openFDA drug safety signal intelligence (quarterly)
Quarterly adverse-event reporting signals for the 40 most-reported drugs in the FDA Adverse Event Reporting System (FAERS), from the official keyless openFDA drug/event API. Per drug: report counts for the trailing 91-day window ending at openFDA's last_updated, serious-outcome and death-outcome counts and shares, quarter-over-quarter report change vs the prior 91-day window, and a documented 0-100 reporting-signal composite (35% min-max(log1p(volume)) + 35% min-max(serious share) + 30% min-max(clipped positive trend)) ranked with deterministic tie-breaks. Only aggregate counts are stored — no individual reports, no patient data. Caveats: FAERS is spontaneous reporting, not incidence — no prescription denominator, Weber effect and media attention bias volumes; the score is a reporting-burden triage signal, not a safety ranking, and must never drive medical decisions. Primary key: drug_term. Cadence: quarterly.
- Rows
- 40
- Columns
- 18
- Source cadence
- Quarterly
- Last refreshed
- Sep 25, 2026
- Theme
- health
| Column | Type | Description |
|---|---|---|
| drug_term | string | Normalized drug name (upper-case medicinalproduct), primary key. |
| drug_label | string | Human-readable drug label. |
| window_start | string | First day of the 91-day reporting window. (unit: date) |
| window_end | string | Last day of the reporting window (openFDA last_updated). (unit: date) |
| prior_window_start | string | First day of the prior 91-day window. (unit: date) |
| prior_window_end | string | Last day of the prior 91-day window. (unit: date) |
| report_count | integer | Adverse-event reports mentioning the drug in the window (openFDA count of patient.drug.medicinalproduct.exact). (unit: count) |
| serious_count | integer | Reports in the window with a serious outcome (serious:1). (unit: count) |
| death_count | integer | Reports in the window with a death outcome (seriousnessdeath:1). (unit: count) |
| prior_count | float | Report count in the prior window; null when the drug was absent from the prior top-40. (unit: count) |
| serious_share_pct | float | Share of window reports with a serious outcome. (unit: percent) |
| death_share_pct | float | Share of window reports with a death outcome. (unit: percent) |
| trend_pct | float | Quarter-over-quarter report change vs the prior window; null when the prior count is missing or zero. (unit: percent) |
| signal_score | float | 0-100 reporting-signal composite: 35% min-max(log1p(volume)) + 35% min-max(serious share) + 30% min-max(clipped positive trend). Reporting burden, not a safety ranking. (unit: 0-100) |
| signal_rank | integer | Deterministic rank: signal_score desc, report_count desc, drug_term asc. (unit: rank) |
| openfda_url | string | Exact openFDA query behind this row. (unit: URL) |
| asof_date | string | Window end date (openFDA last_updated). (unit: date) |
| row_hash | string | Deterministic 16-hex row hash. |
First 10 sample rows — a preview, not the complete dataset.
| drug_term | drug_label | window_start | window_end | prior_window_start | prior_window_end | report_count | serious_count | death_count | prior_count | serious_share_pct | death_share_pct | trend_pct | signal_score | signal_rank | openfda_url | asof_date | row_hash |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PREDNISONE | Prednisone | 2026-05-01 | 2026-07-30 | 2026-01-30 | 2026-04-30 | 5,190 | 3,915 | 627 | 8,414 | 75.43 | 12.08 | -38.3 | 40.41 | 1 | https://api.fda.gov/drug/event.json?search=receivedate:[20260501+TO+20260730]+AND+patient.drug.medicinalproduct.exact:"PREDNISONE"&limit=1 | 2026-07-30 | 2ec812b6103bf5bd |
