IncobotulinumtoxinA Injection
IncobotulinumtoxinA (Xeomin) is a botulinum toxin injection used to treat chronic excessive drooling, upper limb spasticity, cervical dystonia, blepharospasm, and to temporarily improve the appearance of certain facial lines.
🧬 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 2 clinical label sets 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 →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Xeomin carries a serious "black box" warning about the toxin spreading beyond the injection site. In some cases, the effects of the botulinum toxin can travel to other parts of the body and cause symptoms similar to botulism — including general muscle weakness, drooping eyelids, double vision, difficulty speaking, trouble swallowing, loss of bladder control, and breathing problems. These symptoms can appear anywhere from a few hours to several weeks after the injection. Swallowing and breathing difficulties can be life-threatening, and deaths have been reported. The risk is considered greatest in children being treated for spasticity, but it can happen in adults too — particularly those with underlying muscle or nerve conditions. If you or someone you care for develops any of these symptoms after a Xeomin injection, seek emergency medical care immediately.
📖 IncobotulinumtoxinA Injection: Patient Information Guide
A plain-language walkthrough of IncobotulinumtoxinA 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▾
IncobotulinumtoxinA (Xeomin) is a botulinum toxin approved for both medical and cosmetic uses. Below are all FDA-supported indications:
- Xeomin treats chronic sialorrhea (excessive drooling) in patients 2 years of age and older
- Xeomin treats upper limb spasticity (stiff or tight arm muscles) in adults
- Xeomin treats upper limb spasticity in pediatric patients ages 2–17, excluding spasticity caused by cerebral palsy
- Xeomin treats cervical dystonia (involuntary neck muscle contractions) in adults
- Xeomin treats blepharospasm (involuntary eyelid muscle spasms) in adults
- Xeomin temporarily improves the appearance of moderate to severe glabellar lines (frown lines between the eyebrows) in adults
- Xeomin temporarily improves the appearance of moderate to severe horizontal forehead lines in adults
- Xeomin temporarily improves the appearance of moderate to severe lateral canthal lines (crow's feet) in adults
⚙️How it works▾
Xeomin works by blocking the release of acetylcholine — the chemical messenger that tells muscles to contract or glands to secrete. It does this by binding to nerve endings, entering them, and snipping a key protein (called SNAP-25) that the nerve needs to release acetylcholine. Without that signal, the targeted muscle or salivary gland becomes temporarily less active. The body eventually forms new nerve endings, which restores function over time — that's why repeat treatments are needed.
💊How it's taken▾
Xeomin is always given by injection in a clinical setting — never at home. The injection goes directly into the affected muscles, or into the salivary glands for drooling. How often treatment is repeated depends on the condition being treated: no sooner than every 12 weeks for spasticity, every 16 weeks for chronic drooling, and no more than every 3 months for facial lines. The dose and number of injection sites are individualized based on the severity of your condition and your response to previous treatments.
- For drooling: injected into the parotid and submandibular salivary glands
- For spasticity, cervical dystonia, or blepharospasm: injected into the specific affected muscles
- For facial lines: injected into targeted facial muscles
🤒Side effects — in detail▾
Side effects vary depending on where Xeomin is injected and what it's treating. Common ones include:
- Dry mouth
- Eyelid drooping (ptosis) — especially with treatments near the eyes
- Difficulty swallowing (dysphagia) — particularly with cervical dystonia treatment
- Neck pain or muscle weakness
- Injection site pain or bruising
- Headache
- Nasopharyngitis (cold-like symptoms)
- Dry eye
More seriously, the toxin can occasionally spread beyond the injection site and cause body-wide muscle weakness, breathing difficulty, or trouble swallowing — sometimes hours to weeks after the shot. These symptoms require immediate emergency care.
