openFDA Drug Search - Adverse Events, Recalls, Drug Labels & Safety Data

Search the FDA's openFDA database for drug safety information. Look up adverse event reports (FAERS), FDA product recalls, and drug label/package insert data. Find side effects, serious outcomes, recall classifications, and prescribing information for any drug, medical device, or food product. Covers the full FDA adverse event reporting system with millions of records. No API key required.

Data comes directly from the official FDA openFDA API — the same source used by pharmaceutical companies, regulators, and researchers worldwide.

What You Get

Adverse Events (FAERS)

Field	Description
safetyReportId	FDA safety report ID
receiveDate	Date FDA received the report
serious	Whether the event was classified as serious
seriousOutcome	Outcome types (death, hospitalization, disability, life-threatening, etc.)
reactions	List of reported adverse reactions
drugs	Drugs involved in the event, including roles (suspect, concomitant)

Recalls

Field	Description
recallNumber	FDA recall number
classification	Recall severity (Class I = most serious, Class II, Class III)
recallingFirm	Company initiating the recall
reasonForRecall	Stated reason for the recall
brandName	Product brand name
genericName	Generic product name

Drug Labels

Field	Description
brandName	Brand name
genericName	Generic name
Full label sections including indications, dosage, warnings, contraindications, adverse reactions, and manufacturer information

Use Cases

• Pharmacovigilance — Search adverse event reports for a specific drug to identify safety signals before and after market approval.
• Recall monitoring — Track all FDA recalls for a pharmaceutical company or drug class, filtered by classification level.
• Drug safety research — Extract FAERS data for academic or regulatory research without manually querying the FDA website.
• Competitive intelligence — Compare adverse event profiles across drugs in the same therapeutic class.
• Regulatory compliance — Pull recall history for products distributed by a supplier or partner to assess risk exposure.
• Medical device monitoring — Search device recalls across Class I, II, and III classifications.
• Litigation support — Retrieve structured adverse event data for specific drugs and time periods for legal discovery.
• Healthcare risk assessment — Identify drugs with the highest rates of serious outcomes in a target population.

How to Use

Step 1: Open the actor on Apify

Go to the actor page and click Try for free.

Step 2: Configure your input

Option A — Search drug adverse events

{
  "searchType": "adverse_events",
  "query": "ibuprofen",
  "maxResults": 100
}

Option B — Search FDA recalls with date range

{
  "searchType": "recalls",
  "query": "contamination",
  "dateFrom": "2023-01-01",
  "dateTo": "2024-12-31",
  "maxResults": 200
}

Option C — Search drug labels

{
  "searchType": "drug_labels",
  "query": "metformin",
  "maxResults": 10
}

Option D — Get recent adverse events (no query filter)

{
  "searchType": "adverse_events",
  "dateFrom": "2024-01-01",
  "maxResults": 500
}

Step 3: Run and export

Click Start. Most queries complete in under 30 seconds. Larger result sets (up to 25,000 records) may take a few minutes.

Input Reference

Field	Type	Description
searchType	string	"adverse_events", "recalls", or "drug_labels"
query	string	Drug name, company name, or keyword (leave empty for recent results)
dateFrom	string	Start date filter in YYYY-MM-DD format
dateTo	string	End date filter in YYYY-MM-DD format
maxResults	integer	Max results to return (default: 100, max: 25,000; set to 0 for maximum)

Cost Estimate

This actor uses the FDA's openFDA public API, which is free. Apify charges only for compute time.

• Actor start fee: ~$0.10 per run
• Compute: Very low — most runs complete in under 30 seconds
• Typical cost for 500 adverse event records: under $0.15 total
• Large jobs (10,000+ records): under $0.30 total

Output Formats

Results are stored in an Apify dataset and can be exported as:

• JSON — Full structured output preserving nested arrays (reactions, drugs, outcomes)
• CSV — Flat format suitable for spreadsheet analysis
• Excel — Direct download from the dataset view
• Google Sheets — Connect via Apify's Google Sheets integration
• Zapier / Make — Automate downstream workflows on run completion

FAQ

Do I need an API key? No. The FDA's openFDA API is publicly accessible without authentication. This actor handles all API communication and rate limiting.

What is FAERS? The FDA Adverse Event Reporting System is the FDA's database of voluntary safety reports submitted by healthcare professionals, consumers, and pharmaceutical manufacturers. It contains millions of reports going back decades.

What is the difference between Class I, II, and III recalls? Class I recalls are the most serious — there is a reasonable probability the product will cause serious health consequences or death. Class II recalls may cause temporary adverse health consequences. Class III recalls are unlikely to cause adverse health consequences but violate FDA regulations.

How far back does adverse event data go? The openFDA FAERS database contains reports from 2004 to the present. The actor supports date filtering to any range within that window.

Can I search for device recalls separately from drug recalls? The recalls search type covers drugs, medical devices, and food products across all FDA recall categories. Use the query field to filter to a specific product type or company.

How large can result sets get? The openFDA API supports up to 25,000 records per query. Set maxResults to 0 to retrieve the maximum available results for your search criteria.

Is this data appropriate for clinical decisions? FAERS data reflects reported events, not confirmed drug-event causation. It is appropriate for surveillance, research, and regulatory purposes, not individual clinical decision-making.