openfda-mcp-server

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Tools

Seven tools for querying FDA data across drugs, food, devices, and recalls:

Tool	Description
openfda_search_adverse_events	Search adverse event reports across drugs, food, and devices
openfda_search_recalls	Search enforcement reports and recall actions across drugs, food, and devices
openfda_count	Aggregate and tally unique values for any field across any openFDA endpoint
openfda_get_drug_label	Look up FDA drug labeling (package inserts / SPL documents)
openfda_search_drug_approvals	Search the Drugs@FDA database for NDA/ANDA application approvals
openfda_search_device_clearances	Search FDA device premarket notifications — 510(k) clearances and PMA approvals
openfda_lookup_ndc	Look up drugs in the NDC (National Drug Code) Directory

openfda_search_adverse_events

Search adverse event reports across drugs, food, and devices. Use to investigate safety signals, find reports for a specific product, or explore reactions by demographics.

• Category selection: drug, food, or device — each returns different field schemas
• Elasticsearch query syntax for filtering by product, reaction, seriousness, date range
• Pagination via limit (up to 1000) and skip (up to 25000)
• Formatted output includes report ID, seriousness, patient demographics, reactions, drugs with characterization/indication/route, and all remaining fields

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openfda_count

Aggregate and tally unique values for any field across any openFDA endpoint. Returns ranked term-count pairs sorted by count descending.

• Works across all 19 openFDA endpoints (drugs, food, devices, animal/veterinary, other)
• Use .exact suffix on field names for whole-phrase counting
• Optional search filter to scope the aggregation
• Returns up to 1000 terms per query

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openfda_search_recalls

Search enforcement reports and recall actions across drugs, food, and devices.

• Supports enforcement (all categories) and recall (devices only) endpoints
• Filter by classification (Class I/II/III), recalling firm, reason, status
• Formatted output includes recall number, classification, product description, reason, distribution pattern

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openfda_search_device_clearances

Search FDA device premarket notifications — 510(k) clearances and PMA approvals.

• Two pathways: 510k (174K+ records, most common) and pma (higher-risk devices)
• Filter by applicant, product code, advisory committee, device name
• Formatted output adapts to pathway: 510(k) shows K-number/clearance type, PMA shows supplement info

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openfda_get_drug_label