Last reviewed · How we verify
Botox
At a glance
| Generic name | Botox |
|---|---|
| Also known as | Botulinum Toxin Type A, Bolitinum Toxins, onabotulinumtoxinA, botulinum toxin Type A, Botulinem toxin |
| Sponsor | University of California, Irvine |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of BOTOX 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, 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 li
Common side effects
- Urinary tract infection
- Urinary retention
- Constipation
- Muscular weakness
- Dysuria
- Fall
- Gait disturbance
- Muscle spasm
- Localized pain
- Infection
- Inflammation
- Tenderness
Serious adverse events
- Syncope
- Hypotension
- Vasovagal response
- Weakness of nearby muscles
- MS exacerbation
Key clinical trials
- DaxibotulinumtoxinA Injection for Treatment of Adductor Spasmodic Dysphonia (PHASE1, PHASE2)
- Serratus Plane Block (SPB) Versus Capsaïcine Versus Botox-A for Chronic Neuropathic Pain in Post-mastectomy Syndrome (PHASE2)
- A Study to Evaluate Patient Satisfaction With the Overall Face and Neck Appearance After Combined Treatment of OnabotulinumtoxinA, JUVÉDERM® Products, KYBELLA, CoolSculpting Elite and SkinMedica Products (PHASE4)
- DaxibotulinumtoxinA for Blepharospasm (PHASE2)
- Prospective, Non-interventional Study Assessing Periorbital Rejuvenation Procedure
- A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Episodic Migraine (PHASE3)
- A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine (PHASE3)
- Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Botox CI brief — competitive landscape report
- Botox updates RSS · CI watch RSS
- University of California, Irvine portfolio CI