What the label lists and what reports show
Letibotulinumtoxina side effects
Letibotulinumtoxina's FDA label: “The most common adverse reaction is headache (2%).” FAERS holds 252 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is therapy non-responder (111 reports).
- No generic listed
- Boxed warning
Check it at the source: the letibotulinumtoxina FDA label on DailyMed (effective November 18, 2024); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reaction is headache (2%).
Table 2: Adverse Reactions Reported in More Than One Subject in the LETYBO Group Compared to the Placebo Group in BLESS I, II and III
| Reaction | Adverse Reaction LETYBO BLESS I, II, III N=911 n (%) | Treatment PLACEBO BLESS I, II, III N=310 n (%) |
|---|---|---|
| Headache | 17 (2%) | 2 (1%) |
| Brow ptosis | 3 (<1%) | 0 |
| Eyelid ptosis | 3 (<1%) | 0 |
| Blepharospasm | 2 (<1%) | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are discussed in greater detail in other sections of the labeling: Spread of Toxin Effects [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.4 )] Cardiovascular System Adverse Reactions [see Warnings and Precautions ( 5.5 )] Increased Neuromuscular Compromise in Patients with Pre-Existing Neuromuscular Disorders [see Warnings and Precautions ( 5.6 )] Dysphagia and Dyspnea [see Warnings and Precautions ( 5.7 )] Ophthalmic Adverse Reactions in Patients Treated for Glabellar Lines [see Warnings and Precautions ( 5.9 )] The most common adverse reaction is headache (2%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact HUGEL at 1‑888-674-5355 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. …
Source: FDA drug label, Hugel, Inc., effective November 18, 2024 (SPL set 910e5d0e-4d0b-4de8-8e2d-97879a044181), via openFDA; the full label on DailyMed
What do FAERS reports show?
252 reports list letibotulinumtoxina among the medicines taken, 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. Of the 22 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Letibotulinumtoxina: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions