This database allows you to browse and view data on suspected side-effects from various medicinal products (also known as suspected adverse drug reactions (“ADRs”)). All data contained herein is sourced from VigiBase®, the World Health Organization’s (the “WHO”) global database for ADRs, maintained by the Uppsala Monitoring Centre (the “UMC”). The UMC is the WHO Collaborating Centre for International Drug Monitoring based in Uppsala, Sweden providing scientific leadership and operative support to the WHO Program for International Drug Monitoring (www.who-umc.org).
The data contains reports of suspected ADRs, so called Individual Case Safety Reports (ICSRs), collected by national drug authorities in over 110 countries and span over more than 100 000 different medicinal products. Thus, this database is only a repository of ICSRs provided for VigiBase®, and shall not be considered as a systematic register of ADRs that have occurred or may occur.
The volume of ICSRs for a particular medicinal product may be influenced by many different factors, including but not limited to the extent of use of the product, publicity and the nature of the reactions. No information is provided on the number of patients exposed to a particular product, and it is therefore, based on the ICSRs, not possible to calculate frequency of any ADR. Moreover, collection of data is, due to e.g. differing national legislation and policies, heterogeneous between different countries. For these reasons, any interpretation of ADR data, and particularly those based on comparisons between various medicinal products, may be misleading.
Information on suspected ADR should not be interpreted as meaning that the medicinal product in question, or the active substance(s), generally causes the observed effect or is unsafe to use. Any robust conclusion with regard to benefits and risks of a specific medicinal product always requires detailed evaluation and scientific assessment of all available data. The balance between benefit and risk of a specific medicinal product also varies between individual patients.
If you think that you may be experiencing a side-effect from a medicinal product, please seek advice from a health professional as soon as possible. Never stop or change the dose for prescription medicines without consulting your physician.
VigiAccess supports the current and the prior major release of the Chrome-, Firefox-, Internet Explorer- and Safari browsers. The application will not work with unsupported browsers. Older browser versions may have security- and performance issues.
About the release of this data:
The UMC takes great care to ensure that the data contained herein is an accurate record of data collected by the national drug authorities and transmitted to the UMC. The UMC does, however, not guarantee, warrant or make any representation whatsoever regarding the data contained herein, including but not limited to guarantees, warranties or representations of accuracy, reliability, completeness, currency, suitability, fitness or usefulness for any particular purpose or with respect to non-infringement of any third-party rights. In no event shall the UMC be liable for any loss, damage, cost or other expense whatsoever (whether direct, indirect, punitive, incidental, special or consequential) arising out of or in any way connected with the use of or reference to any data contained herein. In no event shall the UMC be liable other than i) under Swedish substantive law and ii) subject to the courts of Sweden with the district court of Uppsala as first instance.
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