Kybella Label Update: What to Change in Your Protocols and Consent Forms
On September 15, 2026, the FDA approved new labeling for Kybella (deoxycholic acid) injection. The update warns of adverse reactions when Kybella is used outside the submental area (under the chin), recommends against that unapproved use, and adds injection site nodules and masses to the Warnings and Precautions section (FDA Drug Safety Communication).
If your practice offers Kybella or generic deoxycholic acid, your written protocol, consent form and aftercare instructions should reflect the new label.
What Changed in the Label
- Use outside the chin. The FDA determined that neuromuscular and other serious adverse events may occur when Kybella is given outside the submental fat region, and it recommends against this use.
- Nodules and masses. Injection site nodules (3 cm or smaller) and masses (larger than 3 cm) may not resolve over time and may require medical intervention.
- On-label use too. The FDA says nodules and masses may occur with injections under the chin as well as at other sites.
What the FDA Found
- Since Kybella's approval in 2015, the FDA identified 129 cases of adverse events when deoxycholic acid was used outside the submental region, including blurred or reduced vision with periorbital use, and muscle or nerve injury such as facial paresis and paresthesia.
- The FDA also identified 117 cases of unresolved nodules or masses. At the time of reporting, they had been present for an average of 143 days (about five months).
- Kybella and a generic deoxycholic acid injection are the only FDA-approved drugs for moderate-to-severe submental fullness. The FDA urges people not to use unapproved injection lipolysis (fat-dissolving) products.
Eight Policy Updates to Make Now
1. Treatment Protocol
Limit the indication to the labeled use: improvement in the appearance of moderate-to-severe submental fullness in adults. Review any off-label sites in your current protocol with your medical director in light of the FDA's recommendation against them.
2. Informed Consent
Add the risk of nodules and masses that may not resolve and may need medical treatment, alongside the labeled risks already in your form, such as marginal mandibular nerve injury, difficulty swallowing, bruising, tissue damage, vascular injury, alopecia, ulceration, necrosis and infection.
3. Patient Education and Aftercare
The FDA asks providers to tell patients to seek medical attention for any adverse event, including signs of marginal mandibular nerve paresis (an asymmetric smile or facial muscle weakness), difficulty swallowing, or serious injection site reactions.
4. Good Faith Exam
Confirm that an authorized prescriber documents the indication before the first treatment, and that a new assessment is done when the patient's history changes or an adverse event is reported.
5. Product Sourcing
Stock only FDA-approved Kybella or generic deoxycholic acid from authorized sources, and no unapproved fat-dissolving products. Our sister site covers the same issue for neuromodulators in Unapproved Botox: What Nurses Need to Know.
6. Dosing and Treatment Limits
Per the FDA, patients can receive up to six treatments at least one month apart, each with up to 50 subcutaneous injections. Build these limits into your protocol and charting.
7. Follow-Up and Documentation
Document the lot number, injection sites, number of injections and volume. Schedule follow-up to check for nodules or masses, and record any that persist.
8. Adverse Event Reporting, Training and Sign-Off
Add FDA MedWatch reporting to your adverse event policy. Then date the revision, have your medical director sign it, and have every treating provider review and initial the change.
Need This Updated for Your Practice?
We write and revise practice-specific policies and procedures, including treatment protocols, consent forms and aftercare instructions, for your state and treatment menu. Book a consult or start with the free Binder Blueprint.
Educational information only, not legal or clinical advice. Follow your medical director-approved protocols. Requirements vary by state; confirm with your state board.
KYBELLA® is a registered trademark of Allergan, an AbbVie company.