openfda-database

The saved excerpt is a snapshot from review. The external source remains the complete and most current version.

---
name: openfda-database
description: >
  Query, search, and download data from the openFDA API for drugs, devices,
  foods, tobacco, cosmetics, animal and veterinary products, substances, and
  transparency data. Use for FDA adverse events, recalls, labeling, approvals,
  shortages, 510(k) clearances, NDC lookups, and any FDA safety or regulatory
  data query across all 28 API endpoints.
---

# openFDA Search and Query

## Prerequisites

1.  **`uv`**: Read the `uv` skill and follow its Setup instructions to ensure
    `uv` is installed and on PATH.
2.  **User Notification**: If .licenses/openfda_database_LICENSE.txt does not
    already exist in the workspace root directory then (1) prominently notify
    the user to check the terms at https://open.fda.gov/apis/ and
    https://open.fda.gov/license, then (2) create the file recording the
    notification text and timestamp.
3.  **`.env` file**: Make sure the `.env` file exists in your home directory.
    Create one if it does not exist.
4.  **`FDA_API_KEY`** (optional but recommended): Raises the daily request limit
    from 1,000 to 120,000. The skill works without it, but an agent can easily
    exhaust the keyless limit in a single session. You can register for a free
    key at https://open.fda.gov/apis/authentication/. You **MUST** use the safe
    credentials protocol in the `credentials` skill to check for and request
    this key if this skill looks relevant to the user's request.

## Core Rules

-   **Use the Wrapper**: ALWAYS execute the provided helper scripts to query the
    database rather than accessing the database directly. The scripts
    automatically enforce the required rate limit gracefully.

-   **Rate Limiting**: Respect openFDA rate limits. Without API key: 240
    requests/min, 1,000 requests/day per IP. With API key: 240 requests/min,
    120,000 requests/day per key. Always set an API key before running
    multi-query workflows.

> **Warning**: An automated agent can easily exhaust the 1,000-request daily
> limit in a single research session. Always set an API key before running
> multi-query workflows.

> You **MUST** use the safe credentials protocol in the `credentials` skill to
> help the user add `FDA_API_KEY` to their `.env` file if this skill looks
> relevant to the user's request. The script will emit a warning to stderr if no
> API key is detected.

-   **Always Use `--output`**: All subcommands require `--output <file>` to
    write results to a file. This prevents large output becoming overwhelming.
    Use jq or code to read the output file.

-   **Notification**: If this skill is used, ensure this is mentioned in the
    output.

## Utility Script

**Single script for all operations:**

```bash
uv run scripts/openfda_query.py {search,count,download} --output <file> [options]
```

### 1. Search

Search any of the 28 endpoints and save JSON results to a file.

```bash
uv run scripts/openfda_query.py search \
  --category drug --endpoint event \
  --search "patient.drug.medicinalproduct:aspirin" \
  --limit 5 --output /tmp/fda_results.json
```

Stdout prints a compact summary:

```json
{"status": "success", "output": "/tmp/fda_results.json", "results_in_file": 5, "total_matching": 601477}
```

*Options:*

-   `--output`: Output file for full JSON results (required).
-   `--category`: API category — `drug`, `device`, `food`, `tobacco`, `other`,
    `animalandveterinary`, `cosmetic`, `transparency`.
-   `--endpoint`: Endpoint within the category (e.g., `event`, `label`, `510k`).
    See [references/api_endpoints.md](references/api_endpoints.md) for full
    list.
-   `--search`: Query string (e.g.,
    `patient.drug.medicinalproduct:aspirin+AND+serious:1`).
-   `--sort`: Sort field and order (e.g., `receivedate:desc`).
-   `--limit`: Max results (default 10, max 1000).
-   `--skip`: Pagination offset (default 0).
-   `--api_key`: API key (also reads `FDA_API_KEY` env var).

### 2. Count

Count unique values of a field within matching res