Prescription medicine
Letibotulinumtoxina Brand names: Letybo
Letibotulinumtoxina (Letybo) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the letibotulinumtoxina FDA label on DailyMed (effective November 18, 2024); every letibotulinumtoxina label on DailyMed.
Highlights of the record
FDA label of November 18, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
DISTANT SPREAD OF TOXIN EFFECT.
The effects of all botulinum toxin products, including LETYBO, may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. 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. LETYBO is not approved for the treatment of spasticity or any conditions other than glabellar lines [see Warnings and Precautions ( 5.1 )]. WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete boxed warning. The effects of all botulinum toxin products, including LETYBO, may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. 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. LETYBO is not approved for the treatment of spasticity or any conditions other than glabellar lines.
Used for
From the label: indications and usageLETYBO is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.
Forms and strengths
Injection (powder) (lyophilized) for solution.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 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
- 252 through July 30, 2026
What is letibotulinumtoxina used for?
From the label: indications and usageLETYBO is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. LETYBO is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.
FDA pharmacologic class: Acetylcholine Release Inhibitor and Neuromuscular Blocker.
Source: FDA drug label (LETYBO), Hugel, Inc., effective November 18, 2024 (SPL set 910e5d0e-4d0b-4de8-8e2d-97879a044181), via openFDA; the full label on DailyMed
Is there a generic for letibotulinumtoxina (Letybo)?
No generic letibotulinumtoxina is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for letibotulinumtoxina?
The FDA Adverse Event Reporting System holds 252 reports that list letibotulinumtoxina among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 18 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other acetylcholine release inhibitors
- the pharmacologic class, with prices and generics
- Letibotulinumtoxina side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other