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.

Data: openFDA (U.S. Food and Drug Administration) and the European Medicines Agency's public data files, read live on every run. Not medical advice: every row carries a notice saying so.

What you get

Real output for {"drug": "semaglutide", "maxItems": 2} (2.1 s, run on 2026-11-06):

{
  "query": "semaglutide",
  "mode": "dossier",
  "drug": {
    "generic_name": "SEMAGLUTIDE",
    "matched_as": "generic",
    "search_term": "semaglutide",
    "fda_labels_matching": 5
  },
  "label": {
    "brand_names": [
      "Ozempic"
    ],
    "generic_name": "SEMAGLUTIDE",
    "manufacturer": "A-S Medication Solutions",
    "product_type": "HUMAN PRESCRIPTION DRUG",
    "routes": [
      "SUBCUTANEOUS"
    ],
    "application_number": "NDA209637",
    "pharmacologic_class": [
      "GLP-1 Receptor Agonist [EPC]"
    ],
    "has_boxed_warning": true,
    "boxed_warning": "WARNING: RISK OF THYROID C-CELL TUMORS • In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether OZEMPIC causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ), Nonclinical Toxicology ( 13.1 )] . • OZEMPIC is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Contraindications ( 4 )] . Counsel patients regarding the potential risk for MTC with the use of OZEMPIC and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with OZEMPIC [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )] . WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. • In rodents, semaglutide causes thyroid C-cell tumors. It is unknown whether OZEMPIC causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined ( 5.1 , 13.1 ). • OZEMPIC is contraindicated in patients with [truncated]",
    "indications": "OZEMPIC is indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease. • to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease. OZEMPIC is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated: • as [truncated]",
    "effective_date": "2026-07-30",
    "labels_matching": 4,
    "set_id": "42bdd912-2393-44c4-b7e0-47672ca28991",
    "label_url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=42bdd912-2393-44c4-b7e0-47672ca28991",
    "source_url": "https://api.fda.gov/drug/label.json?search=openfda.generic_name.exact%3A%22SEMAGLUTIDE%22+AND+openfda.product_type%3A%22HUMAN+PRESCRIPTION+DRUG%22&sort=effective_time%3Adesc&limit=1",
    "provided_by": "Bosco Labs (boscolabs.dev)"
  },
  "adverse_events": {
    "reports_total": 86031,
    "serious_reports": 45165,
    "top_reactions": [
      {
        "reaction": "NAUSEA",
        "report_count": 12276,
        "share_of_reports": 0.1427
      },
      {
        "reaction": "OFF LABEL USE",
        "report_count": 8375,
        "share_of_reports": 0.0973
      }
    ],
    "data_last_updated": "2026-10-28",
    "source_url": "https://api.fda.gov/drug/event.json?search=patient.drug.openfda.generic_name%3A%22semaglutide%22+patient.drug.medicinalproduct%3A%22semaglutide%22&count=patient.reaction.reactionmeddrapt.exact&limit=2",
    "provided_by": "Bosco Labs (boscolabs.dev)"
  },
  "recalls": {
    "total": 57,
    "recalls": [
      {
        "recall_number": "D-0026-2027",
        "classification": "Class II",
        "status": "Ongoing",
        "recall_initiation_date": "2026-09-10",
        "report_date": "2026-10-14",
        "recalling_firm": "Carolina Infusion, LLC",
        "product_description": "SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936",
        "reason_for_recall": "Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.",
        "voluntary_mandated": "Voluntary: Firm initiated"
      },
      {
        "recall_number": "D-0019-2027",
        "classification": "Class II",
        "status": "Ongoing",
        "recall_initiation_date": "2026-09-10",
        "report_date": "2026-10-14",
        "recalling_firm": "Carolina Infusion, LLC",
        "product_description": "SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936",
        "reason_for_recall": "Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.",
        "voluntary_mandated": "Voluntary: Firm initiated"
      }
    ],
    "data_last_updated": "2026-10-28",
    "source_url": "https://api.fda.gov/drug/enforcement.json?search=openfda.generic_name%3A%22semaglutide%22+product_description%3A%22semaglutide%22&sort=recall_initiation_date%3Adesc&limit=2",
    "provided_by": "Bosco Labs (boscolabs.dev)"
  },
  "shortages": {
    "total_records": 3,
    "by_status": {
      "To Be Discontinued": 3
    },
    "shortages": [
      {
        "presentation": "Rybelsus, Tablet, 3 mg (NDC 0169-4303-30)",
        "generic_name": "Semaglutide Tablet",
        "company_name": "Novo Nordisk, Inc.",
        "status": "To Be Discontinued",
        "availability": null,
        "shortage_reason": null,
        "related_info": "Discontinuation of the manufacture of the drug. These products will be replaced by Ozempic (semaglutide) tablets.",
