FDA Approves Additional Information in Labeling for Kybella (Deoxycholic Acid) Injection Warning of Adverse Reactions Associated with Unapproved Use
FDA Drug Safety Communication – September 15, 2026
The Food and Drug Administration has approved an additional warning in labeling for Kybella (deoxycholic acid) injection regarding adverse reactions associated with use of the drug outside of the submental fat region (fat under the chin, known as a “double chin”) and recommends against this unapproved use. The agency approved this revised labeling after its review of FDA Adverse Event Reporting System (FAERS) reports (now known as the FDA Adverse Event Monitoring System) and the medical literature. In this review, FDA determined that when Kybella is administered outside the submental fat region, neuromuscular and other serious adverse events may occur.
The agency has also approved language in the Warnings and Precautions section of labeling about the serious risks of injection site nodules and masses. These newly identified risks are being added to information on other injection site reactions already described in labeling. In this same FAERS review, the agency determined that there is an association between deoxycholic acid injection and reports of injection site nodules (3 cm or smaller) or masses (larger than 3 cm), which may not resolve over time and may require medical intervention. Nodules and masses may occur when patients receive deoxycholic acid injections as indicated in the submental fat region and when patients receive injections of the drug outside the submental fat region.
Kybella (deoxycholic acid) injection was approved in 2015 for improvement in the appearance of moderate-to-severe fullness associated with submental fat in adults. Kybella is not approved for the treatment of subcutaneous fat outside the submental region and such use is not recommended. A generic deoxycholic acid injection product is also FDA-approved.
Kybella is used in an injection lipolysis (fat-dissolving) procedure, which involves breaking down fat cells in the submental area. Only health care providers should administer Kybella. Patients can receive up to six treatments, each at least one month apart. Each treatment consists of up to a maximum of 50 subcutaneous injections.
Patients should be aware of serious adverse events that have been reported when Kybella (deoxycholic acid) is injected at sites other than under the chin, including blurred or reduced vision, involuntary eye contractions, muscle and nerve damage and weakness, numbness, and difficulty walking.
Patients should also be aware that injection site nodules and masses have been reported with use of Kybella as indicated (under the chin), as have other adverse events — such as nerve injury around the lower lips, tongue and jaw; difficulty swallowing; bruising; tissue damage; vascular injury; and injection site baldness, ulceration, necrosis (tissue death), and infection — that are already included in labeling.
If patients experience adverse events from using Kybella, they should seek medical attention.
Kybella and a generic deoxycholic acid injection product are the only drugs approved by FDA for improvement in the appearance of moderate-to-severe fullness associated with submental fat. FDA is aware of adverse events reported with the use of unapproved injection lipolysis (fat-dissolving) products and urges people not to use those products. More information is available on this FDA webpage.
Health care providers should review the prescribing information prior to injecting Kybella (deoxycholic acid) injection, including that the drug is not approved for use in areas of the body other than the submental area. Health care providers should also be aware that FDA has identified an association between Kybella and reports of injection site reactions, including nodules and masses, which may not resolve over time and may require medical intervention.
Providers should advise patients to seek medical attention if they experience any adverse events, including signs of marginal mandibular nerve paresis (e.g., asymmetric smile, facial muscle weakness), difficulty swallowing, or serious injection site reactions.
FDA searched the FDA Adverse Event Monitoring System and the medical literature to identify cases of nodules and masses following deoxycholic acid injections that resolved over time or remained unresolved and required medical intervention. FDA also searched for cases describing adverse events with deoxycholic acid injections administered in sites other than the submental fat region.
Since Kybella’s approval in 2015, FDA identified 129 cases of adverse events when deoxycholic acid injection was used in areas of the body outside of the approved site (submental region). Some serious adverse events reported with use outside the submental fat region include blurred or reduced vision with periorbital use and muscle or nerve injury including facial paresis and paresthesia.
FDA also identified 117 cases of unresolved nodules (3 cm or smaller) or masses (larger than 3 cm) associated with deoxycholic acid injections. At the time of reporting, unresolved nodules or masses had been present for a mean of 143 days (approximately 5 months). These unresolved nodules or masses have occurred after either initial or subsequent deoxycholic acid injections.
To help FDA track safety issues with medicines, we urge patients and health care providers to report adverse events involving deoxycholic acid injections or other medicines to the FDA MedWatch program.
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