FDA-filed SPL labeling · retrieved through openFDA

Deoxycholic Acid Injection

Deoxycholic acid injection (Kybella) is a prescription treatment that reduces moderate to severe submental fat — the fullness under the chin commonly called a 'double chin' — in adults.

Brand name Kybella
Drug class ⓘ Cytolytic Agent
Rx Form 1 Route Subcutaneous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveOct 30, 2024
AvailabilityRx
Earliest approval/marketing year ⓘ2015
FDA-listed product records ⓘ3
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 29, 2026
⭐ Deoxycholic Acid Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Kybella is an injectable treatment given in a medical setting to reduce moderate to severe fat under the chin in adults — it is not for home use or for fat in other areas of the body. Most people experience significant swelling, bruising, and soreness after each session, and up to 6 monthly sessions may be needed. Because of the risk of nerve injury and other serious side effects, it must be administered by a trained healthcare professional using precise injection technique.

📖 Deoxycholic Acid Injection: Patient Information Guide

A plain-language walkthrough of Deoxycholic Acid Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Deoxycholic acid injection is used as a cosmetic medical treatment for submental fat in adults.

  • Kybella (deoxycholic acid) injection is indicated to improve the appearance of moderate to severe convexity or fullness associated with submental fat — the fat pad beneath the chin — in adults.
  • Kybella is not approved or recommended for reducing fat in any part of the body other than the submental region. Its safety and effectiveness outside that area have not been established.
⚙️How it works▾

Kybella is a cytolytic (cell-destroying) agent. When injected into the fat tissue under the chin, it physically disrupts and breaks down fat cell membranes, causing the cells to rupture — a process called lysis. The body then clears the cellular debris over time. Deoxycholic acid is a naturally occurring bile acid; after injection, the drug joins the body's own bile acid pool and is eliminated within about 24 hours, with no buildup expected between monthly sessions.

💊How it's taken▾

Kybella is administered exclusively by a healthcare professional in a clinical setting — it is never self-injected at home. Each session involves multiple small injections placed about 1 cm apart across the planned treatment area under the chin.

  • Up to 6 treatment sessions may be given in total.
  • Sessions must be spaced at least 1 month apart.
  • The number of injections per session is tailored to the individual's fat distribution and goals.
  • Ice or local anesthetic (such as lidocaine) may be used for comfort — follow your provider's guidance.
🤒Side effects — in detail▾

The vast majority of people treated with Kybella experience injection site reactions — these are expected and are the most commonly reported effects.

  • Swelling or edema at the injection site (very common)
  • Bruising or hematoma under the chin (very common)
  • Pain at the injection sites
  • Numbness in the treatment area
  • Redness (erythema)
  • Firmness or hardening of tissue (induration)
  • Tingling or abnormal sensation (paresthesia)
  • Small nodules under the skin
  • Itching (pruritus)
  • Skin tightness or warmth

More serious reactions — including nerve injury causing facial weakness, difficulty swallowing, skin ulceration, infection, or hair loss at the injection site — have been reported and should be reported to your provider promptly.

⚠️Warnings & precautions▾
  • Nerve injury: Incorrect injection placement can injure the marginal mandibular nerve, causing a lopsided smile or facial muscle weakness. This resolved on its own in clinical trial cases, but recovery ranged from 1 day to nearly 10 months.
  • Difficulty swallowing (dysphagia): Swelling from the treatment can make swallowing temporarily difficult. People who already have trouble swallowing should avoid Kybella, as it may worsen their condition.
  • Bruising and bleeding: Heavy bruising is very common (72% of trial participants). People on blood thinners or antiplatelet drugs face an even higher risk and should discuss this with their provider.
  • Skin ulceration and tissue death (necrosis): Injections that are too shallow can cause the skin to break down. If this occurs, further treatment in that area must wait until complete healing.
  • Infection: Infections including abscess (pocket of pus) and cellulitis (skin infection) have been reported, some requiring IV antibiotics or surgical drainage.
  • Hair loss (alopecia) at the injection site: This has been reported and may persist. Further treatment should be paused until it resolves.
  • Risk from nearby structures: Injections too close to salivary glands, lymph nodes, muscles, or blood vessels can cause serious tissue or vascular injury.
🔀What it interacts with▾

The label identifies limited drug interactions based on lab studies, but there are important considerations around medications that affect bleeding.

  • Anticoagulants (blood thinners such as warfarin): May increase risk of excessive bruising and bleeding at injection sites — discuss with your provider before treatment.
  • Antiplatelet drugs (such as aspirin or clopidogrel): Same increased bruising risk — tell your provider about all medications you take.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Active infection at or near injection site: Kybella is contraindicated — treatment cannot be given until the infection clears.
  • History of difficulty swallowing (dysphagia): Kybella may worsen this condition and should be avoided.
  • Blood thinners or antiplatelet medications: Use with caution — greatly increased risk of bruising and bleeding.
  • Prior surgery or cosmetic procedures in the chin/neck area: Altered anatomy or scar tissue may affect safety and results.
  • Excessive skin looseness or prominent neck muscle bands (platysmal bands): Reducing submental fat may produce an undesirable aesthetic outcome — discuss with your provider.
  • Pregnancy: There are no adequate studies in pregnant women. Animal data showed potential fetal effects at some dose levels. Discuss risks with your provider before treatment.
  • Breastfeeding: It is not known whether Kybella passes into human breast milk. Weigh the benefits and risks with your provider.
  • Under 18 years old: Safety and effectiveness have not been established; Kybella is not intended for use in children or adolescents.
  • Older adults (65+): Limited data are available in this age group. Careful treatment planning is recommended, taking into account overall health, liver and kidney function, and other medications.
📡Pharmacodynamics — effects in the body▾

At therapeutic doses, Kybella does not prolong the QTc interval — meaning it does not cause the kind of electrical disturbance in the heart rhythm that some drugs can. Its primary measurable effect is local: it physically destroys the membranes of fat cells at the injection site, leading to cell lysis (rupture) and eventual clearance of submental fat over time.

