Drug Safety & FDA Brief: Approvals, Adverse Events, Recalls

Give it drug names (brand or generic) and get ONE composed safety brief per drug — not four separate scrapes. It fuses four openFDA sources into a single answer: approvals (drugsFDA), FAERS adverse events (aggregated), recalls (enforcement) and the boxed warning (label). Keyless, agent-callable, built to answer "what does the FDA safety picture for this drug look like?"

⚠️ Not causation. FAERS adverse-event reports are voluntary and do not establish that a drug caused an event — counts reflect reporting, not incidence or causation. Every brief says so. Verify against the FDA label and source before any clinical or investment decision.

⚡ Why it's different

Every other FDA actor on the Store scrapes one endpoint (events, or approvals, or labels). This one composes all four into one brief per drug, with the adverse events already aggregated server-side (top reactions, serious and death report counts) — the answer, not the raw rows.

📋 What each brief contains

Field	Meaning
approval	Sponsors, application numbers, generic/brand names, dosage forms, routes, marketing status
adverseEvents.totalReports	Total FAERS reports mentioning the drug
adverseEvents.topReactions	Most-reported reactions with counts (aggregated)
adverseEvents.seriousReports / deathReports	Report counts flagged serious / death
recalls	Total recalls + the most recent (reason, classification, status, date, firm)
label.hasBoxedWarning	Whether the current label carries a boxed ("black box") warning

📥 Input

{ "drugs": ["semaglutide", "aspirin"] }

One brief per drug. Brand or generic names both work.

📤 Example output (real, trimmed — semaglutide)

{
  "drug": "semaglutide", "found": true,
  "approval": { "sponsors": ["NOVO"], "dosageForms": ["TABLET"], "marketingStatus": ["Prescription"] },
  "adverseEvents": { "totalReports": 7580, "seriousReports": 5734, "deathReports": 232,
    "topReactions": [{"reaction":"Nausea","count":1075},{"reaction":"Vomiting","count":940}] },
  "recalls": { "total": 1 },
  "label": { "hasBoxedWarning": true },
  "note": "FAERS reports do not establish that the drug caused the event..."
}

💰 Pricing (pay-per-event)

• Drug brief — $0.02 per drug for which openFDA returns data. No data = free.

💡 Use cases

• Pharmacovigilance / pharma: a fast safety snapshot per drug or across a portfolio.
• Investors / analysts: adverse-event volume, serious/death signal, recalls, boxed warnings at a glance.
• Health researchers / journalists: a sourced FDA summary per drug.
• Pair with Clinical Trials Intelligence: pipeline + safety for the same molecule.

🚀 Ready-made tasks (one click)

• Drug Safety Brief (FAERS + Recalls): adverse events, serious/death counts, recalls and boxed warning per drug.
• FDA Adverse Events Summary: aggregated top reactions and report counts per drug.
• Drug Recall & Boxed Warning Check: recent recalls and whether the label carries a boxed warning.

🤖 For AI agents (MCP)

{ "mcpServers": { "apify": { "url": "https://mcp.apify.com/?tools=actors,docs,centorprat/drug-safety-fda-brief" } } }

Claude Code: claude mcp add --transport http apify "https://mcp.apify.com/?tools=actors,docs,centorprat/drug-safety-fda-brief" --header "Authorization: Bearer <YOUR_APIFY_TOKEN>"

📜 Data & attribution

Source: openFDA (U.S. Food & Drug Administration): drugsFDA, FAERS (drug/event), enforcement/recalls, and labeling. Public data, no login. FAERS reports do not establish causation.

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