        "therapeutic_category": [
          "Endocrinology/Metabolism"
        ],
        "initial_posting_date": "2026-06-04",
        "update_date": "2026-06-04",
        "discontinued_date": "2026-06-04"
      },
      {
        "presentation": "Rybelsus, Tablet, 7 mg (NDC 0169-4307-30)",
        "generic_name": "Semaglutide Tablet",
        "company_name": "Novo Nordisk, Inc.",
        "status": "To Be Discontinued",
        "availability": null,
        "shortage_reason": null,
        "related_info": "Discontinuation of the manufacture of the drug. These products will be replaced by Ozempic (semaglutide) tablets.",
        "therapeutic_category": [
          "Endocrinology/Metabolism"
        ],
        "initial_posting_date": "2026-06-04",
        "update_date": "2026-06-04",
        "discontinued_date": "2026-06-04"
      }
    ],
    "data_last_updated": "2026-11-06",
    "source_url": "https://api.fda.gov/drug/shortages.json?search=generic_name%3A%22semaglutide%22+openfda.generic_name%3A%22semaglutide%22&limit=100",
    "provided_by": "Bosco Labs (boscolabs.dev)"
  },
  "eu_status": {
    "authorised_products": 5,
    "products_total": 5,
    "products": [
      {
        "name": "Kayshild",
        "status": "Authorised",
        "active_substance": "semaglutide",
        "marketing_authorisation_holder": "Novo Nordisk A/S",
        "authorisation_date": "2026-03-26",
        "withdrawn_or_expired_date": null,
        "conditional_approval": true,
        "additional_monitoring": true,
        "orphan_medicine": false,
        "generic": false,
        "biosimilar": false,
        "atc_code": "A10BJ06",
        "therapeutic_area": "Non-alcoholic Fatty Liver Disease;Liver Cirrhosis",
        "epar_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kayshild",
        "last_updated": "2026-04-09"
      },
      {
        "name": "Ozempic",
        "status": "Authorised",
        "active_substance": "semaglutide",
        "marketing_authorisation_holder": "Novo Nordisk A/S",
        "authorisation_date": "2018-02-08",
        "withdrawn_or_expired_date": null,
        "conditional_approval": false,
        "additional_monitoring": false,
        "orphan_medicine": false,
        "generic": false,
        "biosimilar": false,
        "atc_code": "A10BJ06",
        "therapeutic_area": "Diabetes Mellitus",
        "epar_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ozempic",
        "last_updated": "2026-08-25"
      }
    ],
    "shortages_total": 2,
    "shortages": [
      {
        "medicine_affected": "Ozempic",
        "status": "Shortage resolved",
        "forms_affected": "Pre-filled pen",
        "alternatives_available": true,
        "start_date": null,
        "expected_resolution": null,
        "last_updated": "2026-01-13",
        "shortage_url": "https://www.ema.europa.eu/en/medicines/human/shortages/ozempic"
      },
      {
        "medicine_affected": "Rybelsus",
        "status": "Shortage resolved",
        "forms_affected": "Tablet",
        "alternatives_available": true,
        "start_date": null,
        "expected_resolution": null,
        "last_updated": "2024-01-22",
        "shortage_url": "https://www.ema.europa.eu/en/medicines/human/shortages/rybelsus"
      }
    ],
    "data_timestamp": "2026-11-06T06:01:41Z",
    "shortages_data_timestamp": "2026-11-06T06:05:23Z",
    "source_url": "https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json",
    "provided_by": "Bosco Labs (boscolabs.dev)",
    "shortages_source_url": "https://www.ema.europa.eu/en/documents/report/shortages-output-json-report_en.json"
  },
  "failed_sections": [],
  "related": {
    "clinical_trials": {
      "actor": "bosco_labs/clinical-trials",
      "input": {
        "intervention": "semaglutide"
      },
      "why": "Trials testing this drug (status, phase, sponsor, read-out dates)."
    }
  },
  "warnings": [],
  "notice": "Not medical advice. Information for research and reference only; do not use it to make decisions about medical care: ask a doctor or pharmacist. FAERS counts are voluntary reports that list the drug (as suspect or concomitant); they do not show how often a reaction happens or that the drug caused it. FDA describes openFDA data as unvalidated. The official FDA label and EMA texts prevail.",
  "attribution": "US data: U.S. Food and Drug Administration (FDA) via openFDA (https://open.fda.gov), public domain (CC0); not endorsed by FDA. EU data: Source: European Medicines Agency (EMA), https://www.ema.europa.eu (medicines and shortages data files), accessed November 2026. EMA is acknowledged as the source of the EU material; EMA does not endorse Bosco Labs. Modified by Bosco Labs: selected fields only, long texts shortened (cut texts end with [truncated]), adverse events as FAERS report counts only.",
  "retrieved_at": "2026-11-06T08:57:10+00:00",
  "schema_version": "1",
  "provided_by": "Bosco Labs (boscolabs.dev)"
}

