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faers-neurology-cns-2020-2025
1.0.0
Neurology / CNS
FDA FAERS
2020-01-01 to 2025-12-31
302,062
18
[ { "name": "safetyreportid", "type": "string", "description": "Unique FAERS safety report identifier" }, { "name": "receivedate", "type": "string", "description": "Date FDA received the report (ISO 8601)" }, { "name": "serious", "type": "string", "description": "Serious ad...

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Check out the documentation for more information.

Neurology & CNS — Drug Safety Intelligence (FAERS 2020–2025)

Version: 1.0.0 | Records: 302,062 | Source: FDA FAERS

Dataset Summary

Structured adverse event reports for neurology / CNS drugs from the FDA's FAERS database, 2020–2025. Covers serious adverse events only (hospitalization, life-threatening outcomes, death). Each record includes the suspect drug(s), reported reactions (MedDRA coded), patient demographics, outcome codes, reporter country, and seriousness flags. Intended for pharmaceutical safety teams, pharmacovigilance analysts, biotech investors, and clinical researchers.

Source

  • FDA Adverse Event Reporting System (FAERS), public data
  • Serious adverse events only (serious=1)
  • Date range: 2020-01-01 to 2025-12-31
  • License: U.S. Government public domain. CC BY 4.0.
  • PII: No patient names, reporter names, or addresses included.

Fields (18)

safetyreportid, receivedate, serious, seriousnessdeath (1=death/2=other serious), seriousnesslifethreatening, seriousnesshospitalization, patientagegroup, patientsex (1=male/2=female), patientweight, patientonsetage, patientonsetageunit, reaction (MedDRA reaction terms), drug (suspect drugs and indications), outcome, reportercountry, qualification (reporter type), transmissiondate, therapeutic_area

Quality

  • 100% reaction and drug coverage
  • 99.6% reporter country coverage
  • 86.5% patient sex coverage
  • 0 duplicate safetyreportids
  • Validated through Pydantic schema + business rules (no PII, no nulls on required fields)

Known Limitations

  • therapeutic_area is keyword-assigned from drug indications and MedDRA reaction terms. Reports where neither field contains a recognizable keyword are classified as Other and excluded from this subset.
  • seriousnessdeath values: 1=death reported, 2=serious but not death, null=not set. Not all serious reports involve death.
  • Patient weight is sparse (19.2% coverage) — FAERS reporters often omit it.

Update Cadence

Quarterly (FDA releases FAERS quarterly)

License

U.S. Government public domain source. CC BY 4.0 — attribution required.

How to Access

Full dataset available at Ruby Intelligence on Gumroad

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