Status checked on October 6, 2026 dailymed.nlm.nih.gov
Kybella (deoxycholic acid) explained from the FDA label: approved only for under-chin fat, treatment sessions, trial results, side-effect frequencies, nerve and swallowing warnings, pregnancy, cost and the FDA warning on unapproved fat-dissolving injections.
Fact-checked against FDA labels and official sources; not yet reviewed by a licensed clinician. This page is education, not medical advice. Talk to your doctor before starting, stopping or changing any treatment.
Key facts
- Type
- Cosmetic (not weight loss)
- Approach
- Injectable
- Sedation
- Ice, cold packs or local anesthetic for comfort (label)
- Time
- Up to 6 treatments, no less than 1 month apart (label)
- Downtime
- 1-3 days
- Permanence
- Permanent
- Body areas
- Face, Neck and jawline
- Device status
- KYBELLA (deoxycholic acid) injection, NDA approval · Other
- Performed by
- Dermatology, Plastic surgery
Key takeaways
- Kybella is FDA approved only for moderate to severe fat under the chin in adults; it is not approved anywhere else on the body.[1]
- In two trials, 70.0% and 66.5% of treated people improved by at least one grade, against 18.6% and 22.2% on placebo.[1]
- Swelling (87%), bruising (72%), pain (70%) and numbness (66%) were common; 4% had a temporary nerve injury affecting the smile.[1]
- The FDA warns that unapproved fat-dissolving injections such as Lipodissolve can cause permanent scars, infections and deformities.[3]
In short: Kybella is a prescription injection of deoxycholic acid that destroys fat cells. The FDA approved it in April 2015 for one use only: improving the appearance of moderate to severe fullness from fat under the chin (submental fat, a “double chin”) in adults. In its two main trials, about two-thirds of treated people improved by at least one grade, against about one in five on placebo. Swelling, bruising, pain and numbness are very common, and the label warns about a nerve injury that can cause an uneven smile and about trouble swallowing. It is not approved for fat anywhere else on the body, and it is not weight loss.

This page summarizes the current FDA label (revised September 2026): who it is for, how treatment sessions work, what the trials showed with numbers, side effects with their label frequencies, warnings, who should avoid it, pregnancy and breastfeeding, cost, and the FDA’s warning about unapproved “fat-dissolving” injections sold online. It is education only; InstaTuck does not sell or arrange treatments. Research it, speak with a licensed doctor and get examined before deciding.
Kybella at a glance
- April 29, 2015FDA approval (NDA 206333), for submental fat in adults onlyDrugs@FDA
- 70.0% vs 18.6%improved at least one grade, Kybella vs placebo (Trial 1)Kybella label
- Up to 6treatments, no less than 1 month apartKybella label
- 4%had marginal mandibular nerve injury (uneven smile) in trials; all resolvedKybella label
Checked on October 6, 2026
What Kybella is and how it works
Kybella (deoxycholic acid) injection is marketed by AbbVie. Deoxycholic acid is also a bile acid the body makes naturally; the label notes that most of it circulates between the liver and the gut, and that a Kybella dose is about 3% of the body’s total bile acid pool. The label calls Kybella a cytolytic drug: injected into fat under the chin, it physically destroys the fat cells’ membranes. The American Society of Plastic Surgeons (ASPS) calls this “injection lipolysis” and says fat reduction is typically visible by about eight weeks after a treatment. Because the destroyed cells are cleared by the body, ASPS says results should be long lasting unless a person gains weight.
Who it is approved for
The label indication is “improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults”. Its limitation of use is explicit: Kybella is not approved for fat outside the submental region, and such use is not recommended. Safety and effectiveness have not been established in children and teens, and the trials did not include enough people aged 65 and over to know whether they respond differently. Before treatment, the label asks the provider to screen for other causes of fullness under the chin, such as an enlarged thyroid or swollen lymph nodes, and to consider whether loose skin or prominent neck bands would make the result look worse. ASPS adds that people with loose skin or poor tone may not be suitable.
How treatment works
Kybella must be given by a health care provider. In general terms, the label describes many small injections into the fat under the chin in a marked grid about 1 cm apart, with a maximum amount per session, while avoiding the area of the marginal mandibular nerve along the jaw, the salivary glands, lymph nodes and muscles. Up to six treatments may be given, no less than one month apart. Ice, cold packs or local anesthetic may be used for comfort. In the trials, 59% of people received all six treatments. ASPS says most patients have at least two treatments spaced four to six weeks apart, roughly how long the swelling lasts. The number of sessions depends on the amount of fat and the response, which your provider assesses.
