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FDA Drug Safety Intelligence

Under maintenance

Try for free

Cross-reference FDA databases for drug product info, adverse events, and recalls. Normalizes 200+ brand/generic drug names with manufacturer deduplication. Free API, no key needed.

Pricing

Pay per usage

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0.0

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Developer

Chris Wakefield

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Monthly active users

5 days ago

Last modified

FDA Drug Safety Intelligence 🏥

Cross-reference multiple FDA databases to build comprehensive drug safety profiles. Searches drug product labeling (NDC directory), adverse event reports (FAERS), and enforcement actions (recalls) — then normalizes brand/generic drug names and manufacturer data for clean, analyzable output.

Features

🔍 Multi-endpoint intelligence — Products, adverse events, and recalls in one run
🏷️ 200+ drug name normalizations — Brand→generic mapping (Ozempic→Semaglutide, Lipitor→Atorvastatin, etc.)
🏭 Manufacturer deduplication — Canonical names for 50+ pharma companies
⚠️ Recall severity classification — Class I/II/III with risk indicators
📊 Human-readable summary — Formatted table output with reaction frequency bars
🌐 No API key required — OpenFDA is free and public

Input

Field	Type	Description
`searchQuery`	string	Brand or generic drug name (e.g. `ozempic`, `semaglutide`, `ibuprofen`)
`searchType`	enum	`full` (all), `products_only`, `events_only`, `recalls_only`
`maxResults`	integer	Max results per endpoint (1–1000, default 100)
`seriousOnly`	boolean	Only return serious adverse events

Example Input

{
  "searchQuery": "ozempic",
  "searchType": "full",
  "maxResults": 50,
  "seriousOnly": false
}

Example Output

================================================================================
  FDA DRUG SAFETY INTELLIGENCE REPORT
================================================================================
  Search Query:   ozempic
  Normalized:     Semaglutide

  ── PRODUCT INFORMATION (7 unique) ──
   1. Ozempic (semaglutide)
      Mfr: Novo Nordisk | NDC: 0169-1305 | Form: INJECTION, SOLUTION
   2. Ozempic (semaglutide)
      Mfr: Novo Nordisk | NDC: 0169-1310 | Form: INJECTION, SOLUTION

  ── ADVERSE EVENTS (50 reports) ──
  Serious: 34 (68%) | Deaths: 2 | Hospitalizations: 18
  Top Reactions:
    Nausea                         12  ████████████████████████
    Vomiting                        8  ████████████████
    Pancreatitis                    5  ██████████
    ...

  ── RECALLS (1 found) ──
  High Risk (Class I): 1
   1. [HIGH] Ozempic (semaglutide) injection
      Firm: Novo Nordisk | Date: 20240315 | Status: Ongoing

Use Cases

Pharmaceutical competitive intelligence — Track adverse event profiles of competitor drugs
Clinical safety research — Analyze real-world drug safety signals from FAERS
Healthcare compliance — Monitor FDA enforcement actions and recalls
Legal / liability — Gather drug safety evidence for litigation
AI / ML pipelines — Feed normalized drug safety data into predictive models

Data Sources

All data comes from the OpenFDA public API (public domain, no license restrictions):

Drug Product Labeling (drug/ndc.json) — 137K+ products
Adverse Event Reports (drug/event.json) — 20M+ FAERS reports
Drug Enforcement Actions (drug/enforcement.json) — Recalls, market withdrawals

Pricing

Pay-per-result pricing via the Apify platform. Each dataset item after the free tier counts as one event.

Built by Chris The Dev • Data: open.fda.gov (public domain)

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