Side Effects of Kybella (deoxycholic acid)

Kybella (deoxycholic acid) is an injectable medication used for reducing fat in the submental region of the face (below the chin). 

Kybella destroys the cell membrane of fat cells causing fat cells to die. Reducing the number of fat cells reduces fat under the chin. It should not be injected in other tissues because it also destroys other cells. 

In clinical studies 43% of people who received Kybella achieved a 10% reduction in submental fat volume after six or fewer treatments. Only 5% of people who received placebo achieved a 10% reduction in submental fat.

Common side effects of Kybella include

• injection site reactions (swelling, fluid retention, pain, numbness, bruising, skin redness),
• headache,
• difficulty swallowing,
• high blood pressure, and
• nausea.

Serious side effects of Kybella include

• damage to surrounding tissues if injected outside the submental area,
• skin ulceration if injected into the dermis, and
• asymmetric smile and facial muscle weakness if injected into or in close proximity to the facial nerve.

There are no known drug interactions of Kybella. Prior surgeries or aesthetic treatment of the submental area may impact response to Kybella. 

There are no adequate studies of Kybella in pregnant women. Kybella has not been evaluated in nursing mothers. Consult your doctor before breastfeeding.

Side effects of deoxycholic acid include:

• injection site swelling,
• edema,
• pain,
• numbness,
• hematoma (collection of blood in tissues),
• skin redness (erythema),
• headache,
• difficulty swallowing (dysphagia)
• high blood pressure, and
• nausea.

Injecting deoxycholic acid outside the submental area can cause damage to surrounding tissues. Injecting deoxycholic acid into the dermis may cause skin ulceration. Injecting deoxycholic acid into or in close proximity to the facial nerve may cause asymmetric smile and facial muscle weakness.

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 injection 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 2^a

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%).

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Kybella. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Kybella exposure.

• Administration site conditions: injection site ulceration, necrosis, alopecia, and scarring.
• Immune System Disorders: Hypersensitivity reactions including rash, urticaria, and itching.
• Nervous System Disorders: Oral hypoaesthesia and oral paraesthesia.
• Procedural Complications: Vascular injury due to inadvertent intravascular injection.

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