FDA Adverse Event Monitor (FAERS / MAUDE)

One record per new FDA adverse event report for the drugs or medical devices you watch. For drugs, that's FAERS reports where your drug is the suspect drug, optionally narrowed to serious outcomes or specific MedDRA reactions. For devices, it's MAUDE medical device reports (MDRs) for your brand, manufacturer or FDA product code, optionally narrowed to deaths, injuries or malfunctions. Built for pharmacovigilance, product safety and post-market surveillance teams who need "tell me about new reports on my products" as structured records for a signal-review or complaint-trending pipeline, not a raw data dump.

Pricing: pay per event. ae-matched: one event per matched report (not per reaction). A window with no matches costs you nothing.

Precision is the point. openFDA's own search matches a drug name anywhere in a report's drug list. In a live check, of 100 hits for "metformin, suspect drug", only 33 actually had metformin as the suspect drug; in the rest, metformin was a concomitant drug and something else was suspect. This Actor re-checks every hit on one drug (name and role together), or on one device (name, manufacturer and product code together). A near-miss is skipped and never charged. With Only reports not delivered before on (the default), a report is returned and charged once per watch, even when scheduled windows overlap.

Input

Serious FAERS reports where metformin is the suspect drug, looking back 180 days:

{"source": "drug", "drug_names": ["metformin"], "serious_only": true,
 "since_days": 180}

Deaths or life-threatening outcomes with a specific reaction:

{"source": "drug", "drug_names": ["metformin"],
 "outcomes": ["death", "life_threatening"], "reactions": ["Lactic acidosis"]}

MAUDE death and injury reports for a device product code:

{"source": "device", "product_codes": ["LGW"],
 "event_types": ["death", "injury"], "since_days": 30}

How the filters combine:

• Names (drugs, devices, manufacturers) are whole-word, case-insensitive matches: metformin finds METFORMIN HYDROCHLORIDE and SITAGLIPTIN AND METFORMIN, but not METFORMINX.
• Across fields: different fields combine with AND.
• Within a field: entries combine with OR.
• Reactions are exact MedDRA preferred terms, in any case.

A drug watch needs at least one drug. A device watch needs at least one device name, manufacturer or product code. Setting the other source's list fields is refused, rather than silently ignored.

Example output (one dataset item per report; narrative abridged)

{"source": "device", "report_id": "50376410",
 "report_number": "3006630150-2026-06108", "report_version": null,
 "received_date": "2026-08-21", "latest_info_date": null,
 "event_date": "2026-07-28", "report_type": "Initial submission",
 "serious": null, "outcomes": ["Death"], "event_type": "Death",
 "reactions": ["No Clinical Signs, Symptoms or Conditions"],
 "product_problems": ["Adverse Event Without Identified Device or Use Problem"],
 "matched_products": [{"brand_name": "WaveWriter Alpha? 16",
   "generic_name": "STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF",
   "manufacturer": "BOSTON SCIENTIFIC NEUROMODULATION CORPORATION",
   "product_code": "LGW",
   "device_name": "Stimulator, Spinal-Cord, Totally Implanted For Pain Relief",
   "device_class": "3", "model_number": "SC-1216"}],
 "suspect_products": [], "reporter_type": "Other", "reporter_country": "US",
 "patient_sex": "Male", "patient_age": "90 YR",
 "narrative": "It was reported that a spinal cord stimulation (SCS) patient passed away. …",
 "data_updated": "2026-09-08"}

FAERS items have the same fields:

• matched_products holds the matched drug (name, role, active substance, brand and generic names, indication);
• suspect_products lists every suspect drug in the report;
• serious, outcomes, reactions (MedDRA terms), reporter_type and latest_info_date are filled;
• the device-only fields are null or [].

Output fields

One dataset item per result. Every field is always present (empty or null when the source has no value). Defined in .actor/dataset_schema.json.

Field	Type	Description
source	string	drug (FAERS) or device (MAUDE)
report_id	string	FAERS safetyreportid or MAUDE mdr_report_key
report_number	string or null	Manufacturer/company report number
report_version	string or null	FAERS report version (null for MAUDE)
received_date	string or null	Date FDA first received the report, YYYY-MM-DD
latest_info_date	string or null	FAERS: date the most recent information arrived
event_date	string or null	MAUDE: date of the event
report_type	string or null	FAERS report type (e.g. Spontaneous) or MAUDE type of report
serious	boolean or null	FAERS seriousness flag
outcomes	array	FAERS serious outcomes, or MAUDE patient outcomes
event_type	string or null	MAUDE: Death, Injury, Malfunction or Other
reactions	array	FAERS MedDRA reaction terms, or MAUDE patient problems
product_problems	array	MAUDE device problems
matched_products	array	The drug(s) or device(s) in the report that matched your watch
suspect_products	array	FAERS: every drug listed as suspect in the report
reporter_type	string or null	FAERS reporter qualification, or MAUDE report source
reporter_country	string or null	Reporter country code
patient_sex	string or null	Patient sex as reported
patient_age	string or null	Patient age as reported, with unit
narrative	string or null	MAUDE event description (max 1000 characters)
data_updated	string or null	openFDA's last update of this dataset, YYYY-MM-DD

Runs stop cleanly at your max-charge limit: nothing is pushed past what you agreed to pay for.

Coverage and freshness

• FAERS (drugs) loads quarterly. openFDA's docs: the data "may lag by 3 months or more". On 2026-09-23 the newest report was received on 2026-06-30 (openFDA updated 2026-07-30). Drug watches need a window of 120 days or more (the default is 120). New reports then arrive in quarterly batches, and "only new" stops a batch being charged twice. A weekly or monthly schedule is enough for drugs; daily runs find nothing new between quarterly loads.
• MAUDE (devices) loads weekly. On 2026-09-23 the newest report was received on 2026-08-31 (openFDA updated 2026-09-08).
• Window date: the date FDA first received the report (FAERS receivedate, MAUDE date_received). A FAERS follow-up to an old report isn't a new report.
• One event per report, however many reactions or devices it lists.
• No report links: FDA's MAUDE report pages refuse scripted requests, so items carry the report ID and number but no link.

Responsible use (openFDA, verbatim): "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." FAERS: "There is no certainty that the reported event … was actually due to the product." A report is a signal to review, not evidence of harm.

Source: the openFDA drug/event and device/event APIs (public, CC0). Without a key, openFDA allows 1,000 requests per day per IP address, and Apify IPs are shared, so heavy schedules should add a free openFDA API key. openFDA's disclaimer: "Do not rely on openFDA to make decisions regarding medical care." This Actor isn't affiliated with or endorsed by the FDA. Also see the FDA Recall Monitor for drug, food and device recalls. The FDA 510(k) / PMA Clearance Monitor, Drugs@FDA lookup and device establishment lookup cover approvals and registrations.