io.github.cyanheads/openfda-mcp-server

Run a read-only SQL SELECT against a DataCanvas table staged by an openFDA search tool (call one with stage=true; its response carries canvas_id + canvas_table). Enables GROUP BY, COUNT/SUM/AVG, time-series, and joins across the staged result set without re-paging the API. Call openfda_dataframe_describe first to get the exact table and column names. Results are capped at the canvas row limit — when truncated is true, page the rest with ORDER BY plus LIMIT/OFFSET. Scalar fields are stored as text (CAST for numeric math); nested objects/arrays are JSON columns — read them with DuckDB json functions, e.g. json_extract_string(openfda, '$.brand_name[0]'). Only SELECT is allowed — DDL, DML, COPY, and file-reading functions are blocked.

Aggregate and tally unique values for any field across any openFDA endpoint. Returns ranked term-count pairs sorted by count descending. Pair with openfda_search_adverse_events, openfda_search_drug_approvals, openfda_search_device_clearances, openfda_search_recalls, openfda_get_drug_label, or openfda_lookup_ndc when sample records help interpret the aggregates.

List the tables and column schemas on a DataCanvas staged by an openFDA search tool. Call before openfda_dataframe_query to discover the exact table name, column names, and DuckDB types needed for valid SQL. row_count is the full staged result set, not the inline preview count. Columns typed JSON hold nested openFDA objects/arrays — query them with DuckDB json functions.

Return the searchable field paths for an openFDA endpoint, grouped by category with type and description. Use before constructing a search query to find the correct dotted field path — field names differ per endpoint and are not discoverable from the tool schema alone.

Resolve one drug name to its FDA identity, then fan out in parallel across the bounded per-drug openFDA endpoints and merge into one profile: identity, label highlights, adverse-event summary, recall history, Drugs@FDA approval, and shortage status. Replaces chaining openfda_get_drug_label, openfda_search_adverse_events, openfda_search_recalls, openfda_search_drug_approvals, and openfda_search_drug_shortages — and reconciles the identifier drift between endpoints that makes that chaining error-prone. Each section is best-effort: a miss returns null rather than failing the call. For deep dives into any one area, use the dedicated tool.

Look up FDA drug labeling (package inserts / SPL documents). Check indications, warnings, dosage, contraindications, active ingredients, or any structured label section. A label runs to tens of thousands of tokens, so a page that exceeds the inline budget returns the list of available sections instead; re-call with sections to pull the ones you need.

Look up drugs in the NDC (National Drug Code) Directory. Identify drug products by NDC code, find active ingredients, packaging details, or manufacturer info. Pair with openfda_get_drug_label using the returned brand_name or set_id to read the package insert. With stage=true, call openfda_dataframe_describe for the staged columns, then openfda_dataframe_query for SQL.

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. With stage=true, call openfda_dataframe_describe for the staged columns, then openfda_dataframe_query for SQL.

Search adverse event reports for veterinary drugs and devices submitted to the FDA Center for Veterinary Medicine. Records include animal species, breed, age, weight, drug name and route, adverse reactions (using VeDDRA terminology), and outcome. Use to investigate safety signals for veterinary products, find reports by animal species or drug, or explore reaction patterns. Brand and manufacturer names are masked as "MSK" on every record (the FDA null flavor for withheld data), so find a product by active ingredient on drug.active_ingredients.name, unsuffixed. An ingredient search spans every product containing it and cannot attribute reports to one brand; drug.manufacturer.registration_number (the full value, e.g. "USA-USFDACVM-N141426") narrows it to one approval. With stage=true, call openfda_dataframe_describe for the staged columns, then openfda_dataframe_query for SQL.

Search FDA device premarket notifications — 510(k) clearances and PMA approvals. With stage=true, call openfda_dataframe_describe for the staged columns, then openfda_dataframe_query for SQL.

Search the Drugs@FDA database for drug application approvals (NDAs and ANDAs). Returns application details, sponsor info, and full submission history. Pair with openfda_get_drug_label to read the approved label, or openfda_count_values to aggregate by sponsor_name, product_type, or route. With stage=true, call openfda_dataframe_describe for the staged columns, then openfda_dataframe_query for SQL.

Search FDA drug shortage records. Returns per-product shortage status, availability, therapeutic category, dosage form, manufacturer, and dates. Use to check whether a drug is currently in shortage, find all oncology drugs with supply issues, or retrieve the openfda block (brand_name, product_ndc, rxcui) to chain into openfda_get_drug_label or openfda_lookup_ndc. With stage=true, call openfda_dataframe_describe for the staged columns, then openfda_dataframe_query for SQL.

Search enforcement reports and recall actions across drugs, food, and devices. With stage=true, call openfda_dataframe_describe for the staged columns, then openfda_dataframe_query for SQL.

Search problem reports submitted to the FDA for tobacco products, including e-cigarettes, vaping products, cigarettes, and smokeless tobacco. Reports capture product type, reported health problems (e.g. seizure, chest pain), product problems (e.g. exploding battery), whether a non-user was affected, and submission date. Use to investigate safety signals, find reports by product type, or analyze health effects. With stage=true, call openfda_dataframe_describe for the staged columns, then openfda_dataframe_query for SQL.