OpenFDA Drug & Device Safety Data

Extract official FDA safety data — drug adverse events, food recalls, drug recalls, and medical device incidents — from the OpenFDA public API. The FDA's official database with millions of safety reports.

Why use this Actor?

• Official FDA data — direct from the U.S. Food and Drug Administration, not third-party
• No API key required — OpenFDA is a free public API
• No proxy needed — accessible worldwide
• 4 datasets in one Actor — drug adverse events (FAERS), drug recalls, food recalls, and device incidents (MAUDE)
• Simple drug name search — just type "aspirin" instead of learning OpenFDA query syntax
• Millions of records — 20+ million drug adverse events, 23+ million device events, 28K+ food recalls

How much does it cost?

This Actor uses pay-per-event pricing. You are charged per result item returned.

No proxy costs. No API key costs. OpenFDA is freely accessible from any location.

Four data sources

1. Drug Adverse Events (FAERS)

Reports of drug side effects and reactions submitted to the FDA. Over 20 million reports.

Use cases: Drug safety monitoring, pharmacovigilance, side effect analysis, drug comparison studies.

2. Drug Recalls & Enforcement

Official FDA drug recall actions including voluntary recalls, market withdrawals, and safety alerts.

3. Food Recalls & Enforcement

FDA food recall enforcement actions including contamination, undeclared allergens, and safety issues.

4. Medical Device Adverse Events (MAUDE)

Reports of medical device malfunctions, injuries, and deaths. Over 23 million reports.

Input parameters

Parameter	Required	Default	Description
endpoint	Yes	drug_event	Data source to query
search	No	-	OpenFDA search query (advanced)
drugName	No	-	Simple drug name filter (e.g. "aspirin")
dateFrom	No	-	Start date (YYYYMMDD)
dateTo	No	-	End date (YYYYMMDD)
seriousOnly	No	false	Only return serious events
maxResults	No	100	Maximum results to return

Example: Drug adverse event output

{
    "reportId": "10003304",
    "receiveDate": "20140312",
    "serious": "2",
    "drugName": "ASPIRIN",
    "drugBrandName": "ASPIRIN",
    "drugGenericName": "ASPIRIN",
    "drugIndication": "PAIN",
    "reactions": ["Drug hypersensitivity", "Rash", "Pruritus"],
    "reactionOutcome": ["1", "1", "1"],
    "patientAge": "45",
    "patientSex": "2",
    "reportCountry": "US"
}

Example: Food recall output

{
    "reportId": "F-0276-2017",
    "status": "Terminated",
    "classification": "Class II",
    "reason": "Potential contamination with Burkholderia cepacia",
    "productDescription": "Dietary supplement, 1 oz./30 mL",
    "recallingFirm": "Example Corp",
    "state": "CA",
    "country": "US"
}

Use cases

• Pharmacovigilance — monitor drug safety signals and adverse reaction patterns
• Drug comparison — compare side effect profiles across competing medications
• Food safety monitoring — track recalls by product category, reason, or manufacturer
• Medical device surveillance — monitor device failure patterns and injury reports
• Regulatory research — analyze FDA enforcement trends and recall patterns
• Academic research — study drug safety data for publications and reports
• Due diligence — investigate a pharmaceutical company's safety record

FAQ

Q: Can I search by generic drug name instead of brand name? A: Yes. The drugName parameter searches across both brand and generic names. For example, searching "ibuprofen" returns results for Advil, Motrin, and other brands containing ibuprofen.

Q: What does "serious" mean in adverse events? A: The FDA classifies an event as serious if it resulted in death, hospitalization, disability, congenital anomaly, or required medical intervention. Use seriousOnly: true to filter for these.

Q: How far back does the data go? A: Drug adverse events (FAERS) go back to the 1960s, with the most complete data from 2004 onward. Device events (MAUDE) start from the early 1990s. Food recalls from the 2000s.

Q: Can I use the OpenFDA query syntax directly? A: Yes. The search parameter accepts full OpenFDA query syntax (e.g., patient.drug.openfda.brand_name:"ASPIRIN"+AND+serious:1). Use this for complex queries. The drugName shortcut is simpler for basic searches.

Q: How often is the data updated? A: OpenFDA updates quarterly for adverse events and weekly for recalls. There is typically a 3-6 month lag for adverse event reports as they go through processing.

Q: What's the difference between drug adverse events and recalls? A: Adverse events are individual patient reports of side effects (from doctors, patients, or manufacturers). Recalls are official FDA enforcement actions requiring products to be removed from the market.

Integration with Python

from apify_client import ApifyClient

client = ApifyClient("YOUR_API_TOKEN")

# Get serious adverse events for a drug
run = client.actor("aligned_kettledrum/openfda-safety-data").call(
    run_input={
        "endpoint": "drug_event",
        "drugName": "metformin",
        "seriousOnly": True,
        "maxResults": 200,
    }
)

# Analyze reactions
import pandas as pd
from collections import Counter

items = list(client.dataset(run["defaultDatasetId"]).iterate_items())
all_reactions = [r for item in items for r in item.get("reactions", [])]
top_reactions = Counter(all_reactions).most_common(15)

print("Top adverse reactions for Metformin:")
for reaction, count in top_reactions:
    print(f"  {reaction}: {count}")

Technical details

This Actor queries the OpenFDA API, a free public API maintained by the U.S. FDA. Rate limited to 240 requests/minute (without API key). The Actor handles pagination and rate limiting automatically.

OpenFDA data is updated regularly and covers reports from the 1960s to present.

MCP Server

Need OpenFDA data inside your AI agent? Use the OpenFDA MCP Server — same data, native MCP integration for Claude, ChatGPT, and other LLM frameworks.