Open Fda Gov openFDA Drug API

Name: openFDA Drug API
Brand: openFDA Drug API
Availability: InStock

★ Only Publicly Available OpenAPI DocumentHealthcarePharmacyapiKey6 EndpointsREST

For Agents

Search U.S. FDA drug data - adverse events, labels, NDC directory, recalls, approvals, and shortages - through a single keyless search API. Useful for clinical, regulatory, and safety-monitoring agents.

Install Jentic One Beta

Connect the openFDA Drug API to your agent

Jentic One is a self-hosted execution layer for AI agents. It lets your agent call the openFDA Drug API, or any other public or private API you need. You set the rules, the agent never sees your credentials, and every call is logged.

Two steps, two machines. Install the instance in a safe environment, then register your agent from wherever it runs.

Step 1: Jentic One Host machine

# On the machine that will host your Jentic One instance:
curl -fsSL "https://jentic.com/install.sh?src=apis&api=%2Fapis%2Fopen.fda.gov%2Fopenfda" | sh

Step 2: Agent machine

# On the machine where your agent runs (keep this separate from the instance):
curl -fsSL "https://jentic.com/install.sh?src=apis&api=%2Fapis%2Fopen.fda.gov%2Fopenfda" | sh
jentic register       # connects your agent to your Jentic One instance

Jentic One is in public beta. The setup above keeps your agent separate from the instance, which is what you want before using real credentials: an agent running as the same OS user as Jentic One can read its stored keys directly. Just evaluating? A single local install is fine to start. See the secure deployment guide for the tiers.

Capabilities

What an agent can do with openFDA Drug API.

Search FAERS adverse-event reports for a drug name and aggregate by reaction or seriousness

Look up the official FDA-approved product label for a drug, including indications and contraindications

Resolve a brand name to its NDC and active ingredient via the NDC directory

GET STARTED

Start building with openFDA Drug API

Explore with Jentic One

View OpenAPI Document

Use Cases

Patterns agents use openFDA Drug API for, with concrete tasks.

★ Pharmacovigilance Signal Search

Search FAERS adverse-event reports for a drug to surface the most frequently reported reactions and seriousness flags. GET /drug/event.json accepts a Lucene-style search clause and a count parameter, so a pharmacovigilance agent can pull the top reactions in one call rather than iterating reports by hand.

Call GET /drug/event.json with search='patient.drug.medicinalproduct:"IBUPROFEN"' and count='patient.reaction.reactionmeddrapt.exact' and return the 10 most frequent reactions.

Drug Label Retrieval

Fetch the FDA-approved structured product label for a drug to extract indications, dosage, warnings, and contraindications. GET /drug/label.json returns a single JSON record per labeling submission, which a clinical-decision agent can parse into a structured summary for a clinician or patient-facing tool.

Call GET /drug/label.json with search='openfda.brand_name:"LIPITOR"' and return the indications_and_usage and contraindications fields from the first record.

Drug-Shortage Monitoring

Track which drugs are currently flagged as in shortage by the FDA so a hospital pharmacy or supply-chain agent can plan substitutions. GET /drug/drugshortages.json returns the current shortage status, reason, and resolution date for a queried product.

Call GET /drug/drugshortages.json with search='generic_name:"AMOXICILLIN"' and return any records where status is 'Currently in Shortage'.

Recall Tracking by Manufacturer

Pull every drug recall enforcement report for a manufacturer, with classification (Class I, II, III), reason, and the affected lot ranges. GET /drug/enforcement.json supports filtering by recalling firm and date so a regulatory agent can monitor a vendor's recall history continuously.

Call GET /drug/enforcement.json with search='recalling_firm:"Acme Pharma"' and return any Class I recalls in the last 12 months.

AI Agent Clinical Lookup

Let a Jentic-orchestrated clinical agent answer questions about a drug - adverse events, label, recalls, shortages - through a single search that picks the right openFDA endpoint. The agent never holds the optional API key directly; Jentic appends it to raise the rate limit when needed.

Search Jentic for 'look up FDA adverse events for a drug', load the GET /drug/event.json schema, and execute with the drug name from the user's question, returning the top reactions.

