Botulinum Toxin Type Research Articles

12-year effectiveness and safety of botulinum toxin type A for the treatment of blepharospasm and hemifacial spasm

12-year effectiveness and safety of botulinum toxin type A for the treatment of blepharospasm and hemifacial spasm

Phase-Based Gait Prediction after Botulinum Toxin Treatment Using Deep Learning.

Gait disorders in neurological diseases are frequently associated with spasticity. Intramuscular injection of Botulinum Toxin Type A (BTX-A) can be used to treat spasticity. Providing optimal treatment with the highest possible benefit-risk ratio is a crucial consideration. This paper presents a novel approach for predicting knee and ankle kinematics after BTX-A treatment based on pre-treatment kinematics and treatment information. The proposed method is based on a Bidirectional Long Short-Term Memory (Bi-LSTM) deep learning architecture. Our study's objective is to investigate this approach's effectiveness in accurately predicting the kinematics of each phase of the gait cycle separately after BTX-A treatment. Two deep learning models are designed to incorporate categorical medical treatment data corresponding to the injected muscles: (1) within the hidden layers of the Bi-LSTM network, (2) through a gating mechanism. Since several muscles can be injected during the same session, the proposed architectures aim to model the interactions between the different treatment combinations. In this study, we conduct a comparative analysis of our prediction results with the current state of the art. The best results are obtained with the incorporation of the gating mechanism. The average prediction root mean squared error is 2.99° (R2 = 0.85) and 2.21° (R2 = 0.84) for the knee and the ankle kinematics, respectively. Our findings indicate that our approach outperforms the existing methods, yielding a significantly improved prediction accuracy.

Assessing the efficacy and quality of Life improvements of botulinum toxin type a with topical minoxidil versus topical minoxidil in male androgenetic alopecia: a randomized controlled trial.

Androgenetic alopecia (AGA) is a common type of hair loss in men and efficacy and safety of current medical treatment remain limited. Therefore, the present study aimed to investigate the efficacy and safety of botulinum toxin type A (BTA) combined with Minoxidil in patients with AGA. 60 male patients were included in this study and control group received topical 5% Minoxidil and the treatment group received BTA combined with topical 5% Minoxidil. BTA injections (60-70 U) were administered at 30-35 scalp sites. Head photographs were taken at baseline, 2nd, 4th, and 6th months. Clinical descriptions recorded scalp conditions, and patient satisfaction along with Dermatology Life Quality Index scores were documented. The treatment group (TG) showed significant hair growth differences compared to the control group (CG) at the 4th month (P < 0.001) and 6th month (P = 0.0046) post-treatment. TG had improved Investigator Global Assessment (IGA) scores in the 4th month (P = 0.0001) and 6th month (P = 0.0259) compared to CG. Patient satisfaction in TG for hair growth and scalp improvement was higher than CG (all P < 0.05). TG exhibited substantial quality of life improvement at the 4-month (P = 0.0009) and 6-month (P = 0.0099). No adverse reactions were observed post-botulinum toxin injection. BTA combined with Minoxidil effectively promotes hair growth, enhances the quality of life, and alleviates scalp symptoms in male AGA patients at 4th and 6th months, with no adverse effects compared to Minoxidil alone.Trial registration number: Ethics Committee of Shanghai Tongji Hospital (ID: K-2018-026).

The impact of electrotherapy on the quality of life of patients suffering from chronic migraine and cervicalgia

Objective. To evaluate the effect of electrotherapy on quality of life in patients with chronic migraine and neck pain. Material and methods. The study included 45 patients with chronic migraine and neck pain, divided into two groups: the first group (n=25) received treatment with transcutaneous electrical nerve stimulation (TENS), the second group (n=20) received botulinum toxin type A injections PREEMPT scheme. The results were assessed using the MIDAS, HIT-6 and NDI questionnaires before the start of treatment and one month after it began. Results. The use of electrotherapy caused a greater reduction in disability and improved quality of life compared to botulinum toxin. The data obtained indicate the high effectiveness of electrotherapy and the need for its further use in clinical practice to improve the condition of patients with chronic migraine and neck pain.

Botulinum toxin type A inhibits the formation of hypertrophic scar through the JAK2/STAT3 pathway.

