/v1/safety-labeling-changes/searchFind FDA-designated safety labeling changes by drug, application, section and date. Each hit is one application-supplement change; each changed section shows the wording FDA underlined as new. A generic FDA lists nothing for shows its reference drug’s changes, marked as such.
AuthorizationstringRequiredBearer token with your API key. Keep the key server-side.
Idempotency-KeystringOptionalMakes a retry count once. 8 to 128 letters, digits and . _ : / + -, starting with a letter or digit. For 24 hours the key is bound to your workspace and the exact request; reusing it for different work is refused with 409.
Values go in the query string; repeat a field to send several values.
qstringOptionalat most 500 charactersText matched against the drug and active-ingredient names; every word must match as a whole word, leaving out strength, form and words like label or change. Results come newest change first.
change_idstring or array of stringOptionalChange IDs, in any letter case.
application_numberstring or array of stringOptionalFDA application numbers, such as NDA 020702. A number alone matches any type.
sectionstring or array of stringOptionalA section code (5), title (Warnings and Precautions) or FDA’s abbreviation (WP). Repeat for several.
changed_fromstringOptionalEarliest FDA change date, YYYY-MM-DD.
changed_tostringOptionalLatest FDA change date, YYYY-MM-DD.
includestring or array of stringOptionalsection_text adds each section’s full text; source_formatting adds it with FDA’s underline spans.
limitintegerOptionalDefaults to 20min 1 · max 100Changes per page.
cursorstringOptionalThe cursor from the previous page of this same search.
A list of SafetyLabelingChange objects, one per result; page metadata is in meta. Optional fields are left out when empty; a few return null for unknown, as their sentences say. Dates are YYYY-MM-DD and times ISO 8601 UTC.
change_idstringRequiredThe change’s identifier, accepted by the change_id filter.
drug_namestringRequiredThe drug name FDA lists.
active_ingredientstringOptionalThe active ingredient FDA lists.
application_numberstringRequiredThe FDA application number.
application_typestringRequiredNDA, ANDA or BLA.
supplement_typestringRequiredFDA’s supplement type, such as SLR.
supplement_numberstringRequiredThe supplement number.
changed_datestringRequiredThe date FDA lists for the change.
source_urlstringRequiredThe change at FDA.
label_urlstringOptionalThe approved label FDA links, when it links one.
changed_sectionsarray of SafetyLabelSectionChangeRequiredEvery section the change touched, with its text.
via_referenceSafetyLabelChangeViaReferenceOptionalOnly on a reference drug’s change found for a generic: the reference drug and the products it is the reference for.
Errors and limits lists every code and the limits behind them.