🔬Pharmacokinetics — how your body processes it▾

After a subcutaneous injection of Kybella, deoxycholic acid is rapidly absorbed — blood levels peak in about 18 minutes. The drug is about 98% bound to proteins in the bloodstream. It is not significantly broken down by the body's metabolism; instead, it joins the naturally occurring bile acid pool and is excreted through the digestive system, similar to the body's own deoxycholic acid. Blood levels return to their normal baseline range within 24 hours after a treatment session, and no accumulation is expected with monthly treatments.

📦How to store it▾

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C to 30°C (59°F to 86°F) .

📄 Written from Deoxycholic Acid Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Deoxycholic Acid Injection — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly does Kybella do, and will the results be permanent? ▾
Kybella works by physically destroying the fat cells under your chin. Once those cells are gone, they don't come back — so the results can be long-lasting as long as your weight stays relatively stable. Keep in mind it may take several weeks after each session to see the full effect, as your body needs time to clear the treated cells.
How many treatment sessions will I need, and how far apart are they? ▾
You can receive up to 6 Kybella sessions total, and they need to be spaced at least a month apart. How many you actually need depends on how much submental fat you have and your personal goals — your provider will tailor the treatment plan to you. Many people see results after 2 to 4 sessions.
What should I expect after each Kybella treatment — how bad is the downtime? ▾
Expect significant swelling, bruising, pain, and numbness under your chin after each session — these are very common and part of how the treatment works. The swelling in particular can be noticeable for days to weeks. Most reactions resolve on their own, but you may want to plan treatments around events where you need to look your best.
Is there any risk to my face or smile from these injections? ▾
There is a small but real risk of temporary injury to a nearby nerve — the marginal mandibular nerve — which can cause a lopsided smile or weakness in the muscles around your lower lip. In clinical trials, all cases of this nerve injury resolved on their own, though it took anywhere from a couple of days to several months. This is exactly why Kybella must be given by a trained provider who knows the anatomy of that area well.
I take a daily aspirin — is it safe to get Kybella? ▾
You can mention this to your provider before your appointment. Aspirin and similar blood-thinning medications increase the risk of bruising and bleeding at the injection sites, and bruising is already very common with Kybella. Your provider may advise you on whether to adjust anything before treatment. Don't stop a medication on your own without checking with your doctor first.
Can I get Kybella if I'm pregnant or breastfeeding? ▾
There are no good human studies on Kybella use during pregnancy, so it's generally something to put on hold if you're pregnant or planning to become pregnant. If you're breastfeeding, it's also unknown whether the drug passes into breast milk. Have an honest conversation with your provider and OB about the timing — this is typically an elective cosmetic treatment that can wait until after pregnancy and breastfeeding.
Is Deoxycholic Acid Injection available over the counter? ▾
Deoxycholic Acid Injection is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Deoxycholic Acid Injection first available? ▾
Deoxycholic Acid Injection has been available in the United States since at least 2015, based on FDA approval history (Drugs@FDA) and product marketing records.

💬 Answers drafted from Deoxycholic Acid Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Deoxycholic Acid Injection comes

Deoxycholic Acid Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

Under the skin
Brands Kybella
How this form is used
What it may be used for
  • Kybella is used to improve the appearance of moderate to severe fullness or convexity caused by submental fat (under-chin fat) in adults
  • Kybella is not approved for treating fat outside the submental area
Important instructions
  • Kybella is administered by a healthcare professional as multiple small subcutaneous injections spaced about 1 cm apart in the under-chin area
  • Kybella treatment sessions are given at least 1 month apart, with up to 6 sessions total
  • Kybella should be visually inspected before use — discard if the solution is discolored or contains particles
  • Ice packs or local anesthetic may be used before or during Kybella administration to improve comfort
Available strengths 1 strength
3 FDA-listed product records ⓘ

📊 Deoxycholic Acid Injection across the U.S. market

How Deoxycholic Acid Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
1
Manufacturers
1
Brand names
3
FDA-listed product records ⓘ
2015
First marketed ⓘ

🔍 Compare Deoxycholic Acid Injection products

A representative set of FDA-listed product records for Deoxycholic Acid Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Injection
20 mg/2 mL Subcutaneous Kythera Biopharmaceuticals Inc. × 3 listings NDA View NDC →

Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Deoxycholic Acid Injection NDCs →

🏷️ Sold under these brand names

Kybella

🏭 Manufacturers & labelers

Kythera Biopharmaceuticals Inc. 3

RxNorm drug class

Deoxycholic Acid Injection belongs to the Cytolytic Agent class.

Pharmacologic class Cytolytic Agent
Drug family (ATC) Other dermatologicals

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Oct 30, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Deoxycholic Acid Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Deoxycholic Acid Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
3
Distinct labelers/manufacturers represented
1
Linked representative label ⓘ
Kythera Biopharmaceuticals Inc.
Linked label effective
Oct 30, 2024
Composite sections available
19
Linked SPL Set ID
fe431ed4-ea6f-4e99-b4bc-ec25ae7b8553
Linked SPL Document ID
c67c4873-6322-42dc-8a2b-da3a7012a435
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Kythera Biopharmaceuticals Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.