| ACETAMINOPHEN | Acetaminophen | 2026-05-01 | 2026-07-30 | 2026-01-30 | 2026-04-30 | 3,883 | 3,256 | 518 | 6,583 | 83.85 | 13.34 | -41 | 39.6 | 2 | https://api.fda.gov/drug/event.json?search=receivedate:[20260501+TO+20260730]+AND+patient.drug.medicinalproduct.exact:"ACETAMINOPHEN"&limit=1 | 2026-07-30 | 4ebdff6633f0ed6a |
| RITUXIMAB | Rituximab | 2026-05-01 | 2026-07-30 | 2026-01-30 | 2026-04-30 | 2,712 | 2,633 | 629 | 3,866 | 97.09 | 23.19 | -29.8 | 39.6 | 3 | https://api.fda.gov/drug/event.json?search=receivedate:[20260501+TO+20260730]+AND+patient.drug.medicinalproduct.exact:"RITUXIMAB"&limit=1 | 2026-07-30 | fc745e5b4cca3f69 |
| DUPIXENT | Dupixent | 2026-05-01 | 2026-07-30 | 2026-01-30 | 2026-04-30 | 26,687 | 2,196 | 0 | 29,311 | 8.23 | 0 | -9 | 37.94 | 4 | https://api.fda.gov/drug/event.json?search=receivedate:[20260501+TO+20260730]+AND+patient.drug.medicinalproduct.exact:"DUPIXENT"&limit=1 | 2026-07-30 | 937f59c1a34d7ec6 |
| DEXAMETHASONE | Dexamethasone | 2026-05-01 | 2026-07-30 | 2026-01-30 | 2026-04-30 | 2,871 | 2,588 | 423 | 4,665 | 90.14 | 14.73 | -38.5 | 37.87 | 5 | https://api.fda.gov/drug/event.json?search=receivedate:[20260501+TO+20260730]+AND+patient.drug.medicinalproduct.exact:"DEXAMETHASONE"&limit=1 | 2026-07-30 | da59c58197a0387d |
| CYCLOPHOSPHAMIDE | Cyclophosphamide | 2026-05-01 | 2026-07-30 | 2026-01-30 | 2026-04-30 | 2,340 | 2,285 | 410 | 3,563 | 97.65 | 17.52 | -34.3 | 37.87 | 6 | https://api.fda.gov/drug/event.json?search=receivedate:[20260501+TO+20260730]+AND+patient.drug.medicinalproduct.exact:"CYCLOPHOSPHAMIDE"&limit=1 | 2026-07-30 | a3dede904a617f07 |
| CARBOPLATIN | Carboplatin | 2026-05-01 | 2026-07-30 | 2026-01-30 | 2026-04-30 | 2,277 | 2,231 | 299 | 3,442 | 97.98 | 13.13 | -33.8 | 37.62 | 7 | https://api.fda.gov/drug/event.json?search=receivedate:[20260501+TO+20260730]+AND+patient.drug.medicinalproduct.exact:"CARBOPLATIN"&limit=1 | 2026-07-30 | 8f9414f2f0093d9e |
| ATORVASTATIN | Atorvastatin | 2026-05-01 | 2026-07-30 | 2026-01-30 | 2026-04-30 | 4,213 | 3,088 | 240 | 6,514 | 73.3 | 5.7 | -35.3 | 36.9 | 8 | https://api.fda.gov/drug/event.json?search=receivedate:[20260501+TO+20260730]+AND+patient.drug.medicinalproduct.exact:"ATORVASTATIN"&limit=1 | 2026-07-30 | 951c2980a32fa823 |
| METHOTREXATE | Methotrexate | 2026-05-01 | 2026-07-30 | 2026-01-30 | 2026-04-30 | 2,673 | 2,357 | 428 | 3,881 | 88.18 | 16.01 | -31.1 | 36.23 | 9 | https://api.fda.gov/drug/event.json?search=receivedate:[20260501+TO+20260730]+AND+patient.drug.medicinalproduct.exact:"METHOTREXATE"&limit=1 | 2026-07-30 | d42712e38f92b3bc |
| ASPIRIN | Aspirin | 2026-05-01 | 2026-07-30 | 2026-01-30 | 2026-04-30 | 4,823 | 3,042 | 308 | 7,400 | 63.07 | 6.39 | -34.8 | 35.03 | 10 | https://api.fda.gov/drug/event.json?search=receivedate:[20260501+TO+20260730]+AND+patient.drug.medicinalproduct.exact:"ASPIRIN"&limit=1 | 2026-07-30 | 45d9264f27deb5af |
Profiled Sep 25, 2026 from snapshot 20260925T212637Z-9e9886e4616b
Measured- Completeness
- 98.6%
- Rows
- 40
- Columns
- 18
- Columns with gaps
- 2
| Column | Missing | Distinct | Range | Distribution |
|---|---|---|---|---|
| drug_termvarchar | 0% | 41 | — |
|
| drug_labelvarchar | 0% | 35 | — |
|
| window_startvarchar | 0% | 1 | — |
