FDA warns against using the chin‑fat injection Kybella elsewhere on the body, citing 129 adverse event reports

FDA has added a new warning to the labeling for Kybella, the injection used to dissolve fat under the chin, after identifying 129 reports of adverse events in people who received it somewhere else on the body. The agency published the Drug Safety Communication on September 15, 2026.

Kybella is not an obesity treatment and has never been approved as one. It was cleared in 2015 for a single narrow purpose: improving the appearance of moderate to severe fullness under the chin, the area clinicians call submental fat. The label now states that use outside that area is not recommended.

Injections away from the chin were followed by vision and nerve problems

FDA reached this after searching its adverse event reporting system, now called the FDA Adverse Event Monitoring System, together with the medical literature. Since the drug was approved in 2015, the agency identified 129 cases of adverse events tied to injections given outside the approved submental region.

The serious events FDA names from that off-label use include blurred or reduced vision when the drug was injected around the eyes, and muscle or nerve injury including facial paresis and paresthesia. Paresis means partial weakness or loss of movement. Paresthesia means an abnormal sensation such as numbness, tingling or burning.

The full list the agency gives patients for injections at sites other than under the chin is blurred or reduced vision, involuntary eye contractions, muscle and nerve damage and weakness, numbness, and difficulty walking. FDA says anyone who experiences these should seek medical attention.

Lumps that had not gone away after an average of five months

The second change is separate from the off-label question, and it applies to approved use too. FDA added language to the Warnings and Precautions section covering injection site nodules, which it defines as 3 cm or smaller, and masses, which are larger than 3 cm.

The agency identified 117 cases of nodules or masses that had not resolved. At the time each case was reported, the lump had been present for a mean of 143 days, roughly five months. FDA says these may not resolve over time and may require medical intervention, and that they have followed both first and later treatments.

These occurred in patients treated as the label directs, under the chin, as well as in patients injected elsewhere. That is the part worth reading twice, because it is a new risk attached to the approved use, not only to misuse.

Fat-dissolving shots are marketed for the belly, arms and thighs after weight loss

People finishing a large weight loss, whether after bariatric surgery or on an obesity medicine, often look at what to do about loose skin and the pockets of fat that remain. Injection lipolysis, sold as a fat-dissolving shot, is offered in that market for the stomach, flanks, arms and thighs.

FDA's position is that the only approved use of deoxycholic acid injection is under the chin. Kybella and one approved generic deoxycholic acid product are the only drugs the agency has approved for that indication. The agency separately says it is aware of adverse events reported with unapproved injection lipolysis products and urges people not to use them.

For context on how the approved treatment is given: patients can receive up to six treatments, spaced at least one month apart, each consisting of up to 50 injections under the skin. Only health care providers should administer it.

Adverse event reports are voluntary, so 129 and 117 are floors rather than totals

Both counts come from a passive reporting system. Reports are submitted voluntarily, most adverse events are never reported at all, and a report on its own does not establish that the drug caused what happened. The real number of cases is unknown and is almost certainly higher than these figures.

What a system like this does well is surface patterns that were not visible in the trials that supported approval. That is what the agency describes here: a review of accumulated reports and published literature that it judged strong enough to change the label.

The communication does not recall the product, restrict it, or alter the approved indication. It adds warnings and a recommendation against a use that was never approved in the first place. Anyone considering an injectable fat-reduction procedure, or dealing with a lump after one, should take it up with a qualified clinician.