Prescription medicine
Botulinum toxin type a Brand names: Xeomin, Botox, Dysport, Jeuveau, Daxxify
Botulinum toxin type a (Botox) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the botulinum toxin type a FDA label on DailyMed (effective July 10, 2026); every botulinum toxin type a label on DailyMed.
Highlights of the record
FDA label of July 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
DISTANT SPREAD OF TOXIN EFFECT.
Postmarketing reports indicate that the effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including lower limb spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses [see Warnings and Precautions (5.1) ]. WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete boxed warning. The effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. […]
Used for
From the label: indications and usageXEOMIN is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the treatment or improvement of: Chronic sialorrhea in patients 2 years of age and older ( 1.1 ) Upper limb spasticity in patients 2 years of age and older ( 1.2 ) Cervical dystonia in adults ( 1.3 ) Blepharospasm in adults ( 1.4 ) the appearance of upper facial lines in adults: moderate to severe glabellar lines associated wi
Forms and strengths
- 1.2ml
Injection (powder) (lyophilized) for solution; powder.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 8 of which 0 under generic applications, 8 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 97,018 through July 30, 2026
What is botulinum toxin type a used for?
From the label: indications and usageXEOMIN is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the treatment or improvement of: Chronic sialorrhea in patients 2 years of age and older ( 1.1 ) Upper limb spasticity in patients 2 years of age and older ( 1.2 ) Cervical dystonia in adults ( 1.3 ) Blepharospasm in adults ( 1.4 ) the appearance of upper facial lines in adults: moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity ( 1.5 ) moderate to severe horizontal forehead lines associated with frontalis muscle activity ( 1.5 ) moderate to severe lateral canthal lines associated with orbicularis oculi muscle activity ( 1.5 ) 1.1 Chronic Sialorrhea XEOMIN […]
Conditions named in the indications of botulinum toxin type a's FDA labels, with every medicine labeled for each:
From other botulinum toxin type a labelsMuscle spasms and spasticity: Upper Limb Spasticity XEOMIN is indicated for the treatment of upper limb spasticity in patients 2 years of age and older.
Migraine: Prophylaxis of episodic migraine (14 headache days or fewer per month) ( 1.3 ) Treatment of hyperhidrosis in body areas other than axillary
Overactive bladder: Adult Bladder Dysfunction Overactive Bladder BOTOX for injection is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are …
FDA pharmacologic class: Acetylcholine Release Inhibitor and Neuromuscular Blocker.
Source: FDA drug label (Xeomin), Merz Pharmaceuticals, LLC, effective July 10, 2026 (SPL set ccdc3aae-6e2d-4cd0-a51c-8375bfee9458), via openFDA; the full label on DailyMed
What does the patient leaflet for botulinum toxin type a say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about XEOMIN?XEOMIN may cause serious side effects that can be life-threatening. Call your healthcare provider or get medical help right away if you have any of these problems after treatment with XEOMIN: Problems with swallowing, speaking, or breathing. These problems can happen hours to weeks after an injection of XEOMIN if the muscles that you use to breathe and swallow become weak after the injection. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with XEOMIN. People with certain breathing problems may need to use muscles in their neck to help them breathe. These people may be at greater risk for serious breathing problems with XEOMIN. Swallowing problems may last for several months. People who cannot swallow well may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving XEOMIN have the highest risk of getting these problems. Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include: loss of strength and muscle weakness all over the body double vision blurred vision and drooping eyelids hoarseness or change or loss of voice trouble saying words clearly loss of bladder control trouble breathing trouble swallowing These symptoms can happen hours to weeks after you receive an injection of XEOMIN. These problems could make it unsafe for you to drive a car or do other dangerous activities. […]
From the patient leaflet: What should I avoid while taking XEOMIN?XEOMIN may cause loss of strength or general muscle weakness, blurred vision, or drooping eyelids within hours to weeks of taking XEOMIN. If this happens, do not drive a car, operate machinery, or do other dangerous activities. See " What is the most important information I should know about XEOMIN? " What are the possible side effects of XEOMIN? XEOMIN may cause serious side effects, including: See " What is the most important information I should know about XEOMIN? " Injury to the cornea (the clear front surface of the eye) in people treated for blepharospasm. People who receive XEOMIN to treat spasm of the eyelid may have reduced blinking that can cause a sore on their cornea or other problems of the cornea. Call your healthcare provider or get medical care right away if you have eye pain or irritation after treatment with XEOMIN. […]
Source: FDA drug label (Xeomin), Merz Pharmaceuticals, LLC, effective July 10, 2026 (SPL set ccdc3aae-6e2d-4cd0-a51c-8375bfee9458), via openFDA; the full label on DailyMed
Is there a generic for botulinum toxin type a (Botox)?
No generic botulinum toxin type a is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the botulinum toxin type a label say about other medicines?
The botulinum toxin type a label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Lidocaine | warnings and precautions | One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent, and consequently the causal agent cannot be reliably determined. |
Source: FDA drug label (Xeomin), Merz Pharmaceuticals, LLC, effective July 10, 2026 (SPL set ccdc3aae-6e2d-4cd0-a51c-8375bfee9458), via openFDA; the full label on DailyMed
What do FAERS reports show for botulinum toxin type a?
The FDA Adverse Event Reporting System holds 97,018 reports that list botulinum toxin type a among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,022 are coded as a death and 7,448 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as botulinum toxin type a?
2 other medicines are given the same way (intramuscular) and in the same FDA class as botulinum toxin type a or labeled mainly for the same use (muscle spasms and spasticity), the same class first. Muscle spasms and spasticity lists all 12 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intramuscular) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Methocarbamol | Muscle spasms and spasticity | 10 labelers | n/a | No current entry |
| Orphenadrine | Muscle spasms and spasticity | 3 labelers | $6.40 per mL 60 mg/2 mL vial | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does botulinum toxin type a compare with medicines for the same use?
1 side-by-side page set botulinum toxin type a beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other acetylcholine release inhibitors
- the pharmacologic class, with prices and generics
- Botulinum toxin type a side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other