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💊 OpenFDA Drug Intelligence - Adverse Events + AI

Extract FDA drug adverse events, recalls, and safety data with AI severity scoring (0-100). Perfect for pharma research, pharmacovigilance, and healthcare analytics. Free FDA API - no keys needed.

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💊 OpenFDA Drug Intelligence — Adverse Events, Recalls & Safety Data with AI Severity Scoring

Extract FDA drug adverse events, recalls, labels, device events and food recalls from the official openFDA databases — enriched with an AI severity score (0–100) and risk-factor detection on every record. Search by drug name, company or symptom, filter by date and seriousness, and get a clean, ranked dataset for pharmacovigilance and healthcare research — no API key, no login. Export to JSON/CSV/Excel, run on a schedule, call via API, or connect to Make, Zapier or n8n.

💊 What is the OpenFDA Drug Intelligence?

It turns the FDA's public safety databases into a structured, severity-ranked dataset. Pick a mode (adverse events, recalls, labels, device events or food recalls), enter a search term, and it returns every matching report with full FDA metadata plus an AI severity score that surfaces the most critical cases first — so pharma teams, researchers and analysts can monitor safety signals without wrangling raw API responses.

What data does it extract?

Drug adverse events — patient reactions, outcomes (death, hospitalization, life-threatening), age, sex and reporting drugs
Drug recalls — classification (Class I/II/III), reason, recalling firm, status and distribution
Drug labels / SPL — brand & generic names, manufacturer, warnings, dosage, indications and ingredients
Device adverse events — device name, manufacturer, problems and patient outcomes
Food recalls — product description, reason, recalling firm and classification
AI severity score (0–100) with a label (Critical / Severe / Moderate / Mild) and risk factors

⬇️ Input

Choose a search mode, give it a query, and refine with optional filters:

Field	Description
`mode`	`drug_events`, `drug_recalls`, `drug_labels`, `device_events` or `food_recalls`
`searchQuery`	Search term — drug name, company or symptom, e.g. `aspirin`, `pfizer`, `nausea`
`searchField`	Specific field to search (optional; defaults to the best field per mode)
`maxResults`	Maximum results (0 = all available, max 25,000 per query)
`dateFrom` / `dateTo`	Date range filter in `YYYYMMDD` format, e.g. `20240101`
`seriousOnly`	Adverse events only: keep serious reports (death, hospitalization, etc.)
`includeStatistics`	Include summary statistics (severity distribution, top reactions)
`sortBy`	Sort results by a field, e.g. `field:asc` or `field:desc`

Example input

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

⬆️ Output

Every report is one clean row (view as a table, or export JSON / CSV / Excel). An adverse-event record looks like this:

{
  "report_id": "10012345",
  "receive_date": "20240115",
  "serious": true,
  "death": false,
  "hospitalization": true,
  "disability": false,
  "congenital_anomaly": false,
  "life_threatening": false,
  "patient_age": 67.0,
  "patient_sex": "Female",
  "patient_weight": null,
  "reactions": ["Nausea", "Vomiting", "Dizziness"],
  "drugs": [
    {
      "name": "ASPIRIN",
      "characterization": "1",
      "route": "Oral",
      "indication": "Pain"
    }
  ],
  "reporter_qualification": "Physician",
  "report_country": "US",
  "manufacturer": "PFIZER",
  "severity_score": 45,
  "severity_label": "Moderate",
  "risk_factors": ["Elderly patient (65+)", "Required hospitalization"]
}

A drug recall record looks like this:

{
  "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": 60,
  "severity_label": "Serious"
}

The severity score (0–100) weighs outcome severity (death, life-threatening, disability, hospitalization) and the seriousness of reported reactions, then maps to a label. For recalls it follows the FDA classification — Class I is most severe. Risk factors (elderly patient, polypharmacy, fatal outcome) are flagged automatically.

💡 Use cases

🛡️ Pharmacovigilance: monitor adverse-event signals and severity trends for a drug or portfolio in near real time.
🔬 Pharma & competitive research: compare safety profiles, recalls and labels across competitor products.
📊 Healthcare analytics: build dashboards tracking recalls, deaths and severity distributions for reporting.
🎓 Academic research: study drug safety patterns, demographics and outcomes from the official FAERS data.

❓ FAQ

How do I search FDA drug safety data? Pick a mode (e.g. drug_events or drug_recalls), enter a searchQuery like a drug name or company, set maxResults, then Run. You get structured FDA reports with an AI severity score.

Do I need an API key? No. It uses the free, public openFDA API — no authentication, account or token required.

What FDA data sources does it cover? Drug adverse events (FAERS), drug recalls and enforcement reports, Structured Product Labeling (SPL), medical device events (MAUDE) and food recalls — selectable via the mode field.

What is the severity score? A transparent 0–100 score built from the reported outcome (death, hospitalization, life-threatening, etc.) and reaction severity, mapped to a Critical/Severe/Moderate/Mild label. Recalls are scored by FDA classification (Class I–III).

Can I filter by date or seriousness? Yes — use dateFrom/dateTo (YYYYMMDD) for a time range and seriousOnly to keep only serious adverse events.

How many records can it return? Up to your maxResults cap, up to the FDA limit of 25,000 per query. The actor paginates automatically.

Can I export the data? Yes — download results as JSON, CSV or Excel, or pull them straight from the dataset via the Apify API.

Can I run it on a schedule or via API? Yes — schedule recurring runs in Apify, call it via the API/SDK, or connect it to Make, Zapier or n8n.

Is it legal? It uses the official openFDA public API, which provides open government data intended for research and analysis. The severity score is an analytical aid, not medical advice — always verify against the source for clinical or regulatory decisions.

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Keywords: openFDA API, FDA drug data, drug adverse events, FAERS data, drug recalls, drug labels, SPL data, pharmacovigilance, drug safety scraper, adverse event reporting, medical device events, MAUDE data, food recalls, healthcare analytics, pharma research, drug severity score.

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