FDA FAERS Adverse Events

💊 Search FDA FAERS adverse events

This Actor is for pharmacovigilance teams, researchers, and data teams. Search public FDA FAERS reports by drug, adverse reaction, manufacturer, or one focused openFDA/FAERS query, then get structured report rows with reactions, seriousness, dates, patient details, drug products, and reporter context for safety research.

• Search the FAERS Database for structured FDA report rows about a drug.
• Find filtered records in the FDA FAERS Database with date, country, and seriousness choices.
• Look up report-level evidence in the Adverse Event Reporting System by using a reaction or side-effect term.
• Search matching report details with the MedWatch FDA task.
• Review reported reactions and seriousness fields with a MedWatch Report search.

🧾 Report-level FAERS evidence

Each saved dataset row is one matching FDA FAERS report. Rows keep the source report ID and dates, seriousness flags and criteria, available patient and country details, reported and normalized reactions, reported and normalized drug details, and reporter context. Normalized values appear when a mapping is available; missing source values are not invented.

The result output is a JSON link with the returned reports, counts, and ranked summaries. FAERS report data is useful for safety research and signal review, but this Actor does not diagnose, give treatment advice, or decide that a drug caused an event.

▶️ Run a focused FAERS search

1. Choose one Target: Drug, Adverse reaction, Manufacturer, or Advanced query.
2. Fill the field for that Target. Use queryExpression for one focused openFDA or FAERS query.
3. Add guided filters for received dates, seriousness, countries, patient sex, or patient age when you choose Drug, Adverse reaction, or Manufacturer.
4. Set Maximum reports, or leave it empty to return all available results until the source is exhausted.
5. Start the Actor and open the dataset or JSON result after the run.

⚙️ Input

Input fields

Field	Type	What it does
target	string (required)	Chooses one search path: drug, reaction, manufacturer, or advancedQuery.
drugValues	array of strings	Searches matching FAERS reports for one or more drug values. Used only when target is drug.
reactionTerms	array of strings	Searches matching reports for one or more adverse-reaction or side-effect terms. Used only when target is reaction.
manufacturerValues	array of strings	Searches matching FAERS reports for one or more manufacturer values. Used only when target is manufacturer.
queryExpression	string	Sends one focused openFDA or FAERS query expression. Used only when target is advancedQuery.
receivedDateFrom	string (date)	Includes reports received on or after this date. Used with guided targets.
receivedDateTo	string (date)	Includes reports received on or before this date. Used with guided targets.
seriousOnly	boolean	When true, keeps only reports marked serious; when false, keeps all matching reports for a guided target.
countries	array of strings	Matches one or more event or report country names or codes for a guided target.
patientSex	string	Matches the source patient sex for a guided target. Reports without this source value do not match.
patientAgeMin	integer	Matches a source patient age at or above this value for a guided target.
patientAgeMax	integer	Matches a source patient age at or below this value for a guided target.
maxItems	integer	Actor Work Limit. Stops after this many matching reports. Leave it empty to return all available results until the source is exhausted.

The form starts with target set to drug, drugValues set to ibuprofen, seriousOnly set to false, and maxItems set to 100. Only the selected Target is used. Guided targets use the shared filters; Advanced query uses its expression and returns reports with summaries.

Default input example

This is the public input from a successful hosted default-input run:

{
  "target": "drug",
  "drugValues": [
    "ibuprofen"
  ],
  "seriousOnly": false,
  "maxItems": 100
}

🧾 Output

Actor output links

Field	Type	What it does
dataset	string (URL)	Links to the default dataset that holds the matching FAERS report rows.
result	string (URL)	Links to JSON with the returned reports, counts, and ranked summaries.

Dataset row fields

Some fields are optional because FDA does not publish every value for every report. The table lists the complete public dataset shape.