⚠️Warnings & precautions▾
The biggest risk with Xeomin is distant spread of the toxin effect. The toxin can travel beyond the injection site and cause symptoms like generalized weakness, drooping eyelids, double vision, trouble speaking or swallowing, and breathing difficulties — in some cases life-threatening. This has been fatal in rare instances. The risk is highest in children treated for spasticity, but adults with pre-existing nerve or muscle conditions are also at elevated risk. Seek emergency care immediately if any of these symptoms appear.
- Breathing and swallowing difficulties: Patients with pre-existing swallowing, breathing, or neuromuscular disorders (such as myasthenia gravis, ALS, or Lambert-Eaton syndrome) face a higher risk of severe complications
- Eye safety: When used near the eyes for blepharospasm, reduced blinking can lead to corneal exposure and ulceration — protective measures may be needed
- Ptosis risk with facial line treatment: Do not exceed recommended doses; injections must be placed carefully to avoid drooping of the eyelid or brow
- Allergic reactions: Rare but serious reactions — including anaphylaxis — have been reported; stop treatment and get medical help immediately
- Unit equivalency: Xeomin's units cannot be compared or converted to those of any other botulinum toxin product
🔀What it interacts with▾
Several types of drugs can change how Xeomin works or increase the risk of side effects:
- Aminoglycoside antibiotics (e.g., gentamicin, tobramycin) — can amplify the toxin's muscle-blocking effect; use with caution
- Other neuromuscular blocking agents (e.g., tubocurarine-type muscle relaxants) — can intensify toxin effects; requires careful monitoring
- Anticholinergic drugs — taken after Xeomin, these can increase system-wide effects like dry mouth and blurred vision
- Other botulinum toxin products — using another botulinum toxin close in time to Xeomin may cause excessive or prolonged muscle weakness
- Muscle relaxants — using these before or after Xeomin may worsen muscle weakness
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▾
- Do not use Xeomin if you have a known allergy to any botulinum toxin product, or to human albumin or sucrose
- Do not receive Xeomin if you have an active infection at or near the planned injection site
- Tell your provider about any muscle or nerve conditions (such as myasthenia gravis, Lambert-Eaton syndrome, or ALS) — these raise the risk of severe complications
- Tell your provider if you have any trouble swallowing or breathing before starting treatment
- Pregnant patients: animal studies showed fetal harm at high doses; Xeomin should be used in pregnancy only if the benefit clearly outweighs the risk
- Breastfeeding patients: it is unknown whether Xeomin passes into breast milk — discuss with your provider before treatment
- Children: Xeomin is approved in pediatric patients for chronic sialorrhea (ages 2+) and upper limb spasticity (ages 2–17, excluding cerebral palsy); it is not approved for other uses in children
- Older adults: no significant differences in safety or effectiveness have been found, but increased sensitivity cannot be ruled out — monitoring is prudent
- Patients with previous eye surgery may have reduced corneal sensation — corneal assessment is recommended before blepharospasm treatment
🚑If you take too much▾
Too much Xeomin can cause excessive muscle weakness or paralysis, including of the breathing muscles — which can be life-threatening. Symptoms may not appear right away after the injection. If an overdose is suspected, the patient should be medically monitored for several weeks for signs of excessive muscle weakness or paralysis, and respiratory support may be required. An antitoxin is available through the CDC (call 770-488-7100), but it cannot reverse effects that have already appeared.
📡Pharmacodynamics — effects in the body▾
Xeomin blocks the release of acetylcholine at the junction between nerves and muscles (or nerves and salivary glands), temporarily reducing muscle contractions or gland secretions in the treated area. This localized effect is what reduces spasticity, uncontrolled muscle movements, excessive drooling, or facial lines in the targeted region. The body gradually forms new nerve endings over time, which is why the effect wears off and repeat treatments are needed.
🔬Pharmacokinetics — how your body processes it▾
Using current technology, Xeomin cannot be detected in the bloodstream after it is injected at recommended doses — meaning it stays localized at or near the injection site rather than circulating throughout the body in measurable amounts.
