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Kybella

Last reviewed on RxList: 6/1/2020
Kybella Side Effects Center

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
    • swelling,
    • bruising,
    • pain,
    • numbness,
    • redness,
    • itching,
    • warmth,
    • hardness,
    • tingling or burning sensation,
    • skin tightness,
    • nerve injury,
  • headache,
  • 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.

Additional Information

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.

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Kybella Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • trouble swallowing;
  • weak muscles in your face;
  • a crooked smile;
  • open skin sores or drainage around treated areas; or
  • pain, burning, irritation, or skin changes where the injection was given.

Common side effects may include:

  • numbness or hardening of treated areas;
  • hair loss around treated areas; or
  • pain, swelling, redness, or bruising, of treated areas.

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.

Read the entire detailed patient monograph for Kybella (Deoxycholic Acid Injection)

Kybella Professional Information

SIDE EFFECTS

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 2a

Adverse reactionsKYBELLA®
(N=513)
n (%)
Placebo
(N=506)
n (%)
Injection site reactions492 (96%)411 (81%)
  edema/swelling448 (87%)218 (43%)
  hematoma/bruising368 (72%)353 (70%)
  pain356 (70%)160 (32%)
  numbness341 (66%)29 (6%)
  erythema136 (27%)91 (18%)
  induration120 (23%)13 (3%)
  paresthesia70 (14%)20 (4%)
  nodule68 (13%)14 (3%)
  pruritus64 (12%)30 (6%)
  skin tightness24 (5%)6 (1%)
  site warmth22 (4%)8 (2%)
  nerve injury b20 (4 %)1 (<1%)
Headache41 (8%)20 (4%)
Oropharyngeal pain15 (3%)7 (1%)
Hypertension13 (3%)7 (1%)
Nausea12 (2%)3 (1%)
Dysphagia10 (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%).

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.

Read the entire FDA prescribing information for Kybella (Deoxycholic Acid Injection)

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© Kybella Patient Information is supplied by Cerner Multum, Inc. and Kybella Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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