Data sources and licences
Every figure comes from the U.S. Food and Drug Administration's openFDA programme. openFDA data are released under the Creative Commons CC0 1.0 public-domain dedication; FDA asks users to note that the data are unvalidated and not to rely on them for medical decisions, and that notice appears in the footer of every page.
Datasets
| Dataset | Used for | Release used | Licence |
|---|---|---|---|
| Drug Adverse Event (FAERS) bulk export | Every drug, class, reaction and month figure: 20,646,523 reports | 28 Sep 2026; reports received through 30 Jun 2026 | CC0 1.0 |
| Device Adverse Event (MAUDE) bulk export | Every device, device type and manufacturer figure: 26,136,888 reports | 28 Sep 2026; reports received through 31 Aug 2026 | CC0 1.0 |
| National Drug Code Directory | Brand, generic and pharmacologic class (EPC) names; never a count | 17 Sep 2026; 138,018 products | CC0 1.0 |
| Device Classification | Product code names, device class and specialty | 7,093 product codes | CC0 1.0 |
What is read from a report
From a FAERS report: the receive date, the seriousness and outcome flags, the patient's age and sex, the reporter's qualification and country, each drug's reported name, role (suspect, concomitant, interacting), openFDA's harmonised brand, generic and class names, the indication as coded, and the MedDRA reaction terms. From a MAUDE report: the receive date, event type, report source, each device's brand, generic name, manufacturer name and product code, and the device and patient problem codes. Nothing else is read: no narrative text, dosage text, lot numbers, dates of birth, addresses or contact names.
FDA's statements on the data
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.
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.
MedDRA® is a registered trademark of the International Council for Harmonisation; the preferred terms appear here as FDA publishes them in openFDA. Links to FDA open in a new tab.