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驴Qu茅 es una reacci贸n adversa grave? | FDA
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<a href="#subscribe" class="btn btn-sm btn-default header-button-subscribe">Subscribe to Email Updates</a> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://www.fda.gov%2Ffda-en-espanol%2Freporte-problemas-serios-la-fda%2Fque-es-una-reaccion-adversa-grave" class="lcds-share__btn lcds-share--default__btn-facebook js-share" id="fb-share" target="_blank"><span class="fa icon-facebook" aria-hidden="true"></span>Share</a> </li> <li class="lcds-share__item"> <a href="https://x.com/intent/tweet/?text=%C2%BFQu%C3%A9%20es%20una%20reacci%C3%B3n%20adversa%20grave%3F&url=https://www.fda.gov%2Ffda-en-espanol%2Freporte-problemas-serios-la-fda%2Fque-es-una-reaccion-adversa-grave" target="_blank" class="lcds-share__btn lcds-share--default__btn-x-twitter js-share" id="twitter-share"> <svg class="icon-svg-inline" aria-hidden="true"> <use href="/themes/custom/preview/assets/images/fa-icons.svg#icon-x-twitter"> </svg> Post </a> </li> <li class="lcds-share__item hidden-xs"> <a href="https://www.linkedin.com/shareArticle?mini=true&url=https://www.fda.gov%2Ffda-en-espanol%2Freporte-problemas-serios-la-fda%2Fque-es-una-reaccion-adversa-grave&title=%C2%BFQu%C3%A9%20es%20una%20reacci%C3%B3n%20adversa%20grave%3F&source=FDA" class="lcds-share__btn lcds-share--default__btn-linkedin js-share" id="linkedin-share" target="_blank"><span class="fa icon-linkedin" aria-hidden="true"></span>Linkedin</a> </li> <li class="lcds-share__item"> <a href="mailto:?subject=%C2%BFQu%C3%A9%20es%20una%20reacci%C3%B3n%20adversa%20grave%3F&body=https://www.fda.gov%2Ffda-en-espanol%2Freporte-problemas-serios-la-fda%2Fque-es-una-reaccion-adversa-grave" class="lcds-share__btn lcds-share--default__btn-mail"><span class="fa icon-envelope" aria-hidden="true"></span>Email</a> </li> <li class=" lcds-share__item hidden-xs"> <a href="javascript:window.print();" title="Print this page" class="lcds-share__btn lcds-share--default__btn-print"><span class="fa icon-print" aria-hidden="true"></span>Print</a> </li> </ul> <div class="form-group"> </div> </div> </div> </section> </header> <div class="col-md-8 col-md-push-2" role="main"> <p><a class="btn btn-default btn-sm" data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="996aa60c-0cf3-4726-a50a-d4775c9fae80" href="/safety/reporting-serious-problems-fda/what-serious-adverse-event" title="What is a Serious Adverse Event?">English</a></p> <p>Una reacci贸n adversa es cualquier experiencia no deseada que se asocia con el uso de un producto m茅dico en un paciente. La reacci贸n se considera grave y debe informarse a la Administraci贸n de Alimentos y Medicamentos de los Estados Unidos (FDA, por su sigla en ingl茅s) cuando las consecuencias en el paciente son las siguientes:</p> <h2>Muerte</h2> <p>Reportar si se sospecha que la muerte fue el resultado de la reacci贸n adversa e incluya la fecha si la conoce. </p> <h2><strong>Emergencia m茅dica con peligro de muerte</strong></h2> <p>Reportar si se sospecha que el paciente corr铆a un grave riesgo de morir en el momento de la reacci贸n adversa o si el uso o el uso constante del dispositivo u otro producto m茅dico podr铆a haber resultado en la muerte del paciente.</p> <h2>Hospitalizaci贸n (inicial o prolongada)</h2> <p>Reportar si el ingreso hospitalario o la prolongaci贸n de la hospitalizaci贸n fue consecuencia de la reacci贸n adversa.<br> Las visitas a la sala de emergencias que no den como resultado el ingreso hospitalario deben evaluarse para uno de los otros resultados graves (p. ej., emergencia m茅dica con peligro de muerte; intervenci贸n requerida para prevenir un deterioro o da帽o permanente; otro evento grave de importancia m茅dica).</p> <h2>Invalidez o da帽o permanente</h2> <p>Reportar si la reacci贸n adversa result贸 en una alteraci贸n considerable de la capacidad de una persona para llevar a cabo las funciones normales de la vida, es decir, la reacci贸n adversa result贸 en un cambio, deterioro, da帽o o interrupci贸n significativos, persistentes o permanentes en la funci贸n/estructura corporal del paciente, actividades f铆sicas o calidad de vida.</p> <h2>Anomal铆a cong茅nita/defecto de nacimiento</h2> <p>Reportar si se sospecha que la exposici贸n a un producto m茅dico antes de la concepci贸n o durante el embarazo puede haber tenido un resultado adverso en el ni帽o.</p> <p>Intervenci贸n requerida para prevenir un deterioro o da帽o permanente (dispositivos)<br> Reportar si se cree que la intervenci贸n m茅dica o quir煤rgica fue necesaria para evitar el deterioro permanente de una funci贸n corporal o prevenir el da帽o permanente a una estructura corporal, cualquiera de las situaciones que se sospeche que se deban al uso de un producto m茅dico.</p> <h2>Otras reacciones graves (eventos m茅dicos importantes)</h2> <p>Reportar cuando la reacci贸n no da como resultado ninguna de las situaciones mencionadas anteriormente, pero puede poner en peligro al paciente y puede requerir una intervenci贸n m茅dica o quir煤rgica (tratamiento) para prevenir tales resultados. Los ejemplos incluyen broncoespasmo al茅rgico (un problema grave con la respiraci贸n) que requiere tratamiento en una sala de emergencias, discrasias sangu铆neas graves (trastornos de la sangre) o ataques/convulsiones que no resultan en hospitalizaci贸n. El desarrollo de la dependencia farmacol贸gica o el abuso del consumo de medicamentos tambi茅n ser铆an ejemplos de eventos m茅dicos importantes.</p> <h2>Recursos</h2> <ul> <li><a href="https://www.accessdata.fda.gov/scripts/medwatch/">Reporte en l铆nea sobre un problema grave con un producto m茅dico</a></li> <li><a href="https://www.safetyreporting.hhs.gov/SRP2/es/Home.aspx?sid=d9b31098-ecec-4b18-b9ae-87c538d49f2e">Reporte problemas con suplementos nutricionales y productos de tabaco en l铆nea</a></li> <li><a href="/media/122470/download">Formulario de la FDA 3500B (Baje el formulario en espa帽ol)</a>.</li> </ul> <!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET--> <!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET--> </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top"> <ul 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