FDA Database Access

Overview

Access comprehensive FDA regulatory data through openFDA, the FDA's initiative to provide open APIs for public datasets. Query information about drugs, medical devices, foods, animal/veterinary products, and substances using Python with standardized interfaces.

Key capabilities:

Query adverse events for drugs, devices, foods, and veterinary products
Access product labeling, approvals, and regulatory submissions
Monitor recalls and enforcement actions
Look up National Drug Codes (NDC) and substance identifiers (UNII)
Analyze device classifications and clearances (510k, PMA)
Track drug shortages and supply issues
Research chemical structures and substance relationships

When to Use This Skill

This skill should be used when working with:

Drug research: Safety profiles, adverse events, labeling, approvals, shortages
Medical device surveillance: Adverse events, recalls, 510(k) clearances, PMA approvals
Food safety: Recalls, allergen tracking, adverse events, dietary supplements
Veterinary medicine: Animal drug adverse events by species and breed
Chemical/substance data: UNII lookup, CAS number mapping, molecular structures
Regulatory analysis: Approval pathways, enforcement actions, compliance tracking
Pharmacovigilance: Post-market surveillance, safety signal detection
Scientific research: Drug interactions, comparative safety, epidemiological studies

Quick Start

1. Basic Setup

python

from scripts.fda_query import FDAQuery

# Initialize (API key optional but recommended)
fda = FDAQuery(api_key="YOUR_API_KEY")

# Query drug adverse events
events = fda.query_drug_events("aspirin", limit=100)

# Get drug labeling
label = fda.query_drug_label("Lipitor", brand=True)

# Search device recalls
recalls = fda.query("device", "enforcement",
                   search="classification:Class+I",
                   limit=50)

2. API Key Setup

While the API works without a key, registering provides higher rate limits:

Without key: 240 requests/min, 1,000/day
With key: 240 requests/min, 120,000/day

Set as environment variable:

bash

export FDA_API_KEY="your_key_here"

3. Running Examples

bash

# Run comprehensive examples
python scripts/fda_examples.py

# This demonstrates:
# - Drug safety profiles
# - Device surveillance
# - Food recall monitoring
# - Substance lookup
# - Comparative drug analysis
# - Veterinary drug analysis

FDA Database Categories

Drugs

Access 6 drug-related endpoints covering the full drug lifecycle from approval to post-market surveillance.

Endpoints:

Adverse Events - Reports of side effects, errors, and therapeutic failures
Product Labeling - Prescribing information, warnings, indications
NDC Directory - National Drug Code product information
Enforcement Reports - Drug recalls and safety actions
Drugs@FDA - Historical approval data since 1939
Drug Shortages - Current and resolved supply issues

Common use cases:

python

# Safety signal detection
fda.count_by_field("drug", "event",
                  search="patient.drug.medicinalproduct:metformin",
                  field="patient.reaction.reactionmeddrapt")

# Get prescribing information
label = fda.query_drug_label("Keytruda", brand=True)

# Check for recalls
recalls = fda.query_drug_recalls(drug_name="metformin")

# Monitor shortages
shortages = fda.query("drug", "drugshortages",
                     search="status:Currently+in+Shortage")

Reference: See

references/drugs.md

for detailed documentation

Devices

Access 9 device-related endpoints covering medical device safety, approvals, and registrations.

Endpoints:

Adverse Events - Device malfunctions, injuries, deaths
510(k) Clearances - Premarket notifications
Classification - Device categories and risk classes
Enforcement Reports - Device recalls
Recalls - Detailed recall information
PMA - Premarket approval data for Class III devices
Registrations & Listings - Manufacturing facility data
UDI - Unique Device Identification database
COVID-19 Serology - Antibody test performance data

Common use cases:

python

# Monitor device safety
events = fda.query_device_events("pacemaker", limit=100)

# Look up device classification
classification = fda.query_device_classification("DQY")

# Find 510(k) clearances
clearances = fda.query_device_510k(applicant="Medtronic")

# Search by UDI
device_info = fda.query("device", "udi",
                       search="identifiers.id:00884838003019")

Reference: See

references/devices.md

for detailed documentation

Foods

Access 2 food-related endpoints for safety monitoring and recalls.

Endpoints:

Adverse Events - Food, dietary supplement, and cosmetic events
Enforcement Reports - Food product recalls

Common use cases:

python

# Monitor allergen recalls
recalls = fda.query_food_recalls(reason="undeclared peanut")

# Track dietary supplement events
events = fda.query_food_events(
    industry="Dietary Supplements")

# Find contamination recalls
listeria = fda.query_food_recalls(
    reason="listeria",
    classification="I")

Reference: See

references/foods.md

for detailed documentation

Animal & Veterinary

Access veterinary drug adverse event data with species-specific information.

