Drug Safety API: FDA label, FAERS, recalls, EMA status

Answers "is this drug safe, and where does it stand with regulators?" in one call: the FDA boxed warning and indications, the most reported FAERS adverse reactions (counts), US recalls and shortages, and EU authorisation, EPAR link and EU shortages, for one drug name, with a source link for every section. Built for AI agents and people in pharma, health tech, pharmacy, compliance and investing.

Pricing (pay per event): $0.02 per dossier (all five sections), or $0.004 per drug-query for one section. Invalid input, unknown drugs, empty answers and partial answers (a source failed) cost nothing.

Questions agents ask

• “Does semaglutide have a boxed warning, what are its most reported adverse reactions, and is it authorised in the EU? Cite the sources.”

What you get

Use with AI agents (MCP)

Add this URL to your MCP client (Claude, Cursor, VS Code, ...) to load the Actor as a tool through the Apify hosted MCP server. It signs you in with OAuth or accepts Authorization: Bearer <APIFY_TOKEN>. It works once the Actor is live on the Apify Store.

https://mcp.apify.com?tools=bosco_labs/drug-safety

For “Does semaglutide have a boxed warning, what are its most reported adverse reactions, and is it authorised in the EU? Cite the sources.” the agent passes:

{ "drug": "semaglutide" }

one row, stable snake_case fields, ISO dates, numbers as numbers, null for unknown, a source_url per section, and a notice to pass on (not medical advice). The run's status message is a one-line answer, e.g. "semaglutide (semaglutide): boxed warning; 86,031 FAERS reports (top: NAUSEA, OFF LABEL USE); 57 US recalls; ...". Typical run: 1-3 seconds after start-up.

Or call the Apify API: POST https://api.apify.com/v2/acts/bosco_labs~drug-safety/run-sync-get-dataset-items with the input as JSON body. Cost: $0.02 per dossier or $0.004 per single-section query.

HTTP API

Also on the Bosco Labs HTTP API (beta, test mode): same input and same rows as the Actor, $0.004 per sub-query; a full dossier = 5 units ($0.02); partial answers are free from prepaid credits (max 1 drug per call). Get a key with a $0.50 free trial; see prices and limits.

curl https://api.boscolabs.dev/v1/drug-safety \
  -H "Authorization: Bearer $BOSCO_API_KEY" \
  -H "Content-Type: application/json" \
  -d '{"drug": "semaglutide"}'

Input fields

Sources, licence and limits

Is this medical advice? No. It is public regulatory data for research and reference. Do not use it to decide on treatment; ask a doctor or pharmacist. FDA itself says: "Do not rely on openFDA to make decisions regarding medical care." The official label and EMA texts prevail.

What do the FAERS numbers mean? They count voluntary reports to FDA's Adverse Event Reporting System that list the drug, as suspect or concomitant drug. A high count does not mean a reaction is common or that the drug caused it: popular drugs get more reports, and reports can be duplicated or incomplete. share_of_reports is the share of those reports, not an incidence rate. Reports are matched on the generic name (openFDA's harmonised field) or the reported product name, so combination products that contain the drug are included.

Which label is shown? The newest FDA label (by effective date) for the generic name (the plain name or its salt form, never a biosimilar's suffixed name such as adalimumab-ryvk), prescription labels first, or the brand's own label when you give a brand name. Repackagers file their own copies, so manufacturer can be a repackager; labels_matching says how many labels matched. The full label is at label_url (DailyMed).

Which recalls are included? FDA enforcement reports (2004 onwards) whose generic name or product description names the drug, newest first; this includes compounded products, which is where most recent semaglutide recalls are. total counts all of them.

What does EU status cover? Medicines authorised centrally through EMA (one EU-wide licence), including withdrawn and refused ones, and EMA's shortage catalogue. Medicines authorised only nationally by EU member states are not in EMA's files, so an older generic can show products_total: 0 while it is on sale in the EU.

How fresh is it? Live on every run. openFDA updates FAERS and recalls weekly and the shortage list daily (data_last_updated); EMA rebuilds its data files daily (data_timestamp).

What is left out? Individual FAERS case reports, medical device data (and FDA's licensed GMDN device nomenclature), full label texts beyond the boxed warning and indications, contact phone numbers from the shortage list, and EMA documents themselves (follow epar_url).

Why did my run cost nothing? Unknown names, invalid input, sub-queries that find nothing (for example recalls for a drug that was never recalled) and partial answers (a source did not answer, see failed_sections) are not charged. The row is still saved so you can see the answer; run again later for a complete, charged one.

US data from openFDA (U.S. Food and Drug Administration). Under the openFDA terms the drug data are public domain under CC0: "You can copy, modify, distribute, and perform the work, even for commercial purposes, all without asking permission." Not endorsed by FDA. openFDA's device data carry GMDN nomenclature that needs a licence from the GMDN Agency; this Actor reads only the drug endpoints, never device data.

EU data from the European Medicines Agency's public JSON data files (medicines, shortages). EMA's legal notice allows reproduction "for non-commercial and commercial purposes, provided that EMA is always acknowledged as the source of the material", and "Such acknowledgement must be included in each copy of the material." Every row therefore carries an attribution that names EMA as the source with the URL and the month and year of access; keep it with any copy. EMA does not endorse Bosco Labs. Bosco Labs selects fields, shortens long texts (cut texts end with [truncated]) and returns FAERS as counts only.