Kybella (deoxycholic acid): label updated with off-label adverse-reaction warning
FDA approved additional labelling for Kybella warning of adverse reactions associated with unapproved uses beyond submental fat. The safety communication notes reports of tissue injury when the product is used outside its approved injection site.
On 15 September 2026 FDA updated Kybella's labelling ↗ to add warnings about adverse reactions associated with unapproved (off-label) uses. The updated label specifies that reports of tissue injury, ulceration, and necrosis have been received when deoxycholic acid was injected at sites other than submental fat.
About Kybella
Kybella (deoxycholic acid injection 10 mg/mL) ↗ is approved solely for improvement of the appearance of moderate-to-severe convexity or fullness associated with submental fat in adults. Deoxycholic acid is a naturally occurring bile acid that disrupts the cell membrane of adipocytes. When injected, it causes localised adipocytolysis. Its use outside the chin area (e.g. jowls, flanks) is not approved and carries higher risk of injury to adjacent structures.
What prescribers and patients should know
The FDA advises that Kybella should only be administered by trained healthcare professionals exactly as labelled — into submental fat only, in the correct plane, using the approved injection pattern. The full updated prescribing information is available via DailyMed ↗. Adverse events should be reported to FDA MedWatch ↗.
FAQ
What triggers an FDA label update?
Label updates can be triggered by post-market safety data from the FAERS database ↗, new clinical trial results, manufacturer-initiated reviews, or FDA-directed safety communications. The FDA can require label changes under 21 CFR 314.81 or negotiate them with manufacturers. See the FDA Safety-related Labeling Changes (SrLC) database ↗ for a full history.
Where is the updated label published?
Updated labels are published on DailyMed (NLM) ↗ and Drugs@FDA ↗. DailyMed is typically the most current source, as manufacturers submit label updates there directly.