FDA Adverse Events (FAERS) Scraper — Drug Safety Reports

Extract structured drug adverse event data from the FDA Adverse Event Reporting System (FAERS) via the free, public openFDA API. This Actor lets you search across more than 20 million adverse event reports submitted to the FDA since 1968 — no API key, no authentication, no subscription required.

FAERS is the FDA's primary pharmacovigilance database. Healthcare professionals, patients, and manufacturers report suspected drug side effects, medication errors, and product quality problems. The database is used by the FDA for post-market safety surveillance, by pharmaceutical companies for regulatory compliance, by researchers for drug safety studies, and increasingly by litigation teams investigating drug-related injuries.

This Actor flattens the nested FAERS report structure into clean, analyst-ready JSON — no deep parsing required. Filter by drug name, MedDRA reaction term, report severity, and date range. Export to CSV or Excel for direct use in statistical tools or BI dashboards.

What Data Does This Actor Extract?

Field	Description
safetyReportId	Unique FDA safety report identifier
receiveDate	Date FDA received the report (YYYY-MM-DD)
drugs	Semicolon-separated list of all drugs in the report
primaryDrugCharacterization	The suspect drug most likely causing the reaction
indications	Reported therapeutic indications for each drug
reactions	Semicolon-separated MedDRA adverse reaction terms
reactionOutcomes	Outcomes per reaction (Recovered, Fatal, etc.)
serious	Whether the report was flagged as serious (boolean)
seriousnessDeath	Whether death was reported as an outcome (boolean)
seriousnessHospitalization	Whether hospitalization was required (boolean)
patientSex	Patient sex: Male, Female, or Unknown
patientAge	Patient age with unit (e.g., "45 year(s)")
occurCountry	Country where the adverse event occurred

Features

• Filter by drug name, adverse reaction, severity, and date range
• Zero authentication required — uses the public openFDA API
• Returns structured, flattened JSON (no nested objects to parse)
• Pagination up to 25,000 records per run (openFDA's hard limit)
• Empty-input mode returns recent reports across all drugs and reactions
• Handles missing or malformed fields gracefully

How to Scrape FDA Adverse Event Reports

1. Open the FDA Adverse Events Scraper on the Apify Store and click Try for free.
2. In the Drug Name field, enter the drug you want to research (e.g., ASPIRIN, IBUPROFEN, ATORVASTATIN). Leave blank to pull all recent reports.
3. Optionally enter an Adverse Reaction MedDRA term to narrow results (e.g., NAUSEA, CARDIAC ARREST, DEATH).
4. Toggle Serious Reports Only to restrict results to hospitalizations, deaths, and life-threatening events.
5. Set a Date From and Date To to restrict the date range (YYYY-MM-DD format).
6. Set Maximum Results to control the output size (default: 1,000; max: 25,000).
7. Click Start and wait for the run to complete (typically under 60 seconds for 1,000 records).
8. Download results as JSON, CSV, or Excel from the Dataset tab.

Input Example

{
    "drugName": "ASPIRIN",
    "reaction": "NAUSEA",
    "seriousOnly": false,
    "dateFrom": "2023-01-01",
    "dateTo": "2023-12-31",
    "maxResults": 500
}

Output Example

{
    "safetyReportId": "US-BAYER-2023-12345",
    "serious": true,
    "seriousnessDeath": false,
    "seriousnessHospitalization": true,
    "receiveDate": "2023-04-15",
    "occurCountry": "US",
    "patientSex": "Female",
    "patientAge": "67 year(s)",
    "drugs": "ASPIRIN; LISINOPRIL",
    "indications": "PAIN; HYPERTENSION",
    "reactions": "NAUSEA; GASTROINTESTINAL HAEMORRHAGE",
    "reactionOutcomes": "Recovered/Resolved; Recovering/Resolving",
    "primaryDrugCharacterization": "ASPIRIN"
}

Pricing

This Actor calls the free openFDA API with no browser overhead. Compute costs are very low.

• Per-result pricing: $0.003/result
• Typical run: 1,000 records in under 60 seconds
• Cost estimate: ~$3 in Actor fees for 1,000 records plus minimal Apify platform compute

Use Cases

• Pharmacovigilance research — Identify adverse event signals for specific drugs or drug classes
• Drug safety analysis — Compare serious event rates across similar medications
• Regulatory compliance — Monitor FAERS submissions for a specific product or therapeutic area
• Litigation support — Pull historical adverse event reports for a drug under legal scrutiny
• Competitive intelligence — Compare safety profiles of branded vs. generic equivalents
• Academic research — Build datasets for epidemiology, signal detection, or NLP studies
• RAG pipeline ingestion — Feed structured adverse event data into AI safety monitoring systems

FAQ

Q: Do I need an FDA API key? A: No. The openFDA API is free and public. No registration or API key is required for standard usage.

Q: How many records can I get per run? A: Up to 25,000 per run. This is a hard limit enforced by the openFDA API's pagination cap. For larger datasets, consider splitting by date range across multiple runs.

Q: How current is the FAERS data? A: FAERS data is updated quarterly by the FDA. The most recent quarter's data is typically available within 3–4 months of the reporting period.

Q: Can I filter by multiple drugs at once? A: Currently one drug name per run. For multiple drugs, run the Actor multiple times (once per drug) and merge the output datasets.

Q: What are MedDRA terms? A: MedDRA (Medical Dictionary for Regulatory Activities) is the standardized terminology used by the FDA and pharmaceutical industry to classify adverse events. Examples: NAUSEA, MYOCARDIAL INFARCTION, ANAPHYLACTIC REACTION. Use exact MedDRA terms in the reaction field for precise filtering.

Q: Why do some records have empty drug names or reactions? A: FAERS submissions are voluntary and often incomplete. The Actor passes through whatever the FDA received — missing fields are returned as empty strings.

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Legal Disclaimer

This Actor uses the public openFDA API provided by the U.S. Food and Drug Administration. Data is sourced from the FDA Adverse Event Reporting System (FAERS) and is freely available as open government data. This tool is intended for research and informational purposes only and does not constitute medical advice. Adverse event reports in FAERS represent unverified, voluntary submissions and do not establish a causal link between a drug and a reported event. Always consult a qualified healthcare professional for medical decisions. The Actor developer is not affiliated with the FDA or any pharmaceutical company.