Hypertrophic scar (HS) is a fibrous proliferative disorder that occurs in the dermis after skin injury. Studies have confirmed that Botulinum toxin type A (BTA) is effective in scar prevention and treatment. However, the specific mechanism remains uncertain. Hypertrophic scar fibroblasts (HSFs) and normal skin fibroblasts (NSFs) from the skin tissues of HS patients were isolated and cultured. Western blot analysis was conducted to measure the expression of JAK2/STAT3 pathway-related proteins. HSFs were treated with the JAK2 inhibitor (AG490) or agonist (C-A1). The CCK-8 assay, EdU staining, scratch-wound assay and transwell assay were used to examine the biological properties of HSFs. Western blot, immunofluorescence, and Sirius red staining were used to assess the fibrosis of HSFs. Additionally, a mouse full-thickness wound model was constructed to investigate the role of BTA in wound healing. The results showed that the JAK2 and STAT3 phosphorylation levels were markedly increased in HS tissues and HSFs. AG490 treatment reduced cell viability, proliferation and migration capacity, and inhibited the fibrosis of HSFs, whereas C-A1 treatment had the opposite effect. BTA treatment inhibited the JAK2/STAT3 pathway. BTA reduced cell viability, proliferation and migration ability, and inhibited the fibrosis of HSFs, while C-A1 intervention weakened the impact of BTA. Meanwhile, BTA promoted wound healing and reduced collagen deposition in vivo. In conclusion, BTA inhibited the JAK2/STAT3 pathway, which in turn hindered the proliferation, migration and fibrosis of HSFs, and promoted wound healing in mice.

Botulinum toxin type A injection combined with biofeedback in the treatment of spastic pelvic floor syndrome.

Spastic pelvic floor syndrome (SPFS) is a refractory pelvic floor disease characterized by abnormal (uncoordinated) contractions of the external anal sphincter and puborectalis muscle during defecation, resulting in rectal emptation and obstructive constipation. The clinical manifestations of SPFS are mainly characterized by difficult defecation, often accompanied by a sense of anal blockage and drooping. Manual defecation is usually needed during defecation. From physical examination, it is commonly observed that the patient's anal muscle tension is high, and it is difficult or even impossible to enter with his fingers. To investigate the characteristics of anorectal pressure and botulinum toxin A injection combined with biofeedback in treating pelvic floor muscle spasm syndrome. Retrospective analysis of 50 patients diagnosed with pelvic floor spasm syndrome. All patients underwent pelvic floor surface electromyography assessment, anorectal dynamics examination, botulinum toxin type A injection 100 U intramuscular injection, and two cycles of biofeedback therapy. After the botulinum toxin A injection combined with two cycles of biofeedback therapy, the patient's postoperative resting and systolic blood pressure were significantly lower than before surgery (P < 0.05). Moreover, the electromyography index of the patients in the resting stage and post-resting stages was significantly lower than before surgery (P < 0.05). Botulinum toxin A injection combined with biofeedback can significantly reduce pelvic floor muscle tension in treating pelvic floor muscle spasm syndrome. Anorectal manometry is an effective method to evaluate the efficacy of treatment objectively. However, randomized controlled trials are needed.

Clinical effect of botulinum toxin type A combined with autologous fat grafting in patients with nasolabial fold depression.

Nasolabial fold (NLF) depression can affect the facial appearance of patients to some extent and increase their psychological burdens. In recent years, autologous fat grafting (AFG) combined with botulinum toxin A (BTX-A) injection (AFG + BTX-A injection) has been gradually applied in the treatment of patients with NLF depression. Although studies have been conducted on the efficacy and safety of AFG + BTX-A injection in treating NLF depression, the experimental design, observational indicators, and sample enrollment criteria vary remarkably, making it difficult to draw convincing and consistent conclusions. Thus, further relevant research is warranted. To assess the esthetic improvement, efficacy, and safety of AFG + BTX-A injections in patients with NLF depression. This study included 60 patients with NLF depression who were treated in our hospital from February 2019 to April 2021. These patients were categorized into control (n = 30) and observation (n = 30) groups. The observation group received AFG + BTX-A injection, whereas the control group underwent AFG only. All patients were evaluated using the wrinkle severity rating scale (WSRS) and global aesthetic improvement scale. The compactness of facial contours, skin evaluation indexes, adverse reactions, and satisfaction of the two groups were evaluated 3 months postoperatively. The WSRS scores of the observation group at 1, 3, and 6 months postoperatively were lower than those of the control group (P < 0.05). Three months postoperatively, facial fine lines and pores showed obvious improvement and the skin index score was higher in the observation group than in the control group (P < 0.05). The compactness of facial contours was better in the observation group than in the control group (P < 0.05). In addition, no remarkable differences were noted in the incidence of postoperative adverse reactions such as facial stiffness, facial asymmetry, facial bruising, and facial concavity inequality (P > 0.05). AFG + BTX-A injection is a highly safe, cost-effective, effective, and long-lasting treatment for NLF depression with high esthetic value, which should be promoted in the future.

