Reported Reactions

Adverse event reports that FDA received

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Find the reports that FDA received for a medicine or a device

Type a brand name, a generic name, a device or a reaction. Each page gives the count of reports and FDA's statement of what a report can show.

Examples: ozempic metformin insulin pump hair loss

What a report is

A report is not proof that a medicine or a device was the cause of an event.

An adverse event report is one message to FDA about one person: the products, the reactions, the outcome. A patient, a carer, a health professional or a manufacturer can send one. The words below are FDA's, not the site's.

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.

Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on .

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Two systems

FAERS has the reports about drugs. FDA is implementing the Adverse Event Monitoring System (AEMS) to consolidate its reporting systems. MAUDE has the reports about medical devices. Read the guide.

In the latest FDA data

The latest closed quarter in the data is April to June 2026. A quarter is closed when the FDA files have most of its reports.

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.

Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .

MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices.

Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .

Drug reports that FDA received in April to June 2026
352,949
Drug reports that FDA received in January to March 2026
320,823
Device reports that FDA received in April to June 2026
923,529
Device reports that FDA received in January to March 2026
811,618

Drug data (FAERS): reports received through . Device data (MAUDE): reports received through . A count of reports is not a count of events.

Update recorded on

  • FDA changed counts for April to June 2026 in a later export.

See the pages with a different count

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