FDA flags serious risks when Kybella is injected outside the chin

Clinical takeaway: Use deoxycholic acid only in the submental area and counsel patients about neurologic, swallowing, and serious injection-site complications. Evaluate persistent nodules or masses even after approved treatment, because they may not resolve and can require medical intervention.

FDA has updated Kybella (deoxycholic acid) labeling after identifying serious adverse events when the drug was injected outside its approved location. The agency now specifically recommends against use beyond the submental region.

Kybella and an approved generic are indicated only to improve moderate-to-severe fullness from submental fat in adults. Since Kybella’s 2015 approval, FDA identified 129 cases involving injections elsewhere on the body. Reported complications included blurred or reduced vision after injections around the eyes, involuntary eye contractions, facial weakness, paresthesia, and other muscle or nerve injuries. Some patients experienced numbness, weakness, or difficulty walking.

The revised Warnings and Precautions section also highlights injection-site nodules measuring 3 cm or smaller and larger masses. These reactions can occur after approved submental treatment as well as injections elsewhere and may develop after the first or a subsequent treatment.

FDA identified 117 cases in which nodules or masses remained unresolved when reported. They had persisted for an average of approximately five months, and some required medical intervention.

Before treatment, clinicians should confirm that the intended injection site is limited to submental fat and review the updated prescribing information. Patients should be advised to seek care for an asymmetric smile, facial weakness, difficulty swallowing, vision changes, neurologic symptoms, or severe or persistent injection-site reactions.

When evaluating complications after an injection lipolysis procedure, clinicians should ask which product was used and where it was administered. FDA also cautions against unapproved “fat-dissolving” products. Kybella and its generic are the only FDA-approved deoxycholic acid injections for submental fullness. Suspected adverse events should be reported through MedWatch.

Source: FDA. (2026 Sep 15) FDA Drug Safety Communication. FDA approves additional information in labeling for Kybella (deoxycholic acid) injection warning of adverse reactions associated with unapproved use