Botulinum Toxin Type A (BoNT-A) Use for Post-Stroke Spasticity: A Multicenter Study Using Natural Language Processing and Machine Learning.

We conducted a multicenter and retrospective study to describe the use of botulinum toxin type A (BoNT-A) to treat post-stroke spasticity (PSS). Data were extracted from free-text in electronic health records (EHRs) in five Spanish hospitals. We included adults diagnosed with PSS between January 2015 and December 2019, stratified into BoNT-A-treated and untreated groups. We used EHRead® technology, which incorporates natural language processing and machine learning, as well as SNOMED CT terminology. We analyzed demographic data, stroke characteristics, BoNT-A use patterns, and other treatments. We reviewed the EHRs of 1,233,929 patients and identified 2190 people with PSS with a median age of 69 years; in total, 52.1% were men, 70.7% had cardiovascular risk factors, and 63.2% had suffered an ischemic stroke. Among the PSS patients, 25.5% received BoNT-A at least once. The median time from stroke to spasticity onset was 205 days, and the time from stroke to the first BoNT-A injection was 364 days. The primary goal of BoNT-A treatment was pain control. Among the study cohort, rehabilitation was the most common non-pharmacological treatment (95.5%). Only 3.3% had recorded monitoring scales. In conclusion, a quarter of patients with PSS received BoNT-A mainly for pain relief, typically one year after the stroke. Early treatment, disease monitoring, and better data documentation in EHRs are crucial to improve PSS patients' care.

Botulinum toxin type a (BOTOX) in the management of glossopharyngeal neuralgia- A case series

Glossopharyngeal neuralgia [GPN] is a rare, debilitating neurologic condition characterized by intermittent pain radiating to the tongue, pharynx or ear that can be triggered by talking, swallowing or chewing. With an incidence of only 0.2-0.7 persons/100,000/year, the diagnosis is extremely challenging and often gets misdiagnosed and undiagnosed. Many treatment options have been tried by various clinicians in the past, such as medical therapy (antidepressants, opiods, antiepileptics, steroids, and membrane-stabilizing agents), nerve blocks with or without additives, gamma knife radiosurgery, radiofrequency ablation and microvascular decompression. Each of the aforementioned treatment modalities has its own merits and limitations. In the pursuit of delivering optimal treatment for pain relief in GPN and to improve patient's quality of life, we have explored the use of Botulinum toxin type A [BOTOX (Allegran®)]. BOTOX has been widely used in the treatment of chronic facial pain such as headaches, migraine, and trigeminal neuralgia. However, the use of BOTOX in the management of GPN has not been reported in the literature. Despite the small number of cases in our series, BOTOX therapy in GPN appears to be promising. However, further research with larger sample sizes and longer follow-up periods is needed to fully establish its efficacy and safety profile

Contouring With Neuromodulators.

Botulinum toxins, originally used for facial rejuvenation, have emerged as a promising tool for sculpting and refining contours for both the face and body. The peer-reviewed literature on neuromodulator contouring treatments was analyzed, with a particular emphasis on studies and case reports involving the use of botulinum toxin type A. Modification of face, neck, shoulder, arm, and calf contour has been reported. Treatment and dosing protocols vary with the strength and depth of the target muscle. Regional effects of neuromodulator treatment begin to appear approximately 2 weeks after injection and are often most prominent at the 70- to 90-day time point. Although treatments are generally well tolerated, short-term muscle weakness and other side effects may occur. The use of neuromodulators to enhance facial and body contours has demonstrated efficacy, but further research is needed to validate their use and explore the full potential of this intervention through larger randomized controlled trials. The application of neuromodulators as a minimally invasive tool to address the rising demand for nonsurgical body sculpting represents a promising frontier in aesthetics.

