Edition of November 2026
Made from the update of 2 Nov 2026. The drug data run through 30 Jun 2026. The edition before is October 2026.
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.
Counts for all reports
The change is for all reports of the dataset between two editions. It is not a change for one drug or one device.
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 .
| Count | This edition | Edition before | Change |
|---|---|---|---|
| Drug reports (FAERS) that FDA received since 2004 | 20,646,523 (to June 2026) | 20,646,523 (to June 2026) | no change |
| Device reports (MAUDE) that FDA received | 26,326,888 (to September 2026) | 26,326,888 (to September 2026) | no change |
| Drug reports in the latest 12 months | 1,332,454 (12 months to June 2026) | 1,332,454 (12 months to June 2026) | no change |
| Device reports in the latest 12 months | 3,444,740 (12 months to September 2026) | 3,444,740 (12 months to September 2026) | no change |
| Drug reports in the latest closed quarter | 352,949 (April to June 2026) | 352,949 (April to June 2026) | no change |
| Device reports in the latest closed quarter | 923,529 (April to June 2026) | 923,529 (April to June 2026) | no change |
| Device data run through | 30 Sep 2026 | 30 Sep 2026 | n/a |
Search engines list 2,888 pages of drugs, devices, device types, drug classes, manufacturers, reaction terms and months in this edition.
Updates in this month
The record of updates has no entry dated in November 2026. The record of updates.
Reaction terms by number of reports, 12 months to June 2026
In the 12 months to June 2026, the reaction term in the most drug reports was Off label use: 79,953 reports.
The rows are the first 10 rows of the first table of the finding in the edition of November 2026. The rows are not products.
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 .
| Row | Name | Figure | Row in the edition before |
|---|---|---|---|
| 1 | Off label use | 79,953 | 1 |
| 2 | Drug ineffective | 71,499 | 2 |
| 3 | Product dose omission issue | 48,930 | 3 |
| 4 | Nausea | 48,716 | 4 |
| 5 | Death | 48,702 | 5 |
| 6 | Fatigue | 45,513 | 6 |
| 7 | Diarrhoea | 43,937 | 7 |
| 8 | Pruritus | 35,233 | 8 |
| 9 | Headache | 34,426 | 9 |
| 10 | Dyspnoea | 30,572 | 10 |
The full table of this finding, with the figures of the newest update.
Drug and device reports that FDA received, by year
FDA received 1,307,769 drug reports in 2025 and 1,319,106 in 2024.
The rows are the first 10 rows of the first table of the finding in the edition of November 2026. The rows are not products.
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 .
| Row | Name | Figure | Row in the edition before |
|---|---|---|---|
| 1 | 2026 | 673,772 (to June 2026) | 1 |
| 2 | 2025 | 1,307,769 | 2 |
| 3 | 2024 | 1,319,106 | 3 |
| 4 | 2023 | 1,368,572 | 4 |
| 5 | 2022 | 1,523,664 | 5 |
| 6 | 2021 | 1,566,148 | 6 |
| 7 | 2020 | 1,455,117 | 7 |
| 8 | 2019 | 1,434,195 | 8 |
| 9 | 2018 | 1,428,121 | 9 |
| 10 | 2017 | 1,251,778 | 10 |
The full table of this finding, with the figures of the newest update.
Device reports by FDA panel, 12 months to September 2026
In the 12 months to September 2026, the panel with the most device reports was Clinical Chemistry: 1,092,879 reports.
The rows are the first 10 rows of the first table of the finding in the edition of November 2026. The rows are not products.
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 .
| Row | Name | Figure | Row in the edition before |
|---|---|---|---|
| 1 | Clinical Chemistry | 1,092,879 | 1 |
| 2 | Dental | 755,011 | 2 |
| 3 | Unknown | 499,422 | 3 |
| 4 | General Hospital | 274,534 | 4 |
| 5 | Gastroenterology, Urology | 228,973 | 5 |
| 6 | Anesthesiology | 170,979 | 6 |
| 7 | General, Plastic Surgery | 118,921 | 7 |
| 8 | Cardiovascular | 112,718 | 8 |
| 9 | Orthopedic | 73,729 | 9 |
| 10 | Physical Medicine | 19,015 | 10 |
The full table of this finding, with the figures of the newest update.
Who sends drug and device reports to FDA
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.
The rows are the first 6 rows of the first table of the finding in the edition of November 2026. The rows are not products.
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 .
| Row | Name | Figure | Row in the edition before |
|---|---|---|---|
| 1 | Consumer or non-health professional | 9,459,184 | 1 |
| 2 | Physician | 4,526,008 | 2 |
| 3 | Other health professional | 4,076,160 | 3 |
| 4 | Pharmacist | 1,300,396 | 4 |
| 5 | Lawyer | 544,333 | 5 |
| 6 | Not given | 740,442 | 6 |
The full table of this finding, with the figures of the newest update.
How an edition is made
A program writes each edition from the figures that the site shows in that month, with fixed sentence rules. A month keeps the figures of its last update. A change is between this edition and the edition before. It is not a change in how often an event happens.