📦How to store it▾
Store unopened vials of XEOMIN at or below 25°C (77°F). Refrigeration of unopened vials is not required. stored in a refrigerator at 2°C to 8°C (36°F to 46°F) for up to 24 hours until time of use .
📄 Written from IncobotulinumtoxinA 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 IncobotulinumtoxinA Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Xeomin and how is it different from other botulinum toxin shots? ▾
How soon will I notice it working, and how long does it last? ▾
What side effects should I actually watch out for? ▾
Are there any medications I should tell my doctor about before getting Xeomin? ▾
Is it safe if I'm pregnant or breastfeeding? ▾
Can my child receive Xeomin? ▾
Is IncobotulinumtoxinA Injection available over the counter? ▾
When was IncobotulinumtoxinA Injection first available? ▾
Who makes IncobotulinumtoxinA Injection? ▾
💬 Answers drafted from IncobotulinumtoxinA 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 IncobotulinumtoxinA Injection comes
IncobotulinumtoxinA 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
How this form is used
- Xeomin intramuscular injection treats chronic sialorrhea (excessive drooling) in patients 2 years and older
- Xeomin intramuscular injection treats upper limb spasticity in adults and in children ages 2–17 (excluding spasticity caused by cerebral palsy)
- Xeomin intramuscular injection treats cervical dystonia and blepharospasm in adults
- Xeomin is injected into salivary glands (parotid and submandibular) for chronic drooling, and into specific facial or body muscles for other approved uses
- Xeomin is always administered by a trained healthcare provider — never self-injected
- Xeomin for drooling is injected into the parotid and submandibular salivary glands; ultrasound guidance is recommended for pediatric patients
- Xeomin for facial lines should not be given more frequently than every 3 months; for spasticity, no sooner than every 12 weeks; for drooling, no sooner than every 16 weeks
- Reconstituted Xeomin must be stored in a refrigerator and used within 24 hours; each vial is for one injection session and one patient only
📊 IncobotulinumtoxinA Injection across the U.S. market
How IncobotulinumtoxinA 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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely IncobotulinumtoxinA Injection is used
A general measure of how commonly IncobotulinumtoxinA Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely IncobotulinumtoxinA Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is IncobotulinumtoxinA Injection prescribed? Of the 1,596 medications we measure, IncobotulinumtoxinA Injection ranks #966 by Medicaid prescriptions — more than 39% of them.
Utilization by IncobotulinumtoxinA Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
Other IncobotulinumtoxinA Injection products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 3 of 10 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of IncobotulinumtoxinA Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 10 listed IncobotulinumtoxinA Injection NDCs with Medicaid activity.
🔍 Compare IncobotulinumtoxinA Injection products
A representative set of FDA-listed product records for IncobotulinumtoxinA 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 | ||||
| 50 [USP'U] | Intramuscular | Merz North America, Inc. × 8 listings | BLA | View NDC → |
| 100 [USP'U] | Intramuscular | Merz North America, Inc. × 4 listings | BLA | View NDC → |
| 50 [USP'U] | Intramuscular | Merz Pharmaceuticals, LLC × 10 listings | BLA | View NDC → |
| 100 [USP'U] | Intramuscular | Merz Pharmaceuticals, LLC × 10 listings | BLA | View NDC → |
| 200 [USP'U] | Intramuscular | Merz Pharmaceuticals, LLC × 5 listings | BLA | View NDC → |
Showing 37 of 37 products — FDA National Drug Code Directory. See every product, package size and price: browse all 37 IncobotulinumtoxinA Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for IncobotulinumtoxinA Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists IncobotulinumtoxinA Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How IncobotulinumtoxinA Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
📦 Supply & shortage status
Whether IncobotulinumtoxinA Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
IncobotulinumtoxinA Injection belongs to the Acetylcholine Release Inhibitor class.
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.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets 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. Merz North America, 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.