OpenFDA
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Purpose
OpenFDA queries six public drug datasets: Drug Labels, NDC Directory, Drugs@FDA, Drug Recalls, Drug Shortages, and Drug Adverse Events. It returns normalized records for the selected dataset.
It does not make medical-care decisions, prove that a drug caused a reported event, calculate incidence, or expose every FDA dataset.
When to use it
- Read a label's boxed warning, indications, dosing, or adverse reactions.
- Look up NDC products, packages, routes, and active ingredients.
- Review approvals, recalls, or shortage records.
- Inspect reported adverse events while keeping the limits of FAERS data clear.
Required setup
OpenFDA uses public FDA endpoints and requires no account, OAuth connection, or component API key.
How to use it
In Tool Mode:
- Connect the component's tools to Agent Core.
- Give the Agent a focused task and name the relevant dataset when it matters.
- Start with a drug or ingredient query and a limit of 3 results.
- Review the returned records before drawing a safety or clinical conclusion.
For example, ask the Agent to retrieve the boxed warning from a drug label, not to decide whether a patient should take the drug.
In Normal mode:
- Select the dataset under Action.
- Enter a drug or ingredient query and choose the matching Search Field.
- Keep Top Results at 3 for the first run.
- Connect the result to Data Operations.
Drug Labels can search from Product Type or Boxed Warning Only when Query is empty.
Configuration
| Setting | What it controls | Recommended starting point |
|---|---|---|
| Action | The openFDA dataset to query | Pick the dataset that answers the question |
| Query | Drug, ingredient, identifier, company, or reaction search text | Start with a drug or ingredient |
| Search Field | The provider field used for the query | Keep the action-specific default |
| Top Results | The returned record count | Start with 3; the range is 1 to 10 |
| Product Type | Prescription or OTC label filter | Keep Any unless product class matters |
| Boxed Warning Only | Label filter | Enable only for boxed-warning research |
| Finished Products Only | NDC filter | Enable to exclude unfinished products |
| Serious Reports Only | Adverse-event filter | Use for narrower review, not a causation conclusion |
Expected result
Each result includes the selected endpoint, search details, provider metadata, result count, and normalized matches. A no-match response becomes an empty result.
Long label sections stop at 4,000 characters. Drugs@FDA includes up to five products and five submissions per record. Adverse-event results include up to ten reactions and five patient-drug entries.
Reference details
Change Search Field when an identifier, sponsor, firm, reaction, or another dataset-specific field is more precise than a generic drug name.
Use Data Operations to filter normalized records. Type Convert can adapt a result to Message or DataFrame.