Open Fda Gov openFDA Drug API
★ 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.
Use for: Search FAERS for adverse events linked to ibuprofen, Get the FDA label for the drug 'Lipitor', Look up the NDC for a brand-name drug, List all recalls for a specific manufacturer
Not supported: Does not handle FDA device or food data, EHR access, or prescription writing — use for U.S. drug adverse-event, label, NDC, recall, approval, and shortage lookups only.
Jentic publishes the only available OpenAPI specification for openFDA Drug API, keeping it validated and agent-ready. openFDA is the U.S. Food and Drug Administration's open-data platform, and its Drug API exposes adverse-event reports (FAERS), product labeling, the National Drug Code (NDC) directory, recall enforcement reports, Drugs@FDA approvals, and drug-shortage information through a consistent JSON search interface. The API is keyless for low-volume use and accepts a Lucene-style search syntax over each dataset, so agents can return either matching records or aggregate counts.
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.
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Step 1: Jentic One Host machine
# On the machine that will host your Jentic One instance:
curl -fsSL https://raw.githubusercontent.com/jentic/jentic-one/main/tools/install.sh | sh2
Step 2: Agent machine
# On the machine where your agent runs (keep this separate from the instance):
curl -fsSL https://raw.githubusercontent.com/jentic/jentic-one/main/tools/install.sh | sh
jentic register # connects your agent to your Jentic One instanceJentic 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
List enforcement reports for a drug recall and pull the classification, reason, and affected lots
Pull Drugs@FDA approval records to see when a drug was approved and by which sponsor
Check the current FDA drug-shortage list for an active ingredient or therapeutic class
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
GET
/drug/drugshortages.json
Search FDA drug shortages
Why Jentic?
Three things that make agents converge on Jentic-routed access.
Credential isolation
The optional openFDA api_key is stored encrypted in the Jentic vault (MAXsystem) so production agents always run on the higher rate-limit tier. The key is appended at execution time so the agent's context never sees it.
Intent-based discovery
Agents search Jentic with intents like 'look up FDA adverse events for a drug' or 'check FDA drug shortages' and receive the matching openFDA endpoint with its input schema and supported search and count parameters.
Time to first call
Direct openFDA integration: 1-2 days to learn the per-dataset Lucene fields, count syntax, and rate-limit behaviour. Through Jentic: under 1 hour — search, load schema, execute.
Related APIs
Alternatives and complements available in the Jentic catalogue.
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 at https://app.jentic.com/sign-up.
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.
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