Field	Type	What it does
reportId	string	Source report ID used to find the report again.
reportVersion	integer	Version number for the source report.
dates	object	Holds dates tied to the report.
dates.receivedDate	string (date)	Date FDA received the report.
dates.transmissionDate	string (date)	Date the source sent the report.
reportType	string	Type of report recorded by the source.
seriousness	object	Holds the serious status and available reasons for it.
seriousness.isSerious	boolean	Says whether the source marks the report as serious.
seriousness.criteria	object	Holds the seriousness criteria reported by the source.
seriousness.criteria.death	boolean	Says whether death is a seriousness criterion.
seriousness.criteria.lifeThreatening	boolean	Says whether a life-threatening event is a seriousness criterion.
seriousness.criteria.hospitalization	boolean	Says whether hospitalization is a seriousness criterion.
seriousness.criteria.disability	boolean	Says whether disability is a seriousness criterion.
seriousness.criteria.congenitalAnomaly	boolean	Says whether a congenital anomaly is a seriousness criterion.
seriousness.criteria.other	boolean	Says whether another serious event is a seriousness criterion.
patient	object	Holds available patient details from the report.
patient.age	number	Patient age as reported by the source.
patient.ageUnit	string	Unit used for the reported patient age.
patient.ageGroup	string	Patient age group reported by the source.
patient.sex	string	Patient sex reported by the source.
patient.weight	number	Patient weight as reported by the source.
patient.weightUnit	string	Unit used for the reported patient weight.
patient.onsetDate	string (date)	Date the patient event began, when reported.
geography	object	Holds event and report countries from the source.
geography.eventCountry	string	Country where the event occurred.
geography.reportCountry	string	Country tied to the primary report source.
reactions	array of objects	Lists reaction terms and outcomes reported in the report.
reactions[].reportedTerm	string	Reaction term as reported by the source.
reactions[].normalizedTerm	string	Human-readable reaction term when a mapping is available.
reactions[].outcome	string	Outcome reported for the reaction.
drugs	array of objects	Lists drug products recorded in the report, including the searched product when present.
drugs[].reportedName	string	Drug name as reported by the source.
drugs[].normalizedName	string	Human-readable drug name when a mapping is available.
drugs[].brandNames	array of strings	Lists brand names linked to the drug product.
drugs[].genericNames	array of strings	Lists generic names linked to the drug product.
drugs[].activeSubstances	array of strings	Lists active substances linked to the drug product.
drugs[].manufacturer	object	Holds manufacturer names for the drug product.
drugs[].manufacturer.reportedName	string	Manufacturer name as reported by the source.
drugs[].manufacturer.normalizedName	string	Human-readable manufacturer name when a mapping is available.
drugs[].indication	string	Reason for use reported for the drug product.
drugs[].dose	string	Dose text reported for the drug product.
drugs[].route	string	Administration route reported for the drug product.
drugs[].startDate	string (date)	Date use of the drug product started, when reported.
drugs[].endDate	string (date)	Date use of the drug product ended, when reported.
reporter	object	Holds available reporter context for the report.
reporter.country	string	Country reported for the primary reporter.
reporter.qualification	string	Qualification of the primary reporter.
reporter.organization	string	Organization linked to the report sender.

Genuine hosted dataset row

This full row is copied from the successful hosted default-input run for ibuprofen:

