Kybella Cost, Side Effects, FDA Approval and Drug Information for Reducing Double Chin | Wing (Bernadette) Cheung, PharmD | RxEconsult

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Kybella (deoxycholic acid) Side Effects, Cost, Approval and Prescribing Information for Double Chin (Submental Fat) Category: Diet & Weight Loss by - May 3, 2015 | Views: 95629 | Likes: 1 | Comment: 1  

How effective is Kybella at improving double chin (submental fat)?

In a study of 506 patients who had moderate or severe (grade 2 or 3) submental fullness, patients received either KYBELLA (up to 6 treatments) or placebo at no less than 1-month intervals. The severity of submental fullness was based on a 5-point grading scale with 0 being none and 4 being extreme. At baseline, 51% had a clinician-rated submental fat severity of moderate and 49% had a severe submental fat rating. 0.2 mL was administered into the submental fat tissue with each injection site spaced 1 cm apart (2 mg/cm2). Maximum of 100 mg (10 mL) was permitted over the entire treatment area. 

The efficacy of Kybella was based on at least 1-Grade and 2-Grade improvements in submental fullness on the clinician-reported and patient-reported rating scales 12 weeks after the final treatment. 70% of Kybella treated patients versus 18.6% of patients that received placebo had at least 1-grade reduction on both the clinician-reported and patient-reported ratings of submental fat improvement. 13.4% of treated patients versus <0.1% patients that received placebo had at least a 2 grade reduction on both clinician-reported and patient-reported ratings of submental fat improvement. In a subset of patients, more Kybella treated patients (43%) achieved at least a 10% reduction in submental fat volume compared to placebo (5%) when evaluated by MRI. 

Interesting facts about Kybella

  • Kybella is the first FDA-approved submental contouring injectable drug.
  • Sixty-eight percent of consumers are bothered by fullness under their chin from a consumer survey by the American Society for Dermatologic Surgery.
  • Kybella is administered by injection into the fat under the chin and is not approved for use in other body areas.
  • Each in-office treatment session is typically 15-20 minutes. 

What are side effects of Kybella?

Common side effects reported with Kybella include:

Injection site swelling

Bruising (hematoma)



Redness (erythema)

Hardening (induration)

Trouble swallowing (dysphagia)

Facial (marginal mandibular) nerve injury, resulting in an asymmetric smile or facial muscle weakness may occur.


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