Data · Drug events
Drug adverse event reports, ingredient by ingredient
Which drugs appear most in adverse event reports to the Food and Drug Administration, how many of those reports are serious or report a death, which reactions are reported most often and how the counts moved over the last eight quarters. We count them from openFDA, once per report, and tag the ingredients that open product-liability dockets name.
What is in this dataset?
Adverse event reports about drugs that reached the FDA Adverse Event Reporting System (FAERS) and are served by openFDA, received 2024Q3 to 2026Q2: 2,649,395 reports in all, 1,430,033 serious and 197,378 with a death outcome. One record per active ingredient for the 312 ingredients with the most reports plus every ingredient named in an open multidistrict litigation (31 of them tagged with their MDL numbers): reports that list the ingredient, how many were serious, how many reported a death outcome, the same counts for each of the last eight quarters, and the five most reported reactions. National, one shard. A report names a drug and an event; it does not show that the drug caused the event, and FAERS holds duplicates, follow-ups and reports from outside the United States.
Use it to see which drugs generate the most serious adverse event reports, how fast reports about an ingredient are rising or falling by quarter, and which reactions are reported most often, next to the open product-liability dockets that name the ingredient. Agents can look up the national record, compare ingredients and search by name.
- Records
- 313
- Look up by
- 313
- ingredient
- Primary source
- 313
The letters are explained in what P, S, D and U mean.
Where does the data come from?
Counted server-side on the openFDA drug adverse event API (api.fda.gov/drug/event.json): `count` on patient.drug.openfda.substance_name.exact by quarter of `receivedate` for all reports, serious reports (serious:1) and reports with a death outcome (seriousnessdeath:1), plus one count over the whole window and one per ingredient for its five most reported reactions. No report text or patient field is read. The window is the last eight complete quarters. An ingredient is counted once per report that lists it, whether as suspect, concomitant or interacting drug, in the name openFDA harmonizes it to (a salt form such as 'losartan potassium' is its own name; every name that is the ingredient plus only a salt word is kept). A gate asks openFDA for the all-drug totals again, checks that each ingredient's quarters add up to its window, and re-counts fifty random ingredient-period cells with a different query.
- Period covered
- July 1, 2024 to June 30, 2026
- Places
- The whole US
- How often we refresh it
- Every quarter
- Records read
- October 29, 2026
Official sources
- U.S. Food and Drug Administration (openFDA, FDA Adverse Event Reporting System), by official API. openFDA content is public domain, made available with a Creative Commons CC0 1.0 Universal dedication (https://open.fda.gov/license/)..
- U.S. Food and Drug Administration (openFDA, FDA Adverse Event Reporting System), by official web pages. openFDA content is public domain, made available with a Creative Commons CC0 1.0 Universal dedication (https://open.fda.gov/license/)..
The sources the records cite most
- FDA openFDA drug adverse event API (FAERS): 313 records
- openFDA licence (CC0 1.0) and terms: 313 records
What does a record look like?
-
DUPILUMAB: 230,520 FAERS reports listing this ingredient were received 2024Q3 to 2026Q2; 23,391 were serious (10.1%) and 1,075 reported a death outcome (0.5%). Most reported reactions: PRURITUS (31,755); DERMATITIS ATOPIC (26,189); INJECTION SITE PAIN (20,196); PRODUCT USE IN UNAPPROVED INDICATION (18,405); RASH (17,149). Named in open multidistrict litigation MDL-3180. A report does not show that the drug caused the event.
Status P · checked October 29, 2026 · source: FDA openFDA drug adverse event API (FAERS)
-
TIRZEPATIDE: 120,102 FAERS reports listing this ingredient were received 2024Q3 to 2026Q2; 24,360 were serious (20.3%) and 734 reported a death outcome (0.6%). Most reported reactions: INCORRECT DOSE ADMINISTERED (19,670); NAUSEA (12,596); INJECTION SITE PAIN (8,498); DIARRHOEA (7,901); EXTRA DOSE ADMINISTERED (7,055). Named in open multidistrict litigation MDL-3094, MDL-3163. A report does not show that the drug caused the event.
Status P · checked October 29, 2026 · source: FDA openFDA drug adverse event API (FAERS)
-
ACETAMINOPHEN: 98,552 FAERS reports listing this ingredient were received 2024Q3 to 2026Q2; 66,782 were serious (67.8%) and 13,298 reported a death outcome (13.5%). Most reported reactions: OFF LABEL USE (9,309); FATIGUE (7,677); NAUSEA (7,011); HEADACHE (6,697); DRUG INEFFECTIVE (6,674). Named in open multidistrict litigation MDL-3043. A report does not show that the drug caused the event.
Status P · checked October 29, 2026 · source: FDA openFDA drug adverse event API (FAERS)
The full records add the dates, the quoted source text and every field in the CSV and JSON files below.