Endpoint:

Adverse Events - Animal drug side effects by species, breed, and product

Common use cases:

python

# Species-specific events
dog_events = fda.query_animal_events(
    species="Dog",
    drug_name="flea collar")

# Breed predisposition analysis
breed_query = fda.query("animalandveterinary", "event",
    search="reaction.veddra_term_name:*seizure*+AND+"
           "animal.breed.breed_component:*Labrador*")

Reference: See

references/animal_veterinary.md

for detailed documentation

Substances & Other

Access molecular-level substance data with UNII codes, chemical structures, and relationships.

Endpoints:

Substance Data - UNII, CAS, chemical structures, relationships
NSDE - Historical substance data (legacy)

Common use cases:

python

# UNII to CAS mapping
substance = fda.query_substance_by_unii("R16CO5Y76E")

# Search by name
results = fda.query_substance_by_name("acetaminophen")

# Get chemical structure
structure = fda.query("other", "substance",
    search="names.name:ibuprofen+AND+substanceClass:chemical")

Reference: See

references/other.md

for detailed documentation

Common Query Patterns

Pattern 1: Safety Profile Analysis

Create comprehensive safety profiles combining multiple data sources:

python

def drug_safety_profile(fda, drug_name):
    """Generate complete safety profile."""

    # 1. Total adverse events
    events = fda.query_drug_events(drug_name, limit=1)
    total = events["meta"]["results"]["total"]

    # 2. Most common reactions
    reactions = fda.count_by_field(
        "drug", "event",
        search=f"patient.drug.medicinalproduct:*{drug_name}*",
        field="patient.reaction.reactionmeddrapt",
        exact=True
    )

    # 3. Serious events
    serious = fda.query("drug", "event",
        search=f"patient.drug.medicinalproduct:*{drug_name}*+AND+serious:1",
        limit=1)

    # 4. Recent recalls
    recalls = fda.query_drug_recalls(drug_name=drug_name)

    return {
        "total_events": total,
        "top_reactions": reactions["results"][:10],
        "serious_events": serious["meta"]["results"]["total"],
        "recalls": recalls["results"]
    }

Pattern 2: Temporal Trend Analysis

Analyze trends over time using date ranges:

python

from datetime import datetime, timedelta

def get_monthly_trends(fda, drug_name, months=12):
    """Get monthly adverse event trends."""
    trends = []

    for i in range(months):
        end = datetime.now() - timedelta(days=30*i)
        start = end - timedelta(days=30)

        date_range = f"[{start.strftime('%Y%m%d')}+TO+{end.strftime('%Y%m%d')}]"
        search = f"patient.drug.medicinalproduct:*{drug_name}*+AND+receivedate:{date_range}"

        result = fda.query("drug", "event", search=search, limit=1)
        count = result["meta"]["results"]["total"] if "meta" in result else 0

        trends.append({
            "month": start.strftime("%Y-%m"),
            "events": count
        })

    return trends

Pattern 3: Comparative Analysis

Compare multiple products side-by-side:

python

def compare_drugs(fda, drug_list):
    """Compare safety profiles of multiple drugs."""
    comparison = {}

    for drug in drug_list:
        # Total events
        events = fda.query_drug_events(drug, limit=1)
        total = events["meta"]["results"]["total"] if "meta" in events else 0

        # Serious events
        serious = fda.query("drug", "event",
            search=f"patient.drug.medicinalproduct:*{drug}*+AND+serious:1",
            limit=1)
        serious_count = serious["meta"]["results"]["total"] if "meta" in serious else 0

        comparison[drug] = {
            "total_events": total,
            "serious_events": serious_count,
            "serious_rate": (serious_count/total*100) if total > 0 else 0
        }

    return comparison

Pattern 4: Cross-Database Lookup

Link data across multiple endpoints:

python

def comprehensive_device_lookup(fda, device_name):
    """Look up device across all relevant databases."""

    return {
        "adverse_events": fda.query_device_events(device_name, limit=10),
        "510k_clearances": fda.query_device_510k(device_name=device_name),
        "recalls": fda.query("device", "enforcement",
                           search=f"product_description:*{device_name}*"),
        "udi_info": fda.query("device", "udi",
                            search=f"brand_name:*{device_name}*")
    }

