Who sends drug and device reports to FDA
What a report is
A report is not proof that a medicine or a device was the cause of an event.
FDA says:
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 . The data have the reports that FDA received through .
FDA also says:
There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on .
Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). 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.
The answer in sentences
Reports from consumers or other non-health professionals were 45.8% of the 20,646,523 drug reports that FDA received from January 2004 to June 2026.
Reports from physicians were 21.9% of the drug reports, and reports from pharmacists 6.3%.
Manufacturer reports were 94.9% of the 26,326,888 device reports that FDA received from December 1991 to September 2026.
Data version
Drug data: openFDA FAERS release of 12 Oct 2026. Reports received through 30 Jun 2026.
Device data: openFDA MAUDE release of 14 Oct 2026. Reports received through 30 Sep 2026.
Drug reports by type of reporter
The table has every type of reporter that the FAERS reports give, most reports first. The type is the qualification that the report gives for the primary source.
FDA says:
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. The site read the page on .
Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .
| Type of reporter | Reports | Share of drug reports |
|---|---|---|
| Consumer or non-health professional | 9,459,184 | 45.8% |
| Physician | 4,526,008 | 21.9% |
| Other health professional | 4,076,160 | 19.7% |
| Pharmacist | 1,300,396 | 6.3% |
| Lawyer | 544,333 | 2.6% |
| Not given | 740,442 | 3.6% |
FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.
Device reports by source
The table has every source of the MAUDE reports, most reports first.
FDA says:
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. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
| Source of the report | Reports | Share of device reports |
|---|---|---|
| Manufacturer report | 24,995,719 | 94.9% |
| Distributor report | 950,653 | 3.6% |
| Voluntary report | 227,066 | 0.9% |
| User facility report | 0 | 0% |
| Not given | 153,450 | 0.6% |
FDA releases MAUDE data every month. Reports can arrive months after an event, so the newest months grow in later releases.
How the figures were made
The reports for a drug can come from a consumer, a health professional, a lawyer or a manufacturer that passes on a report. FDA does not verify the type that a report gives.
Manufacturers, importers and device user facilities must report some device events to FDA. Other people can send a voluntary report. A source is the kind of report that FDA records.
A count is a count of reports, not of events or of patients, and it is not a rate.
A program makes this page from the openFDA files with fixed sentence rules. See how the site counts reports and the data sources.
In earlier editions
This table is in the edition of October 2026, the first edition. Each month adds an edition that keeps the first rows of the table as they were.