KYBELLA® – Safety Information

Key Information About KYBELLA® (deoxycholic acid) Injection 10 mg/mLINDICATION

KYBELLA® (deoxycholic acid) is an FDA-approved injectable treatment designed to reduce moderate to severe submental fat, often referred to as a “double chin,” in adult patients.
 
The use of KYBELLA® for fat reduction in other areas of the body has not been established as safe or effective and is not recommended.

Important Safety Information

CONTRAINDICATIONS

KYBELLA® is contraindicated in the presence of infection at the injection sites.

WARNINGS AND PRECAUTIONS
Nerve Impact on the Jawline (Mandibular Branch)
In clinical trials, approximately 4% of patients experienced temporary facial muscle weakness or an asymmetrical smile due to marginal mandibular nerve injury. Recovery occurred naturally over a period ranging from 1 to 298 days (median recovery time: 44 days).
To minimize this risk, KYBELLA® should not be injected directly into or too close to the mandibular nerve.
Swallowing Difficulties (Dysphagia)
About 2% of patients in clinical trials reported difficulty swallowing following KYBELLA® treatment. This was typically associated with temporary swelling, pain, or hardening in the submental area. Symptoms resolved naturally, lasting anywhere from 1 to 81 days (median recovery time: 3 days).
Patients with a history of swallowing difficulties should discuss potential risks with their healthcare provider before considering KYBELLA®, as the treatment may worsen existing conditions.
Injection-Site Bruising and Bleeding Risks
In clinical trials, 72% of patients experienced bruising or hematoma at the injection site.
  • Patients with bleeding disorders or those taking blood-thinning medications (such as anticoagulants or antiplatelets) may have an increased risk of prolonged bruising or excessive bleeding.
  • Healthcare providers should carefully evaluate patients on such medications before proceeding with treatment.
Anatomical Considerations & Injection Safety
To prevent unintended tissue damage, KYBELLA® should be injected at least 1 to 1.5 cm away from lymph nodes, salivary glands, and muscles in the neck area.
 

Adverse Reactions

Common side effects reported in clinical trials included:

  • Swelling, redness, and bruising at the injection site
  • Pain, tenderness, or numbness in the treated area
  • Hardened or firm nodules developing temporarily under the skin

For a complete list of potential side effects, consult the full KYBELLA® Prescribing Information.

KYBELLA® - Approved Usage & Pre-Treatment Considerations

Who Can Receive KYBELLA®?
 
KYBELLA® is a prescription-only injectable designed for adults looking to reduce moderate to severe submental fullness.
 
It has not been studied for use in patients under 18 or for fat reduction in areas outside the chin and neck region.

What to Discuss With Your Provider Before Treatment

Before receiving KYBELLA®, inform your healthcare provider if you:

  • Have had, or plan to undergo, cosmetic procedures or surgeries on your face, neck, or chin
  • Have medical conditions affecting the neck area
  • Experience swallowing difficulties
  • Have a bleeding disorder
  • Are pregnant or planning to become pregnant (KYBELLA®’s effects on fetal development remain unknown)
  • Are breastfeeding (It is not known if KYBELLA® passes into breast milk; alternative feeding options may need to be discussed)
  • Are currently taking any medications, including prescription drugs, over-the-counter treatments, vitamins, or herbal supplements—especially blood-thinning medications.

Potential Risks & Side Effects

While serious side effects are rare, complications may occur in some patients:
  • Temporary jaw muscle weakness (leading to an uneven smile)
  • Swallowing difficulties
  • Significant swelling, bruising, or hardness at the injection site
These effects typically resolve over time but should be discussed with your provider.
 
For comprehensive safety details, consult your healthcare provider or visit MyKybella.com.
Scroll to Top