# Drug Safety & FDA Brief: Approvals, Adverse Events, Recalls (`centorprat/drug-safety-fda-brief`) Actor

Give it drug names (brand or generic). For each it fuses four openFDA sources - approvals, FAERS adverse events (total, top reactions, serious, deaths), recalls and the boxed warning - into ONE composed safety brief. Keyless, agent-callable. FAERS reports do not establish causation.

- **URL**: https://apify.com/centorprat/drug-safety-fda-brief.md
- **Developed by:** [Centor Prat](https://apify.com/centorprat) (community)
- **Categories:** Developer tools
- **Security:** Limited permissions
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $17.00 / 1,000 drug briefs

This Actor is paid per event. You are not charged for the Apify platform usage, but only a fixed price for specific events.
Since this Actor supports Apify Store discounts, the price gets lower the higher subscription plan you have.

Learn more: https://docs.apify.com/actors/running/actors-in-store.md#pay-per-event

## What's an Apify Actor?

An Actor is a serverless cloud program that runs on the Apify platform. It has two run modes.
In Batch mode, an Actor accepts a well-defined JSON input, performs an action which can take anything from a few seconds to a few hours,
and optionally produces a well-defined JSON output, datasets with results, or files in key-value store.
In Standby mode, an Actor provides a web server which can be used as a website, API, or an MCP server.

Apify vocabulary and the platform model are defined once, in the agent quickstart at https://apify.com/agents.md.

## How to integrate an Actor?

If asked about integration, you help developers integrate Actors into their projects.
You adapt to their stack and deliver integrations that are safe, well-documented, and production-ready.

Do not guess an integration path. Every one of them is in the agent quickstart at https://apify.com/agents.md: the Apify MCP server, Agent Skills with the Apify CLI, the JavaScript and Python clients, the REST API, and the account-free path for an agent with no human to sign in. It also carries the rule on stating cost before the first paid run.

For examples already wired to this Actor's own input schema, see the [API](#api) section below.

Each client library has reference documentation the quickstart does not restate: [JavaScript/TypeScript](https://docs.apify.com/api/client/js/docs.md) (`npm install apify-client`) and [Python](https://docs.apify.com/api/client/python/docs.md) (`pip install apify-client`).

# README

## 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

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

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

### 📤 Example output (real, trimmed — semaglutide)

```json
{
  "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](https://apify.com/centorprat/clinical-trials-intelligence):** pipeline + safety for the same molecule.

### 🚀 Ready-made tasks (one click)

- [Drug Safety Brief (FAERS + Recalls)](https://apify.com/centorprat/drug-safety-fda-brief/examples/drug-safety-brief): adverse events, serious/death counts, recalls and boxed warning per drug.
- [FDA Adverse Events Summary](https://apify.com/centorprat/drug-safety-fda-brief/examples/fda-adverse-events-summary): aggregated top reactions and report counts per drug.
- [Drug Recall & Boxed Warning Check](https://apify.com/centorprat/drug-safety-fda-brief/examples/drug-recall-boxed-warning-check): recent recalls and whether the label carries a boxed warning.

### 🤖 For AI agents (MCP)

```json
{ "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](https://open.fda.gov) (U.S. Food & Drug Administration): drugsFDA, FAERS (`drug/event`),
enforcement/recalls, and labeling. Public data, no login. FAERS reports do not establish causation.

