openFDA Drug and Adverse Event Database

Overview

openFDA provides public access to FDA regulatory data through a simple REST API. Key datasets include the FDA Adverse Event Reporting System (FAERS) with 20M+ adverse event reports, drug product labeling (NDC, SPL), drug approvals (Drugs@FDA), medical device reports, and recall enforcement actions. The API supports full-text search and structured queries using Elasticsearch-style syntax.

When to Use

• Retrieving adverse event reports for a drug to assess safety signals and side effect profiles
• Querying FAERS for disproportionality analysis (comparing drug vs. drug adverse event profiles)
• Looking up official drug labeling (indications, contraindications, warnings, dosing) by drug name or NDC
• Searching for drug recalls and enforcement actions by drug name or company
• Identifying all marketed products containing a given active ingredient
• Building pharmacovigilance pipelines that monitor drug safety signals from public regulatory data
• For clinical trial efficacy data use clinicaltrials-database-search; for drug structures/targets use drugbank-database-access

Prerequisites