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OpenFDA API

| 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.j

Claude Code Knowledge Pack7/10/2026

Overview

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

EndpointDescription
/drug/event.jsonDrug adverse events (FAERS)
/drug/label.jsonDrug product labeling (SPL)
/drug/ndc.jsonNDC directory
/drug/drugsfda.jsonDrugs@FDA (approvals)
/drug/enforcement.jsonDrug recalls
/device/event.jsonDevice adverse events
/device/510k.json510(k) clearances
/food/event.jsonFood adverse events
/food/enforcement.jsonFood 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

TierRequests/minRequests/day
No API key401,000
With API key (free)240120,000