World’s Largest Adverse Events Database Maintained By The WHO

VigiBase is the unique WHO global database of reported potential side effects of medicinal products. It is the largest database of its kind in the world, with over 30 million reports of suspected adverse effects of medicines, submitted, since 1968, by member countries of the WHO PIDM (Programme for International Drug Monitoring). It is continuously updated with incoming reports.

The WHO PIDM was created in 1968 to ensure that evidence about harm to patients was collected from as many sources as possible. This enables individual countries to be alerted to patterns of harm emerging across the world, but which might not be evident from their local data alone.

Members of the programme work nationally and collaborate internationally to monitor and identify the harm caused by medicines, to reduce the risks to patients, and to establish worldwide pharmacovigilance standards and systems. UMC has been responsible for the technical and operational aspects of the WHO PIDM since 1978.

What is VigiBase?

VigiBase is UMC’s starting-point for the journey from data to wisdom about safer use of medicines and wise therapeutic decisions in clinical practice. It is the driving-force at the heart of the work of UMC and the WHO Programme for International Drug Monitoring (WHO PIDM). The purpose is to ensure that early signs of previously unknown medicines-related safety problems are identified as rapidly as possible.

Alongside its data management and quality assurance tools, the VigiBase system is linked to medical and drug classifications such as WHODrug, MedDRA, WHO ICD, and WHO-ART. These classifications enable structured data entry, retrieval and analysis at different levels of precision and aggregation, which are vital in order to enable effective and accurate analysis.

Important points to consider

VigiAccess is intended as a useful starting point for people who wish to understand more about the types of potential side effects that have been reported in association with the use of medicinal products. However, VigiAccess cannot be used to infer any confirmed link between a suspected side effect and any specific medicine. See the VigiAccess FAQ for a more detailed explanation.

When using VigiAccess, it is important to consider the following:

1. The information on this website relates to potential side effects; that is, symptoms and other circumstances that have been observed following the use of a medicinal product, but which may or may not be related to or caused by that product .
2. Information in VigiAccess on potential side effects should not be interpreted as meaning that the medicinal product or its active substance either caused the observed effect or is unsafe to use. Confirming a causal link is a complex process that requires a thorough scientific assessment and detailed evaluation of all available data. The information on this website, therefore, does not reflect any confirmed link between a medicinal product and a side effect .
3. VigiAccess cannot be used to determine the likelihood of a side effect occurring . A VigiAccess search on a medicinal product will return a basic list of reported potential side effects and the number of times each effect has been reported. However, the database does not include other factors needed to put that number into context, such as how many people have taken the product, how long they have taken it, how long it has been on the market, and the differing reporting practices that influence which observations are included in the reports.
4. VigiAccess cannot be used to compare the safety profiles of different medicinal products . For the same reasons explained in point 3, VigiAccess cannot provide sufficient context to make such comparisons possible.
5. The information on VigiAccess should not be used in isolation to make any decisions regarding a patient’s treatment regimen . Patients and their healthcare providers should always consult other sources of information, including the product inserts and other recognised sources of prescribing information.

If you think that you may be experiencing a side effect from a medicinal product, please seek advice from a healthcare professional as soon as possible. Never stop or change the dose for any prescription medicines without consulting your physician .

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