What each of the 35 main columns means
jurisdiction- Two-letter code of the state, DC or territory, or US
level- us (all drugs together) or ingredient
county- 5-digit county FIPS code (vintage 2025; Connecticut's retired counties keep their old codes); empty for other levels
countyName- County name as the Census Bureau writes it
stateName- State name
value- Same as reports: FAERS reports received in the window that list the ingredient
unit- What the value counts
ingredient- Active ingredient as openFDA names it (patient.drug.openfda.substance_name), or 'All drugs'
rank- Rank by reports in the window among the published ingredients (0 for the all-drug record)
quarters- The eight calendar quarters of the window, oldest first, comma separated
reports- Reports received in the window that list the ingredient (all drugs: all reports)
serious- Of those, reports openFDA marks serious
deaths- Of those, reports with a death outcome (seriousnessdeath)
serious_pct- serious as a percent of reports
death_pct- deaths as a percent of reports
topReactions- The five most reported reactions (MedDRA preferred terms) among the window's reports for the ingredient, with counts
mdl- Open multidistrict litigation dockets (from the mdl dataset) that name the ingredient
reports_q1- Reports received in quarter 1 of the window (quarter 1 = the 1st quarter listed in `quarters`, oldest first)
serious_q1- Serious reports received in quarter 1 of the window
reports_q2- Reports received in quarter 2 of the window (quarter 2 = the 2nd quarter listed in `quarters`, oldest first)
serious_q2- Serious reports received in quarter 2 of the window
reports_q3- Reports received in quarter 3 of the window (quarter 3 = the 3rd quarter listed in `quarters`, oldest first)
serious_q3- Serious reports received in quarter 3 of the window
reports_q4- Reports received in quarter 4 of the window (quarter 4 = the 4th quarter listed in `quarters`, oldest first)
serious_q4- Serious reports received in quarter 4 of the window
reports_q5- Reports received in quarter 5 of the window (quarter 5 = the 5th quarter listed in `quarters`, oldest first)
serious_q5- Serious reports received in quarter 5 of the window
reports_q6- Reports received in quarter 6 of the window (quarter 6 = the 6th quarter listed in `quarters`, oldest first)
serious_q6- Serious reports received in quarter 6 of the window
reports_q7- Reports received in quarter 7 of the window (quarter 7 = the 7th quarter listed in `quarters`, oldest first)
serious_q7- Serious reports received in quarter 7 of the window
reports_q8- Reports received in quarter 8 of the window (quarter 8 = the 8th quarter listed in `quarters`, oldest first)
serious_q8- Serious reports received in quarter 8 of the window
effectiveFrom- First day of the window
effectiveTo- Last day of the window
How do I use it in my own tools?
drugevents_lookup- For one active ingredient name as openFDA writes it (for example DUPILUMAB, or ALL DRUGS for the all-drug totals): reports received in the last eight quarters, serious reports, deaths, the quarterly counts, the five most reported reactions and any open MDL dockets that name it.
drugevents_compare- Up to 10 active ingredients (names as openFDA writes them) side by side: reports, serious reports, deaths and the quarterly trend; ALL DRUGS gives the all-drug totals for reference.
drugevents_search- FAERS ingredient records whose text matches the words given, such as an ingredient ("semaglutide"), a reaction ("pancreatitis") or an MDL number ("MDL-3094").
How to cite this dataset
You can reuse, adapt and republish this data, including commercially, under the Creative Commons Attribution 4.0 license (CC BY 4.0). The only condition is that you credit Probative and link to the source.
- Version
- 1.0.0, released October 29, 2026
- Every version
- 10.5281/zenodo.23752993 (always points to the newest)
- License
- CC BY 4.0
Download the data
- CSV: drug-events.csv 288 KB · one row per record (columns in README.txt)
- JSON: drug-events.json 601 KB · every record with its sources
Free, no email or login. The files are hosted on this site and Zenodo, a public research archive.
Suggested citation
Probative. (2026). Serious drug adverse event reports by active ingredient (openFDA FAERS) (Version 1.0.0) [Data set]. Zenodo. https://doi.org/10.5281/zenodo.23752994
Credit line for a chart, table or article
Source: Probative, Serious drug adverse event reports by active ingredient (openFDA FAERS), version 1.0.0, https://doi.org/10.5281/zenodo.23752994, licensed CC BY 4.0.
Add to a reference manager (Zotero, Mendeley, EndNote)
Not legal advice. This is not medical advice either. A report in the FDA Adverse Event Reporting System is not proof that a drug caused an event; reports come from patients, clinicians and manufacturers, can be duplicated and are not verified. Questions about a medicine are for a health professional, and questions about an injury are for a licensed attorney.
What changed recently?
- 2026-10-29 · FAERS reports received 2024Q3 to 2026Q2 for 312 active ingredients: 2,649,395 drug reports in all, 1,430,033 serious. (source)
The full log is in changes.json.
What are the limits?
- A report names a drug and an event. It does not show that the drug caused the event: many drugs appear often only because many people take them, and the patient may have been ill or taking several medicines.
- Anyone can report, reports are voluntary for patients and clinicians, and some are required of manufacturers. Counts rise with a drug's popularity, with news and with patient support programs, so they cannot be read as rates of harm.
- The files hold duplicates and follow-up reports, and reports from outside the United States. An ingredient is counted once per report that lists it, whether the drug is suspected or not.
- Ingredients are counted under the name openFDA harmonizes them to, so a salt form of the same medicine can sit under its own name. Reports with no matched ingredient name are in the all-drug total but in no ingredient record.
- The newest quarter reflects what the agency had loaded when we read it and can grow afterwards. We re-read the whole window every quarter and log any change to a published figure.
- Only the most reported ingredients and those named in open dockets are published, so a drug missing from the list is not a drug without reports.
- Records older than 130 days since their last check are marked
stalein the files until we re-check them. Every confirmed error we fix is listed in the data corrections log.
Found a wrong value? Report an error with the record id and the source that shows the right value.
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