Comparing the efficacy, safety, and satisfaction for moderate to severe glabellar frown lines between abobotulinum toxin A and incobotulinum toxin A: a multicenter randomized study

Background Botulinum toxin type A is widely used to improve facial wrinkles associated with aging, and various types are available. However, the efficacy, particularly the duration of effect, varies among these types, and research on this subject is limited. This study aimed to compare the efficacy and safety of incobotulinum toxin A and abobotulinum toxin A.Methods This prospective analysis included cases of moderate to severe glabellar lines treated with either incobotulinum toxin A or abobotulinum toxin A. After a 24-week follow-up, clinical photos were taken at each visit. The severity of the glabellar lines was evaluated by three groups: the investigator, the patients, and an independent evaluator.Results The study included a total of 42 patients. When comparing the improvement rates of glabellar lines at maximum frown for both groups at the week-4 visit, which was the primary efficacy endpoint, no statistically significant difference was observed. However, the abobotulinum toxin A group demonstrated a higher improvement at the week-24 visit, as evaluated by the investigator, and this difference was statistically significant.Conclusions Overall, the abobotulinum toxin A group exhibited a higher improvement rate in the glabellar lines at the frown state. The difference in the improvement rate at the week-24 visit was 36.86%, which was statistically significant.

Neurotoxins and Combination Therapies.

Facial aging involves multilevel changes, extending from the skin to deep support structures. A comprehensive treatment approach targeting the many aspects of facial dynamics and architecture is often necessary to achieve optimal correction, prevent changes before they occur, and/or help highlight inherited features. To explore the integration of botulinum toxin type A (BoNT-A) into multimodal aesthetic treatment plans. This article reviews evidence supporting the combination of BoNT-A with other minimally invasive cosmetic therapies, including dermal fillers, lasers, and energy-based devices as well as with plastic and reconstructive surgeries for more controlled healing and improved scar cosmesis. Combination treatment protocols including BoNT-A demonstrate higher patient satisfaction and retention rates compared to monotherapy or sequential treatments. Some guidelines for sequencing of treatments exist, but evidence is scant with certain combinations. Integrating BoNT-A into a larger aesthetic treatment plan is crucial for achieving natural and satisfying results in facial rejuvenation. Evidence supports better outcomes when incorporating with both surgical and nonsurgical modalities. Understanding how to address anatomy over time through different aesthetic therapies together allows for individually tailored, more deeply impactful treatment plans.

Is Botulinum Toxin Type A Safe for Gummy Smile Treatment in Bronchial Asthma Patients? A Case Report

Background and Aim: The increasing demand for aesthetic enhancements has led to the widespread use of Botox for various facial concerns, including gummy smiles. While its efficacy in treating gummy smiles is established, the safety profile of Botox in patients with underlying medical conditions, such as asthma, remains relatively unexplored. This case report presents a patient with asthma who underwent Botox treatment to correct excessive gingival display. The study aims to demonstrate the potential of Botox for aesthetic improvement in this patient population while emphasizing the need for further research to assess its safety profile. Results: A two-week Botox treatment course successfully eliminated the patient's gummy smile without inducing any asthma-related complications or adverse effects. Conclusion: Although this case suggests the potential of Botox for treating gummy smiles in patients with asthma, it is essential to conduct larger studies to establish its safety and efficacy. A comprehensive medical evaluation is crucial before considering Botox treatment for individuals with underlying health conditions.

Temporary Delayed Hypersensitivity Reaction to Botulinum Toxin-A After COVID-19 Vaccination: A Case Series.

The occurrence of a hypersensitivity reaction with the injection of botulinum toxin type A (BTX-A) in cosmetic use is a rare complication. We report the largest case series of temporary delayed hypersensitivity reaction (DHR) with BTX-A following COVID-19 vaccination and the first cases to incobotulinum toxin A (incoBTX-A). A retrospective multicentric case series of patients who developed a DHR to BTX-A after COVID-19 vaccination. Twelve patients were treated with BTX-A injections for the management of facial rhytids. The age range was between 29 and 45years. Ten (83.3%) were female. Ten (83.3%) patients received incoBTX-A, and two received onabotulinum toxin A (onaBTX-A). All patients had COVID-19 vaccination (mRNA vaccine) between 1 and 7months before. Within an average time of 24h after BTX-A injection, all patients developed progressive facial swelling and erythema that were more prominent at the injection points. Intradermal allergic tests to BTX-A were performed in six (50%) patients, and the results were all negative. Adequate clinical control was achieved with systemic corticosteroids and antihistamines. After 1year with no further vaccination, a new BTX-A treatment (provocation test) was performed in all patients with no secondary effects. Previous COVID-19 vaccination and the absence of new adverse events with further BTX-A injections suggest a temporary DHR. Clinicians should be aware of the importance of immunization history and its potential post-vaccine immunogenic effects with BTX-A. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

IncobotulinumtoxinA for Aesthetic Treatments: Review and Recommendations From Latin America.

