# FDA FAERS — Adverse-Event Drug Involvement (DRUG file)

`drug_silver.fact_faers_drug` · Drugs and formularies · status live · 11,131,453 rows

FDA FAERS (Adverse Event Reporting System) DRUG file — per adverse-event report × drug: the drug's role (PS primary-suspect / SS secondary / C concomitant / I interacting), drug name, active ingredient, NDA number, route/dose, dechallenge/ rechallenge. The drug-safety surveillance signal — links adverse events to the drug substrate (join drugname/prod_ai/nda_num to dim_drug / dim_drug_application). ~1.6-2.2M rows/quarter; 2025Q1-2026Q2 loaded (six quarters).

**Grain.** One row per line of a quarter's FAERS DRUG file: physical key (report_quarter, row_seq), row_seq = the line's position in that quarter's file (accepted 2026-09-23). (report_quarter, primaryid, drug_seq) is NOT a key: the publisher repeats it (21,797 duplicate groups / 68,550 rows in 2025Q1). Quarters are noncumulative and case-versioned; count cases with the current-case rule in the context doc, never rows or distinct primaryid.

| column | type | meaning |
|---|---|---|
| report_quarter | string |  |
| row_seq | bigint |  |
| primaryid | string |  |
| caseid | string |  |
| role_cod | string |  |
| drugname | string |  |
| prod_ai | string |  |
| val_vbm | string |  |
| route | string |  |
| dose_vbm | string |  |
| cum_dose_chr | string |  |
| cum_dose_unit | string |  |
| dechal | string |  |
| rechal | string |  |
| nda_num | string |  |
| dose_amt | string |  |
| dose_unit | string |  |
| dose_form | string |  |
| dose_freq | string |  |
| drug_seq | double |  |
| observed_period | date |  |
| asserted_at | date |  |
| effective_period_start | date |  |
| effective_period_end | date |  |
| cms_vintage_sequence | int |  |
| parse_revision | int |  |
| parser_artifact_hash | string |  |
| source_url | string |  |
| sha256_content_hash | string |  |
| source_id | string |  |
| is_current | boolean |  |
| bronze_object_key | string |  |
| s3_version_id | string |  |
| vintage_tag | string |  |
| drug_source_version_id | string |  |

Query it: `query_substrate` with `SELECT ... FROM drug_silver.fact_faers_drug WHERE ... LIMIT 100`; read `describe_data_source("drug_silver.fact_faers_drug")` first.