A Kybella course, step by step
- AssessmentExam of the chin and neck to rule out other causes and judge skin laxity; review of medicines and any trouble swallowing.
- SessionArea marked with a 1 cm grid; ice or local anesthetic; small injections into the fat.
- First days to weeksSwelling is expected and can make the area look fuller at first; bruising, pain, numbness and firmness are common.
- Next sessionNo sooner than one month later; ASPS says most people need at least two.
- ResultsASPS: fat reduction usually visible by 6 to 8 weeks after a treatment; up to six treatments in total.
What the trials showed
Two identical randomized, double-blind, placebo-controlled trials enrolled 1,022 healthy adults aged 19 to 65 with a BMI up to 40 and moderate or severe fat under the chin (514 received Kybella, 508 placebo), up to six treatments at least a month apart. Their average age was 49 and average BMI 29; 85% were women and 87% white. Success was judged 12 weeks after the last treatment, when both the clinician and the patient rated the chin as improved. At least a 1-grade improvement was seen in 70.0% and 66.5% of Kybella patients, against 18.6% and 22.2% on placebo. A 2-grade improvement, a larger change, was much less common: 13.4% and 18.6%, against under 0.1% and 3.0%. In an MRI subset, 43% of Kybella patients had at least a 10% reduction in submental fat volume, versus 5% on placebo.
| Item | Kybella | Placebo |
|---|---|---|
| Swelling | 87% | 43% |
| Bruising or hematoma | 72% | 70% |
| Pain | 70% | 32% |
| Numbness | 66% | 6% |
| Redness | 27% | 18% |
| Hardening (induration) | 23% | 3% |
| Tingling | 14% | 4% |
| Nodule | 13% | 3% |
"Composite
Source: KYBELLA prescribing information, Table 1 (pooled Trials 1 and 2; 513 Kybella, 506 placebo) (checked on October 6, 2026)
Warnings and serious risks
- Marginal mandibular nerve injury: an asymmetric smile or facial muscle weakness occurred in the trials (4% vs under 1% on placebo); all cases resolved without treatment, in 1 to 298 days (median 44).
- Dysphagia (trouble swallowing): occurred with swelling, pain and hardening; cases resolved in 1 to 81 days (median 3). Avoid Kybella with current or past swallowing problems.
- Bleeding and bruising: use with caution if you have a bleeding disorder or take antiplatelet or anticoagulant medicines.
- Hair loss at the site: cases have been reported and may persist.
- Ulceration, tissue death, nodules, masses and infection: very superficial injection can cause skin ulcers and necrosis; some nodules or masses do not resolve, and some infections needed IV antibiotics and drainage.
- Injury from injecting near vulnerable structures such as salivary glands, lymph nodes, muscles, arteries or veins.
- Unapproved use elsewhere: serious reactions have been reported, including blurred or reduced vision with use around the eyes, muscle or nerve injury, and nodules or masses.
Reports after approval also include hypersensitivity reactions (rash, hives, itching), numbness or tingling in the mouth, and vascular injury from accidental injection into a blood vessel. The only contraindication on the label is an infection in the injection area.
Interactions, pregnancy and breastfeeding
Laboratory studies in the label found that deoxycholic acid does not inhibit or induce the main liver enzymes (CYP) or common drug transporters at clinical concentrations; the practical interaction issue is bleeding risk with blood thinners and antiplatelet drugs. There are no adequate studies in pregnant women; animal studies at up to five times the maximum human dose showed no fetal harm. There is no information on whether it passes into breast milk. ASPS says people who are pregnant or breastfeeding should not have non-surgical fat-reduction treatments. Tell your provider if you are pregnant, planning pregnancy or nursing.
Unapproved “fat-dissolving” injections: the FDA warning
The FDA warns that products sold as fat-dissolving injections under names such as Lipodissolve, Aqualyx, Lipo Lab and Kabelline, which typically contain phosphatidylcholine and sodium deoxycholate, are not FDA approved and pose a significant safety risk. It has received reports of permanent scars, serious infections, skin deformities, cysts and deep, painful knots. The FDA says Kybella is the only FDA-approved fat-dissolving injection, only for fat under the chin in adults and only given by a health care professional, and advises never to inject yourself with products bought online. We do not link to sellers of any injectable. If you have had one of these injections and have a problem, see a doctor and report it to FDA MedWatch.
