openFDA
openFDA is the U.S. Food and Drug Administration's open data API. Through ScholarMuse, an agent can look up a drug by name and get two things: the reaction terms most often reported for it in the FDA Adverse Event Reporting System (FAERS), and highlights from its most recent FDA product label. Report counts are spontaneous reports, not incidence or risk, and this is not medical advice.
ScholarMuse tools: lookup_drug. Each successful call uses credits.
Ask your agent
What your agent gets back
Every record carries id, source, title, url, license, attribution and retrievedAt. The fields below are the data that comes from openFDA.
lookup_drug
openFDA adds up to two records: type "adverse_events" (first six fields) and type "drug_label" (the rest). Each appears only when openFDA has a match.
- reactions
- Top 15 MedDRA reaction terms with report counts
- totalReports
- Total FAERS reports that list the drug
- matchedOn
- Which openFDA field the drug name matched
- dataUpdated
- openFDA last-updated date for the data
- caveat
- Plain-language warning on reading report counts
- drug
- Drug name used for the search
- brandName
- Brand name on the label
- genericName
- Generic name on the label
- manufacturer
- Manufacturer name
- indications
- Indications and usage text, up to 1,500 characters
- boxedWarning
- True when the label has a boxed warning
- effectiveDate
- Label effective date
What it covers
- Drug data only: FAERS spontaneous adverse event reports and FDA structured product labels. Devices, food and recalls are not covered.
- Adverse events are matched on the generic name first, then on the product name as written in the report.
- Labels are matched on generic name, then brand name, then substance name. The most recent matching label is returned.
- This is United States regulatory data. Labels and reports from other regulators are not included.
Limits
- Report counts are not incidence or risk. FAERS reports are unverified, may be duplicated, and do not show that the drug caused the event.
- Only the 15 most reported reaction terms are returned. Individual case reports are not.
- One label per call, with selected sections only: indications are cut at 1,500 characters and boxed warning text at 600. Dosage, contraindications and interactions are not returned.
- Search is by drug name. When ChEMBL recognises the drug, its preferred name is used for the openFDA search, so a brand-name query may return the label of another product with the same ingredient.
How ScholarMuse reaches openFDA
The connector calls the openFDA drug adverse event and drug label endpoints at api.fda.gov/drug. It works without a key. If an openFDA API key is configured on our server, it is sent as the HTTP basic-auth username.
Adverse event counts are cached for up to 1 day and label lookups for up to 7 days, so a label revision can take a week to appear.
API key: the upstream API can be called without one, so you do not add one.
Licence and attribution
Licence: CC0-1.0 (openFDA; unvalidated data, not for clinical decisions)
Data from openFDA (open.fda.gov), U.S. Food and Drug Administration.
Records that come from openFDA carry this licence and attribution. When you cite the data in a paper, follow openFDA's own citation guidance.