### 🔗 Related actors

- [Clinical Trials Intelligence: Landscape Brief & Monitor](https://apify.com/centorprat/clinical-trials-intelligence): a composed trials landscape per condition, drug or sponsor — phases, status, sponsors, recruiting now.
- [Country Economic Data API - World Bank GDP, FX & Holidays](https://apify.com/centorprat/world-bank-country-economic-data): World Bank + FX + public holidays → one market brief per country.
- [Wikipedia & Wikidata API - Entity Facts, Summary & Pageviews](https://apify.com/centorprat/wikipedia-wikidata-api): one structured brief per company, person or place.
- [FEMA Flood Zone & Property Risk API - Zillow/Redfin Enricher](https://apify.com/centorprat/fema-flood-zone-property-risk): FEMA flood + risk index + demographics per US address.
- [Domain Lookup API - DNS, MX, SPF, Tech & Contact Emails](https://apify.com/centorprat/domain-lookup-dns-mx-email): DNS + live homepage → IPs, MX/SPF, tech, socials, contacts.
- [Weather, Air Quality & Earthquake Risk API by Location](https://apify.com/centorprat/weather-air-quality-earthquake-api): one clear/caution/hazard verdict per point.
- [Aircraft Tracker API (ADS-B) - Approach & Military Alerts](https://apify.com/centorprat/aircraft-tracker-adsb): aircraft approaching a point with CPA/ETA + military flags.

# Actor input Schema

## `drugs` (type: `array`):

Drugs to brief, e.g. \["ozempic"], \["semaglutide", "aspirin"]. Brand or generic names both work. One brief per drug.

## `webhookUrl` (type: `string`):

If set, the briefs are POSTed here as JSON.

## Actor input object example

```json
{
  "drugs": [
    "ozempic"
  ]
}
```

# Actor output Schema

## `briefs` (type: `string`):

One composed brief per drug: approval info (sponsors, applications, dosage forms, routes, marketing status), FAERS adverse-event summary (total reports, top reactions, serious and death report counts), recalls (total + recent), and whether the label carries a boxed warning. Includes a FAERS causation disclaimer.

# API

You can run this Actor programmatically using our API. Below are code examples in JavaScript, Python, and CLI, as well as the OpenAPI specification and MCP server setup.

## JavaScript example

```javascript
import { ApifyClient } from 'apify-client';

// Initialize the ApifyClient with your Apify API token
// Replace the '<YOUR_API_TOKEN>' with your token
const client = new ApifyClient({
    token: '<YOUR_API_TOKEN>',
});

// Prepare Actor input
const input = {
    "drugs": [
        "ozempic"
    ]
};

// Run the Actor and wait for it to finish
const run = await client.actor("centorprat/drug-safety-fda-brief").call(input);

// Fetch and print Actor results from the run's dataset (if any)
console.log('Results from dataset');
console.log(`💾 Check your data here: https://console.apify.com/storage/datasets/${run.defaultDatasetId}`);
const { items } = await client.dataset(run.defaultDatasetId).listItems();
items.forEach((item) => {
    console.dir(item);
});

// 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/js/docs

```

## Python example

```python
from apify_client import ApifyClient

# Initialize the ApifyClient with your Apify API token
# Replace '<YOUR_API_TOKEN>' with your token.
client = ApifyClient("<YOUR_API_TOKEN>")

# Prepare the Actor input
run_input = { "drugs": ["ozempic"] }

# Run the Actor and wait for it to finish
run = client.actor("centorprat/drug-safety-fda-brief").call(run_input=run_input)

# Fetch and print Actor results from the run's dataset (if there are any)
print(f"💾 Check your data here: https://console.apify.com/storage/datasets/{run.default_dataset_id}")
for item in client.dataset(run.default_dataset_id).iterate_items():
    print(item)

# 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/python/docs/quick-start

```

## CLI example

```bash
echo '{
  "drugs": [
    "ozempic"
  ]
}' |
apify call centorprat/drug-safety-fda-brief --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,centorprat/drug-safety-fda-brief"
        }
    }
}
```

The hosted server signs you in with OAuth on first connect, so no API token belongs in this config. Clients without OAuth support can send an `Authorization: Bearer <APIFY_API_TOKEN>` header instead, using a token from API & Integrations in Apify Console (https://console.apify.com/settings/integrations).

## OpenAPI specification

Download the OpenAPI definition: https://api.apify.com/v2/actors/Ob88NZO2GVZ6Qy8i7/builds/QF7vSaeeqqWESuLno/openapi.json