Public Pharmacovigilance Databases: Where to Find Reported Drug Side Effects

Publicly accessible pharmacovigilance databases play a vital role in global drug safety monitoring. They collect reports of potential adverse drug reactions, helping to identify potential safety issues. This article reviews the main open databases, including VigiAccess, EudraVigilance, FDA AEMS, MedEffect Canada, and DAEN, along with their capabilities, applications, and limitations.

Public Pharmacovigilance Databases and Their Importance

In recent years, due to changes in legislation and increased transparency requirements, open pharmacovigilance databases have been created in many countries and internationally. These public pharmacovigilance databases are centralised repositories that store Individual Case Safety Reports (ICSRs) of adverse events and continue to track real-world side effects once a medicine is available to diverse patients, helping protect public health.

These resources make drug safety data more readily available for analysis not only by regulatory authorities but also by researchers, physicians, and other specialists. They also act as early warning systems to identify previously unknown risks and monitor rare side effects, and enable healthcare providers to review reporting trends for specific demographics often excluded from clinical trial settings.

The DrugCard team regularly uses publicly available PV databases in its work. In this article, we share the resources our specialists use daily, which may also be useful in your practice.

The Role of Pharmacovigilance Safety Database

The main goals of pharmacovigilance are the early detection of new and previously unknown adverse drug reactions and the monitoring of changes in the incidence of known reactions. Furthermore, pharmacovigilance helps identify risk factors, study possible mechanisms for the development of adverse reactions, evaluate the benefit-risk balance of drugs, and disseminate important safety information.

All of these tasks depend on a single key element: the high-quality collection, storage, and analysis of adverse reaction reports. Therefore, drug safety databases are the foundation of the entire PV system.

Such databases collect reports of suspected adverse reactions and often provide tools for analysis, visualisation, and reporting. These tools enable transforming individual spontaneous reports into signals that may indicate potential safety issues.

VigiBase – the global medicines safety database

VigiBase is a large global database of the World Health Organisation (WHO) that collects information on possible adverse reactions to drugs and vaccines. It contains over 40 million reports from more than 180 countries participating in the WHO Programme for International Drug Monitoring.

This database facilitates drug safety specialists worldwide to identify rare or unexpected signals of potential problems that are difficult to detect in individual countries or studies. This makes it easier to improve the safety of pharmaceutical products and vaccines.

Public access to the WHO database

To simplify access to this data, WHO created VigiAccess, an open web interface launched in 2015. It allows anyone to view statistics on registered reports of possible adverse reactions. Searches can be made by trade or international name of the drug. The service displays general statistics, including the distribution of reports by country, age, and gender. It’s important to understand this data correctly:

• A reported adverse reaction does not necessarily mean the drug or vaccine caused it. It is only a suspicion.

• Proving a causal relationship requires a separate scientific investigation.

• The data comes from different countries and different specialists, so it is broad in scope. Still, it is not intended to allow independent conclusions about the cause of the reaction without a medical evaluation.

EudraVigilance: EU system for signal detection and monitoring suspected adverse drug reactions

The EudraVigilance database is one of the world’s largest databases. It is used to collect, store, and analyse reports of suspected adverse reactions to medicines authorised for use in the European Economic Area (EEA).

The database was launched in 2001 and currently contains over 31.2 million safety reports, representing nearly 17.9 million individual reports of possible adverse reactions (according to the 2025 annual report).

Since April 2012, the European Medicines Agency (EMA) has made some of the data available to physicians, researchers, and the general public. The system can be used without registration, but before viewing the information, users must confirm that they have read the warning about correctly interpreting the data.

It is important to remember that reports in the database only reflect a suspected link between the medicine and the reaction and do not constitute proof of a causal relationship.

Working with the EudraVigilance Database

If a drug has been centrally approved, you can search the system by both its trade name and its International Nonproprietary Name (INN). If a drug has not been centrally approved, searching is only available by INN.

After entering the drug name, the system displays summarised data, including:

• the total number of individual case safety reports registered in EudraVigilance,

• the number of reports for the selected time period,

• the distribution of cases by European union countries,

• data by patient group (age, gender, reaction severity, etc.), as well as the number of cases for specific reactions or reaction groups.

You can also work with a line listing, filter the data, and generate individual reports based on selected criteria.

FDA Adverse Event Monitoring System (AEMS) – USA Public Dashboard

On March 11, 2026, the U.S. Food and Drug Administration (FDA) announced the launch of a new platform, the FDA Adverse Event Monitoring System (AEMS). The FDA AEMS Dashboard is an online tool that makes it easy to search and view adverse event reporting data. It was designed to make this information accessible to everyone: patients, physicians, pharmaceutical industry, and researchers.

The system collects adverse event reports from healthcare professionals, drug manufacturers, and consumers. The dashboard allows users to search for data on various drugs and view aggregated information on reported cases.

