{"id":461,"date":"2014-04-30T08:20:14","date_gmt":"2014-04-30T08:20:14","guid":{"rendered":"http:\/\/eurekainfomed.it\/?p=461"},"modified":"2026-08-03T14:29:50","modified_gmt":"2026-08-03T14:29:50","slug":"more-than-one-million-adverse-reactions","status":"publish","type":"post","link":"https:\/\/eurekainfomed.it\/en\/more-than-one-million-adverse-reactions\/","title":{"rendered":"More than one million adverse reactions"},"content":{"rendered":"<p>With more than <strong>one million post-marketing adverse reaction reports<\/strong> recorded in 2013, Europe reached a new annual record for adverse event reporting. These data were published in the second <strong><a href=\"&quot;http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Report\/2014\/04\/WC500165&lt;\/strong\"> released in April.<\/p>\n<p><!--more--><\/a><\/strong><\/p>\n<h4><strong>How the statistics have changed in the adverse reaction report<\/strong><\/h4>\n<p>In 2013, reports submitted to <strong>EudraVigilance<\/strong> increased by 26% compared with the previous year. Patients made a particularly important contribution to this increase, submitting 30,614 reports, approximately 10,000 more than in 2012.<\/p>\n<p>The number of reports analyzed by EudraVigilance is even higher because, in addition to the one million reports related to products already on the market, the database also collects approximately <strong>six million adverse reactions reported from clinical trials<\/strong> that were ongoing in 2013.<\/p>\n<p>It should be noted that not all reports submitted to EudraVigilance result in a safety signal. The analysis of the reports received led to the prioritization and assessment of 100 safety signals by the <strong>Pharmacovigilance Risk Assessment Committee (PRAC)<\/strong>, including 43 signals detected and validated by the EMA and 57 by the European Member States.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>With more than one million post-marketing adverse reaction reports recorded in 2013, Europe reached a new annual record for adverse event reporting. These data were published in the second released&#8230;<\/p>\n","protected":false},"author":1,"featured_media":469,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[25,4],"tags":[],"class_list":["post-461","post","type-post","status-publish","format-standard","has-post-thumbnail","category-pharmacovigilance","category-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>More than one million adverse reactions<\/title>\n<meta name=\"description\" content=\"According to data published in the second EudraVigilance Annual Report, Europe recorded a new annual high in adverse reaction reporting.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/eurekainfomed.it\/en\/more-than-one-million-adverse-reactions\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"More than one million adverse reactions\" \/>\n<meta property=\"og:description\" content=\"According to data published in the second EudraVigilance Annual Report, Europe recorded a new annual high in adverse reaction reporting.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/eurekainfomed.it\/en\/more-than-one-million-adverse-reactions\/\" \/>\n<meta property=\"og:site_name\" content=\"Eureka Info Med\" \/>\n<meta property=\"article:published_time\" content=\"2014-04-30T08:20:14+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-08-03T14:29:50+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/eurekainfomed.it\/en\/wp-content\/uploads\/2014\/04\/EudraVigilance-2013-adr-report.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1150\" \/>\n\t<meta property=\"og:image:height\" content=\"580\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"admin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"admin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/eurekainfomed.it\\\/en\\\/more-than-one-million-adverse-reactions\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/eurekainfomed.it\\\/en\\\/more-than-one-million-adverse-reactions\\\/\"},\"author\":{\"name\":\"admin\",\"@id\":\"https:\\\/\\\/eurekainfomed.it\\\/en\\\/#\\\/schema\\\/person\\\/ca409c130f9741e5a586ec422bb0a39a\"},\"headline\":\"More than one million adverse