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sapientsai

OpenFDA MCP Server

by sapientsai

Server Configuration

Describes the environment variables required to run the server.

NameRequiredDescriptionDefault
OPENFDA_API_KEYNoFDA API key for higher rate limits. Get a free API key at https://open.fda.gov/apis/authentication/.

Capabilities

Features and capabilities supported by this server

CapabilityDetails
tools
{}
logging
{}
completions
{}

Tools

Functions exposed to the LLM to take actions

NameDescription
search_drug_adverse_eventsA

Search FDA Adverse Event Reporting System (FAERS) for drug safety reports. Find adverse events by drug name, reaction type, manufacturer, date range, and seriousness. Retrieve a specific report by safetyReportId. Returns patient demographics, drug details, and reported reactions.

search_drug_labelsA

Search FDA drug labeling (SPL) information including prescribing information, indications, warnings, boxed warnings, dosage, and active ingredients. Retrieve a specific label by setId. Filter for drugs with boxed warnings using hasBoxedWarning. Request specific sections (e.g., indications_and_usage, adverse_reactions, boxed_warning) to limit response.

search_drug_ndcA

Search the National Drug Code (NDC) Directory for drug product identification. Find drugs by NDC, brand name, generic name, labeler, dosage form, or route. Returns product details, active ingredients, and packaging information.

search_drug_recallsB

Search FDA drug recall and enforcement reports. Find recalls by company, classification (I-III), status, state, and date range. Class I is most serious (may cause death), Class III is least serious.

search_drugs_at_fdaA

Search the Drugs@FDA database for approved drug applications. Find approved drugs by sponsor, application number, brand name, or marketing status. Returns application details, products, and submission history.

search_drug_shortagesA

Search the FDA Drug Shortage Database for current and resolved drug shortages. Find shortages by generic drug name or status (Current/Resolved). Returns shortage details, posting dates, and resolution information.

search_device_510kA

Search FDA 510(k) premarket notification database for medical device clearances. Find device clearances by device name, applicant, product code, clearance type, or decision date. Returns clearance decisions and device classification details.

search_device_classificationsA

Search FDA medical device classification database. Find devices by name, class (1-3), medical specialty, product code, or regulation number. Class 1 is lowest risk, Class 3 is highest risk (implants, life-sustaining).

search_device_adverse_eventsA

Search FDA Medical Device Report (MDR) database for device adverse events. Find adverse events by device name, brand, manufacturer, event type (Injury/Death/Malfunction), and date. Retrieve a specific MDR report by reportNumber. Returns device details, event descriptions, and patient outcomes.

search_device_recallsB

Search FDA medical device recall and enforcement reports. Find recalls by company, product description, classification (I-III), status, and date. Class I is most serious (may cause death), Class III is least serious.

search_fda_orange_bookA

Search FDA Orange Book for approved drug products with therapeutic equivalence evaluations. Find drugs by trade name, ingredient, applicant, application number, or TE code. Returns product details, patent counts, and exclusivity counts. Data is downloaded from FDA bulk files and cached for 24 hours.

search_fda_orange_book_patentsA

Search FDA Orange Book patent data for drug products. Find patents by drug name, application number, or patent number. Returns patent details including expiry dates, substance/product/use flags, and associated exclusivities.

search_fda_purple_bookA

Search FDA Purple Book for licensed biological products. Find biologics by product name, applicant, BLA number, license type (351(a)/351(k)), biosimilar status, or interchangeability. Returns product details, licensing status, and reference product information.

search_fda_drug_patent_expiryA

Unified patent expiry and exclusivity view across FDA Orange Book and optionally Purple Book. Search by drug name or application number. Returns patents sorted by earliest expiry date with associated exclusivity data. Set includePurpleBook=true to also include biologics data.

Prompts

Interactive templates invoked by user choice

NameDescription

No prompts

Resources

Contextual data attached and managed by the client

NameDescription

No resources

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