OpenFDA Drug Data Scraper

Access the FDA's massive pharmaceutical database through the official OpenFDA API. This scraper extracts drug labels, adverse event reports, recall notices, and NDC (National Drug Code) directory data in structured, analysis-ready formats.

What Data Can You Extract?

The FDA maintains one of the world's largest pharmaceutical databases, and this scraper gives you direct access to four critical datasets:

Drug Labels (253,000+ records)

Complete FDA-approved drug labeling including indications, warnings, dosage information, active ingredients, and manufacturer details. Essential for understanding what drugs are approved for, their risks, and how they should be used.

Adverse Event Reports (19.6 million+ records)

The FDA Adverse Event Reporting System (FAERS) contains reports of adverse drug reactions submitted by healthcare professionals, consumers, and manufacturers. Each report includes patient demographics, suspected drugs, reported reactions, and outcome information.

Drug Recalls & Enforcement (50,000+ records)

Enforcement reports covering drug recalls, market withdrawals, and safety alerts. Includes recall classification (Class I/II/III), reason for recall, affected products, and distribution information.

NDC Directory (300,000+ records)

The National Drug Code Directory provides a unique identifier for every drug product marketed in the United States, with labeler information, dosage forms, routes of administration, and active ingredients.

Who Uses This Data?

Pharmaceutical Companies

• Monitor competitor drug labels and market positioning
• Track adverse events for your drugs and competitors
• Identify market opportunities through label analysis
• Support pharmacovigilance and safety signal detection

Healthcare Compliance Teams

• Set up automated recall alerts for your formulary
• Monitor regulatory actions affecting your supply chain
• Ensure compliance with FDA safety communications
• Track enforcement trends by product category or manufacturer

Medical Researchers

• Analyze adverse event patterns across drug classes
• Study demographic factors in drug reactions
• Support post-market surveillance research
• Identify potential drug-drug interactions

Law Firms & Legal Teams

• Gather evidence for pharmaceutical litigation
• Research adverse event history for specific drugs
• Document recall timelines and company responses
• Support mass tort and product liability cases

Healthcare IT & Developers

• Build drug reference databases
• Power clinical decision support systems
• Create pharmacy management integrations
• Develop patient safety applications

Supplement & Nutraceutical Companies

• Research ingredient safety profiles
• Monitor FDA enforcement in your category
• Track adverse events for similar products
• Support regulatory compliance efforts

Data Fields by Mode

Drug Labels

{
  "brand_name": "LIPITOR",
  "generic_name": "ATORVASTATIN CALCIUM",
  "manufacturer_name": "Pfizer Laboratories Div Pfizer Inc",
  "product_ndc": "0071-0155",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "route": "ORAL",
  "indications_and_usage": "LIPITOR is indicated as an adjunct to diet...",
  "warnings": "Skeletal muscle effects (e.g., myopathy and rhabdomyolysis)...",
  "dosage_and_administration": "The recommended starting dose is 10 or 20 mg...",
  "active_ingredient": "ATORVASTATIN CALCIUM",
  "inactive_ingredient": "CALCIUM CARBONATE, CANDELILLA WAX...",
  "spl_id": "b2e9c47e-bb55-448a-a23c-f5e3e8c6bb37",
  "scrapedAt": "2025-01-25T10:30:00.000Z"
}

Adverse Events

{
  "safetyreportid": "10123456",
  "serious": "1",
  "seriousnessdeath": "0",
  "patient_age": "65",
  "patient_age_unit": "801",
  "patient_sex": "2",
  "patient_weight": "70",
  "reactions": ["MYALGIA", "RHABDOMYOLYSIS", "MUSCLE WEAKNESS"],
  "drugs": [
    {
      "name": "LIPITOR",
      "dosage": "40 MG DAILY",
      "indication": "HYPERCHOLESTEROLEMIA",
      "route": "ORAL",
      "characterization": "1"
    }
  ],
  "receivedate": "20240115",
  "reporttype": "1",
  "primarysource_country": "US",
  "scrapedAt": "2025-01-25T10:30:00.000Z"
}

Recalls

{
  "recall_number": "D-0123-2025",
  "classification": "Class II",
  "recalling_firm": "Example Pharma Inc",
  "city": "New York",
  "state": "NY",
  "country": "United States",
  "reason_for_recall": "Presence of foreign particulate matter",
  "product_description": "Metformin HCl Extended Release Tablets, 500mg",
  "recall_initiation_date": "20250110",
  "report_date": "20250115",
  "distribution_pattern": "Nationwide",
  "quantity": "50,000 bottles",
  "status": "Ongoing",
  "voluntary_mandated": "Voluntary: Firm Initiated",
  "scrapedAt": "2025-01-25T10:30:00.000Z"
}

NDC Codes

{
  "product_ndc": "0071-0155",
  "brand_name": "LIPITOR",
  "generic_name": "ATORVASTATIN CALCIUM",
  "labeler_name": "Pfizer Laboratories Div Pfizer Inc",
  "dosage_form": "TABLET, FILM COATED",
  "route": "ORAL",
  "marketing_category": "NDA",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "active_ingredients": [
    {"name": "ATORVASTATIN CALCIUM", "strength": "10 mg/1"}
  ],
  "packaging": [
    {"package_ndc": "0071-0155-23", "description": "90 TABLET, FILM COATED in 1 BOTTLE"}
  ],
  "finished": "true",
  "listing_expiration_date": "20261231",
  "scrapedAt": "2025-01-25T10:30:00.000Z"
}

Input Options

Parameter	Description	Default
mode	Data type: drug-labels, adverse-events, recalls, or ndc-codes	drug-labels
searchQuery	OpenFDA search syntax (e.g., openfda.brand_name:aspirin)	empty
maxResults	Maximum records to retrieve (up to 10,000 per run)	100
dateFrom	Start date filter (YYYY-MM-DD) for adverse events and recalls	empty
dateTo	End date filter (YYYY-MM-DD) for adverse events and recalls	empty
apiKey	Your OpenFDA API key for higher rate limits	empty

Search Query Examples

• Brand name search: openfda.brand_name:lipitor
• Manufacturer search: openfda.manufacturer_name:pfizer
• Active ingredient: active_ingredient:acetaminophen
• Product type: openfda.product_type:"HUMAN PRESCRIPTION DRUG"
• Route of administration: openfda.route:ORAL
• Recall classification: classification:"Class I"
• Multiple conditions: openfda.brand_name:aspirin AND openfda.route:ORAL

API Rate Limits

The OpenFDA API has rate limits that affect how quickly data can be retrieved:

• Without API key: 40 requests per minute, 1,000 per day
• With API key: 240 requests per minute, 120,000 per day

You can get a free API key from open.fda.gov to significantly increase your throughput. The scraper automatically adjusts its request timing based on whether an API key is provided.

Technical Notes

• Maximum 10,000 results per run (OpenFDA API limitation)
• Results are returned in JSON format
• The scraper handles pagination automatically
• Empty searches return all available records (subject to limits)
• Date filtering uses the receivedate field for adverse events and report_date for recalls

Pricing

This Actor uses pay-per-result pricing. You only pay for the data you extract, making it cost-effective for both small queries and large data pulls.

Support

For questions about this scraper, reach out through Apify support. For questions about the underlying data, consult the OpenFDA documentation.