reactions\",\"datePublished\":\"2014-04-30T08:20:14+00:00\",\"dateModified\":\"2026-08-03T14:29:50+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/eurekainfomed.it\\\/en\\\/more-than-one-million-adverse-reactions\\\/\"},\"wordCount\":168,\"image\":{\"@id\":\"https:\\\/\\\/eurekainfomed.it\\\/en\\\/more-than-one-million-adverse-reactions\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/eurekainfomed.it\\\/en\\\/wp-content\\\/uploads\\\/2014\\\/04\\\/EudraVigilance-2013-adr-report.jpg\",\"articleSection\":[\"Pharmacovigilance\",\"News\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/eurekainfomed.it\\\/en\\\/more-than-one-million-adverse-reactions\\\/\",\"url\":\"https:\\\/\\\/eurekainfomed.it\\\/en\\\/more-than-one-million-adverse-reactions\\\/\",\"name\":\"More than one million adverse reactions\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/eurekainfomed.it\\\/en\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/eurekainfomed.it\\\/en\\\/more-than-one-million-adverse-reactions\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/eurekainfomed.it\\\/en\\\/more-than-one-million-adverse-reactions\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/eurekainfomed.it\\\/en\\\/wp-content\\\/uploads\\\/2014\\\/04\\\/EudraVigilance-2013-adr-report.jpg\",\"datePublished\":\"2014-04-30T08:20:14+00:00\",\"dateModified\":\"2026-08-03T14:29:50+00:00\",\"author\":{\"@id\":\"https:\\\/\\\/eurekainfomed.it\\\/en\\\/#\\\/schema\\\/person\\\/ca409c130f9741e5a586ec422bb0a39a\"},\"description\":\"According to data published in the second EudraVigilance Annual Report, Europe recorded a new annual high in adverse reaction reporting.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/eurekainfomed.it\\\/en\\\/more-than-one-million-adverse-reactions\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/eurekainfomed.it\\\/en\\\/more-than-one-million-adverse-reactions\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/eurekainfomed.it\\\/en\\\/more-than-one-million-adverse-reactions\\\/#primaryimage\",\"url\":\"https:\\\/\\\/eurekainfomed.it\\\/en\\\/wp-content\\\/uploads\\\/2014\\\/04\\\/EudraVigilance-2013-adr-report.jpg\",\"contentUrl\":\"https:\\\/\\\/eurekainfomed.it\\\/en\\\/wp-content\\\/uploads\\\/2014\\\/04\\\/EudraVigilance-2013-adr-report.jpg\",\"width\":1150,\"height\":580,\"caption\":\"ema eudravigilance adverse reactions report\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/eurekainfomed.it\\\/en\\\/more-than-one-million-adverse-reactions\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/eurekainfomed.it\\\/en\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"More than one million adverse reactions\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/eurekainfomed.it\\\/en\\\/#website\",\"url\":\"https:\\\/\\\/eurekainfomed.it\\\/en\\\/\",\"name\":\"Eureka Info Med\",\"description\":\"documentazione medico-scientifica e farmacovigilanza\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/eurekainfomed.it\\\/en\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/eurekainfomed.it\\\/en\\\/#\\\/schema\\\/person\\\/ca409c130f9741e5a586ec422bb0a39a\",\"name\":\"admin\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/009e20f21b91cfd0cd6677ff27909f5f0d8115fedc68149e2f06dbadfdbe12f8?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/009e20f21b91cfd0cd6677ff27909f5f0d8115fedc68149e2f06dbadfdbe12f8?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/009e20f21b91cfd0cd6677ff27909f5f0d8115fedc68149e2f06dbadfdbe12f8?s=96&d=mm&r=g\",\"caption\":\"admin\"},\"url\":\"https:\\\/\\\/eurekainfomed.it\\\/en\\\/author\\\/claudiospada\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"More than one million adverse reactions","description":"According to data published in the second EudraVigilance Annual Report, Europe recorded a new annual high in adverse reaction reporting.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/eurekainfomed.it\/en\/more-than-one-million-adverse-reactions\/","og_locale":"en_US","og_type":"article","og_title":"More than one million adverse reactions","og_description":"According to data published in the second EudraVigilance Annual Report, Europe recorded a new annual high in adverse reaction reporting.","og_url":"https:\/\/eurekainfomed.it\/en\/more-than-one-million-adverse-reactions\/","og_site_name":"Eureka Info Med","article_published_time":"2014-04-30T08:20:14+00:00","article_modified_time":"2026-08-03T14:29:50+00:00","og_image":[{"width":1150,"height":580,"url":"https:\/\/eurekainfomed.it\/en\/wp-content\/uploads\/2014\/04\/EudraVigilance-2013-adr-report.jpg","type":"image\/jpeg"}],"author":"admin","twitter_card":"summary_large_image","twitter_misc":{"Written by":"admin","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/eurekainfomed.it\/en\/more-than-one-million-adverse-reactions\/#article","isPartOf":{"@id":"https:\/\/eurekainfomed.it\/en\/more-than-one-million-adverse-reactions\/"},"author":{"name":"admin","@id":"https:\/\/eurekainfomed.it\/en\/#\/schema\/person\/ca409c130f9741e5a586ec422bb0a39a"},"headline":"More