Cost
ASPS does not publish a separate Kybella price. Its 2023 survey reported an average fee of $1,157 per procedure for non-surgical fat reduction, a category that includes Kybella along with CoolSculpting and other devices. Since many people need two or more Kybella sessions, ask for a written price per session and for the full course. As a cosmetic treatment, it is not covered by insurance. Our costs hub explains how to compare quotes.
Alternatives for a fuller chin
Options depend on whether the fullness is fat, loose skin or both. Cryolipolysis has an FDA clearance for the submental area at a BMI up to 46.2. Chin (submental) liposuction is surgery; ASPS counted 18,842 in 2025 and reported a 2024 surgeon’s fee range of $3,000 to $5,500 (see liposuction). Loose skin of the neck may be addressed with skin tightening or a neck lift; our loose skin guide explains why skin may not shrink back after weight loss. Our double chin guide covers all of these, and Ozempic face explains facial changes after fast weight loss.
Choosing a provider
Choose a licensed physician experienced with Kybella, such as a board-certified dermatologist or plastic surgeon, or a provider they directly supervise. Ask how many treatments they have given, how they avoid the nerve along the jaw, how many sessions they expect for you, and how they handle swelling, nodules or nerve injury. Check that the vial carries the product’s hologram, which the label says confirms the genuine product. Our plastic surgeon guide explains how to check credentials, and the body contouring hub compares all the options, and the shape and look better hub puts contouring next to weight loss and training.
Contouring is not weight loss
This treatment changes the shape of a specific area. It does not lead to meaningful overall weight loss or improve metabolic health. Every proven approach to losing weight
Who explores it
Label: adults with moderate to severe convexity or fullness associated with submental fat. Not approved for fat outside the submental region; not recommended for children and teens.
How it works
Deoxycholic acid is a cytolytic drug: injected into submental fat it physically destroys fat-cell membranes (label); the body clears the cells over weeks.
Typical results
Trials 1 and 2: at least 1-grade improvement in 70.0% and 66.5% vs 18.6% and 22.2% on placebo; 2-grade improvement in 13.4% and 18.6% vs under 0.1% and 3.0%; 43% vs 5% had at least a 10% MRI fat-volume reduction.
Ranges from published studies; individual results vary.
Recovery
Swelling, bruising, pain, numbness and firmness are common; numbness lasted over 30 days in 42%. Up to 6 treatments at least 1 month apart; ASPS: results visible by 6 to 8 weeks after a treatment.
Risks
- Injection-site swelling 87%, bruising 72%, pain 70%, numbness 66%, redness 27%, hardening 23% (label)
- Marginal mandibular nerve injury (uneven smile) 4%; all resolved in trials (median 44 days)
- Trouble swallowing 2%; avoid with current or past dysphagia
- Skin ulceration, necrosis, nodules, masses, infection, hair loss at the site
- Serious reactions with unapproved use outside the chin, including vision problems near the eyes
FDA authorization
| Device | Pathway | Number | Date |
|---|---|---|---|
| KYBELLA (deoxycholic acid) injection, NDA approval | Other | NDA 206333 | April 29, 2015 |
Clearance (510(k)) means the FDA found a device similar to one already on the market; it is not the same as approval.
Cost and insurance
| Price | Amount | Basis | Checked on |
|---|---|---|---|
| Typical total (national data) | 1,157 USD | average fee per non-surgical fat reduction procedure (category includes Kybella), 2023 ASPS | October 6, 2026 |
Prices change often and depend on pharmacy, plan and location. Insurance can change what you pay. Every price shows the date we checked it.
Cosmetic; not covered by insurance. Many people need two or more sessions; ask for the price per session and for the full course.
Insurance information checked on October 6, 2026.
