manus-skills/.kortix/opencode/skills/data/database-lookup/references/fda.md

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