ReviewAesthetic plastic surgery2021
Adverse Events Associated With Botox as Reported in a Food and Drug Administration Database.
Review in Aesthetic plastic surgery, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 32 citations in OpenAlex.
- DaxibotulinumtoxinA for Injection in Adults with Cervical Dystonia: Clinical Insights from a Real-World Early Experience Program.Movement disorders clinical practice · 2026Observational
- Management of Complications Following Botulinum Toxin Facial Injections: A Narrative Review.Cureus · 2026Review
- Monitoring complications of botulinum toxin in community practice: A pharmacological study.Bioinformation · 2026Article
- Botulinum toxin treatment in a resource-limited setting: Experiences from a public institution in a developing countryBiomedica : revista del Instituto Nacional de Salud · 2025Article
- Periocular Aging Across Populations and Esthetic Considerations: A Narrative Review.Journal of clinical medicine · 2025Review
- The Esthetic Use of Botulinum Toxins in Cancer Patients: Providing a Foundation for Future Indications.Toxins · 2025Review
- A Decade in Focus: Examining Lessons Learned From Office-Directed Injectables in an Academic Practice.Aesthetic surgery journal. Open forum · 2025Article
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- Review
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- Botulinum toxin A versus microwave thermolysis for primary axillary hyperhidrosis: A randomized controlled trial.JAAD international · 2024Article
- The Role of Botulinum Toxin Type-A in Spasticity: Research Trends from a Bibliometric Analysis.Toxins · 2024Review
- Efficacy and Safety Analysis of Botox Application and Iatrogenic Botulism: Panacea or Peril?Current pharmaceutical design · 2024Review
- The Telltale Botox: Botulinum Toxin Injection by an Expert Hand as an Intracranial Aneurysm Detector.Plastic and reconstructive surgery. Global open · 2023Article
- [New botulinum toxins for aesthetic dermatology : A comprehensive review].Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete · 2021Review
- The Need for Regulated Training and Certification for Providers Entering into Aesthetic Medicine.The Journal of clinical and aesthetic dermatologyReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBotulinum toxin treatment is the most frequently performed noninvasive cosmetic procedure performed in the USA. Because of its widespread use, an analysis of the adverse event (AE) profile of Botox injections is needed.
methodsThe FDA Adverse Event Report System was queried using an online web-based tool to determine the top 15 adverse events reported for four Botox brand names: Botox/Botox Cosmetic, Dysport, and Xeomin. The proportional reporting ratios (PRR) and relative odds ratios (ROR) were determined. A literature review was performed for eight AEs of clinical significance: eyelid/eyebrow ptosis, asthenia, muscular weakness, facial paresis, dysphagia, botulism, and death.
resultsBotox/Botox Cosmetic had 38367 AEs. Dysport had 3582 AEs. Xeomin had 1405 AEs. All drugs with reported cases of eyelid and eyebrow ptosis had significant PRR and ROR values. The PRR and ROR values for asthenia were not significant in any of the drugs and only reached significance for Dysport for muscular weakness and dysphagia. Both Botox/Botox Cosmetic and Dysport had elevated PRRs and RORs for facial paresis and botulism. While all drugs had at least one reported case of death related to Botox injection use, none of the PRR or ROR values were significant.
conclusionKnown AEs for Botox injection use include eyelid/brow ptosis and muscular weakness. Feared but rare complications of Botox injection use include dysphagia, botulism, and possibly death, owing to systemic spread of the toxin. This is the first study to analyze the AE data reported to the FDA on Botox injection use. EBM LEVEL: III.
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Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.