Key Endpoints

6 endpoints — jentic publishes the only available openapi specification for openfda drug api, keeping it validated and agent-ready.

METHOD

PATH

DESCRIPTION

GET

/drug/event.json

Search FAERS adverse-event reports

GET

/drug/label.json

Search FDA-approved drug product labels

GET

/drug/ndc.json

Search the NDC directory

GET

/drug/enforcement.json

Search drug recall enforcement reports

GET

/drug/drugsfda.json

Search Drugs@FDA approval records

GET

/drug/drugshortages.json

Search FDA drug shortages

GET

/drug/event.json

Search FAERS adverse-event reports

GET

/drug/label.json

Search FDA-approved drug product labels

GET

/drug/ndc.json

Search the NDC directory

GET

/drug/enforcement.json

Search drug recall enforcement reports

GET

/drug/drugsfda.json

Search Drugs@FDA approval records

Why Jentic?

What agents get from Jentic-routed access to this vendor.

Setup

Wiring the openFDA Drug API by hand means appending your api_key query parameter, learning the Elasticsearch-style search syntax, and paging results yourself. Through Jentic you install once, import the openFDA Drug API from the API Directory, store the API key once, and your agent calls it.

Permission scoping

The openFDA Drug API is read-only and takes its search terms as query parameters rather than a resource id in the URL path, so limit the agent to the operations it needs, such as searching adverse events, labels, or recall enforcement reports. You credit the agent only with the operations you allow.

Credential isolation

Your openFDA API key is stored once, encrypted, by your own Jentic One instance and injected at execution time. It never enters the agent's prompt, logs, or context.

Intent-based discovery

Agents search Jentic by intent such as 'search drug adverse-event reports' or 'look up an approved drug label', and Jentic returns the matching openFDA Drug operation with its input schema so the agent calls the right endpoint without browsing the reference docs.

FAQs

Specific to using openFDA Drug API through Jentic.

Why is there no official OpenAPI spec for openFDA Drug API?

openFDA publishes documentation per dataset on open.fda.gov but does not maintain a single OpenAPI document covering the Drug endpoints together. Jentic generates and maintains this spec so AI agents and developers can call openFDA Drug API via structured tooling. It is validated against the live API and kept up to date. Get started with Jentic One, the self-hosted execution layer.

What authentication does the openFDA Drug API use?

openFDA accepts an optional api_key query parameter. Without a key the limit is 40 requests per minute and 1,000 per day; with a key it rises to 240 requests per minute and 120,000 per day. Through Jentic the api_key is held in the vault and appended at execution time.

Can I aggregate adverse events by reaction in a single call?

Yes. GET /drug/event.json supports a count parameter that returns aggregated counts grouped by a field, such as patient.reaction.reactionmeddrapt.exact, in one response. This is the canonical way to get top-N reactions without paging individual reports.

What are the rate limits for the openFDA Drug API?

Without an API key: 40 requests per minute and 1,000 per day. With an API key: 240 per minute and 120,000 per day. The query-string api_key parameter is the only knob; there is no per-endpoint quota differentiation.

How do I look up adverse events for a drug through Jentic?

Run pip install jentic and search for 'look up FDA adverse events for a drug'. Jentic returns the GET /drug/event.json operation; load the schema and execute with a search clause like 'patient.drug.medicinalproduct:"IBUPROFEN"' to receive matching reports or aggregate counts.

Does openFDA cover devices and food as well as drugs?

openFDA also exposes Device and Food datasets, but this spec is the Drug API only - the six endpoints above are scoped to FAERS, label, NDC, enforcement, Drugs@FDA, and shortages. Device and food queries require separate openFDA endpoints not in this spec.

Can I limit what my agent is allowed to do with the openFDA Drug API?

Yes. Because you run Jentic One yourself, you decide which openFDA Drug operations the agent may call, so you can allow only searching adverse-event reports, product labels, the NDC directory, recall enforcement reports, Drugs@FDA approvals, or drug shortages. The API is read-only and takes its search terms as query parameters rather than a resource id in the URL path, so there are no write actions to permit and the agent can only run the read operations you grant. Your rules also control the credential used, so the optional API key is applied only when you allow it.