As new aesthetic treatment techniques are developed, the understanding of botulinum toxin type A safety and treatment outcomes continues to evolve. This article was developed to provide a comprehensive up-to-date reference for clinicians using incobotulinumtoxinA (INCO; Xeomin/Bocouture, Merz Pharmaceuticals GmbH, Frankfurt, Germany) for aesthetic treatments. A Latin American panel of 11 physicians was assembled to discuss and develop recommendations on the use of INCO for aesthetic treatment based on the literature review and their private medical practice. The panel found that INCO is a highly purified botulinum toxin, without other clostridial proteins (hemagglutinins and nonhemagglutinins). IncobotulinumtoxinA has proven its efficacy and duration over time, maintaining response after multiple treatment cycles. This recommendation provides up-to-date information on the use of INCO for aesthetic treatment, focusing on the differential properties of this product regarding its purity, performance, customization, and patient satisfaction.

Botulinum toxin combined with static progressive stretching improves fibrous stiffness of knee joint in rats through TGF-β1/Smad pathway.

Joint stiffness and fibrosis are common complications that affect mobility and quality of life, necessitating effective therapeutic strategies to alleviate these issues. The study aimed to observe the therapeutic effect of static progressive stretching (SPS) combined with botulinum toxin type A (BTX-A) on knee joint stiffness in rats and its effect on the transforming growth factor beta 1 (TGF-β1)/small mother against decapentaplegic (Smad) pathway in the development of joint capsule fibrosis. Forty Sprague Dawley rats were randomly divided into the blank control group, model control group, SPS intervention group, BTX-A intervention group, and SPS combined with BTX-A intervention group. Except for the blank control group, the right knee joints of the other rats were surgically fixed with Kirschner wire internal immobilization in full flexion for four weeks to form joint flexion contracture and cause fibrotic stiffness of the joint. The therapeutic effect of each intervention was assessed by the range of motion (ROM) of the knee joint, joint stiffness, the number of total cells, and collagen deposition in the posterior joint capsule, as well as the protein level expressions of TGF-β1, Smad2, Smad3, Smad4, p-Smad2/3, collagen I and III, and alpha smooth muscle actin (α-SMA) in the posterior joint capsule in the TGF-β1/Smad pathway. SPS combined with BTX-A was more effective in relieving joint fibrosis stiffness, improving the histopathological changes in the posterior joint capsule, and suppressing the high expression of target proteins and the overactivated TGF-β1/Smad pathway. The overactivated TGF-β1/Smad pathway was involved in the formation of knee joint fibrosis stiffness in rats. SPS combined with BTX-A was effective in relieving joint flexion contracture and fibrosis of the joint capsule. Moreover, the inhibition of the overactivated TGF-β1/Smad pathway may be the potential molecular mechanism for its therapeutic effect.

A preliminary study on ultrasound techniques applied to evaluate the curative effect of botulinum toxin type a in hypertrophic scars

ObjectiveTo validate the feasibility of ultrasound in assessing the curative effect of botulinum toxin type A (BTXA) in treating hypertrophic scar (HS). MethodsEight healthy New Zealand long-eared rabbits were utilized in the study. Four wounds, each measuring 1.0 cm in diameter, were created on both ears of each rabbit. Immediately after surgery, each of these wounds received an injection containing a distinct concentration of BTXA. On postoperative week 6, scar thickness, vascularity, and hardness were assessed based on high frequency ultrasound (HFUS), superb microvascular imaging (SMI), shear wave elastography (SWE), Masson staining, and immunohistochemical staining for CD31. ResultsAll wounds healed well, and HSs formed after 6 weeks post-surgery. Scar thickness based on HFUS presented a significant decrease with increasing BTXA concentration (p < 0.05), aligning with the gross morphology. Simultaneously, scar stiffness, evaluated using SWE, showed a significant decrease in accordance with the variation of the collagen volume fraction, which refers to the ratio of the collagen positive area to the total area (p < 0.05). Although the vascularity index obtained by SMI did not exhibit a statistically significant change across different BTXA concentrations, this technique effectively illustrated the microvascular perfusion in HS. Immunohistochemical staining for CD31 revealed that BTXA inhibited angiogenesis. ConclusionHFUS and SWE displayed excellent performance in evaluating HS thickness and stiffness. SMI showed a good performance in reflecting microvascular signals in HS. These ultrasound techniques have great potential in assessing the therapeutic effect of BTXA in HS.