{
  "reportId": "10004377",
  "reportVersion": 1,
  "dates": {
    "receivedDate": "2014-03-12",
    "transmissionDate": "2014-10-02"
  },
  "reportType": "1",
  "seriousness": {
    "isSerious": true,
    "criteria": {
      "death": false,
      "lifeThreatening": false,
      "hospitalization": false,
      "disability": false,
      "congenitalAnomaly": false,
      "other": true
    }
  },
  "patient": {
    "age": 24,
    "ageUnit": "years",
    "sex": "female"
  },
  "geography": {
    "eventCountry": "GB",
    "reportCountry": "GB"
  },
  "reactions": [
    {
      "reportedTerm": "Hypoaesthesia oral",
      "normalizedTerm": "Hypoaesthesia oral",
      "outcome": "recovered/resolved with sequelae"
    },
    {
      "reportedTerm": "Hypoaesthesia",
      "normalizedTerm": "Hypoaesthesia",
      "outcome": "recovered/resolved with sequelae"
    }
  ],
  "drugs": [
    {
      "reportedName": "IBUPROFEN (UNKNOWN)",
      "normalizedName": "IBUPROFEN (UNKNOWN)",
      "indication": "TOOTHACHE",
      "dose": "UNK",
      "route": "048",
      "startDate": "2014-02-17"
    },
    {
      "reportedName": "AMOXICILLIN",
      "normalizedName": "AMOXICILLIN",
      "brandNames": [
        "AMOXICILLIN"
      ],
      "genericNames": [
        "AMOXICILLIN"
      ],
      "activeSubstances": [
        "AMOXICILLIN"
      ],
      "manufacturer": {
        "reportedName": "Hikma Pharmaceuticals USA Inc.",
        "normalizedName": "Hikma Pharmaceuticals USA Inc."
      },
      "indication": "TOOTH INFECTION",
      "dose": "UNK",
      "route": "065",
      "startDate": "2014-02-14"
    },
    {
      "reportedName": "ORAJEL",
      "normalizedName": "SODIUM FLUORIDE",
      "brandNames": [
        "ORAJEL TOY STORY 5 ANTICAVITY"
      ],
      "genericNames": [
        "SODIUM FLUORIDE"
      ],
      "activeSubstances": [
        "SODIUM FLUORIDE"
      ],
      "manufacturer": {
        "reportedName": "Church & Dwight Co., Inc.",
        "normalizedName": "Church & Dwight Co., Inc."
      },
      "indication": "PRODUCT USED FOR UNKNOWN INDICATION",
      "dose": "UNK",
      "route": "065"
    },
    {
      "reportedName": "PARACETAMOL",
      "normalizedName": "PARACETAMOL",
      "indication": "PRODUCT USED FOR UNKNOWN INDICATION",
      "dose": "UNK",
      "route": "065"
    }
  ],
  "reporter": {
    "country": "GB",
    "qualification": "consumer or other non-health professional",
    "organization": "FDA-Public Use"
  }
}

💳 Pricing

Pricing event

This Actor uses pay-per-event pricing. The configured event is $0.0007 for each FDA FAERS adverse-event report saved to the dataset. The pricing tab on the Actor page is the current source for price details.

🔌 Integrations

Run access

Run the Actor in Apify Console or use the Apify API to read the dataset and JSON result after the run. Use dataset exports or schedules in your workflow.

❓ FAQ

What does a matching FAERS report prove?

It is report-level evidence from the FDA FAERS source. It does not prove that a drug caused an event, and this Actor does not provide medical advice, diagnosis, treatment guidance, or causal analysis.

Which Target should I choose?

Choose Drug for drug values, Adverse reaction for side-effect terms, Manufacturer for manufacturer values, or Advanced query for one focused openFDA or FAERS query expression. Fields for other Targets are ignored.

Can I combine filters with a guided Target?

Yes. A guided search can use received-date, seriousness, country, patient sex, and patient age filters together when the source values are available. Advanced query uses its expression instead of the shared guided filters.

What happens if I leave Maximum reports empty?

The Actor returns all available matching results until the source is exhausted. Set a value when you want the run to stop after that many matching reports.

Can I search by an adverse reaction or manufacturer?

Yes. Choose Adverse reaction or Manufacturer, then enter one or more values in the matching field. You can also choose Drug for one or more drug values.

What is the Advanced query option?

It accepts one focused openFDA or FAERS query expression. Use it when you need a source query that is not covered by the guided Target fields; the result includes reports with summaries.

Do I need a login or a source API key?

No. The Actor searches public FDA FAERS data without a buyer-supplied login or source API key.

Does this search clinical trials, drug labels, recalls, or devices?

No. This Actor searches drug adverse-event reports in FAERS. It does not replace clinical-trial, label, recall, device, diagnosis, treatment, or causal-analysis tools.

Why can a report field be missing?

FDA does not publish every field for every report. Optional values stay absent when the source does not provide them, and normalized values appear only when a mapping is available.

📝 Changelog

0.0: Initial release

🆘 Support

For issues, questions, or feature requests, file a ticket and I'll fix or implement it in less than 24h 🫡

🔗 Related Actors

• FDA Drug Shortage API — check drug supply status beside patterns found in FAERS reports.
• ClinicalTrials.gov — compare trial status and study details with post-market report evidence.
• FDA Drug Adverse Events & Side Effects (openFDA) — review ranked reactions or individual FAERS reports for a drug.
• OpenFDA Drug Adverse Events Search — search normalized FAERS reports by drug, query, or received-date range.
• openFDA Drug Adverse Events Scraper — export FAERS reports by drug, reaction term, or received-date range.

Made with ❤️ by Maxime Dupré