OpenFDA

OpenFDA

US Food and Drug Administration open data API providing access to drug adverse events, recalls, labeling, and device reports. No authentication required (rate-limited).

Data Model

• Drug Adverse Event — An adverse event report (FAERS/AERS) with patient info, drugs involved, reactions, and outcomes.
• Drug Label — Structured product labeling (SPL) with indications, warnings, dosage, and ingredients.
• Enforcement — Recall/enforcement reports for drugs, food, and devices with classification, distribution, and reason.
• Device Event — Medical device adverse event reports (MAUDE) with device info, patient outcomes, and event descriptions.

Search Syntax

OpenFDA uses a custom search syntax:

• Field search: search=field:value (e.g. search=patient.drug.openfda.brand_name:"aspirin")
• AND: search=field1:value1+AND+field2:value2
• Exact match: Use double quotes "value"
• Date range: search=receivedate:[20200101+TO+20201231]
• Count: count=field.exact returns frequency distribution

Gotchas

• Rate limit: 240 requests/minute without configured credentials; 120K/day with credentials.
• Results limited to 99 skip + limit. For larger datasets, use date-based partitioning.
• Not all records have openfda enrichment fields — some older records lack structured drug identification.
• Adverse event reports are NOT confirmed causal relationships.
• Drug names can be brand or generic — search both when looking for specific drugs.