Advantages and limitations
Advantages
- FDA-approved drug with two large placebo-controlled trials
- No incisions; done in the office
- Destroyed fat cells do not come back unless weight is gained (ASPS)
Limitations
- Approved only for fat under the chin
- Swelling, bruising, pain and numbness in most people; several sessions often needed
- Risk of temporary nerve injury and trouble swallowing
- Does not tighten loose skin
Choosing a provider
Check board certification, where the procedure is done (accredited facility), how many of these procedures the provider performs, and what follow-up care is included. Find a Board-Certified Plastic Surgeon for Body Contouring
Alternatives
CosmeticFDA cleared deviceNon-invasiveCoolSculpting and Cryolipolysis (Fat Freezing): results, risks and costDevice, non-invasive · None
CosmeticSurgicalLiposuction: what it removes, what it does notSurgical · 1-2 weeks
CosmeticFDA cleared deviceNon-invasiveSkin Tightening: radiofrequency, ultrasound and surgery comparedDevice, non-invasive · NoneRelated procedures
Research mentioning it
Related guides
Double Chin: exercises, injections and contouring comparedDouble chin explained: causes, whether weight loss or exercises help, Kybella trial results and side effects,…
Body Contouring: fat reduction and shaping, surgical and non-surgicalBody contouring explained: non-invasive fat reduction vs surgery, what CoolSculpting, Kybella and liposuction can and cannot…
Find a Board-Certified Plastic Surgeon for Body ContouringHow to find a board-certified plastic surgeon for body contouring after weight loss: ABPS checks, facility…Questions to ask a professional
- Is my chin fullness mainly fat, loose skin, or another cause such as the thyroid?
- How many sessions do you expect for me, and what is the price for the full course?
- How do you avoid the nerve along the jaw, and what happens if it is affected?
- Do any of my medicines raise my bleeding or bruising risk?
- Would cryolipolysis, chin liposuction or skin tightening suit me better?
Frequently asked questions
What is Kybella approved for?
Only for improving the appearance of moderate to severe fullness from fat under the chin in adults. The label says it is not approved for fat elsewhere and such use is not recommended.
How many Kybella treatments are needed?
The label allows up to six treatments, at least one month apart. In the trials 59% received all six; ASPS says most people have at least two.
How well does Kybella work?
In the two main trials, about two-thirds of treated people improved by at least one grade on a five-point scale, against about one in five on placebo. A larger 2-grade improvement was seen in 13% to 19%.
What are the side effects of Kybella?
Most people had swelling, bruising, pain and numbness at the injection site. The label also warns about temporary nerve injury causing an uneven smile (4%), trouble swallowing (2%), skin ulcers, nodules, infection and hair loss at the site.
How long does Kybella swelling last?
ASPS says swelling typically lasts about four to six weeks, which is why sessions are spaced that far apart. In the trials numbness lasted over 30 days in 42% and swelling over 30 days in 20%.
Are Kybella results permanent?
The treated fat cells are destroyed. ASPS says results should be long lasting unless a person gains weight.
Can Kybella be used on the belly or arms?
Not under its approval. The label reports serious reactions with unapproved use outside the chin, including nodules, masses and nerve injury. The FDA also warns against unapproved fat-dissolving injections.
Can I have Kybella while pregnant or breastfeeding?
There are no adequate studies in pregnancy and no data on breast milk. ASPS says people who are pregnant or breastfeeding should not have non-surgical fat reduction. Talk with your doctor.
References
- KYBELLA (deoxycholic acid) injection: prescribing information. Kythera Biopharmaceuticals (AbbVie), via DailyMed, 2026. (accessed October 6, 2026) Drug label
- Drugs@FDA: Kybella, NDA 206333. U.S. Food and Drug Administration, 2015. (accessed October 7, 2026) Government page
- Using Fat-Dissolving Injections That Are Not FDA Approved Can Be Harmful. U.S. Food and Drug Administration, 2023. (accessed October 6, 2026) Government page
- Injection lipolysis. American Society of Plastic Surgeons. (accessed October 6, 2026) Society statement
- Nonsurgical Fat Reduction. American Society of Plastic Surgeons. (accessed October 6, 2026) Society statement
- 510(k) K233732: CoolSculpting Elite system (indications for use). U.S. Food and Drug Administration, 2024. (accessed October 7, 2026) Government page
- 2025 ASPS Procedural Statistics Release. American Society of Plastic Surgeons, 2026. (accessed October 7, 2026) Society statement
- 2024 ASPS Procedural Statistics Release (archived copy captured 2026-01-02). American Society of Plastic Surgeons, 2025. (accessed October 7, 2026) Society statement
- 2023 ASPS Procedural Statistics Release (archived copy). American Society of Plastic Surgeons, 2024. (accessed October 7, 2026) Society statement
Facts checked on October 6, 2026
Educational information, not medical advice. Talk with a qualified healthcare professional about your own situation. In an emergency call 911.


