正文
获取原文件references/fda.md
Base URL
https://api.fda.gov
Auth
Optional free API key (240 req/min with or without). Register at https://open.fda.gov/apis/authentication/
Pass as: ?api_key=YOUR_KEY
Key Endpoints
| Endpoint | Description |
|---|---|
/drug/event.json |
Drug adverse events (FAERS) |
/drug/label.json |
Drug product labeling (SPL) |
/drug/ndc.json |
NDC directory |
/drug/drugsfda.json |
Drugs@FDA (approvals) |
/drug/enforcement.json |
Drug recalls |
/device/event.json |
Device adverse events |
/device/510k.json |
510(k) clearances |
/food/event.json |
Food adverse events |
/food/enforcement.json |
Food enforcement |
Query Parameters
search— query using OpenFDA syntaxcount— count unique values for a fieldlimit— results per request (max 1000)skip— pagination offset (max 25000)
Search Syntax
- Field search:
field:"value" - AND:
field1:value1+AND+field2:value2 - OR:
field1:value1+OR+field2:value2 - Date range:
field:[20230101+TO+20231231] - Wildcards:
field:aspir* - OpenFDA harmonized fields use
openfda.prefix
Example Calls
# Adverse events for aspirin
/drug/event.json?search=patient.drug.openfda.brand_name:"aspirin"&limit=5
# Top adverse reactions for a drug
/drug/event.json?search=patient.drug.openfda.generic_name:"metformin"&count=patient.reaction.reactionmeddrapt.exact
# Drug labels by generic name
/drug/label.json?search=openfda.generic_name:"ibuprofen"&limit=3
# Drug recalls in date range
/drug/enforcement.json?search=report_date:[20230101+TO+20231231]&limit=10
# Serious adverse events only
/drug/event.json?search=patient.drug.openfda.brand_name:"warfarin"+AND+serious:1&limit=10
Rate Limits
| Tier | Requests/min | Requests/day |
|---|---|---|
| No API key | 240 | 1,000 |
| With API key (free) | 240 | 120,000 |
FAERS reports are not incidence estimates or proof that a drug caused an event. Preserve report versions and avoid double-counting follow-ups. OpenFDA harmonization is incomplete; a missing harmonized name is not evidence of absence.