openfda

Query the FDA's public openFDA APIs for post-market drug data — FAERS adverse-event reports, Drugs@FDA approval and submission history, Structured Product Labels including boxed warnings, the National Drug Code directory, recall enforcement reports, and drug shortages. Use this skill to check what a regulator has already concluded about a molecule or its class, to date an approval and count its efficacy supplements, to read an approved indication or boxed warning, and to score a drug-event pair for disproportionate reporting with PRR, ROR, and chi-squared. Also trigger on openFDA, api.fda.gov, FAERS, Drugs@FDA, SPL, NDC, pharmacovigilance, boxed warning, adverse event report, drug recall, or safety signal.

Version

1.0

License

MIT

Compatibility

Requires Python 3.10+ and outbound HTTPS access to api.fda.gov. The bundled scripts use only the Python standard library. No key is needed, but the anonymous quota is 1000 requests/day; set OPENFDA_API_KEY (free, from open.fda.gov) to raise it to 120000/day. Data is public domain (CC0). FAERS publishes quarterly and lags by three months or more.