AEMS Data Limitations

It’s important to understand that the data in AEMS has limitations. The presence of a drug report does not necessarily mean that it caused the adverse event. The cause may be related to an underlying condition, other medications, or other factors.

Effective pharmacovigilance also depends on timely and accurate data collection from diverse sources for risk management, patient health, and patient safety. The system may also contain duplicate or incomplete reports, and the data itself is not always validated in clinical trials. Furthermore, these reports cannot be used to determine the actual frequency of a particular reaction.

Therefore, the information in AEMS reflects only reports and observations, not confirmed causal relationships. Despite this, such data management is important for ensuring drug safety and helps regulators monitor the benefit-risk balance of drugs throughout their use.

How to Use the FDA AEMS Dashboard

When you visit the FDA AEMS dashboard website, the first thing that appears is a warning pop-up. Accept this warning, which explains how to interpret the data. It’s important to remember that AEMS data alone cannot accurately determine event frequency, compare rates across drugs, or track changes over time.

After accepting the warning, the dashboard itself opens with three sections: “Drugs and Biologics,” “Cosmetics,” and “Vaccines.” For example, in the “Drugs and Biologics” section, you can see the total number of reported cases, including serious ones.

You can then search by specific drug or by adverse reaction term. Depending on your search, the system displays relevant data.

Interestingly, recently, more and more scientific publications are using this database for analysis – this is also noted in literature monitoring in DrugCard.

Canada Vigilance adverse reaction online database

MedEffect Canada is a Canadian database hosted on the Health Canada website. It collects information on suspected adverse reactions to medicinal products marketed in Canada. The database contains reports dating back to 1965.

Reports are received from patients, healthcare providers, and pharmaceutical companies. It’s important to understand that the presence of a report in the database does not necessarily indicate that the drug caused the reaction. These data reflect only a suspected connection and require further evaluation.

The system allows you to search for information by various parameters, including:

• report data,

• patient characteristics,

• suspected drug,

• and the type of adverse reaction.

After searching, results can be viewed in two formats:

Standard View – a standard table with basic information (report number and the date, the patient’s age and gender, the suspected drug, and the reported ADR);

Custom View – a customizable format where the user selects the desired fields.

Australia’s DAEN Pharmacovigilance Database

Database of Adverse Event Notifications (DAEN) is an Australian pharmacovigilance database maintained by the Therapeutic Goods Administration (TGA). It collects reports of suspected adverse reactions to medicinal products used in Australia.

The database contains approximately 670,000 reports dating back to 1971, and was made publicly available on the TGA website in 2012.

When first logging in, users must read and accept the data usage warning. Afterward, they can search for information by drug name and select the desired time period.

The system allows for convenient data analysis using interactive filters, graphs, and tables. Search results can also be downloaded in CSV or XLSX formats for further analysis.

Major Global Pharmacovigilance Databases for Post Marketing Surveillance and Monitoring Adverse Drug Reactions with Public Access

The table below provides an overview of the main PV safety databases discussed in this article. There are also other publicly available databases; however, the ones listed here are those most frequently used by our specialists for adverse drug reaction analysis.

Drug safety database	Country / Organisation	Data Content	Access Type	Key functions and features	Limitations
VigiAccess	WHO (public interface)	Aggregated statistics from VigiBase	Open access	Drug search, country/age/gender distribution	Reports represent suspicions only
EudraVigilance	EMA / European Economic Area	>31 million reports of suspected adverse reactions	Partially open access	Analysis by country, patient groups, reactions, Line listing	No confirmed causality
FDA AEMS	USA (FDA)	>33 million reports of adverse reactions	Public dashboard	Search by drugs, biologics, vaccines, cosmetics	Possible duplicates; no true incidence rates
MedEffect (Canada Vigilance)	Health Canada	Reports of suspected adverse reactions (since 1965)	Open access	Flexible search and reporting views	Reports are not proof of causality
DAEN	Australia (TGA)	~670,000 adverse event reports (since 1971)	Open access	Filters, charts, and data export (CSV/XLSX)	Only suspected associations, not confirmed reactions

Conclusion

Pharmacovigilance drug safety databases are a key part of modern systems for monitoring the safety of authorised medicines. They collect and store large numbers of reports on suspected ADRs from healthcare professionals, patients, companies, and regulators worldwide.

The databases described in this article, both global and regional, are important for detecting early safety signals. They help identify rare, unexpected, or delayed ADRs that may not be seen during pre-marketing studies. This makes them essential tools for regulators and specialists when assessing the ongoing benefit–risk balance of medicines.

However, these systems also have important limitations. Reports do not prove that a drug caused an adverse reaction, and data may be incomplete, duplicated, or influenced by reporting bias. Therefore, they should not be used to estimate exact frequencies or draw conclusions about safety without further evaluation.

Overall, these databases are essential for post marketing surveillance, but their data must always be interpreted carefully and in context.