# Microgram: fda-otc-ae-reporting

`station__algovigilance__microgram-fda-otc-ae-reporting` · native (always callable) · domain `algovigilance` · pv-relevance `pv-core`

FDA OTC postmarketing adverse event reporting obligations: routes by product status and seriousness per FDA Guidance 'Postmarketing AE Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application' (2009) and Dietary Supplement and Nonprescription Drug Consumer Protection Act (2006)

## Agent metadata

- `idempotent`: true
- `read_only`: true
- `expected_latency_ms`: unknown (not yet contract-tested)
- `cost_tokens_estimate`: unknown

## Input schema

- `product_status` *string* (required) — OTC product regulatory status: otc_monograph, approved_nda, unapproved_marketed, dietary_supplement
- `serious` *boolean* (required) — Whether the adverse event meets serious criteria
- `reporter_type` *string* — Who reported: consumer, healthcare_professional, manufacturer

## Example call

```json
POST /api/mcp
Content-Type: application/json

{
  "jsonrpc": "2.0",
  "id": 1,
  "method": "tools/call",
  "params": {
    "name": "station__algovigilance__microgram-fda-otc-ae-reporting",
    "arguments": {
      "product_status": "",
      "serious": false
    }
  }
}
```

## Related

- [/tools](/tools) — all 7718 tools
- [/tools/algovigilance__microgram-fda-otc-ae-reporting](/tools/algovigilance__microgram-fda-otc-ae-reporting) — HTML page
- [/tools/algovigilance__microgram-fda-otc-ae-reporting/json](/tools/algovigilance__microgram-fda-otc-ae-reporting/json) — JSON form (agent-friendly)
- [/api/mcp](/api/mcp) — endpoint
- [/AGENTS.md](/AGENTS.md) — agent guide