Data sources and licences

Every count comes from the openFDA program of the U.S. Food and Drug Administration. FDA releases the openFDA data under the Creative Commons CC0 1.0 public domain dedication.

FDA does not review or endorse this site. The footer of every page shows the notice of openFDA.

The files

The openFDA files that the site reads
File	What the site uses it for	Release used	Licence
Drug adverse events (FAERS)	Every drug, class, reaction term and month count. 20,646,523 reports.	29 Oct 2026. Reports received to 30 Jun 2026.	CC0 1.0
Device adverse events (MAUDE)	Every device, device type and manufacturer count. 26,326,888 reports.	23 Oct 2026. Reports received to 30 Sep 2026.	CC0 1.0
National Drug Code Directory	Brand names, generic names and drug classes. It gives no count.	2 Nov 2026. 138,173 products.	CC0 1.0
Device Classification	Names of product codes, device class and panel.	7,097 product codes.	CC0 1.0

The site reads the files in the bulk form. openFDA describes the first file as FAERS data. FDA is now implementing AEMS to consolidate its reporting systems. See how the site counts reports.

What the site reads from a report

From a drug report, the site reads these fields:

The receive date and the seriousness fields.
The age and sex of the patient.
The type and the country of the reporter.
The name and the role of each drug.
The reason for use and the reaction terms.

From a device report, the site reads these fields:

The receive date, the event type and the report source.
The brand name, the generic name, the manufacturer name and the product code of each device.
The codes of device problems and patient problems.

The site reads no narrative text, no dose text, no lot number, no date of birth, no address and no contact name.

The words of FDA on this site

The caveat on every data page is the paragraph "Responsible use of the data" of the two openFDA pages. The notice in the footer is the first two sentences of the disclaimer in every API response. The site read these pages on 2 Oct 2026.

The FDA and openFDA pages that the site quotes
Page	Source	Content current as of
Drug Adverse Event Overview	openFDA	The page gives no date
Device Adverse Event Overview	openFDA	The page gives no date
Manufacturer and User Facility Device Experience	openFDA	The page gives no date
FDA Adverse Event Monitoring System (AEMS) Public Dashboard	FDA	11 Mar 2026
FDA Adverse Event Monitoring System (AEMS)	FDA	11 Mar 2026
About Manufacturer and User Facility Device Experience (MAUDE) Database	FDA Center for Devices and Radiological Health	8 Dec 2025
What is a Serious Adverse Event?	FDA	18 May 2023
Reporting Serious Problems to FDA	FDA	26 Sep 2025
MedWatch Online Voluntary Reporting Form	FDA	The page gives no date
Medical Device Reporting (MDR): How to Report Medical Device Problems	FDA Center for Devices and Radiological Health	27 Mar 2025
Drug adverse event fields (YAML reference)	openFDA	The page gives no date
Device adverse event fields (YAML reference)	openFDA	The page gives no date
Response of the drug event API (meta.disclaimer)	openFDA	The page gives no date
988 Lifeline	988 Suicide & Crisis Lifeline	The page gives no date

The notice of openFDA

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, the field meta.disclaimer of a response of the API.

MedDRA

MedDRA is the Medical Dictionary for Regulatory Activities. The reaction terms of the reports are MedDRA preferred terms. The site shows each term as openFDA publishes it. The plain meaning under a term is the site's own gloss.

MedDRA® is a registered trademark. The site did not find a written position of the MedDRA organisation on the use of preferred terms. It shows the terms as openFDA publishes them.

Links to FDA and to other sites open in a new tab.

Last checked against FDA pages: 2 Oct 2026.