level is determined on the basis of corresponding\u00a0 PT term according to the MedDRA hierarchy. IME list is updated in accordance with current version of MedDRA.<\/p><p>Latest IME List is available <a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2026\/03\/meddra-important-medical-event-terms-list-version-29-0_en.xlsx\" target=\"_blank\" rel=\"noopener\">here<\/a>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-e991f61\" data-id=\"e991f61\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-869e352 elementor-widget elementor-widget-shortcode\" data-id=\"869e352\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t    <div class=\"sidebar-menu-wrapper\">\r\n        <div class=\"sidebar-menu-header\">\r\n            <img decoding=\"async\" class=\"sidebar-menu-header-icon\" src=\"\/wp-content\/uploads\/2022\/11\/4.png\" \/>\r\n            <P><a class=\"sidebar-menu-header-title\" href=\"\">Pharmacovigilance<\/a><\/P>\r\n        <\/div>\r\n        <div class=\"sidebar-items-background\">\r\n            <div class=\"sidebar-items-wrapper\">\r\n                <div class=\"menu-farmakovigilanca-container\"><ul id=\"menu-farmakovigilanca\" class=\"list-none\t\"><li id=\"menu-item-7342\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7342 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/farmakovigilanca\/osnovni-pojmovi\/\">General information<\/a><\/li>\n<li id=\"menu-item-7343\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7343 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition 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list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/farmakovigilanca\/godisnji-izvjestaji\/\">Annual reports<\/a><\/li>\n<\/ul><\/div>            <\/div>\r\n        <\/div>\r\n    <\/div>\r\n\t\t<div class=\"elementor-shortcode\"><\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f4f6c46 elementor-widget elementor-widget-text-editor\" data-id=\"f4f6c46\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\n<div class=\"overflow-hidden relative p-6 text-white rounded-2xl shadow-md bg-primary\">\n\t<div class=\"mb-5\">\n\t\t<div class=\"flex gap-3 justify-between items-center mb-2\">\n\t\t\t<h2 class=\"text-2xl font-bold tracking-tight leading-tight text-white\">\n\t\t\t\tFind medicines <span class=\"font-normal text-[#fbf2db]\"> and medical devices<\/span>\t\t\t<\/h2>\n\t\t\t<div class=\"flex relative z-20 flex-shrink-0 gap-1.5 items-center\">\n\t\t\t\t<button type=\"button\" class=\"flex relative z-10 justify-center items-center w-8 h-8 text-white rounded-full transition-all duration-200 cursor-pointer sidebar-register-prev bg-white\/20 hover:bg-white hover:text-primary shadow-xs focus:outline-none\" aria-label=\"Previous register\">\n\t\t\t\t\t<svg class=\"w-4 h-4 pointer-events-none\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" viewBox=\"0 0 24 24\"><path stroke-linecap=\"round\" stroke-linejoin=\"round\" d=\"M15 19l-7-7 7-7\"\/><\/svg>\n\t\t\t\t<\/button>\n\t\t\t\t<button type=\"button\" class=\"flex relative z-10 justify-center items-center w-8 h-8 text-white rounded-full transition-all duration-200 cursor-pointer sidebar-register-next bg-white\/20 hover:bg-white hover:text-primary shadow-xs focus:outline-none\" aria-label=\"Next register\">\n\t\t\t\t\t<svg class=\"w-4 h-4 pointer-events-none\" 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src=\"https:\/\/cinmed.me\/wp-content\/themes\/cinmed\/images\/medical_services.png\" alt=\"Database of medicines for human use\">\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<h3 class=\"mb-2 text-xl font-bold leading-snug\" style=\"color: rgb(221, 111, 16);\">\n\t\t\t\t\t\t\t<a class=\"relative z-20 transition-colors duration-200 hover:!text-[#c25e1a] !no-underline hover:!no-underline\" style=\"color: inherit;\" href=\"\/en\/register-of-medicines-for-human-use\/\">\n\t\t\t\t\t\t\t\tHuman medicines database\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t<\/h3>\n\t\t\t\t\t\t<p class=\"flex-grow mb-6 text-sm leading-relaxed text-gray-600\">Search authorised human medicines<\/p>\n\t\t\t\t\t\t<a class=\"relative z-20 inline-flex items-center gap-2 mt-auto font-semibold text-sm !text-[#E37222] hover:!text-[#c25e1a] !cursor-pointer transition-colors duration-200 !no-underline hover:!no-underline group\" href=\"\/en\/register-of-medicines-for-human-use\/\">\n\t\t\t\t\t\t\t<span>Search 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