|
| window_endvarchar | 0% | 1 | — |
|
| prior_window_startvarchar | 0% | 1 | — |
|
| prior_window_endvarchar | 0% | 1 | — |
|
| report_countbigint | 0% | 41 | 1,865 → 26,687median 2,693 | 2 outside 1st–99th percentile |
| serious_countbigint | 0% | 32 | 0 → 3,915median 1,736 | 1 outside 1st–99th percentile |
| death_countbigint | 0% | 22 | 0 → 629median 98 | 1 outside 1st–99th percentile |
| prior_countdouble | 12.5% | 40 | 3,019 → 29,311median 3,909 | 2 outside 1st–99th percentile |
| serious_share_pctdouble | 0% | 38 | 0 → 97.98median 63.1 | 1 outside 1st–99th percentile |
| death_share_pctdouble | 0% | 21 | 0 → 23.63median 2.85 | 1 outside 1st–99th percentile |
| trend_pctdouble | 12.5% | 35 | -70.9 → -9median -37.4 | 2 outside 1st–99th percentile |
| signal_scoredouble | 0% | 35 | 0.89 → 40.41median 27.07 | 2 outside 1st–99th percentile |
| signal_rankbigint | 0% | 41 | 1 → 40median 20.5 | 2 outside 1st–99th percentile |
| openfda_urlvarchar | 0% | 41 | — |
|
| asof_datevarchar | 0% | 1 | — |
|
| row_hashvarchar | 0% | 48 | — |
|
- Current
20260925T212637Z-9e9886e4616b · sha256 9e9886e4616b…
40 rows · first snapshot
Point any LLM at the metadata endpoint — the documentation above is machine-readable too (JSON-LD + Croissant).
curl "https://datazimuts.com/v1/datasets/openfda_drug_safety_intel/openfda_drug_safety_quarterly" | jq '{title, rows, columns_count, license}'import requests
ds = requests.get("https://datazimuts.com/v1/datasets/openfda_drug_safety_intel/openfda_drug_safety_quarterly").json()
print(ds["title"], ds["rows"], "rows")
# Sample rows for an LLM context window
for row in ds.get("sample_rows", [])[:5]:
print(row)API endpoint: https://datazimuts.com/v1/datasets/openfda_drug_safety_intel/openfda_drug_safety_quarterly
Tip: fetch /llms.txt for the full machine-readable catalog.
Where this data comes from and what was made from it. Other people's work shows as counts; only shared projects are named.
Cite this snapshot
Pinned to snapshot 20260925T212637Z-9e9886e4616b and its content hash, so readers get exactly the data you used.
openFDA drug safety intelligence (agent-curated). (2026). openFDA drug safety signal intelligence (quarterly) [Data set, snapshot 20260925T212637Z-9e9886e4616b, sha256 9e9886e4616b]. Datazimuts. Retrieved 2026-09-25, from https://datazimuts.com/en/datasets/openfda_drug_safety_intel/openfda_drug_safety_quarterly?snapshot=20260925T212637Z-9e9886e4616b
@misc{dz_openfda_drug_safety_intel_openfda_drug_s_9e9886e4,
title = {{openFDA drug safety signal intelligence (quarterly)}},
author = {{openFDA drug safety intelligence (agent-curated)}},
year = {2026},
publisher = {Datazimuts},
howpublished = {\url{https://datazimuts.com/en/datasets/openfda_drug_safety_intel/openfda_drug_safety_quarterly?snapshot=20260925T212637Z-9e9886e4616b}},
note = {Snapshot 20260925T212637Z-9e9886e4616b, sha256 9e9886e4616bb61b1261563c394196c4fc7e0c3d651f61773dd8eb949ba88163; accessed 2026-09-25}
}Embed a table or a chart
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<iframe src="https://datazimuts.com/embed/chart?dataset=openfda_drug_safety_intel%2Fopenfda_drug_safety_quarterly&lang=en&theme=auto&snapshot=20260925T212637Z-9e9886e4616b&x=asof_date&y=report_count&agg=avg" title="openFDA drug safety signal intelligence (quarterly)" width="100%" height="380" style="border:0" loading="lazy"></iframe>
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