Working with Results

Response Structure

All API responses follow this structure:

python

{
    "meta": {
        "disclaimer": "...",
        "results": {
            "skip": 0,
            "limit": 100,
            "total": 15234
        }
    },
    "results": [
        # Array of result objects
    ]
}

Error Handling

Always handle potential errors:

python

result = fda.query_drug_events("aspirin", limit=10)

if "error" in result:
    print(f"Error: {result['error']}")
elif "results" not in result or len(result["results"]) == 0:
    print("No results found")
else:
    # Process results
    for event in result["results"]:
        # Handle event data
        pass

Pagination

For large result sets, use pagination:

python

# Automatic pagination
all_results = fda.query_all(
    "drug", "event",
    search="patient.drug.medicinalproduct:aspirin",
    max_results=5000
)

# Manual pagination
for skip in range(0, 1000, 100):
    batch = fda.query("drug", "event",
                     search="...",
                     limit=100,
                     skip=skip)
    # Process batch

Best Practices

1. Use Specific Searches

DO:

python

# Specific field search
search="patient.drug.medicinalproduct:aspirin"

DON'T:

python

# Overly broad wildcard
search="*aspirin*"

2. Implement Rate Limiting

The

FDAQuery

class handles rate limiting automatically, but be aware of limits:

240 requests per minute
120,000 requests per day (with API key)

3. Cache Frequently Accessed Data

The

FDAQuery

class includes built-in caching (enabled by default):

python

# Caching is automatic
fda = FDAQuery(api_key=api_key, use_cache=True, cache_ttl=3600)

4. Use Exact Matching for Counting

When counting/aggregating, use

.exact

suffix:

python

# Count exact phrases
fda.count_by_field("drug", "event",
                  search="...",
                  field="patient.reaction.reactionmeddrapt",
                  exact=True)  # Adds .exact automatically

5. Validate Input Data

Clean and validate search terms:

python

def clean_drug_name(name):
    """Clean drug name for query."""
    return name.strip().replace('"', '\\"')

drug_name = clean_drug_name(user_input)

API Reference

For detailed information about:

Authentication and rate limits → See
```
references/api_basics.md
```
Drug databases → See
```
references/drugs.md
```
Device databases → See
```
references/devices.md
```
Food databases → See
```
references/foods.md
```
Animal/veterinary databases → See
```
references/animal_veterinary.md
```
Substance databases → See
```
references/other.md
```

Scripts

scripts/fda_query.py

Main query module with

FDAQuery

class providing:

Unified interface to all FDA endpoints
Automatic rate limiting and caching
Error handling and retry logic
Common query patterns

scripts/fda_examples.py

Comprehensive examples demonstrating:

Drug safety profile analysis
Device surveillance monitoring
Food recall tracking
Substance lookup
Comparative drug analysis
Veterinary drug analysis

Run examples:

bash

python scripts/fda_examples.py

Additional Resources

openFDA Homepage: https://open.fda.gov/
API Documentation: https://open.fda.gov/apis/
Interactive API Explorer: https://open.fda.gov/apis/try-the-api/
GitHub Repository: https://github.com/FDA/openfda
Terms of Service: https://open.fda.gov/terms/

Support and Troubleshooting

Common Issues

Issue: Rate limit exceeded

Solution: Use API key, implement delays, or reduce request frequency

Issue: No results found

Solution: Try broader search terms, check spelling, use wildcards

Issue: Invalid query syntax

Solution: Review query syntax in
```
references/api_basics.md
```

Issue: Missing fields in results

Solution: Not all records contain all fields; always check field existence

Getting Help

GitHub Issues: https://github.com/FDA/openfda/issues
Email: open-fda@fda.hhs.gov

fda-database

NPX Install

SKILL.md Content

FDA Database Access

Overview

When to Use This Skill

Quick Start

1. Basic Setup

2. API Key Setup

3. Running Examples

FDA Database Categories

Drugs

Devices

Foods

Animal & Veterinary

Substances & Other

Common Query Patterns

Pattern 1: Safety Profile Analysis

Pattern 2: Temporal Trend Analysis

Pattern 3: Comparative Analysis

Pattern 4: Cross-Database Lookup

Working with Results

Response Structure

Error Handling

Pagination

Best Practices

1. Use Specific Searches

2. Implement Rate Limiting

3. Cache Frequently Accessed Data

4. Use Exact Matching for Counting

5. Validate Input Data

API Reference

Scripts

`scripts/fda_query.py`

`scripts/fda_examples.py`

Additional Resources

Support and Troubleshooting

Common Issues

Getting Help