• One row per call, about 5-15 KB. Sections you did not ask for are null.
• Every section has its own source_url: the exact openFDA query (re-run it to verify) or the EMA data file, plus label_url (DailyMed), epar_url and shortage_url (EMA pages).
• FAERS as counts only: reports_total, serious_reports and the top reactions with report_count and share_of_reports. No individual case reports are fetched or returned.
• Brand names work: Ozempic resolves to semaglutide for FAERS, recalls, shortages and EMA, and the label section shows Ozempic's own label. drug.matched_as says how the name was matched.
• Dates are ISO 8601; unknown values are null; warnings says why a section is empty or missing. If a source fails (for example EMA not answering), you still get the other sections, failed_sections names the missing ones, and the run is not charged.
• related.clinical_trials gives a ready input for the clinical-trials Actor (trials testing the drug).

A cheaper sub-query returns one section. Real output for {"drug": "metformin", "mode": "adverse_events_top", "maxItems": 5} (1.3 s; notice and attribution shortened here):

{
  "query": "metformin",
  "mode": "adverse_events_top",
  "drug": {
    "generic_name": "METFORMIN HYDROCHLORIDE",
    "matched_as": "generic",
    "search_term": "metformin",
    "fda_labels_matching": 351
  },
  "label": null,
  "adverse_events": {
    "reports_total": 467986,
    "serious_reports": 315926,
    "top_reactions": [
      {
        "reaction": "NAUSEA",
        "report_count": 32159,
        "share_of_reports": 0.0687
      },
      {
        "reaction": "DIARRHOEA",
        "report_count": 30140,
        "share_of_reports": 0.0644
      },
      {
        "reaction": "BLOOD GLUCOSE INCREASED",
        "report_count": 29258,
        "share_of_reports": 0.0625
      },
      {
        "reaction": "DRUG INEFFECTIVE",
        "report_count": 24041,
        "share_of_reports": 0.0514
      },
      {
        "reaction": "FATIGUE",
        "report_count": 22778,
        "share_of_reports": 0.0487
      }
    ],
    "data_last_updated": "2026-10-28",
    "source_url": "https://api.fda.gov/drug/event.json?search=patient.drug.openfda.generic_name%3A%22metformin%22+patient.drug.medicinalproduct%3A%22metformin%22&count=patient.reaction.reactionmeddrapt.exact&limit=5",
    "provided_by": "Bosco Labs (boscolabs.dev)"
  },
  "recalls": null,
  "shortages": null,
  "eu_status": null,
  "failed_sections": [],
  "related": {
    "clinical_trials": {
      "actor": "bosco_labs/clinical-trials",
      "input": {
        "intervention": "metformin"
      },
      "why": "Trials testing this drug (status, phase, sponsor, read-out dates)."
    }
  },
  "warnings": [],
  "notice": "Not medical advice. Information for re ...",
  "attribution": "US data: U.S. Food and Drug Administration (FDA) via openFDA ...",
  "retrieved_at": "2026-11-06T08:57:13+00:00",
  "schema_version": "1",
  "provided_by": "Bosco Labs (boscolabs.dev)"
}

Input

{ "drug": "semaglutide" }

Field	Meaning
drug	Generic name, active ingredient or brand, e.g. semaglutide, metformin, Ozempic (required)
mode	dossier (default, $0.02) or one section for $0.004: label, adverse_events_top, recalls, shortages, eu_status
maxItems	Cap on each list (reactions, recalls, shortage records, EU products), default 10, max 50. Totals are always complete

An unknown or misspelled name fails within seconds, costs nothing, and suggests close names: semaglutid answers No drug "semaglutid" in FDA labels, FAERS or EMA's medicines list. Did you mean: semaglutide, oral semaglutide, teduglutide, liraglutide, dulaglutide?

Use from an AI agent (MCP)

Agents can call this Actor as a tool through the Apify MCP server. Add this server URL to your MCP client (Claude, Cursor, VS Code, ...):

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

It loads this Actor as a tool, plus the tools that read its results (get-actor-run, get-dataset-items). The hosted server signs you in with OAuth, or accepts your Apify token as Authorization: Bearer <APIFY_TOKEN>.

Example prompt: "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" }

Output for agents: 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.

Cost: $0.02 per dossier or $0.004 per single-section query, billed to the Apify account the MCP server is signed in with.

FAQ

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.

Source and terms

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.