OpenFDA Drug Intelligence - AI-Powered FDA Safety Data

Extract drug adverse events, recalls, and safety data from the FDA with AI severity scoring. Perfect for pharmacovigilance, pharma research, and healthcare analytics.

What can this actor extract?

• Drug Adverse Events: Patient reactions, hospitalizations, deaths with AI severity scores (0-100)
• Drug Recalls: Enforcement actions, contamination, mislabeling with risk classification
• Drug Labels: Complete product information, warnings, dosage, ingredients
• Device Adverse Events: Medical device problems and patient outcomes
• Food Recalls: Food safety enforcement actions

Why choose this actor?

• AI Severity Scoring: Unique 0-100 severity score based on outcomes and reactions
• Risk Factor Identification: Automatically identifies key risk factors
• No API Keys: Uses free FDA public API
• Complete Data: All FDA metadata included
• Statistics: Summary statistics for analysis

Quick Start

Drug Adverse Events

{
  "mode": "drug_events",
  "searchQuery": "aspirin",
  "maxResults": 100,
  "seriousOnly": false
}

Drug Recalls

{
  "mode": "drug_recalls",
  "searchQuery": "contamination",
  "maxResults": 50
}

Drug Labels

{
  "mode": "drug_labels",
  "searchQuery": "advil",
  "maxResults": 10
}

Input Parameters

Parameter	Type	Description
mode	string	Search mode: drug_events, drug_recalls, drug_labels, device_events, food_recalls
searchQuery	string	Search term (drug name, company, symptom)
searchField	string	Specific field to search (optional)
maxResults	integer	Max results (0 = all, max 25,000)
dateFrom	string	Start date (YYYYMMDD)
dateTo	string	End date (YYYYMMDD)
seriousOnly	boolean	Only serious events (drug_events mode)
includeStatistics	boolean	Include summary statistics

Output Example

Adverse Event

{
  "report_id": "10012345",
  "receive_date": "20240115",
  "serious": true,
  "death": false,
  "hospitalization": true,
  "reactions": ["nausea", "vomiting", "dizziness"],
  "drugs": [
    {
      "name": "ASPIRIN",
      "indication": "pain relief",
      "route": "oral"
    }
  ],
  "severity_score": 45,
  "severity_label": "moderate",
  "risk_factors": ["hospitalization", "multiple reactions"]
}

Drug Recall

{
  "recall_number": "D-123-2024",
  "status": "Ongoing",
  "classification": "Class II",
  "product_description": "Aspirin 325mg tablets",
  "reason_for_recall": "Contamination with foreign particles",
  "recalling_firm": "Example Pharma Inc",
  "distribution_pattern": "Nationwide",
  "severity_score": 65,
  "severity_label": "high"
}

Use Cases

1. Pharmacovigilance

Monitor drug safety signals and adverse event trends for regulatory compliance.

2. Pharma Research

Analyze competitor drug safety profiles and identify market opportunities.

3. Healthcare Analytics

Build dashboards tracking drug recalls and safety issues.

4. Academic Research

Study drug safety patterns, demographics, and outcomes.

5. Risk Assessment

Evaluate drug safety for formulary decisions and patient safety programs.

AI Severity Scoring

The actor calculates a 0-100 severity score based on:

Outcome Severity (60 points max)

• Death: 60 points
• Life-threatening: 50 points
• Disability: 40 points
• Hospitalization: 30 points
• Other serious: 20 points

Reaction Severity (40 points max)

• Critical reactions (cardiac arrest, anaphylaxis): 40 points
• Severe reactions (seizure, hemorrhage): 30 points
• Moderate reactions (arrhythmia, syncope): 20 points

Labels

• 0-20: Low
• 21-40: Moderate
• 41-60: High
• 61-80: Severe
• 81-100: Critical

Pricing

$5 per 1,000 results

Results	Cost	Use Case
100	$0.50	Quick analysis
1,000	$5.00	Research project
10,000	$50.00	Comprehensive study
25,000	$125.00	Enterprise analysis

Technical Details

• Uses official FDA openFDA API
• No authentication required
• Rate limited to respect API guidelines
• Pagination handled automatically
• Max 25,000 results per query (FDA limit)

Data Sources

All data comes from official FDA databases:

• FAERS (FDA Adverse Event Reporting System)
• Drug recall enforcement reports
• Structured Product Labeling (SPL)
• MAUDE (device events)

Support

Questions or feature requests? Contact via Apify.

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