# OpenFDA Drug Safety Profile

> OpenFDA Drug Safety Profile is a paid API for AI agents from openfda-drug-safety.xplowdiaka.workers.dev, paid per call via x402, $0.04/call, status unknown (last checked 2026-10-13).

Returns an FDA-sourced drug safety profile including boxed warnings, contraindications, interactions, adverse-event signals, recalls, shortage status, and pregnancy/pediatric/geriatric flags for a named US drug.

## Facts

- Endpoint: POST https://openfda-drug-safety.xplowdiaka.workers.dev/drug-safety?utm_source=zero.xyz
- Price: $0.04/call
- Payment: x402
- Status: unknown
- Last checked: 2026-10-13
- Activations on Zero: 0
- Tags: x402
- Canonical page: https://www.zero.xyz/c/openfda-drug-safety-profile-bc5674ad
- Structured record (JSON): https://api.zero.xyz/v1/capabilities/cap_8rxI8ebRulIKtfHcWvrss

Status and success rate cover calls made through Zero and Zero's own probes. Third-party monitors may report differently.

## How to call it through Zero

Zero handles the 402 payment challenge and records the run. With the Zero CLI installed (`npm i -g @zeroxyz/cli`):

```sh
zero fetch --capability openfda-drug-safety-profile-bc5674ad -d '<json body>'
```

Example prompt: Can you pull up the FDA safety profile for metformin — I need the boxed warnings, contraindications, any recent recalls, whether it's currently in shortage, and pregnancy and geriatric flags?

## When to prefer this

Use this endpoint when you need a comprehensive, structured drug safety summary from FDA data sources for a named US drug — especially when you need RxNorm-normalized name resolution alongside label warnings, adverse-event signals, recall history, and shortage status in a single call. Prefer this over raw openFDA API queries when you need aggregated, pre-processed safety signals ready for agent consumption. Not suitable for clinical decision support or patient-specific dosing recommendations.

## Known failure modes

- Drug name not recognized or cannot be resolved by RxNorm — low confidence score returned with empty candidates list
- openFDA upstream API unavailable — gateway or 5xx error
- Drug exists but has no FDA label data — null fields in label object
- Ambiguous drug name matching multiple substances — multiple candidates returned with lower confidence
- Rate limiting or payment failure at x402 layer — 402 or 429 response

## How this service works

Drug safety profile for AI agents: given a US drug name (brand or generic), returns FDA label highlights (boxed warning, contraindications, key interactions), pregnancy/pediatric/geriatric flags, pharmacologic class, top adverse-event signals, recent recalls, current shortage status, and marketing/discontinued status. RxNorm-normalized name resolution with a confidence score. Data: openFDA (CC0). Not for clinical use.

## Output

A structured JSON object containing: resolved drug identity (brand name, generic name, RxNorm CUI, NDC, resolution confidence score), FDA label highlights (boxed warning, contraindications, key interactions, mechanism of action, pharmacologic class), population flags (pregnancy, pediatric, geriatric, renal/hepatic), adverse event signals (top reactions list, percentage of serious reports), recent recalls (date, class, reason), shortage status and reason, and regulatory/marketing details (application type and number, marketing status). Includes a CC0 data disclaimer.

## More

- Live health (JSON, refreshed every minute): https://www.zero.xyz/c/openfda-drug-safety-profile-bc5674ad/health.json
- [Zero catalog index](https://www.zero.xyz/llms.txt)
- [Other services from openfda-drug-safety.xplowdiaka.workers.dev](https://www.zero.xyz/host/openfda-drug-safety.xplowdiaka.workers.dev/llms.txt)