than one million adverse reactions","datePublished":"2014-04-30T08:20:14+00:00","dateModified":"2026-08-03T14:29:50+00:00","mainEntityOfPage":{"@id":"https:\/\/eurekainfomed.it\/en\/more-than-one-million-adverse-reactions\/"},"wordCount":168,"image":{"@id":"https:\/\/eurekainfomed.it\/en\/more-than-one-million-adverse-reactions\/#primaryimage"},"thumbnailUrl":"https:\/\/eurekainfomed.it\/en\/wp-content\/uploads\/2014\/04\/EudraVigilance-2013-adr-report.jpg","articleSection":["Pharmacovigilance","News"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/eurekainfomed.it\/en\/more-than-one-million-adverse-reactions\/","url":"https:\/\/eurekainfomed.it\/en\/more-than-one-million-adverse-reactions\/","name":"More than one million adverse reactions","isPartOf":{"@id":"https:\/\/eurekainfomed.it\/en\/#website"},"primaryImageOfPage":{"@id":"https:\/\/eurekainfomed.it\/en\/more-than-one-million-adverse-reactions\/#primaryimage"},"image":{"@id":"https:\/\/eurekainfomed.it\/en\/more-than-one-million-adverse-reactions\/#primaryimage"},"thumbnailUrl":"https:\/\/eurekainfomed.it\/en\/wp-content\/uploads\/2014\/04\/EudraVigilance-2013-adr-report.jpg","datePublished":"2014-04-30T08:20:14+00:00","dateModified":"2026-08-03T14:29:50+00:00","author":{"@id":"https:\/\/eurekainfomed.it\/en\/#\/schema\/person\/ca409c130f9741e5a586ec422bb0a39a"},"description":"According to data published in the second EudraVigilance Annual Report, Europe recorded a new annual high in adverse reaction reporting.","breadcrumb":{"@id":"https:\/\/eurekainfomed.it\/en\/more-than-one-million-adverse-reactions\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/eurekainfomed.it\/en\/more-than-one-million-adverse-reactions\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/eurekainfomed.it\/en\/more-than-one-million-adverse-reactions\/#primaryimage","url":"https:\/\/eurekainfomed.it\/en\/wp-content\/uploads\/2014\/04\/EudraVigilance-2013-adr-report.jpg","contentUrl":"https:\/\/eurekainfomed.it\/en\/wp-content\/uploads\/2014\/04\/EudraVigilance-2013-adr-report.jpg","width":1150,"height":580,"caption":"ema eudravigilance adverse reactions report"},{"@type":"BreadcrumbList","@id":"https:\/\/eurekainfomed.it\/en\/more-than-one-million-adverse-reactions\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/eurekainfomed.it\/en\/"},{"@type":"ListItem","position":2,"name":"More than one million adverse reactions"}]},{"@type":"WebSite","@id":"https:\/\/eurekainfomed.it\/en\/#website","url":"https:\/\/eurekainfomed.it\/en\/","name":"Eureka Info Med","description":"documentazione medico-scientifica e farmacovigilanza","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/eurekainfomed.it\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/eurekainfomed.it\/en\/#\/schema\/person\/ca409c130f9741e5a586ec422bb0a39a","name":"admin","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/009e20f21b91cfd0cd6677ff27909f5f0d8115fedc68149e2f06dbadfdbe12f8?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/009e20f21b91cfd0cd6677ff27909f5f0d8115fedc68149e2f06dbadfdbe12f8?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/009e20f21b91cfd0cd6677ff27909f5f0d8115fedc68149e2f06dbadfdbe12f8?s=96&d=mm&r=g","caption":"admin"},"url":"https:\/\/eurekainfomed.it\/en\/author\/claudiospada\/"}]}},"_links":{"self":[{"href":"https:\/\/eurekainfomed.it\/en\/wp-json\/wp\/v2\/posts\/461","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eurekainfomed.it\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eurekainfomed.it\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eurekainfomed.it\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/eurekainfomed.it\/en\/wp-json\/wp\/v2\/comments?post=461"}],"version-history":[{"count":2,"href":"https:\/\/eurekainfomed.it\/en\/wp-json\/wp\/v2\/posts\/461\/revisions"}],"predecessor-version":[{"id":43561,"href":"https:\/\/eurekainfomed.it\/en\/wp-json\/wp\/v2\/posts\/461\/revisions\/43561"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/eurekainfomed.it\/en\/wp-json\/wp\/v2\/media\/469"}],"wp:attachment":[{"href":"https:\/\/eurekainfomed.it\/en\/wp-json\/wp\/v2\/media?parent=461"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eurekainfomed.it\/en\/wp-json\/wp\/v2\/categories?post=461"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eurekainfomed.it\/en\/wp-json\/wp\/v2\/tags?post=461"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}