Medical Editor: John P. Cunha, DO, FACOEP
What Is Kybella?
Kybella (deoxycholic acid) injection contains a cytolytic agent used to improve the appearance of moderate to severe convexity or fullness associated with submental (under the chin) fat in adults.
What Are Side Effects of Kybella?
Common side effects of Kybella include:
- injection site reactions
- tingling or burning sensation,
- skin tightness,
- nerve injury,
- mouth or throat pain,
- high blood pressure (hypertension),
- nausea, or
- difficulty swallowing.
Dosage for Kybella
A single treatment of Kybella consists of up to a maximum of 50 injections, 0.2 mL dose each (up to a total of 10 mL), spaced 1-cm apart. Up to 6 single treatments may be administered at intervals no less than 1 month apart.
What Drugs, Substances, or Supplements Interact with Kybella?
Kybella may interact with other drugs. Tell your doctor all medications and supplements you use.
Kybella During Pregnancy and Breastfeeding
During pregnancy, Kybella should be administered only if prescribed. It is unknown if Kybella passes into breast milk. Consult your doctor before breastfeeding.
Our Kybella (deoxycholic acid) injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In two double-blind, placebo-controlled clinical trials 513 subjects were treated with KYBELLA and 506 subjects were treated with placebo. The population was 19-65 years old, 85% were women, 87% Caucasian, 8% African American. At baseline the population had a mean BMI of 29 kg/m², moderate to severe submental convexity (graded as 2 or 3 on a 0 to 4 scale) and without excessive skin laxity. Subjects received up to 6 treatments at least 1 month apart and were followed for up to 6 months after the last received treatment.
The most commonly reported adverse reactions are listed below (Table 1).
Table 1: Adverse Reactions in the Pooled Trials 1 and
(N=513) n (%)
(N=506) n (%)
|Injection site reactions||492 (96%)||411 (81%)|
|edema/swelling||448 (87%)||218 (43%)|
|hematoma/bruising||368 (72%)||353 (70%)|
|pain||356 (70%)||160 (32%)|
|numbness||341 (66%)||29 (6%)|
|erythema||136 (27%)||91 (18%)|
|induration||120 (23%)||13 (3%)|
|paresthesia||70 (14%)||20 (4%)|
|nodule||68 (13%)||14 (3%)|
|pruritus||64 (12%)||30 (6%)|
|skin tightness||24 (5%)||6 (1%)|
|site warmth||22 (4%)||8 (2%)|
|nerve injuryb||20 (4 %)||1 ( < 1%)|
|Headache||41 (8%)||20 (4%)|
|Oropharyngeal pain||15 (3%)||7 (1%)|
|Hypertension||13 (3%)||7 (1%)|
|Nausea||12 (2%)||3 (1%)|
|Dysphagia||10 (2%)||1 ( < 1%)|
|a Adverse reactions that occurred in ≥
2% KYBELLA treated subjects and at greater incidence than placebo
b Marginal mandibular nerve paresis
Other adverse reactions associated with the use of KYBELLA include: injection site hemorrhage, injection site discoloration, pre-syncope/syncope, lymphadenopathy, injection site urticaria and neck pain.
Adverse reactions that lasted more than 30 days and occurred in more than 10% of subjects were injection site numbness (42%), injection site edema/swelling (20%), injection site pain (16%), and injection site induration (13%).
Read the entire FDA prescribing information for Kybella (Deoxycholic Acid Injection)