Search FDA databases

Search and read FDA databases records through the Assyro API: openFDA drug labels, approvals, adverse event reports, recalls, and device 510(k), PMA and…

GEThttps://api.assyro.com/v1/sources/openfda/search

Preview: api.assyro.com is not serving production data yet. This page follows the API's published description and may change before launch.

Search and read FDA databases records from your own code: openFDA drug labels, approvals, adverse event reports, recalls, and device 510(k), PMA and classification records. Adverse event counts are reports, not incidence, and do not establish causation. Published by U.S. Food and Drug Administration; answered from Assyro's copy.

Licence: public domain (see the terms). Each record links to its page at the source.

Example: "What 510(k)s cleared the FreeStyle Libre?"

Databases

Every search and read names one database with dataset.

FDA databases databases on the Assyro API
Database	dataset	Refreshed
Drugs@FDA	`drug_approvals`	daily 12:00 UTC
FDA Drug Labels	`drug_label`	daily 11:00 UTC
FDA Adverse Event Reporting System (FAERS)	`drug_adverse_events`	daily 11:00 UTC
FDA Drug Shortages	`drug_shortages`	daily 12:00 UTC
NDC Directory	`drug_ndc`	daily 11:00 UTC
FDA Complete Response Letters	`complete_response_letters`	daily 12:00 UTC
FDA 510(k) Premarket Notifications	`device_510k`	daily 06:30 UTC
FDA Premarket Approvals (PMA)	`device_pma`	daily 06:30 UTC
FDA Product Classification	`device_classification`	daily 12:00 UTC
MAUDE Device Adverse Events	`device_adverse_events`	daily 11:00 UTC
FDA Medical Device Recalls	`device_recalls`	daily 11:00 UTC
FDA Establishment Registration & Device Listing	`device_registrations`	daily 11:00 UTC
FDA Enforcement Reports (Recalls)	`drug_recalls`, `device_enforcement`, `food_recalls`	daily 11:00 UTC
CFSAN Adverse Event Reporting System (CAERS)	`food_adverse_events`	daily 12:00 UTC
FDA Cosmetic Adverse Event Reports	`cosmetic_adverse_events`	daily 12:00 UTC
FDA Animal Drug Adverse Events (CVM)	`animal_adverse_events`	daily 11:00 UTC
FDA Tobacco Product Problem Reports	`tobacco_problem_reports`	daily 12:00 UTC

Search

GET https://api.assyro.com/v1/sources/openfda/search with any of these query parameters. Repeat a parameter for a list (?phase=PHASE2&phase=PHASE3). An unknown parameter is refused by name.

Search parameters

datasetstringrequired
DRUGS. drug_label: structured product labels (indications, dosing, boxed warnings). drug_approvals: Drugs@FDA applications (NDA/ANDA/BLA), approval and supplement history. drug_ndc: NDC directory (labeler, packages, marketing category). drug_shortages: FDA drug shortage and discontinuation entries. drug_adverse_events: FAERS reports. drug_recalls: drug recall enforcement reports (class I-III). complete_response_letters: FDA complete response letters to NDAs/BLAs, full text. DEVICES. device_510k: 510(k) and De Novo decisions. device_pma: PMA approvals and supplements. device_classification: product codes with class and regulation. device_registrations: establishment registrations and their device listings. device_udi: GUDID device identifiers (UDI-DI) and attributes. device_recalls: device recalls with root cause and 510(k)/PMA numbers. device_enforcement: the same device recalls (Z-numbers) as enforcement reports, with recall class I-III. device_adverse_events: MAUDE reports. OTHER. food_recalls: food and dietary supplement recall enforcement reports. food_adverse_events: CAERS reports on foods and dietary supplements. cosmetic_adverse_events: cosmetic adverse event reports. animal_adverse_events: animal drug adverse event reports. tobacco_problem_reports: tobacco product problem reports. substances: FDA substance registry (GSRS): UNII, CAS and other codes, names, structure.
querystring
Free text; every word must appear somewhere in the record (e.g. "sterility", "kink"). Also finds identifiers inside records: a CAS number in substances, "761438" in complete_response_letters.
productNamestring
Drug brand or generic name, or device name (e.g. "Keytruda", "warfarin", "catheter"). animal_adverse_events: active ingredient. substances: the exact substance name (use query for part of a name). complete_response_letters: a word or phrase in the letter.
companystring
Manufacturer, applicant, sponsor, labeler or recalling firm (e.g. "Merck", "Penumbra"). Not for device_classification, food_adverse_events, cosmetic_adverse_events, animal_adverse_events, tobacco_problem_reports, substances.
productCodestring
Three-letter FDA device product code (e.g. "DQY"). Only for device_510k, device_pma, device_classification, device_registrations, device_udi, device_recalls, device_adverse_events.
dateFromstring
Earliest date, YYYY-MM-DD, on the dataset's own date: label effective date, approval or decision date, report received date, recall report/posting date, shortage update date, letter date, marketing start. Not for device_classification, device_registrations, substances.
dateTostring
Latest date, YYYY-MM-DD, same date as dateFrom.
dateFieldstring
Adverse event reports: the date dateFrom/dateTo, the order and countBy year use. received (default); event: when the event happened (device_adverse_events); latest: latest information received (drug_adverse_events). One of: received, event, latest.
eventTypestring
Outcome the report states. device_adverse_events: death, injury, malfunction, other. One of: death, injury, malfunction, other.
seriousnessstring
Serious or not, or one serious outcome. drug_adverse_events: serious, not_serious, death, life_threatening, hospitalization, disability, congenital_anomaly, other_serious. One of: serious, not_serious, death, life_threatening, hospitalization, disability, congenital_anomaly, other_serious.
reportSourcestring
Who sent the report. drug_adverse_events: physician, pharmacist, other_health_professional, lawyer, consumer. device_adverse_events: manufacturer, user_facility, distributor, voluntary. One of: physician, pharmacist, other_health_professional, lawyer, consumer, manufacturer, user_facility, distributor, voluntary.
deviceProblemstring
device_adverse_events: one term exactly as countBy device_problem lists it (e.g. "Break"), case included.
patientProblemstring
device_adverse_events: one term exactly as countBy patient_problem lists it (e.g. "Break"), case included.
countBystring
Adverse event datasets only. drug_adverse_events: reaction, drug, country, year. device_adverse_events: device_problem, patient_problem, event_type, device_brand, year. food_adverse_events: reaction, outcome. cosmetic_adverse_events: reaction, outcome. animal_adverse_events: reaction, drug, species, outcome. tobacco_problem_reports: health_problem, product_problem. Returns the top terms with report counts (year: reports per year over the chosen date, newest first); the other filters narrow which reports are counted. One of: reaction, drug, country, outcome, device_problem, patient_problem, event_type, device_brand, species, health_problem, product_problem, year.
limitinteger
Records (or terms) to return, 1 to 10; default 8.

Each result is a record; read one in full with Get a record.

What a record holds

id, title, url: the source's identifier, its title and its page at the source, to verify it.
authority, publishedDate, version: who published it, when, and the edition read.
snippet and fields: the matching text and the source's own fields.
asOf: the day Assyro's copy of the source was read.