OpenFDA API

Base URL

https://api.fda.gov

Auth

Optional free API key (40 req/min without, 240 req/min with). 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 syntax
count — count unique values for a field
limit — 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	40	1,000
With API key (free)	240	120,000