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OpenFDA Drug Adverse Events & Recalls Search

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from $5.00 / 1,000 results

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OpenFDA Drug Adverse Events & Recalls Search

OpenFDA Drug Adverse Events & Recalls Search

Pricing

from $5.00 / 1,000 results

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Ava Torres

Ava Torres

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openFDA Drug Search - 600K+ Adverse Events, Product Recalls & Drug Labels

Search the FDA's public openFDA database for drug safety data, product recalls, and drug labels. One actor covers three high-value FDA datasets:

  • Drug Adverse Events (FAERS) -- 600,000+ reports of drug side effects, injuries, and deaths reported to the FDA
  • FDA Recalls -- Drug, medical device, and food recall/enforcement actions with classification, reason, and distribution details
  • Drug Labels -- Package inserts with indications, warnings, dosage, contraindications, and active ingredients

No API key required. No proxies needed. Pure public FDA data.

Who uses this data?

  • Pharmaceutical companies monitoring adverse event signals for their products
  • Compliance teams tracking FDA recall activity across competitors
  • Insurance & legal researching drug safety history for claims and litigation
  • Healthcare researchers studying drug safety patterns at scale
  • Journalists investigating FDA recall trends and drug safety issues
  • Sales intelligence identifying companies affected by recalls

What data do you get?

Adverse Events (FAERS)

FieldDescription
Safety Report IDUnique FDA report identifier
Receive DateWhen FDA received the report
SeriousWhether the event was serious (death, hospitalization, disability)
Serious OutcomeSpecific outcomes: Death, Hospitalization, Life-Threatening, Disability
Patient Sex/AgeDemographics when available
ReactionsAll reported adverse reactions with outcomes
DrugsAll drugs involved with role (suspect/concomitant), active ingredients, route
Report TypeSpontaneous, Literature, Study
CountryWhere the event occurred

Recalls / Enforcement

FieldDescription
Recall NumberFDA recall identifier
ClassificationClass I (dangerous), Class II (may cause harm), Class III (unlikely harm)
Product TypeDrugs, Devices, or Food
Recalling FirmCompany issuing the recall
Reason for RecallWhy the product was recalled
Product DescriptionDetailed product info including NDC, lot numbers
Distribution PatternWhere the recalled product was distributed
StatusOngoing, Terminated, or Completed
DatesInitiation, classification, report, and termination dates

Drug Labels

FieldDescription
Brand NameCommercial drug name
Generic NameGeneric/chemical name
ManufacturerManufacturing company
Active IngredientActive pharmaceutical ingredients
IndicationsApproved uses
WarningsSafety warnings including boxed warnings
DosageDosage and administration instructions
ContraindicationsWhen NOT to use the drug
Adverse ReactionsKnown side effects
Drug InteractionsInteractions with other drugs
Application NumberFDA application (NDA/ANDA) number
NDCNational Drug Code

Input parameters

ParameterTypeDescription
searchTypeSelectadverse_events, recalls, or drug_labels
queryStringDrug name, company, or keyword (e.g. "aspirin", "Pfizer")
dateFromStringStart date in YYYY-MM-DD format
dateToStringEnd date in YYYY-MM-DD format
maxResultsIntegerMaximum results to return (default: 100, max: 25,000)

Example searches

Find adverse events for aspirin:

{
"searchType": "adverse_events",
"query": "aspirin",
"maxResults": 50
}

Find all FDA recalls mentioning contamination in 2024:

{
"searchType": "recalls",
"query": "contamination",
"dateFrom": "2024-01-01",
"dateTo": "2024-12-31"
}

Get drug label for ibuprofen:

{
"searchType": "drug_labels",
"query": "ibuprofen",
"maxResults": 10
}

FAQ

Is this data free? Yes. openFDA is a free public API provided by the U.S. Food and Drug Administration. No API key is needed.

What is FAERS? The FDA Adverse Event Reporting System (FAERS) is a database of adverse event reports, medication error reports, and product quality complaints submitted to the FDA. It contains over 600,000 reports.

What do recall classifications mean?

  • Class I: Dangerous or defective product that could cause serious health problems or death
  • Class II: Product that might cause a temporary health problem or pose a slight threat of a serious nature
  • Class III: Product that is unlikely to cause any adverse health reaction but violates FDA regulations

How current is the data? openFDA data is updated regularly. Drug adverse events are typically updated monthly. Recall data is updated as new enforcement actions are filed.

Can I search for medical devices and food recalls too? Yes. The recalls search type automatically queries across drug, device, and food enforcement databases.

Integrations

Connect this actor to Google Sheets, Slack, email, or 2,000+ apps via Apify integrations. Set up monitoring to get notified when new recalls are filed for specific drugs or companies.

Pricing

Usage-based pricing on the Apify platform. This actor uses minimal compute (pure API calls, no browser needed). Typical cost: a few cents per run.

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