Comparison between botulinum toxin type A injection on masseter muscle only and additional injection on anterior belly of digastric muscle in sleep bruxism patients: A clinical trial.

This study aims to evaluate the effects on bite force and muscle thickness of the botulinum toxin (BoNT) injection for patients with sleep bruxism (SB) by comparing injections into the masseter muscle only and both the masseter and the anterior belly of the digastric muscle (ABDM) in a clinical trial. Twelve SB patients received BoNT-A injections using US-guided techniques into the masseter muscle only (Group A), while the remaining 12 SB patients received injections into both the masseter and ABDM (Group B). Bite force and muscle thickness were measured before injection, as well as 1 and 2 months after injection. The bite force and masseter muscle thickness decreased in both Group A and Group B before injection, and at 1 and 2 months after injection. However, there was no significant difference (p > .05, repeated measures analysis of variance) between the two groups, and there was also no significant difference in ABDM thickness (p > .05, repeated measures analysis of variance). This study is the first to assess the short-term effects of BoNT injected into ABDM for SB control. Results show no influence on SB reduction, suggesting the need for further research on BoNT's effectiveness in controlling intense ABDM contractions during sleep and assessing suprahyoid muscle potential impact on rhythmic masticatory muscle activity occurrence.

Neuromodulators in Men.

Botulinum toxin treatment is gaining popularity among men for cosmetic purposes driven by workplace competition and a desire for confidence and youthfulness. Because of the unique features of male facial anatomy, careful consideration is necessary during assessment and treatment execution. The peer-reviewed literature on male facial anatomy in relation to neuromodulator treatment was analyzed with a particular emphasis on studies involving male subjects and the use of botulinum toxin type A. Anatomic differences in muscle mass and contraction patterns between men and women help guide treatment. Men appear to require higher doses for effective treatment of facial wrinkles and, in the case of glabellar lines, often require double the standard dose for women. Treatment of the frontalis muscle in men, responsible for forehead creases, requires precise dosage and placement to avoid brow ptosis. The lateral canthal wrinkles are often the first area that men seek consultation for. Although FDA approval for lower face regions is lacking, off-label use can still be considered. Successful botulinum toxin treatment in men necessitates understanding facial anatomy, customized treatment plans, and appropriate dosing. Further research is warranted to refine protocols and enhance outcomes for male patients.

Adverse events related to botulinum toxin type A, reported in Brazil between 2019 and 2022

The International Society of Aesthetic Plastic Surgery estimates that 18,857,311 non-invasive aesthetic procedures were carried out worldwide in 2022. This represents an increase of 7.2% compared to 2021 and 57.8% compared to 2018. Brazil is the second country in the world, just behind the United States, in the number of aesthetic procedures, with 3,020,552. Of these, 971,294 were non-invasive, with the administration of botulinum toxin, at 433,263, being the most frequent procedure. In aesthetics, it is used for the treatment of facial asymmetries, expression lines, hyperhidrosis in the hands, feet, armpits, face, and inguinal region, and in the treatment of gummy smile, attenuation of forehead wrinkles, perioral wrinkles, mental creases, glabellar lines, periorbital wrinkles, nasal wrinkles, wrinkles found on the décolletage, nasal tip stabilization, drooping lips, eyebrow lifting, and platysma bands. The most common adverse reactions associated with the use of botulinum toxin are burning, pain, swelling, irritation at the application sites, hypersensitivity, anaphylaxis in extreme cases, blurred vision, dry mouth, rarely respiratory failure, and muscle weakness. The objective of the study was to describe the adverse events (AEs) reported in the Vigimed system between 2019 and 2022. In the period analyzed, only 50 possible AEs were reported, with the female gender and the age group of 18 to 44 years being the most frequent. The pharmaceutical industry was responsible for 82% of the notifications analyzed, however, when evaluating the reporting professional, it was observed that pharmacists reported in only 8% of the cases. When evaluating the most reported AEs, swelling and pain were the most frequent, at 30% and 24% respectively. The underreporting of these events and the need for public and private incentives to raise awareness among health professionals and users about the need for identification and reporting of AEs is clear.